Method for detection and treatment of sexually transmitted infections

Abstract

The present disclosure provides methods for detection, devices, and methods for using the device in treatment and eradication of STIs. For instance, the present disclosure provides the use of multiple capture and / or detection epitopes that can be utilized simultaneously in order to amplify the detection signal for identification of an STI.

Description

METHOD FOR DETECTION AND TREATMENT OF SEXUALLY TRANSMITTED INFECTIONSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application Serial No. 63 / 516,363, filed on July 28, 2023, the entire disclosure of which is incorporated herein by reference.INCORPORATION BY REFERENCES OF MATERIAL SUBMITTED ELECTRONICALLY

[0002] Incorporated by reference in its entirety is a computer-readable nucleotide / amino acid sequence listing submitted concurrently herewith and identified as follows: 17 kilobyte .xml file named “67635-410981_SEQUENCES”, created on July 25, 2024.BACKGROUND and SUMMARY

[0003] Sexually transmitted infections (STIs) continue to be a global concern, leading to acute illness, infertility, long term disability and death, as well as severe medical and psychological consequences for millions of men, women, and infants. For instance, STIs such as syphilis, gonorrhoea, chlamydia, and trichomoniasis have all increased in incidence over the past twenty years.

[0004] In particular, Trichomoniasis (trich) continues to affect both men and women worldwide. Trich is a STI caused by the Trichomonas vaginalis (Tv) protozoan parasite and can be readily cured with existing anti-protozoal medications, such as metronidazole and for refractory cases by tinidazole. Trich is human-specific and the most common, non- viral curable STI worldwide. For the majority of patients infected with Tv parasite, the trich disease is asymptomatic but damages epithelial tissue in the patint. Adverse health outcomes among trich patients are numerous and include maternal and perinatal morbidity and mortality, ectopic pregnancy, pelvic inflammatory disease, adverse birth outcomes, congenital infections, cervical cancer, and increasing seroconversion to human immunodeficiency virus (HIV). More recently, experimental evidence indicates a relation between trich and prostate cancer.

[0005] Epidemiological studies indicate that there is a need for a rapid, inexpensive and accurate test with high sensitivity and specificity for detection of Tv proteins in patients.Although an antigen-detection test (the OSOM® Tv Test) is commercially available, the test has several shortcomings. For instance, tt does not detect protein in male patient secretions, such asurine, and is therefore a test exclusively for female patients. It also suffers from highly variable intensity of signal, which can give ambiguous results.

[0006] Furthermore, although nucleic acid amplification tests (NAATs) or polymerase chain reaction (PCR) tests for both men and women exist, these tests do not fulfil the World Health Organization ASSURED criteria for POC tests, especially for low-resource environments. The ASSURED criteria refer to Affordability, Sensitive, Specific, User-friendly, Rapid, Equipment-free, and Deliverable regardless of environmental conditions. Increased availability of rapid and reliable detection offers the opportunity to increase treatment, reduce transmission, and improve individual and collective human life through surveillance of large at- risk populations for STI such as trich.

[0007] Therefore, there exists a need for new compositions and methods for rapid and effective diagnosis of STI. Accordingly, the present disclosure provides methods for detection, devices, and methods for using the device in treatment and eradication of STIs. For instance, the present disclosure provides the use of multiple capture and / or detection epitopes that can be utilized simultaneously in order to amplify the detection signal for identification of an STI.

[0008] The methods and devices of the present disclosure provide several benefits compared to the current state of the art. For example, multiple types of samples can be utilized for the described methods, including detection of proteins in vaginal swabs and urine of female patients and in urine of male patients. Further, utilizing highly specific MAbs that react with epitope amino acid sequences that are specific to the proteins of interest provides unambiguous results for both the capture of the protein and for the detection of the protein with detection (e.g., gold-conjugated) MAbs. Finally, the described methods and devices fulfill the World Health Organization ASSURED criteria of a) affordability, b) sensitivity, c) specificity, d) rapid results within minutes, e) no equipment and trained personnel are required, and f) is deliverable to all environments, especially low-resource environments worldwide.

[0009] Other objects, features and advantages of the present disclosure will become apparent from the following detailed description. It should be understood, however, that the detailed description and the specific examples, while indicating specific embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.BRIEF DESCRIPTIONS OF THE DRAWINGS

[0010] The detailed description particularly refers to the accompanying figures in which:

[0011] FIGURE 1 shows an exemplary embodiment for capture of an T. vaginalis protein antigen from a patient sample by an immobilized monoclonal antibody (MAb) (labeled Yi) immobilized onto nitrocellulose membrane on an exemplary Vertical Flow Technology test platform. The MAb Y i is reactive with an epitope comprised of a specific amino acid sequence unique to the T. vaginalis protein of interest. A vaginal swab of a patient with STI is obtained and immersed in buffer consisting of phosphate-buffered saline (PBS) with Triton X-100 detergent or, alternatively, a sample of urine mixed with PBS-Triton X-100. The buffered sample with the T. vaginalis protein binds to the capture MAb Y i , and the solution is added to the to the test well. Excess buffer flows through the membrane after which is added a solution containing gold-conjugated MAb (colored red) that is to an epitope of the captured T. vaginalis protein distinct from the epitope detected by MAb Y i . The gold-MAb complex yields a color indicative of a positive, current T. vaginalis infection.

[0012] FIGURE 2 depicts the Vertical Flow Technology platform for immobilizing the primary MAb Y i onto the nitrocellulose-reactive membrane. The primary MAb can capture the target T. vaginalis protein obtained from a vaginal swab of female patients and of urine samples from either females or males. A vertical control line (labeled C) is included for capturing excess gold-conjugated secondary MAbs to different epitopes of the captured protein antigen. The test (T) dot shows a positive reaction of gold-conjugated secondary MAbs that can detect epitopes different from MAb Y i of the bound protein.

[0013] FIGURE 3 illustrates amplification of captured protein antigen detection using multiple, combined gold-conjugated MAbs (colored yellow, red, blue and green) to epitopes different from MAb Yi. The net effect is (1) to increase the intensity of color of the detected T. vaginalis captured protein and (2) to produce a positive signal in less time than that developed using a single MAb for detection.

[0014] FIGURE 4 shows the ability of the monomeric metabolic enzymes to form multiples of the monomer, e.g., dimers, tetramers, and octamers. Of note, the MAbs used for capture and detection of the enzyme protein antigens are specific to epitope amino acid sequences that are unique to the infectious proteins. This circumvents non-specific binding of similar proteins of other microorganisms and / or humans that may be immune-cross-reactive with the infectious proteins (e.g., T. vaginalis proteins). For instance, this can demonstrate the percent specificity of the diagnostic test for this STI of interest (e.g., T. vaginalis).

[0015] FIGURE 5 shows the further amplification of detection signal for any combination of bound monomers, dimers, tetramers, and / or octamers of multiple trichomonad protein antigens immobilized onto the test nitrocellulose membrane to be detected by the T. vaginalis protein capture diagnostic. In this configuration, the test can incorporate combinations of T. vaginalis proteins or all of the T. vaginalis proteins together. Further, multiple gold-MAbs to epitopes unique to each T. vaginalis protein and to epitopes different from the capture MAb will readily detect the captured T. vaginalis protein. The use of multiple captured T. vaginalis proteins on nitrocellulose in combination with the numerous MAbs to each of the T. vaginalis proteins will significantly increase the intensity of signal and decrease the delay before signal visibility using vaginal swabs and / or urine of patients with this T. vaginalis STI.

[0016] FIGURE 6 further illustrates signal amplification effect to enhance detection using multiple gold-conjugated MAbs to different epitopes of monomeric, dimeric, tetrameric, and octameric proteins after capture protein is immobilized on platform membrane.DETAILED DESCRIPTION

[0017] The methods, compositions, and devices of the present disclosure employ combinations of monoclonal antibodies (MAbs) to different epitopes for both capture and detection of the target proteins. For instance, various Trichomonas vaginalis-s^ocific target proteins can be utilized for detecting an infection in a human subject. In certain embodiments, Trichomonas vaginalis-spedfic target proteins include decarboxylating malic enzyme (also known as AP65), a-actinin, a-enolase, glyceraldehyde-6-phosphate dehydrogenase (GAPDH), and fructose- 1,6-bisphosphate aldolase. An exemplary platform for illustration and testing of this method is Vertical Flow Technology.

[0018] A target protein contained in a sample can be captured by a single immobilized MAb or by multiple immobilized MAbs. Thereafter, one or more detection MAbs can bind to one or more additional amino acid sequences of the target proteins. The detection MAb can bind to the same amino acid sequence that is captured by the immobilized MAb but at a location that is different than the sequence captured by the immobilized MAb. Alternatively, one or more different target proteins can be bound by the detection MAb (i.e., target proteins that are not captured by the immobilized MAb). For instance, multiple detection MAbs can bind to one or more epitopes of a target protein that is bound to an immobilized MAb. Amplification is achieved when multiple detection MAbs bind to a target protein, and multiple instances and types of proteins can be captured for each organism in a sample.Advantageously, signal amplification can be increased via multiple detection epitopes on a bound multimeric target protein. In contrast, poorer amplification is achieved using other methods such as NAAT amplification of nucleic acid antigens using non- ASSURED compliant equipment and use of silver halide photography to amplify single epitope outputs.

[0019] In a specific embodiment, a vaginal swab sample of a T. vaginalis-positive patient will have trichomonad proteins present. The protein(s) on the swab are solubilized in buffer, followed by application of protein-containing buffer to the membrane with immobilized MAbs. One or more immobilized MAbs bind the trichomonad target protein(s) onto the membrane. The bound target protein is then detected one or more detection MAbs (e.g., gold- conjugated MAbs) to at least one epitope of the captured target protein distinct from the capture epitope. The availability of MAbs to different epitopes permits optimization of immobilization of one MAb onto the membrane for capturing the patient T. vaginalis target protein. The T. vaginalis target protein is then detected by one or several different gold-conjugated detection MAbs that recognize distinct epitopes from the captured MAb epitope.

[0020] The following tables list various MAbs that have been generated to Trichomonas vaginalis -specific target proteins. All MAbs are of the IgGl isotype and were generated using techniques known to the skilled artisan. The various MAbs detect distinct epitope amino acid sequences as noted below.

[0021] For example, Table 1 below identifies three different MAbs to the AP65 protein (i.e., DM116, 12G4, and Fll-1). Each MAb is specific to a different epitope amino acid sequence within the AP65 protein. Therefore, any single MAb can be used as an immobilized MAb to capture a the AP65 target protein. The other MAbs (e.g., 12G4, Fll-1, or both) can be used as a detection MAb to detect the captured AP65 target protein. Likewise, the 12G4 MAb or the Fll-1 MAb can be used as an immobilized MAb to capture the AP65 target protein and the other two MAbs can function as detection MAbs (e.g., as gold-conjugated MAbs).

[0022] The concept described in the exemplary paragraph above is equally pertinent to the MAbs for capture of the different proteins of a-actinin, a-enolase, GAPDH, and aldolase as described herein. Further, as described herein, the MAbs used for capture and detection of the enzyme protein antigens can be to epitope amino acid sequences that are unique to the target proteins of interest. This will avoid non-specific binding of similar proteins of other microorganisms and / or humans that may be immune cross-reactive with the target proteins of interest, demonstrating the high specificity of the diagnostic tests for STIs described herein.Table 1. Listing of MAbs generated to AP65 and their associated epitope.Table 2. Listing of MAbs generated to a-actinin and their associated epitope.Table 3. Listing of MAbs generated to a-enolase and their associated epitope.Table 4. Listing of MAbs generated to GAPDH and their associated epitope.Table 5. Listing of MAbs generated to aldolase and their associated epitope.

[0023] The disclosures of U.S. Patent Application Publication No. 2016 / 0041169, U.S. Patent Application Publication No. 2019 / 0154689, and U.S. Patent Application Publication No. 2023 / 0080865 are incorporated herein by reference in their entirety, including the descriptions of sequences contained therein.

[0024] Various embodiments of the invention are described herein as follows. In an illustrative aspect, a method to detect an infection in a human subject is provided. The method comprises the steps of collecting a sample from the human subject; exposing the sample to a membrane configured with one or more immobilized monoclonal antibodies (MAbs) to one or more target proteins; capturing one or more of the one or more target proteins via at least one of the immobilized MAbs; and detecting one or more additional amino acid sequences of the target proteins using one or more detection MAbs, wherein the one or more detection MAbs provide a signal indicative of the one or more target proteins.

[0025] In an embodiment, the infection is a sexually-transmitted infection (STI). In an embodiment, the infection is a vaginal disorder. In an embodiment, the infection is vulvovaginal candidiasis (VVC). In an embodiment, the infection is bacterial vaginosis (BV). In an embodiment, the infection is syphilis. In an embodiment, the infection is a Chlamydia trachomatis infection. In an embodiment, the infection is a Neisseria gonorrhoeae.

[0026] In an embodiment, the infection is a Treponema pallidum. In an embodiment, the infection is a Treponema pallidum sp. pallidum infection. In an embodiment, the infection is a Treponema pallidum sp. pertenue infection. In an embodiment, the infection is aTreponema pallidum sp. carateum infection. In an embodiment, the infection is a Treponema pallidum sp. endemicum infection. In an embodiment, the infection is a Trichomonas vaginalis infection.

[0027] In an embodiment, the sample is a vaginal swab. In an embodiment, the sample is urine. In an embodiment, the sample is blood. In an embodiment, the sample is serum. In an embodiment, the sample is plasma. In an embodiment, the sample is vaginal mucosa. In an embodiment, the sample is cervicovaginal fluid. In an embodiment, the sample is saliva.

[0028] In an embodiment, the membrane comprises nitrocellulose. In an embodiment, the membrane comprises polyvinylidene difluoride. In an embodiment, the membrane is configured on a lateral flow assay. In an embodiment, the membrane is configured on a capillary flow matrix. In an embodiment, the membrane is configured on a microfluidic system.

[0029] In an embodiment, the one or more immobilized MAbs comprise two different immobilized MAbs. In an embodiment, the one or more immobilized MAbs comprise three different immobilized MAbs. In an embodiment, the one or more immobilized MAbs comprise four different immobilized MAbs. In an embodiment, the one or more immobilized MAbs comprise five different immobilized MAbs.

[0030] In an embodiment, the one or more immobilized MAbs are selected from the group consisting of Al DM116, A2 12G4, A3 Fl 1-1, A4 C55, B 1 HA423, B267B, B3 74B, B4 15B, B5 68B, Cl B44, C2 ALD11, C3 ALD25, C4 ALD55, C5 ALD12, DI B43, D2 ALD30, D3 ALD32, El ALD13, E2 ALD55, and E3 ALD12.

[0031] In an embodiment, the one or more immobilized MAbs is Al DM116. In an embodiment, the one or more immobilized MAbs is A2 12G4. In an embodiment, the one or more immobilized MAbs is A3 Fl 1-1. In an embodiment, the one or more immobilized MAbs is A4 C55.

[0032] In an embodiment, the one or more immobilized MAbs is Bl HA423. In an embodiment, the one or more immobilized MAbs is B2 67B. In an embodiment, the one or more immobilized MAbs is B3 74B. In an embodiment, the one or more immobilized MAbs is B4 15B. In an embodiment, the one or more immobilized MAbs is B5 68B.

[0033] In an embodiment, the one or more immobilized MAbs is Cl B44. In an embodiment, the one or more immobilized MAbs is C2 ALD 11. In an embodiment, the one or more immobilized MAbs is C3 ALD25. In an embodiment, the one or more immobilized MAbs is C4 ALD55. In an embodiment, the one or more immobilized MAbs is C5 ALD12.

[0034] In an embodiment, the one or more immobilized MAbs is DI B43. In an embodiment, the one or more immobilized MAbs is D2 ALD30. In an embodiment, the one or more immobilized MAbs is D3 ALD32.

[0035] In an embodiment, the one or more immobilized MAbs is El ALD13. In an embodiment, the one or more immobilized MAbs is E2 ALD55. In an embodiment, the one or more immobilized MAbs is E3 ALD12.

[0036] In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 1. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 2. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 3. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 4. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 5. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 6. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 7. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 8. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 9. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 10. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 11. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 12. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 13. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 14. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 15. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 16. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 17. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 18. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 19.

[0037] In an embodiment, the target protein is a Trichomonas vaginalis-s^&ctfC. In an embodiment, the Trichomonas vagmalis-s^&cfic protein is selected from the group consisting of AP65, a-ac tinin, a-enolase, GAPDH, aldolase, and any combination thereof. In an embodiment, the Trichomonas va a / A-specific protein is decarboxylating malic enzyme (AP65). In an embodiment, the Trichomonas vaginalis-specific protein is a-actinin. In an embodiment, the Trichomonas vaginalis-specific protein is a-enolase. In an embodiment, the Trichomonas vaginal tv-specific protein is glyceraldehyde-6-phosphate dehydrogenase (GAPDH). In an embodiment, the Trichomonas vaginalis-specific protein is fructose- 1,6- bisphosphate aldolase.

[0038] In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 1. In an embodiment, the Trichomonas vagma / zs-specific protein comprises SEQ ID NO: 2. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 3. In an embodiment, the Trichomonas vag aZA-specific protein comprises SEQ ID NO: 4. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 5. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 6. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 7. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 8. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 9. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 10. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 11. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 12. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 13. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 14. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 15. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 16. In an embodiment, the Trichomonas vaginalis-spec fic protein comprises SEQ ID NO: 17. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 18. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 19.

[0039] In an embodiment, the Trichomonas vaginalis-specific protein is in an oligomeric state selected from the group consisting of monomer, dimer, tetramer, octamer, and any combination thereof. In an embodiment, the Trichomonas vaginalis-specific protein is of an oligomeric state comprising a monomer. In an embodiment, the Trichomonas vaginalis- specific protein is of an oligomeric state comprising a dimer. In an embodiment, the Trichomonas vaginalis-specific protein is of an oligomeric state comprising a tetramer. In an embodiment, the Trichomonas vaginalis-specific protein is of an oligomeric state comprising an octamer.

[0040] In an embodiment, the one or more detection MAbs are selected from the group consisting of Al DM116, A2 12G4, A3 Fll-1, A4 C55, Bl HA423, B2 67B, B3 74B, B4 15B, B5 68B, Cl B44, C2 ALD11, C3 ALD25, C4 ALD55, C5 ALD12, DI B43, D2 ALD30, D3 ALD32, El ALD13, E2 ALD55, and E3 ALD12.

[0041] In an embodiment, the one or more detection MAbs is Al DM116. In an embodiment, the one or more detection MAbs is A2 12G4. In an embodiment, the one or more detection MAbs is A3 Fll-1. In an embodiment, the one or more detection MAbs is A4 C55.

[0042] In an embodiment, the one or more detection MAbs is Bl HA423. In an embodiment, the one or more detection MAbs is B2 67B. In an embodiment, the one or more detection MAbs is B3 74B. In an embodiment, the one or more detection MAbs is B4 15B. In an embodiment, the one or more detection MAbs is B5 68B.

[0043] In an embodiment, the one or more detection MAbs is Cl B44. In an embodiment, the one or more detection MAbs is C2 ALDI 1. In an embodiment, the one or more detection MAbs is C3 ALD25. In an embodiment, the one or more detection MAbs is C4 ALD55. In an embodiment, the one or more detection MAbs is C5 ALD12.

[0044] In an embodiment, the one or more detection MAbs is DI B43. In an embodiment, the one or more detection MAbs is D2 ALD30. In an embodiment, the one or more detection MAbs is D3 ALD32.

[0045] In an embodiment, the one or more detection MAbs is El ALDI 3. In an embodiment, the one or more detection MAbs is E2 ALD55. In an embodiment, the one or more detection MAbs is E3 ALD12.

[0046] In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 1. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 2. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 3. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 4. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 5. In an embodiment, the one or more detection MAbs compriszes SEQ ID NO: 6. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 7. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 8. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 9. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 10. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 11. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 12. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 13. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 14. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 15. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 16. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 17. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 18. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 19.

[0047] In an embodiment, the detection MAb comprises a detectable label. In an embodiment, the detectable label is selected from the group comprising a radioactive label, a Huorophore, a dye, an enzyme, a gold-conjugated label, a chemiluminescent label, and anycombination thereof. In an embodiment, the detectable label is a radioactive label. In an embodiment, the detectable label is a fluorophore. In an embodiment, the detectable label is dye. In an embodiment, the detectable label is an enzyme. In an embodiment, the detectable label is a gold-conjugated label. In an embodiment, the detectable label is a chemiluminescent label.

[0048] In an embodiment, the sample is placed into a buffer solution to form a buffered sample. In an embodiment, the buffer solution comprises phosphate-buffered saline (PBS). In an embodiment, the buffer solution comprises a detergent.

[0049] In an illustrative aspect, a device for detection of an infection in a human subject is provided. The device comprises a reaction chamber; one or more immobilized monoclonal antibodies (MAbs) to one or more target proteins, wherein the one or more immobilized MAbs are coupled to the reaction chamber, and one or more detection MAbs.

[0050] In an embodiment, the infection is a sexually-transmitted infection (STI). In an embodiment, the infection is a vaginal disorder. In an embodiment, the infection is vulvovaginal candidiasis (VVC). In an embodiment, the infection is bacterial vaginosis (BV). In an embodiment, the infection is syphilis. In an embodiment, the infection is a Chlamydia trachomatis infection. In an embodiment, the infection is a Neisseria gonorrhoeae. In an embodiment, the infection is a Treponema pallidum. In an embodiment, the infection is a Treponema pallidum sp. pallidum infection. In an embodiment, the infection is a Treponema pallidum sp. pertenue infection. In an embodiment, the infection is a Treponema pallidum sp. carateum infection. In an embodiment, the infection is a Treponema pallidum sp. endemicum infection. In an embodiment, the infection is a Trichomonas vaginalis infection.

[0051] In an embodiment, the reaction chamber comprises a membrane. In an embodiment, the membrane comprises nitrocellulose. In an embodiment, the membrane comprises polyvinylidene difluoride.

[0052] In an embodiment, the reaction chamber comprises a liquid receptacle. In an embodiment, the reaction chamber is a lateral flow assay. In an embodiment, the reaction chamber is a capillary flow matrix. In an embodiment, the reaction chamber is a microfluidic system.

[0053] In an embodiment, the reaction chamber is a solid support. In an embodiment, the solid support comprises nitrocellulose. In an embodiment, the solid support comprises polyvinylidene difluoride. In an embodiment, the reaction chamber is dried.

[0054] In an embodiment, the one or more immobilized MAbs comprise two different immobilized MAbs. In an embodiment, the one or more immobilized MAbs comprise threedifferent immobilized MAbs. In an embodiment, the one or more immobilized MAbs comprise four different immobilized MAbs. In an embodiment, the one or more immobilized MAbs comprise five different immobilized MAbs.

[0055] In an embodiment, the one or more immobilized MAbs are selected from the group consisting of Al DM116, A2 12G4, A3 Fl 1-1, A4 C55, Bl HA423, B267B, B3 74B, B4 15B, B5 68B, Cl B44, C2 ALD11, C3 ALD25, C4 ALD55, C5 ALD12, DI B43, D2 ALD30, D3 ALD32, El ALD13, E2 ALD55, and E3 ALD12.

[0056] In an embodiment, the one or more immobilized MAbs is Al DM116. In an embodiment, the one or more immobilized MAbs is A2 12G4. In an embodiment, the one or more immobilized MAbs is A3 Fl 1-1. In an embodiment, the one or more immobilized MAbs is A4 C55.

[0057] In an embodiment, the one or more immobilized MAbs is Bl HA423. In an embodiment, the one or more immobilized MAbs is B267B. In an embodiment, the one or more immobilized MAbs is B3 74B. In an embodiment, the one or more immobilized MAbs is B4 15B. In an embodiment, the one or more immobilized MAbs is B5 68B.

[0058] In an embodiment, the one or more immobilized MAbs is Cl B44. In an embodiment, the one or more immobilized MAbs is C2 ALDI 1. In an embodiment, the one or more immobilized MAbs is C3 ALD25. In an embodiment, the one or more immobilized MAbs is C4 ALD55. In an embodiment, the one or more immobilized MAbs is C5 ALD12.

[0059] In an embodiment, the one or more immobilized MAbs is DI B43. In an embodiment, the one or more immobilized MAbs is D2 ALD30. In an embodiment, the one or more immobilized MAbs is D3 ALD32.

[0060] In an embodiment, the one or more immobilized MAbs is El ALD13. In an embodiment, the one or more immobilized MAbs is E2 ALD55. In an embodiment, the one or more immobilized MAbs is E3 ALD12.

[0061] In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 1. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 2. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 3. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 4. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 5. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 6. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 7. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 8. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 9. In anembodiment, the one or more immobilized MAbs comprises SEQ ID NO: 10. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 11. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 12. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 13. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 14. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 15. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 16. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 17. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 18. In an embodiment, the one or more immobilized MAbs comprises SEQ ID NO: 19.

[0062] In an embodiment, the target protein is a Trichomonas vaginalis-specific. In an embodiment, the Trichomonas vaginalis-specific protein is selected from the group consisting of AP65, a-ac tinin, a-enolase, GAPDH, aldolase, and any combination thereof. In an embodiment, the Trichomonas vaginalis-specific protein is decarboxylating malic enzyme (AP65). In an embodiment, the Trichomonas vaginalis-specific protein is a-actinin. In an embodiment, the Trichomonas vaginalis-specific protein is a-enolase. In an embodiment, the Trichomonas vaginalis-specific protein is glyceraldehyde-6-phosphate dehydrogenase (GAPDH). In an embodiment, the Trichomonas vagzna / A-specific protein is fructose- 1,6- bisphosphate aldolase.

[0063] In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 1. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 2. In an embodiment, the Trichomonas vagzrza / w-specific protein comprises SEQ ID NO: 3. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 4. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 5. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 6. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 7. In an embodiment, the Trichomonas vaginalis-specifc protein comprises SEQ ID NO: 8. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 9. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 10. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 11. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 12. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 13. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 14. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 15. In anembodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 16. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 17. In an embodiment, the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 18. In an embodiment, the Trichomonas vaginalis-spe fic protein comprises SEQ ID NO: 19.

[0064] In an embodiment, the Trichomonas vaginalis-specific protein is in an oligomeric state selected from the group consisting of monomer, dimer, tetramer, octamer, and any combination thereof. In an embodiment, the Trichomonas vaginalis-sp&cific protein is of an oligomeric state comprising a monomer. In an embodiment, the Trichomonas vaginalis- specific protein is of an oligomeric state comprising a dimer. In an embodiment, the Trichomonas vaginalis-specific protein is of an oligomeric state comprising a tetramer. In an embodiment, the Trichomonas vaginalis-speci ic protein is of an oligomeric state comprising an octamer.

[0065] In an embodiment, the one or more detection MAbs are selected from the group consisting of Al DM116, A2 12G4, A3 Fll-1, A4 C55, Bl HA423, B2 67B, B3 74B, B4 15B, B5 68B, Cl B44, C2 ALD11, C3 ALD25, C4 ALD55, C5 ALD12, DI B43, D2 ALD30, D3 ALD32, El ALD13, E2 ALD55, and E3 ALD12.

[0066] In an embodiment, the one or more detection MAbs is Al DM116. In an embodiment, the one or more detection MAbs is A2 12G4. In an embodiment, the one or more detection MAbs is A3 Fll-1. In an embodiment, the one or more detection MAbs is A4 C55.

[0067] In an embodiment, the one or more detection MAbs is Bl HA423. In an embodiment, the one or more detection MAbs is B2 67B. In an embodiment, the one or more detection MAbs is B3 74B. In an embodiment, the one or more detection MAbs is B4 15B. In an embodiment, the one or more detection MAbs is B5 68B.

[0068] In an embodiment, the one or more detection MAbs is Cl B44. In an embodiment, the one or more detection MAbs is C2 ALD11. In an embodiment, the one or more detection MAbs is C3 ALD25. In an embodiment, the one or more detection MAbs is C4 ALD55. In an embodiment, the one or more detection MAbs is C5 ALD12.

[0069] In an embodiment, the one or more detection MAbs is DI B43. In an embodiment, the one or more detection MAbs is D2 ALD30. In an embodiment, the one or more detection MAbs is D3 ALD32.

[0070] In an embodiment, the one or more detection MAbs is El ALD13. In an embodiment, the one or more detection MAbs is E2 ALD55. In an embodiment, the one or more detection MAbs is E3 ALD12.

[0071] In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 1. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 2. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 3. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 4. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 5. In an embodiment, the one or more detection MAbs compriszes SEQ ID NO: 6. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 7. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 8. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 9. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 10. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 11. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 12. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 13. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 14. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 15. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 16. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 17. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 18. In an embodiment, the one or more detection MAbs comprises SEQ ID NO: 19.

[0072] In an embodiment, the detection MAb comprises a detectable label. In an embodiment, the detectable label is selected from the group comprising a radioactive label, a fluorophore, a dye, an enzyme, a gold-conjugated label, a chemiluminescent label, and any combination thereof. In an embodiment, the detectable label is a radioactive label. In an embodiment, the detectable label is a fluorophore. In an embodiment, the detectable label is dye. In an embodiment, the detectable label is an enzyme. In an embodiment, the detectable label is a gold-conjugated label. In an embodiment, the detectable label is a chemiluminescent label.

[0073] In an illustrative aspect, a method to reduce adverse individual health risks and population transmission of an infection is provided. The method comprises the steps of identifying a human subject suspected to have the infection; testing the human subject for presence of the infection according to a method described herein; and administering a therapeutically effective dose of a medication to the human subject testing positive for presence of the infection.

[0074] In an embodiment, the infection is a sexually-transmitted infection (STI). In an embodiment, the infection is a vaginal disorder. In an embodiment, the infection is vulvovaginal candidiasis (VVC). In an embodiment, the infection is bacterial vaginosis (BV).In an embodiment, the infection is syphilis. In an embodiment, the infection is a Chlamydia trachomatis infection. In an embodiment, the infection is a Neisseria gonorrhoeae . In an embodiment, the infection is a Treponema pallidum. In an embodiment, the infection is a Treponema pallidum sp. pallidum infection. In an embodiment, the infection is a Treponema pallidum sp. pertenue infection. In an embodiment, the infection is a Treponema pallidum sp. carateum infection. In an embodiment, the infection is a Treponema pallidum sp. endemicum infection. In an embodiment, the infection is a Trichomonas vaginalis infection.

[0075] The following numbered embodiments are contemplated and are non-limiting:1. A method to detect an infection in a human subject, comprising: collecting a sample from the human subject; exposing the sample to a membrane configured with one or more immobilized monoclonal antibodies (MAbs) to one or more target proteins; capturing one or more of the one or more target proteins via at least one of the immobilized MAbs; and detecting one or more additional amino acid sequences of the target proteins using one or more detection MAbs, wherein the one or more detection MAbs provide a signal indicative of the one or more target proteins.2. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the infection is a sexually-transmitted infection (STI).3. The method of clause 2, any other suitable clause, or any combination of suitable clauses, wherein the infection is a vaginal disorder.4. The method of clause 2, any other suitable clause, or any combination of suitable clauses, wherein the infection is vulvovaginal candidiasis (VVC).5. The method of clause 2, any other suitable clause, or any combination of suitable clauses, wherein the infection is bacterial vaginosis (BV).6. The method of clause 2, any other suitable clause, or any combination of suitable clauses, wherein the infection is syphilis.7. The method of clause 2, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Chlamydia trachomatis infection.8. The method of clause 2, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Neisseria gonorrhoeae.9. The method of clause 2, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Treponema pallidum.The method of clause 2, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Treponema pallidum sp. pallidum infection. The method of clause 2, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Treponema pallidum sp. pertenue infection. The method of clause 2, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Treponema pallidum sp. carateum infection. The method of clause 2, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Treponema pallidum sp. endemicum infection. The method of clause 2, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Trichomonas vaginalis infection. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the sample is a vaginal swab. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the sample is urine. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the sample is blood. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the sample is serum. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the sample is plasma. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the sample is vaginal mucosa. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the sample is cervicovaginal fluid. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the sample is saliva. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the membrane comprises nitrocellulose. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the membrane comprises polyvinylidene difluoride. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the membrane is configured on a lateral flow assay. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the membrane is configured on a capillary flow matrix.The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the membrane is configured on a microfluidic system. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprise two different immobilized MAbs. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprise three different immobilized MAbs. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprise four different immobilized MAbs. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprise five different immobilized MAbs. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs are selected from the group consisting of Al DM116, A2 12G4, A3 Fl 1-1, A4 C55, B l HA423, B2 67B, B3 74B, B4 15B, B5 68B, Cl B44, C2 ALD11, C3 ALD25, C4 ALD55, C5 ALD12, DI B43, D2 ALD30, D3 ALD32, El ALD13, E2 ALD55, and E3 ALD12. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is Al DM116. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is A2 12G4. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is A3 Fl 1-1. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is A4 C 5. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is B 1 HA423. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is B2 67B. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is B3 74B. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is B4 15B. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is B5 68B.The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is Cl B44. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is C2 ALD 11. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is C3 ALD25. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is C4 ALD55. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is C5 ALD 12. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is DI B43. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is D2 ALD30. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is D3 ALD32. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is El ALDI 3. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is E2 ALD55. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is E3 ALD 12. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 1. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 2. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 3. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 4. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 5. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 6.The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 7. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 8. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 9. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 10. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 11. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 12. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 13. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 14. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 15. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 16. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 17. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 18. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 19. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the target protein is a Trichomonas vaginalis-specific. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein is selected from the group consisting of AP65, a-actinin, a-enolase, GAPDH, aldolase, and any combination thereof. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-spedfic protein is decarboxylating malic enzyme (AP65).The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein is a-actinin. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein is a-enolase. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein is glyceraldehyde-6-phosphate dehydrogenase (GAPDH). The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein is fructose- 1,6-bisphosphate aldolase. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 1. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 2. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 3. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 4. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 5. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 6. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 7. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 8. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 9. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 10. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 11. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 12.The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-sp&ciiic protein comprises SEQ ID NO: 13. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 14. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-sp&cific protein comprises SEQ ID NO: 15. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 16. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 17. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 18. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-sp&c ic protein comprises SEQ ID NO: 19. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-spec ic protein is in an oligomeric state selected from the group consisting of monomer, dimer, tetramer, octamer, and any combination thereof. The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-speciiic protein is of an oligomeric state comprising a monomer. . The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein is of an oligomeric state comprising a dimer. . The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein is of an oligomeric state comprising a tetramer. . The method of clause 72, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-speciiic protein is of an oligomeric state comprising an octamer. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs are selected from the group consisting of Al DM116, A2 12G4, A3 Fl 1-1, A4 C55, Bl HA423, B2 67B, B3 74B, B4 15B, B5 68B, Cl B44, C2 ALD11, C3 ALD25, C4 ALD55, C5 ALD12, DI B43, D2 ALD30, D3 ALD32, El ALDI 3, E2 ALD55, and E3 ALDI 2.. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is Al DM116. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is A2 12G4. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is A3 Fl 1-1. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is A4 C55. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is Bl HA423. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is B2 67B. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is B3 74B. . The method of clause 1 , any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is B4 15B. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is B5 68B. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is Cl B44. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is C2 ALD 11. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is C3 ALD25. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is C4 ALD55. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is C5 ALD 12. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is DI B43. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is D2 ALD30. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is D3 ALD32.. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is El ALD13. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is E2 ALD55. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is E3 ALDI 2. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 1. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 2. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 3. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 4. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 5. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs compriszes SEQ ID NO: 6. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 7. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 8. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 9. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 10. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 11. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 12. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 13. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 14.. The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 15. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 16. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 17. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 18. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 19. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the detection MAb comprises a detectable label. . The method of clause 143, any other suitable clause, or any combination of suitable clauses, wherein the detectable label is selected from the group comprising a radioactive label, a fluorophore, a dye, an enzyme, a gold-conjugated label, a chemiluminescent label, and any combination thereof. . The method of clause 143, any other suitable clause, or any combination of suitable clauses, wherein the detectable label is a radioactive label. . The method of clause 143, any other suitable clause, or any combination of suitable clauses, wherein the detectable label is a fluorophore. . The method of clause 143, any other suitable clause, or any combination of suitable clauses, wherein the detectable label is dye. . The method of clause 143, any other suitable clause, or any combination of suitable clauses, wherein the detectable label is an enzyme. . The method of clause 143, any other suitable clause, or any combination of suitable clauses, wherein the detectable label is a gold-conjugated label. . The method of clause 143, any other suitable clause, or any combination of suitable clauses, wherein the detectable label is a chemiluminescent label. . The method of clause 1, any other suitable clause, or any combination of suitable clauses, wherein the sample is placed into a buffer solution to form a buffered sample.. The method of clause 151, any other suitable clause, or any combination of suitable clauses, wherein the buffer solution comprises phosphate -buffered saline (PBS).. The method of clause 151, any other suitable clause, or any combination of suitable clauses, wherein the buffer solution comprises a detergent.. A device for detection of an infection in a human subject, the device comprising: a reaction chamber; one or more immobilized monoclonal antibodies (MAbs) to one or more target proteins, wherein the one or more immobilized MAbs are coupled to the reaction chamber, and one or more detection MAbs. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the infection is a sexually-transmitted infection (STI). . The device of clause 155, any other suitable clause, or any combination of suitable clauses, wherein the infection is a vaginal disorder. . The device of clause 155, any other suitable clause, or any combination of suitable clauses, wherein the infection is vulvovaginal candidiasis (VVC). . The device of clause 155, any other suitable clause, or any combination of suitable clauses, wherein the infection is bacterial vaginosis (BV). . The device of clause 155, any other suitable clause, or any combination of suitable clauses, wherein the infection is syphilis. . The device of clause 155, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Chlamydia trachomatis infection. . The device of clause 155, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Neisseria gonorrhoeae. . The device of clause 155, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Treponema pallidum. . The device of clause 155, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Treponema pallidum sp. pallidum infection. . The device of clause 155, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Treponema pallidum sp. pertenue infection. . The device of clause 155, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Treponema pallidum sp. carateum infection. . The device of clause 155, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Treponema pallidum sp. endemicum infection. . The device of clause 155, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Trichomonas vaginalis infection. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the reaction chamber comprises a membrane.. The device of clause 168, any other suitable clause, or any combination of suitable clauses, wherein the membrane comprises nitrocellulose. . The device of clause 168, any other suitable clause, or any combination of suitable clauses, wherein the membrane comprises polyvinylidene difluoride. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the reaction chamber comprises a liquid receptacle. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the reaction chamber is a lateral flow assay. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the reaction chamber is a capillary flow matrix. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the reaction chamber is a microfluidic system. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the reaction chamber is a solid support. . The device of clause 175, any other suitable clause, or any combination of suitable clauses, wherein the solid support comprises nitrocellulose. . The device of clause 175, any other suitable clause, or any combination of suitable clauses, wherein the solid support comprises polyvinylidene difluoride. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the reaction chamber is dried. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprise two different immobilized MAbs. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprise three different immobilized MAbs. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprise four different immobilized MAbs. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprise five different immobilized MAbs. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs are selected from the groupconsisting of Al DM116, A2 12G4, A3 Fl 1-1, A4 C55, Bl HA423, B2 67B, B3 74B, B4 15B, B5 68B, Cl B44, C2 ALD11, C3 ALD25, C4 ALD55, C5 ALD12, DI B43, D2 ALD30, D3 ALD32, El ALD13, E2 ALD55, and E3 ALD12. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is Al DM116. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is A2 12G4. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is A3 Fl 1-1. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is A4 C55. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is Bl HA423. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is B2 67B. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is B3 74B. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is B4 15B. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is B5 68B. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is Cl B44. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is C2 ALDI 1. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is C3 ALD25. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is C4 ALD55. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is C5 ALDI 2. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is DI B43.. The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is D2 ALD30. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is D3 ALD32. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is El ALDI 3. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is E2 ALD55. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs is E3 ALD12. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 1. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 2. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 3. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 4. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 5. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 6. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 7. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 8. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 9. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 10. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 11. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 12.. The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 13. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 14. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 15. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 16. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 17. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 18. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more immobilized MAbs comprises SEQ ID NO: 19. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the target protein is a Trichomonas vaginalis-specific. . The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-s^&cific protein is selected from the group consisting of AP65, a-actinin, a-enolase, GAPDH, aldolase, and any combination thereof.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein is decarboxylating malic enzyme (AP65). . The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vagina / A- specific protein is a-actinin. . The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginal is- specific protein is a-enolase. . The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein is glyceraldehyde-6- phosphate dehydrogenase (GAPDH). . The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginal A-specific protein is fructose- 1,6-bisphosphate aldolase. . The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vagina / A’- specific protein comprises SEQ ID NO: 1.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 2.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 3.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 4.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 5.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 6.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 7.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 8.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 9.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 10.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 11.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 12.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 13.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 14.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 15.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 16.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 17.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 18.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein comprises SEQ ID NO: 19.. The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein is in an oligomeric state selected from the group consisting of monomer, dimer, tetramer, octamer, and any combination thereof. . The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein is of an oligomeric state comprising a monomer. . The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein is of an oligomeric state comprising a dimer. . The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein is of an oligomeric state comprising a tetramer. . The device of clause 223, any other suitable clause, or any combination of suitable clauses, wherein the Trichomonas vaginalis-specific protein is of an oligomeric state comprising an octamer. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs are selected from the group consisting of Al DM116, A2 12G4, A3 Fll-1, A4 C55, Bl HA423, B2 67B, B3 74B, B4 15B, B5 68B, Cl B44, C2 ALD11, C3 ALD25, C4 ALD55, C5 ALD12, DI B43, D2 ALD30, D3 ALD32, El ALD13, E2 ALD55, and E3 ALD12. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is Al DM116. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is A2 12G4. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is A3 Fll-1. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is A4 C55. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is Bl HA423.. The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is B2 67B. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is B3 74B. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is B4 15B. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is B5 68B. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is Cl B44. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is C2 ALD11. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is C3 ALD25. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is C4 ALD55. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is C5 ALD12. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is DI B43. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is D2 ALD30. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is D3 ALD32. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is El ALDI 3. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is E2 ALD55. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs is E3 ALD12. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 1. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 2.. The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 3. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 4. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 5. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 6. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 7. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 8. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 9. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 10. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 11. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 12. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 13. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 14. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 15. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 16. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 17. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 18. . The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the one or more detection MAbs comprises SEQ ID NO: 19.. The device of clause 154, any other suitable clause, or any combination of suitable clauses, wherein the detection MAb comprises a detectable label. . The device of clause 294, any other suitable clause, or any combination of suitable clauses, wherein the detectable label is selected from the group comprising a radioactive label, a fluorophore, a dye, an enzyme, a gold-conjugated label, a chemiluminescent label, and any combination thereof. . The device of clause 294, any other suitable clause, or any combination of suitable clauses, wherein the detectable label is a radioactive label. . The device of clause 294, any other suitable clause, or any combination of suitable clauses, wherein the detectable label is a fluorophore. . The device of clause 294, any other suitable clause, or any combination of suitable clauses, wherein the detectable label is dye. . The device of clause 294, any other suitable clause, or any combination of suitable clauses, wherein the detectable label is an enzyme. . The device of clause 294, any other suitable clause, or any combination of suitable clauses, wherein the detectable label is a gold-conjugated label. . The device of clause 294, any other suitable clause, or any combination of suitable clauses, wherein the detectable label is a chemiluminescent label. . A method to reduce adverse individual health risks and population transmission of an infection, the method comprising: identifying a human subject suspected to have the infection; testing the human subject for presence of the infection according to the method of any one of the above clauses; and administering a therapeutically effective dose of a medication to the human subject testing positive for presence of the infection. . The method of clause 302, any other suitable clause, or any combination of suitable clauses, wherein the infection is a sexually-transmitted infection (STI). . The method of clause 303, any other suitable clause, or any combination of suitable clauses, wherein the infection is a vaginal disorder. . The method of clause 303, any other suitable clause, or any combination of suitable clauses, wherein the infection is vulvovaginal candidiasis (VVC). . The method of clause 303, any other suitable clause, or any combination of suitable clauses, wherein the infection is bacterial vaginosis (BV).307. The method of clause 303, any other suitable clause, or any combination of suitable clauses, wherein the infection is syphilis.308. The method of clause 303, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Chlamydia trachomatis infection.309. The method of clause 303, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Neisseria gonorrhoeae.310. The method of clause 303, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Treponema pallidum.311. The method of clause 303, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Treponema pallidum sp. pallidum infection.312. The method of clause 303, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Treponema pallidum sp. pertenue infection.313. The method of clause 303, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Treponema pallidum sp. carateum infection.314. The method of clause 303, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Treponema pallidum sp. ende iicum infection.315. The method of clause 303, any other suitable clause, or any combination of suitable clauses, wherein the infection is a Trichomonas vaginalis infection.EXAMPLESEXAMPLE 1Exemplary Experimental Procedures

[0076] The instant example provides exemplary materials and methods utilized in the examples as described herein.Capture ofT. vaginalis protein(s) from patient samples

[0077] The example Vertical Flow Technology platform, illustrated in FIG. 2, and as modified based on the present disclosure, offers a representative embodiment, and has been described for POC serum-antibody based diagnostic testing. Alternate platforms can be used to the extent they are capable of or can be modified for use with multiple detection MAbs. In this test, the a-actinin protein immobilized onto a nitrocellulose reactive membrane on the platform is the target detected by serum antibody in patients with trichomoniasis.

[0078] In the test kit, a sample from a patient’s vaginal swab or urine sample is placed in buffer, then exposed to the reactive membrane with MAb for capture of protein, with the reactive membrane housed on top of an absorbent pad for excess fluid capture.

[0079] The primary MAb captures the target T. vaginalis protein obtained from the sample. A control (C) indicator, such as a line, can be included for capturing excess gold- conjugated secondary MAbs to different epitopes of the captured protein antigen. A test (T) indicator, such as a dot, shows a positive reaction of gold-conjugated secondary MAbs that detect different epitopes of the bound protein.

[0080] The basic procedure (summarized in FIG. 1) is as follows: (1) Ipg of a “capture” MAb (labeled MAb Y i in FIG. 1 or MAbl) will be immobilized onto the nitrocellulose membrane; (2) A sample of 100 microliters (lOOpL) of a fluid obtained from a suspected infected patient will then be added to buffer of PBS-Triton X-100 and mixed followed by addition to the platform well, and the solution will penetrate the membrane; (3) a gold- conjugated MAb or a combination of gold-MAbs as shown in FIG. 3 (colored red, blue, green and yellow) that react with epitopes different from MAbl are then added to the well. Bound gold-MAbs that react with the protein antigen will then give a visible spot indicative of a positive reaction as shown in FIG. 2.EXAMPLE 2Testing of serodiagnostic for trichomoniasis

[0081] To demonstrate proof-of-principle, a lysate was prepared from T. vaginalis organisms grown in batch culture overnight. Cells were washed twice in phosphate-buffered saline (PBS) and pelleted followed by suspending the pellet to a defined cell density in 0.5% Triton X-100 for solubilization of proteins. Any cell debris was removed by centrifugation at 12,000 rpm for 60-minutes. Different lysates of isolates used for the experiment are shown in Table 6 below.

[0082] Lysates in Table 6 were prepared in 0.5% Triton X-100 in PBS from T. vaginalis batch cultures for examination of antigen capture. The Vertical Flow Technology platform used immobilized MAb for capture and gold-conjugated MAbs to different epitopes for detection.Amplification of signal for the protein antigen-capture test

[0083] FIG. 3 shows the capture of a trichomonad protein antigen with MAbl as above for FIG. 1. The captured protein antigen is then detected by the different gold-conjugated MAbs in combination. The interaction of multiple gold- MAbs with the captured protein result in amplification of the signal for detection of the protein.Property of metabolic enzymes relevant to amplification of signal for the protein antigencapture test

[0084] The five different proteins of T. vaginalis used for the protein antigen-detection diagnostic are metabolic enzymes.

[0085] FIG. 4 shows structural aspects of target proteins. These target proteins are multimeric, forming dimers, tetramers, and octamers. This amplifies the signal by providing multiple bonding locations for gold-conjugated detection MAbs.

[0086] MAbs used for capture and detection of the T. vaginalis enzyme protein antigens are to epitope amino acid sequences that are unique to the trichomonad proteins. This avoids non-specific binding of similar proteins of other microorganisms and / or humans that may be immune cross-reactive with the parasite proteins. This ensures specificity of the diagnostic test for trichomoniasis.Development of multiplex test for amplification of signal and detection of multiple protein antigens on the protein antigen capture test

[0087] The ability of the monomeric metabolic enzymes to form multiples of the monomer, e.g., dimers, tetramers, and octamers, allows for further amplification of the detection of T. vaginalis protein antigens from patient samples.

[0088] Using the example of tetramers as shown in FIG. 5, MAbl to each respective protein antigen will bind one monomer that is complexed with three other monomers to form a tetramer. The multiple gold-conjugated MAbs to different epitopes for each of the protein antigens will then bind to the four different monomers. FIG. 6 illustrates this amplification effect for multiple forms of multimeric proteins each bonding to multiple detection MAbs on portion of a planar membrane. The net result is a highly amplified signal for detection, which results in very fast and specific detection rates.

[0089] This multiplicative effect at signal amplification is not evident in any other protein antigen detection tests. This feature contributes to detect T. vaginalis proteins present in the urine of both women and men patients where the amount of each individual protein antigen is too low to otherwise be reliably detectable. Thus, a multiplex test with multiple proteins detected simultaneously facilitates diagnosis of trichomoniasis.

Claims

WHAT IS CLAIMED IS:

1. A method to detect an infection in a human subject, comprising: collecting a sample from the human subject; exposing the sample to a membrane configured with one or more immobilized monoclonal antibodies (MAbs) to one or more target proteins; capturing one or more of the one or more target proteins via at least one of the immobilized MAbs; and detecting one or more additional amino acid sequences of the target proteins using one or more detection MAbs, wherein the one or more detection MAbs provide a signal indicative of the one or more target proteins.

2. The method of claim 1, wherein the infection is a sexually-transmitted infection (STI).

3. The method of claim 2, wherein the infection is a vaginal disorder.

4. The method of claim 2, wherein the infection is a Trichomonas vaginalis infection.

5. The method of claim 1, wherein the sample is a vaginal swab.

6. The method of claim 1, wherein the sample is urine.

7. The method of claim 1, wherein the one or more immobilized MAbs comprise two different immobilized MAbs.

8. The method of claim 1, wherein the one or more immobilized MAbs comprise three different immobilized MAbs.

9. The method of claim 1 , wherein the one or more immobilized MAbs comprise four different immobilized MAbs.

10. The method of claim 1, wherein the one or more immobilized MAbs comprise five different immobilized MAbs.

11. The method of claim 1 , wherein the one or more immobilized MAbs are selected from the group consisting of Al DM116, A2 12G4, A3 Fl 1-1, A4 C55, Bl HA423, B2 67B, B3 74B, B4 15B, B5 68B, Cl B44, C2 ALD11, C3 ALD25, C4 ALD55, C5 ALD12, DI B43, D2 ALD30, D3 ALD32, El ALD13, E2 ALD55, and E3 ALD12.

12. The method of claim 1, wherein the one or more immobilized MAbs comprises SEQ ID NO: 1.

13. The method of claim 1, wherein the one or more immobilized MAbs comprises SEQ ID NO: 2.

14. The method of claim 1 , wherein the one or more immobilized MAbs comprises SEQ ID NO: 3.

15. The method of claim 1 , wherein the one or more immobilized MAbs comprises SEQ ID NO: 4.

16. The method of claim 1 , wherein the one or more immobilized MAbs comprises SEQ ID NO: 5.

17. The method of claim 1 , wherein the one or more immobilized MAbs comprises SEQ ID NO: 6.

18. The method of claim 1 , wherein the one or more immobilized MAbs comprises SEQ ID NO: 7.

19. The method of claim 1 , wherein the one or more immobilized MAbs comprises SEQ ID NO: 8.

20. The method of claim 1 , wherein the one or more immobilized MAbs comprises SEQ ID NO: 9.

21. The method of claim 1 , wherein the one or more immobilized MAbs comprises SEQ ID NO: 10.

22. The method of claim 1 , wherein the one or more immobilized MAbs comprises SEQ ID NO: 11.

23. The method of claim 1 , wherein the one or more immobilized MAbs comprises SEQ ID NO: 12.

24. The method of claim 1 , wherein the one or more immobilized MAbs comprises SEQ ID NO: 13.

25. The method of claim 1 , wherein the one or more immobilized MAbs comprises SEQ ID NO: 14.

26. The method of claim 1 , wherein the one or more immobilized MAbs comprises SEQ ID NO: 15.

27. The method of claim 1 , wherein the one or more immobilized MAbs comprises SEQ ID NO: 16.

28. The method of claim 1 , wherein the one or more immobilized MAbs comprises SEQ ID NO: 17.

29. The method of claim 1 , wherein the one or more immobilized MAbs comprises SEQ ID NO: 18.

30. The method of claim 1 , wherein the one or more immobilized MAbs comprises SEQ ID NO: 19.

31. The method of claim 1, wherein the target protein is a Trichomonas vaginalis-sp& fic.

32. The method of claim 31, wherein the Trichomonas vaginalis-speciiic protein is selected from the group consisting of AP65, a-actinin, a-enolase, GAPDH, aldolase, and any combination thereof.

33. The method of claim 31, wherein the Trichomonas vaginalis-sp&dfic protein is in an oligomeric state selected from the group consisting of monomer, dimer, tetramer, octamer, and any combination thereof.

34. The method of claim 31, wherein the Trichomonas vaginalis-s^& ic protein is of an oligomeric state comprising a monomer.

35. The method of claim 31, wherein the Trichomonas vaginalis-specif c protein is of an oligomeric state comprising a dimer.

36. The method of claim 31, wherein the Trichomonas vaginalis-specific protein is of an oligomeric state comprising a tetramer.

37. The method of claim 31, wherein the Trichomonas vaginalis-sp&cif c protein is of an oligomeric state comprising an octamer.

38. The method of claim 1, wherein the one or more detection MAbs are selected from the group consisting of Al DM116, A2 12G4, A3 Fl 1-1, A4 C55, B l HA423, B2 67B, B3 74B, B4 15B, B5 68B, Cl B44, C2 ALD11, C3 ALD25, C4 ALD55, C5 ALD12, DI B43, D2 ALD30, D3 ALD32, El ALD13, E2 ALD55, and E3 ALD12.

39. The method of claim 1, wherein the detection MAb comprises a detectable label.

40. The method of claim 39, wherein the detectable label is selected from the group comprising a radioactive label, a fluorophore, a dye, an enzyme, a gold-conjugated label, a chemiluminescent label, and any combination thereof.

41. The method of claim 39, wherein the detectable label is a gold- conjugated label.

42. The method of claim 1, wherein the sample is placed into a buffer solution to form a buffered sample.

43. The method of claim 42, wherein the buffer solution comprises phosphate -buffered saline (PBS).

44. A method to detect an infection in a human subject, comprising: collecting a sample from the human subject;exposing the sample to a membrane configured with one or more immobilized monoclonal antibodies (MAbs) to one or more target proteins; capturing one or more of the one or more target proteins via at least one of the immobilized MAbs; and detecting one or more additional amino acid sequences of the target proteins using one or more detection MAbs, wherein the one or more detection MAbs provide a signal indicative of the one or more target proteins, wherein the infection is a Trichomonas vaginalis infection, wherein the one or more immobilized MAbs are selected from the group consisting of Al DM116, A2 12G4, A3 Fll-1, A4 C55, Bl HA423, B2 67B, B3 74B, B4 15B, B5 68B, Cl B44, C2 ALDI 1, C3 ALD25, C4 ALD55, C5 ALD12, DI B43, D2 ALD30, D3 ALD32, El ALD13, E2 ALD55, and E3 ALD12, wherein the one or more detection MAbs are selected from the group consisting of Al DM116, A2 12G4, A3 Fll-1, A4 C55, Bl HA423, B2 67B, B3 74B, B4 15B, B5 68B, Cl B44, C2 ALDI 1, C3 ALD25, C4 ALD55, C5 ALD12, DI B43, D2 ALD30, D3 ALD32, El ALD13, E2 ALD55, and E3 ALD12, wherein the detection MAb comprises a detectable label, and wherein the detectable label is a gold-conjugated label.

45. The method of claim 44, wherein the target protein is in an oligomeric state selected from the group consisting of monomer, dimer, tetramer, octamer, and any combination thereof.

46. The method of claim 44, wherein the target protein is of an oligomeric state comprising a monomer.

47. The method of claim 44, wherein the target protein is of an oligomeric state comprising a dimer.

48. The method of claim 44, wherein the target protein of an oligomeric state comprising a tetramer.

49. The method of claim 44, wherein the target protein is of an oligomeric state comprising an octamer.

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