Application of IFI27 protein as marker for discriminating acute respiratory virus infection and non-virus infection

Abstract

The invention relates to the technical field of biomedicine, in particular to application of IFI27 protein as a marker for discriminating acute respiratory virus infection and non-virus infection. The detection marker provided by the invention can effectively eliminate false positive results in diagnosis, has the advantage of being capable of distinguishing bacterial infection or virus infection, and makes up for the defect that currently common inflammatory markers cannot prompt virus infection.

Description

Technical Field

[0001] This invention relates to the field of biomedical technology, and more specifically, to the application of IFI27 protein as a biomarker for differentiating between acute respiratory viral infections and non-viral infections. Background Technology

[0002] Acute respiratory infections (ARIs) are the infectious disease with the highest disease burden globally, causing approximately 12.8 billion new cases annually worldwide, with 70%–80% of these cases caused by viral infections. Common respiratory viruses include influenza viruses, coronaviruses, adenoviruses, and respiratory syncytial viruses. Respiratory viral infections not only have a high incidence rate but also place continuous pressure on public health systems due to their rapid transmissibility. Although most ARI cases are self-limiting, clinical observations show that some patients with respiratory viral ARIs develop secondary bacterial infections, and even serious complications such as bronchitis and pneumonia, leading to poor prognosis. This is especially true in children, the elderly, and immunocompromised individuals.

[0003] However, the clinical manifestations of viral and bacterial respiratory infections highly overlap, making accurate differentiation difficult based solely on clinical symptoms. Currently, there is a lack of specific biomarkers for diagnosing viral infections in routine diagnostics, directly leading to the overuse of antibiotics. It is estimated that approximately 50% of antibiotic prescriptions worldwide are for treating viral infections, accelerating the evolution of drug-resistant strains. Furthermore, the diagnosis of viral respiratory infections currently relies primarily on amplifying viral-specific nucleic acids. However, PCR requires specialized laboratories, sophisticated instruments, and highly trained technicians, with testing cycles lasting several hours, making it difficult to implement in resource-scarce areas or primary healthcare institutions. While plaque assays based on cell culture can assess viral activity, they are time-consuming and costly, limiting their application to research settings.

[0004] Therefore, there is an urgent clinical need for rapid and convenient viral infection markers to differentiate between respiratory viral and non-viral infections, optimize patient treatment, and reduce the overuse of antibiotics. Summary of the Invention

[0005] This invention covers the following technical solutions: This invention relates to the application of quantitative detection reagents for IFI27 protein in the preparation of diagnostic reagents for differentiating between acute respiratory viral infections and non-viral infections.

[0006] According to another aspect of the invention, a system for distinguishing between acute respiratory viral infections and non-viral infections also relates, the system comprising: Sample information processing module, diagnostic module, and information output module; The sample information module is used to receive the subject information of patients with acute respiratory infections. The subject information includes at least the IFI27 protein concentration information from the patient's sample and the dynamic quantitative detection results. The diagnostic module receives information input from the sample information processing module, determines whether the IFI27 protein concentration is greater than or equal to 41 ng / mL. If yes, it is determined to be an acute respiratory viral infection; if no, it is determined to be a non-viral infection. The determination result is then output to the information output module.

[0007] IFI27, as an effector molecule in the interferon signaling pathway, is produced in large quantities by host cells due to viral replication, potentially providing an earlier diagnostic window and overcoming the detection escape problem caused by viral mutations. The detection biomarker provided by this invention can effectively eliminate false positive results in diagnosis, possessing the advantage of distinguishing between bacterial and viral infections, and compensating for the deficiency of commonly used inflammatory biomarkers in indicating viral infections. Attached Figure Description

[0008] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0009] Figure 1 ROC curves for differentiating between viral and non-viral infections using IFI27. Detailed Implementation

[0010] Reference will now be made to detailed embodiments of the present invention, one or more of which are described below. Each example is provided for explanation and not for limitation of the invention. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the invention without departing from its scope or spirit. For example, features described or illustrated as part of one embodiment may be used in another embodiment to produce further embodiments.

[0011] Unless otherwise stated, all terms used to disclose this invention (including technical and scientific terms) have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Further guidance is provided below for a better understanding of the teachings of this invention. The terminology used herein in the specification of this invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0012] In this invention, unless otherwise stated, the scientific and technical terms used herein have the meanings commonly understood by those skilled in the art. Furthermore, the terms and laboratory procedures related to protein and nucleic acid chemistry, molecular biology, cell and tissue culture, microbiology, and immunology used herein are all widely used terms and routine procedures in their respective fields. To better understand this invention, definitions and explanations of relevant terms are provided below.

[0013] The terms "and / or," "or / and," and "and / or" as used herein include any one of two or more of the related listed items, as well as any and all combinations of the related listed items. These arbitrary and all combinations include any two related listed items, any more related listed items, or a combination of all related listed items. It should be noted that when at least three items are connected using at least two conjunctions selected from "and / or," "or / and," and "and / or," it should be understood that in this invention, the technical solution undoubtedly includes solutions connected by "logical AND," and also undoubtedly includes solutions connected by "logical OR." For example, "A and / or B" includes three parallel solutions: A, B, and A+B. For example, the technical solution of "A, and / or, B, and / or, C, and / or, D" includes any one of A, B, C, and D (that is, a technical solution that is connected by "logical OR"), as well as any and all combinations of A, B, C, and D, that is, combinations of any two or three of A, B, C, and D, and also combinations of all four of A, B, C, and D (that is, a technical solution that is connected by "logical AND").

[0014] The terms “containing,” “comprising,” and “including” as used in this invention are synonyms and are inclusive or open-ended, not excluding additional, uncited members, elements, or method steps.

[0015] In this invention, the numerical range represented by endpoints includes all numerical values ​​and fractions contained within that range, as well as the endpoints mentioned.

[0016] When this document uses the term "about" to refer to a value or parameter, it includes (and describes) an implementation of the value or parameter itself. For example, a description referring to "about X" includes a description of "X".

[0017] This invention relates to concentration values, which include fluctuations within a certain range. For example, fluctuations are allowed within a corresponding precision range. For instance, 2% can fluctuate within ±0.1%. For larger values ​​or values ​​that do not require overly precise control, even greater fluctuations are permitted. For example, 100mM can fluctuate within ranges of ±1%, ±2%, ±5%, etc. Regarding molecular weight, fluctuations of ±10% are allowed.

[0018] As used herein, unless otherwise indicated, the singular forms of the articles “a,” “an,” and “the” include plural referents.

[0019] In this invention, the terms "multiple" or "various" are used unless otherwise specified, referring to a quantity of 2 or more.

[0020] In this invention, the technical features described in an open-ended manner include both closed-ended technical solutions composed of the listed features and open-ended technical solutions that include the listed features.

[0021] In this invention, terms such as "preferred," "better," "more suitable," and "ideal" merely describe implementation methods or embodiments with better effects and should be understood not to limit the scope of protection of this invention. In this invention, terms such as "optionally," "optionally," and "optional" mean that something is optional, that is, selected from either "with" or "without" a parallel solution. If multiple "optional" statements appear in a technical solution, unless otherwise specified and without contradiction or mutual constraint, each "optional" statement is independent.

[0022] In this invention, "non-viral infection" refers to bacterial infection, fungal infection, and / or no infection.

[0023] All references to this invention are incorporated herein by reference as if each document were individually incorporated herein by reference. Unless they conflict with the inventive purpose and / or technical solution of this invention, the referenced documents are incorporated herein by reference in their entirety and for all purposes. When references are made in this invention, the definitions of relevant technical features, terms, nouns, phrases, etc., are also incorporated herein by reference. Examples and preferred embodiments of the referenced technical features may also be incorporated herein by reference, but only to the extent that they enable the implementation of this invention. It should be understood that when the cited content conflicts with the description in this invention, this invention shall prevail or modifications shall be made adaptively according to the description in this invention.

[0024] Application of quantitative detection reagents for IFI27 protein in the preparation of diagnostic reagents for differentiating between acute respiratory viral infections and non-viral infections.

[0025] In this invention, the IFI27 protein is used as a molecular marker for distinguishing between acute respiratory viral infections and non-viral infections and is detected.

[0026] In this invention, the molecular marker protein used as a biomarker is expected to include naturally occurring variants of the protein and fragments of the protein or the variants, particularly immunologically detectable fragments. The immunologically detectable fragment preferably comprises at least 5, 6, 7, 8, 9, 10, 11, 12, 15, or 20 consecutive amino acids of the biomarker polypeptide. For example, the expression "IFI27 protein" includes the complete protein sequence of IFI27 and the biomarker polypeptide as defined above.

[0027] Those skilled in the art will recognize that ribonucleotides / proteins / peptides released by cells or present in the extracellular matrix can be damaged (e.g., during inflammation) and can be degraded or cleaved into such fragments. As those skilled in the art will understand, mRNA, proteins, or fragments thereof can also be present as part of a complex. Such complexes can also be used as biomarkers in the sense of this invention. Alternatively, the biomarker peptide or a variant thereof may carry post-translational modifications. Non-limiting examples of post-translational modifications are glycosylation, acylation, and / or phosphorylation. "Naturally present variants" should be understood to mean that genes in higher animals are typically accompanied by a high frequency of polymorphism. Many homotypes of molecules containing mutually different amino acid sequences also exist during splicing.

[0028] In some embodiments, the pathogens causing the acute respiratory viral infection include at least one of the following: influenza virus, parainfluenza virus, rhinovirus, adenovirus, respiratory syncytial virus, metapneumovirus, and coronavirus.

[0029] In some embodiments, the influenza virus includes at least one of influenza A virus, influenza B virus, and influenza C virus.

[0030] In some implementations, the coronavirus includes human coronaviruses.

[0031] In some implementations, the human coronavirus includes severe acute respiratory syndrome coronavirus type 2.

[0032] In some embodiments, the quantitative detection reagent includes a reagent for detecting changes in IFI27 protein, which is suitable for at least one of the following detection methods: immunoassay, biomolecular mass spectrometry, lectin-based detection method, and nucleic acid aptamer-based detection method.

[0033] As a method for determining the molecular markers of the present invention, any known method, such as immunoassay or mass spectrometry, can be used, as long as it is a method that specifically determines the molecular marker protein. Among the reagents used to determine the marker protein of the present invention, antibodies, lectins, and aptamers can be used as detection agents.

[0034] Mass spectrometry is not particularly limited in scope; it can utilize mass spectrometers that combine ion sources using electrospray ionization (ESI), matrix-assisted laser desorption / ionization (MALDI), and surface-enhanced laser desorption / ionization (SELDI) with time-of-flight (TOF), ion trap (IT), or Fourier transform (FT) analyzers. LC-MS and CE-MS, which connect mass spectrometers to separation devices such as high-performance liquid chromatography (HPLC) or capillary electrophoresis (CE), can also be used. Furthermore, methods for obtaining mass spectrometry data include data-independent analysis (DIA), data-dependent analysis (DDA), and multiple reaction monitoring (MRM). Mass spectrometry also includes the use of stable isotope labeling of samples with reagents such as iTRAQ (SCIEX).

[0035] As an immunoassay method, there are no particular limitations. Examples of immunoassay methods include at least one of the following: colloidal gold method, electrophoresis method, immunofluorescence method, direct competitive method, indirect competitive method, radioimmunoassay (RIA), enzyme-linked immunosorbent assay (ELISA), flow cytometry method, and immunochromatography method.

[0036] In some embodiments, the quantitative detection reagent includes a specific antibody or antibody fragment of the IFI27 protein.

[0037] In this article, the term "antibody" refers to an immunoglobulin molecule capable of binding to a specific antigen. It comprises two lighter chains (H chains) and two heavier chains (L chains), linked by disulfide bonds to form a tetrapeptide chain. The amino-terminal (N-terminus) sequence of the peptide chain varies considerably and is called the variable region (V region), while the carboxyl-terminus (C-terminus) is relatively stable and changes very little, called the constant region (C region). The constant region of the antibody mediates the binding of the immunoglobulin to host tissues or factors, including various cells of the immune system (e.g., effector cells) and the first component (CIq) of the classical complement system. The V regions of the L and H chains are referred to as VL and VH, respectively.

[0038] The term "antibody fragment" refers to a portion of a complete antibody molecule that retains the specific antigen-binding (HbA1c) ability of the parent antibody, and typically includes at least a portion of the parent antibody's antigen-binding region or variable region (e.g., one or more CDRs). Examples of antigen-binding fragments include, but are not limited to, Fv fragments, disulfide-bonded Fv fragments (dsFv), Fab fragments, (Fab)2, scFv-Fc fusion proteins, scFv-Fv fusion proteins, Fv-Fc fusion proteins, multispecific antibodies formed from antigen-binding fragments, single-domain antibodies, domain antibodies, bivalent domain antibodies, or at least one of the smallest recognition units.

[0039] As a reagent used in immunoassays, commercially available anti-IFI27 protein antibodies can be used, or antibodies can be prepared using conventional methods based on the known amino acid sequence of the IFI27 protein.

[0040] There are no particular restrictions on the animal species or clone from which an antibody can detect the IFI27 protein. Antibodies derived from rabbits, goats, mice, rats, guinea pigs, horses, sheep, camels, chickens, etc., are acceptable; both monoclonal and polyclonal antibodies are acceptable. Furthermore, antibodies suitable for specifically binding to all subclasses of the IFI27 protein can be used. Recombinant antibodies, Fab, Fab', or F(ab')2 fragments can also be used.

[0041] In some embodiments, the antibody is a monoclonal antibody or a polyclonal antibody.

[0042] In some embodiments, the diagnostic reagent is a lateral flow immunoassay device.

[0043] Lateral flow assays, also known as lateral flow immunoassays (LFIA), laminar flow, immunochromatographic assays, or strip tests, are simple devices used to detect the presence (or absence) of antigens (such as reporter molecules) in fluid samples. Many LFIA tests are currently used in medical diagnostics, or for home testing, point-of-care testing, or laboratory use. An LFIA test is a form of immunoassay in which the test sample flows along a solid matrix via capillary action. After the sample is applied to the strip, it encounters a colored reagent (usually including an antibody specific to the target antigen being tested) bound to particles. This reagent mixes with the sample and travels through a substrate that has been pretreated with the antibody. Depending on the level of the target present in the sample, the colored reagent can be captured and bound to the test line or test area. LFIA is essentially an immunoassay adapted for uniaxial operation to accommodate strip or dipstick formats. Strip tests are highly versatile and can be easily modified by those skilled in the art to detect a wide variety of antigens from fluid samples such as urine, blood, water, and / or homogenized tissue samples. The test strip test, also known as the dip stick test, gets its name from the literal meaning of "immersing" the test strip into the fluid sample being tested. The LFIA test strip test is easy to use, requires minimal training, and can be readily incorporated as part of point-of-care testing (POCT) diagnostics used in the field.

[0044] Typically, a lateral flow test strip includes a sample pad, a conjugation pad, a detection membrane, and an optional absorbent pad. The sample pad is the first pad on the flow test strip and is the location for adding a sample (e.g., the amplification reaction described in this invention). In some embodiments of any aspect, the sample pad includes a cellulose fiber filter and / or a woven mesh. In some embodiments of any aspect, the sample pad also includes a buffer solution. The conjugation pad is located between the sample pad and the membrane; the conjugation pad includes detection molecules that are distributed into the membrane of the lateral flow test strip after contact with the running buffer from the sample pad. In some embodiments of any aspect, the conjugation pad includes glass fibers, cellulose fibers, and / or surface-modified polyester. In some embodiments of any aspect, the detection membrane is a nitrocellulose membrane including a test line and a control line. In use, the absorbent pad is placed at the distal end of the lateral flow test strip. The primary function of the absorbent pad is to increase the total volume of running buffer entering the lateral flow test strip. In some embodiments, a specific antibody or antibody fragment of the IFI27 protein is conjugated to the lateral flow test strip. In some embodiments, a specific antibody or antibody fragment of the IFI27 protein is coated on a sample pad.

[0045] In this invention, the terms "biological sample," "sample," etc., refer to animal samples; tissues or organs, tissue lysates, or other samples that may be derived from animals (preferably including at least mammals, such as primates, including humans); cells (in vivo of the subject, directly taken from the subject, or held in a culture, or derived from a cultured cell line), cell lysates (or portions thereof), or cell extracts; solutions containing one or more molecules derived from cells or cell materials; or solutions containing naturally occurring or non-naturally occurring nucleic acids, which are or can be measured as described in this invention. In some embodiments, the test samples for the kit are selected from whole blood, serum, or plasma.

[0046] In some embodiments, the subjects of the kit are mammals.

[0047] In some embodiments, the subjects of the kit are primates.

[0048] In some embodiments, the subjects of the kit are humans.

[0049] According to another aspect of the invention, a system for distinguishing between acute respiratory viral infections and non-viral infections also relates to, the system comprising: Sample information processing module, diagnostic module, and information output module; The sample information module is used to receive the subject information of patients with acute respiratory infections. The subject information includes at least the IFI27 protein concentration information from the patient's sample and the dynamic quantitative detection results. The diagnostic module receives information input from the sample information processing module, determines whether the IFI27 protein concentration is greater than or equal to 41 ng / mL. If yes, it is determined to be an acute respiratory viral infection; if no, it is determined to be a non-viral infection. The determination result is then output to the information output module.

[0050] In some implementations, the subject information may also include one or more of the following: subject's photograph, age, gender, height, weight, dietary habits, underlying diseases, immune status, medication history, mood, time from symptom onset to medical visit, family history of genetic diseases, frequency of smoking, and type of exercise.

[0051] In some implementations, the information output module outputs information through the main interface of the reporting system. The information displayed on the main interface of the reporting system may include one, more, or all of the following: 1) Invoke and display the examined object information in the specimen information receiving function module; 2) Date information recording and modification functions; 3) Display the text template of the disease assessment results and provide modification permissions; 4) Report printing and creation of custom report templates; custom items include the tested object number, report header, test value, reference value, report image, health advice, reviewer, and printer. The date information may further include one or more of the following: sampling time, sample delivery time, instrument testing date, user information entry date, date of receiving instrument testing results, report review date, report printing date, and report sending date.

[0052] The embodiments of the present invention will be described in detail below with reference to examples. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. For experimental methods in the following embodiments where specific conditions are not specified, please refer to the guidelines given in this invention, or follow experimental manuals or conventional conditions in the art, or other experimental methods known in the art, or follow the conditions recommended by the manufacturer.

[0053] In the specific embodiments described below, the measurement parameters involving raw material components may have slight deviations within the weighing accuracy range unless otherwise specified. Temperature and time parameters are subject to acceptable deviations due to instrument testing accuracy or operational precision.

[0054] Example 1: Determining the Optimal Cutoff Value for IFI27 I. Test Subjects This study enrolled 287 patients with uncomplicated acute respiratory infections (ARIs) at the China-Japan Friendship Hospital from December 2023 to June 2024. Recruitment was initially conducted for uncomplicated ARIs, with patients meeting the following criteria: ① presence of at least two respiratory symptoms or signs: cough, sore throat, runny nose, nasal congestion, hoarseness, or loss of smell; with or without fever; ② duration of illness ≤ 7 days. Patients meeting any one or more of the following criteria were excluded: receiving interferon treatment within the past 30 days, experiencing major trauma / burns, major surgery, myocardial infarction, stroke within the past 30 days, or receiving any vaccination within the past 30 days.

[0055] On the day of recruitment, clinical data of all ARI patients meeting the inclusion and exclusion criteria were collected using a pre-defined case report form, including the patient's gender, age, comorbidities, date of onset, and anti-infective treatment. Simultaneously, etiological screening was performed, and oropharyngeal swabs were collected for targeted genome sequencing (tNGS). Experienced respiratory clinicians interpreted the tNGS results, and patients with detected respiratory pathogens and diagnosed by the clinician as having acute respiratory infection were included in subsequent trials.

[0056] This study was confirmed and approved by the hospital's ethics committee, and all participants obtained written informed consent from themselves or their legal representatives.

[0057] II. Test Methods Peripheral venous blood samples (2-4 mL) were collected from all included patients with uncomplicated viral ARI. The IFI27 assay kit was used to test samples from 287 patients. Based on the Youden index, the optimal diagnostic threshold for IFI27 in differentiating acute respiratory viral infections was established. If the IFI27 level in an individual sample was greater than the optimal threshold, it was classified as an acute respiratory viral infection; if the IFI27 level was less than or equal to the optimal threshold, it was classified as an acute non-viral respiratory infection. The differences between the IFI27 diagnostic kit and tNGS diagnostic results were compared, and the sensitivity and specificity of the assays were statistically analyzed.

[0058] III. Test Results Figure 1 The ROC curves for using IFI27 to distinguish between acute respiratory viral infections and non-viral infections in individuals are presented. Based on the Youden index, the optimal cutoff value for IFI27 to distinguish between acute respiratory viral infections and non-viral infections in individuals was determined to be 41 ng / mL.

[0059] Table 1 shows the results. The IFI27 kit showed a specificity and sensitivity of 95.6% and 88.1% respectively in differentiating between individual acute respiratory viral infections and non-viral infections.

[0060] Table 1. Results of 287 Experiments

[0061] Therefore, it is evident that using IFI27 as a biomarker to differentiate between acute respiratory viral infections and non-viral infections in individuals has a very outstanding diagnostic detection effect.

[0062] Example 2: Clinical Validation I. Test Subjects This study enrolled 108 patients with uncomplicated acute respiratory infections (ARIs) at the China-Japan Friendship Hospital between October 2024 and February 2025. Recruitment was initially conducted for uncomplicated ARIs, with patients meeting the following criteria: ① presence of at least two respiratory symptoms or signs: cough, sore throat, runny nose, nasal congestion, hoarseness, or loss of smell; with or without fever; ② duration of illness ≤ 7 days. Patients meeting any one or more of the following criteria were excluded: receiving interferon treatment within the past 30 days, experiencing major trauma / burns, major surgery, myocardial infarction, stroke within the past 30 days, or receiving any vaccination within the past 30 days.

[0063] On the day of recruitment, clinical data of all ARI patients meeting the inclusion and exclusion criteria were collected using a pre-defined case report form, including the patient's gender, age, comorbidities, date of onset, and anti-infective treatment. Simultaneously, etiological screening was performed, and oropharyngeal swabs were collected for targeted genome sequencing (tNGS). Experienced respiratory clinicians interpreted the tNGS results, and patients with detected respiratory pathogens and diagnosed by the clinician as having acute respiratory infection were included in subsequent trials.

[0064] This study was confirmed and approved by the hospital's ethics committee, and all participants obtained written informed consent from themselves or their legal representatives.

[0065] II. Test Methods Peripheral venous blood samples (2-4 mL) were collected from all included patients with uncomplicated viral ARI. The IFI27 test kit was used to analyze samples from 108 patients. If the IFI27 level in an individual sample was greater than 41 ng / mL, it was classified as an acute respiratory viral infection; if the level was less than or equal to 41 ng / mL, it was classified as an acute respiratory non-viral infection. The differences in diagnostic results between the IFI27 diagnostic kit and tNGS were compared, and the sensitivity and specificity of the tests were statistically analyzed.

[0066] III. Test Results Table 2 shows the results. The IFI27 kit showed a specificity and sensitivity of 93.1% and 86.1% respectively in differentiating between individual acute respiratory viral infections and non-viral infections.

[0067] Therefore, it is evident that using IFI27 as a biomarker to differentiate between acute respiratory viral infections and non-viral infections in individuals has a very outstanding diagnostic detection effect.

[0068] Table 2. Results of 108 Experiments

[0069] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims, and the specification and drawings can be used to interpret the content of the claims.

Claims

1. Application of quantitative detection reagents for IFI27 protein in the preparation of diagnostic reagents for differentiating between acute respiratory viral infections and non-viral infections.

2. The application according to claim 1, wherein the pathogen of the acute respiratory viral infection comprises: At least one of the following: influenza virus, parainfluenza virus, rhinovirus, adenovirus, respiratory syncytial virus, metapneumovirus, and coronavirus.

3. The application according to claim 2, wherein the influenza virus includes at least one of influenza A virus, influenza B virus, and influenza C virus.

4. The application according to claim 2, wherein the coronavirus comprises human coronavirus, preferably severe acute respiratory syndrome coronavirus type 2.

5. The application according to claim 1, wherein the quantitative detection reagent comprises a reagent for detecting changes in IFI27 protein, which is suitable for at least one of the following detection methods: immunoassay, biomolecular mass spectrometry, lectin-based detection method, and nucleic acid aptamer-based detection method.

6. The application according to claim 5, wherein the immunoassay comprises: At least one of the following methods: colloidal gold method, electrophoresis method, immunofluorescence method, direct competition method, indirect competition method, radioimmunoassay, enzyme-linked immunosorbent assay, flow cytometry method, and immunochromatography method.

7. The application according to claim 1, wherein the quantitative detection reagent comprises a specific antibody or antibody fragment of the IFI27 protein.

8. The application according to claim 7, wherein the diagnostic reagent is a lateral flow immunoassay device.

9. The application according to any one of claims 1 to 8, wherein the test sample of the kit is selected from whole blood, serum or plasma.

10. A system for differentiating between acute respiratory viral infections and non-viral infections, the system comprising: Sample information processing module, diagnostic module, and information output module; The sample information module is used to receive the subject information of patients with acute respiratory infections. The subject information includes at least the IFI27 protein concentration information from the patient's sample and the dynamic quantitative detection results. The diagnostic module receives information input from the sample information processing module, determines whether the IFI27 protein concentration is greater than or equal to 41 ng / mL. If yes, it is determined to be an acute respiratory viral infection; if no, it is determined to be a non-viral infection. The determination result is then output to the information output module.

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