Method for conducting express diagnosis of pneumococcal infection using diaper

Abstract

FIELD: medicine.SUBSTANCE: method for rapid diagnostics of pneumococcal infection using a diaper is proposed, which consists of placing a strip in the adsorbent layer of the diaper to determine the soluble antigen of Streptococcus pneumoniae in urine, the indicators of which are located in the non-woven surface layer of the diaper, ensuring contact of the strip with the patient's urine and carrying out a visual assessment of the result based on the presence or absence of colored lines.EFFECT: invention simplifies the solution to the problem of conducting express diagnostics of pneumococcal infection in children and bedridden patients.1 cl, 3 dwg, 4 ex

Description

[0001] The invention relates to medicine, specifically to clinical laboratory diagnostics. It can be used in clinical settings for the rapid diagnosis of clinically significant forms of pneumococcal infection.

[0002] The technical result of the invention is to simplify the solution to the issue of conducting an express test for the presence of pneumococcal infection in children and bedridden patients.

[0003] The essence of the invention is that express diagnostics of pneumococcal infection is carried out using a diaper: a strip for determining the soluble antigen of Streptococcus pneumoniae in urine is placed in the adsorbent layer of the diaper, the indicators of which are located in the non-woven surface layer, for this purpose, adsorbed rabbit antibodies to the antigen of S. pneumoniae are placed in two lines on the strip and, as a control line, goat antibodies against rabbit IgG, when the patient's urine interacts with reagents for determining the presence of antigens of S. pneumoniae in the adsorbent layer, an immunochromatographic reaction occurs, accompanied by the appearance of lines in the analyzed area in the presence of antigens of S. pneumoniae in the urine, the antigen of S. pneumoniae contained in the test sample binds to the rabbit antibodies to the antigen of S.pneumoniae, forming a colored line, goat anti-rabbit IgG antibodies adsorbed on the strip also bind rabbit antibodies, forming a control line, the number of formed lines of the indicator strip on the surface non-woven layer of the diaper is compared with the number of vertical lines of the graduated indicator strip supplied with the diaper, the number of vertical lines on the reference graduated indicator strip corresponds to the qualitative composition of urine, the test results are interpreted by the presence or absence of visually distinguishable colored lines from pink to purple, a positive result, recorded after 15 minutes, depending on the concentration of the antigen present in the test sample, includes the detection of two colored lines in the reading zone of the patient's test result, a negative result, also read after 15 minutes, gives only one colored control line, indicating that the S.pneumoniae was not detected in the test sample, the absence of a colored control line, regardless of the presence or absence of a colored line in the patient's result reading area, indicates the invalidity of the test performed.

[0004] The proposed method for detecting pneumococcal infection using a diaper consists in placing an indicator strip in the adsorbent layer of the diaper to detect soluble Streptococcus pneumoniae antigen in urine (Fig. 1; 1, Fig. 2), the indicators of which are located in the non-woven surface layer (2, Fig. 2). For this purpose, rabbit antibodies to the S. pneumoniae antigen (3, Fig. 2) are placed on the strip in two adsorbing lines and goat antibodies against rabbit IgG (4, Fig. 2) are placed as a control line. When the patient's urine interacts with reagents for detecting the presence of S. pneumoniae antigens in the adsorbent layer, an immunochromatographic reaction occurs, accompanied by the appearance of lines in the analyzed area in the presence of S. pneumoniae antigens in the urine (Fig. 3). The S. antigen contained in the test sample pneumoniae binds to membrane-immobilized rabbit antibodies to S. pneumoniae antigen, forming a colored line (3, Fig. 3).Goat anti-rabbit IgG antibodies adsorbed on the strip also bind rabbit antibodies, forming a control line (4, Fig. 3).

[0005] Compare the number of lines formed on the indicator strip on the surface non-woven layer of the diaper with the number of vertical lines on the graduated indicator strip supplied with the diaper (Fig. 3). The number of vertical lines on the reference graduated indicator strip corresponds to the qualitative composition of the urine. Test results are interpreted based on the presence or absence of visually distinguishable colored lines ranging from pink to purple:

[0006] • A positive result, recorded after 15 minutes, depending on the concentration of antigen present in the test sample, includes the detection of two colored lines in the reading area of ​​the patient's test result;

[0007] • a negative result, also read after 15 minutes, yields only one colored control line, indicating that S. pneumoniae antigen was not detected in the test sample;

[0008] • The absence of a colored control line, regardless of the presence or absence of a colored line in the patient's result reading area, indicates that the test performed is invalid.

[0009] Example 1

[0010] A 9-month-old child. For three days, the child has been experiencing restlessness, general weakness, loss of appetite, a fever of 39.2°C, and an unproductive cough. Examination revealed catarrhal symptoms, harsh breathing, and isolated crepitant sounds on auscultation. A chest X-ray revealed dilated pulmonary roots and a 1.5 x 1.0 cm shadow in the lower lobe of the right lung, indirectly indicating the presence of right-sided lower lobe pneumonia. Using a diaper with an indicator strip, it was found that the child's urine contained polysaccharides of S. pneumoniae. This analysis, performed using a diaper with an indicator strip, allowed us to quickly confirm the etiology of the inflammatory lung disease and decide on additional testing methods for an accurate diagnosis.A complete blood count and sputum culture performed in a hospital setting using analyzers confirmed signs of bacterial inflammation. S. pneumoniae was detected in the sputum culture, allowing a diagnosis of streptococcal pneumonia to be made based on the patient's medical history, clinical examination, and additional testing. Thus, early detection of urinary tract inflammation allowed for prompt and accurate diagnosis and appropriate treatment.

[0011] Example 2

[0012] A 75-year-old patient with a sedentary lifestyle and a history of stroke and diabetes mellitus has presented with a three-day history of fever (39.2°C), cough with brick-red sputum, shortness of breath, and decreased oxygen saturation to 95-94%. Auscultation revealed harsh breathing and isolated crepitations on the right side. A urine test for S. pneumoniae antigens was performed at home using a diaper with an indicator strip. It was found that the urine contained S. pneumoniae antigen. A decision was made to hospitalize the patient. In hospital, the diagnosis of right-sided focal pneumonia was confirmed after additional laboratory and instrumental examinations. Sputum culture confirmed the presence of S. pneumoniae 5 days after sample collection. Rapid diagnostics allowed for a prompt diagnosis and the selection of further patient management tactics.

[0013] Example 3

[0014] A 7-month-old patient presented with a high fever of up to 38.0°C. Parents reported decreased appetite and refusal to eat. The patient was restless and refused to allow his right ear to be touched. A diaper test revealed the presence of S. pneumoniae antigens, and an examination by an otolaryngologist in the emergency department confirmed the diagnosis of acute right-sided otitis media. After hospitalization in the ENT department, a middle ear sample was collected and cultured, which revealed S. pneumoniae as the causative agent. Appropriate antimicrobial therapy was prescribed. Thus, this rapid method allowed us to quickly identify the causative agent of acute otitis media and determine the patient's treatment plan.

[0015] Example 4

[0016] A 70-year-old patient with a history of stroke and reduced mobility presented with a two-day fever of 38.4°C. He complained of a severe headache with intermittent throbbing, primarily in the forehead, purulent nasal discharge, and severe weakness. A rapid diaper test for pneumococcal infection revealed a positive result for S. pneumoniae antigens in the urine. Upon admission to the hospital, acute sinusitis was diagnosed. A sinus aspirate was analyzed bacteriologically, and the result was positive for S. pneumoniae. The patient was prescribed antibacterial treatment. This rapid diagnostic method made it possible to identify the suspected pathogen at the prehospital stage, thereby preventing potential complications of bacterial inflammation.

[0017] Thus, the proposed method is quite simple and informative, reduces the time for obtaining results for the presence of S. pneumoniae antigens in the urine of patients with symptoms of bacterial inflammation, which allows it to be used for the initial diagnosis of clinically significant nosologies of pneumococcal etiology (acute otitis media, sinusitis, pneumonia, meningitis, meningoencephalitis), and reduces financial costs and time for diagnosing pneumococcal infection in infants and bedridden patients.

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