Factors Reducing the Diagnostic Efficiency of Rapid Tuberculosis Tests Based on Immunochromatographic Assay

The objective: to study factors that reduce the diagnostic efficiency of rapid testing for tuberculosis based on the detection of antibodies to PstS1 and PstS3 antigens of M. tuberculosis and highly purified lipoglycan of the M. tuberculosis cell wall.

Subjects and Methods. Clinical and laboratory data of 290 tuberculosis patients were analyzed. Logistic regression analysis and ROC analysis were used to identify factors associated with a negative result of rapid tuberculosis testing.

Results. 45/290 (16%) patients had a positive result of the rapid test for PstS1, PstS3 antigens and 154/290 (53%) patients responded positively to lipoglycan antigen. The number of people who tested positive was 164/290 (57%). However, in HIV negative patients these values were higher and amounted to 41/196 (21%), 137/196 (70%) and 144/196 (73%), respectively. The following factors were found to be positively associated with a negative result of rapid testing: positive HIV status (OR=7.803; 95% CI 3.845-15.834; p<0.001) and male gender (OR=2.040; 95% CI 1.117-3.725; p =0.020). The combination of these two factors had a more significant predictive value (AUC 0.787; p<0.0001) of a negative rapid test result. In case of HIV infection, the lipoglycan antigen showed a greater degree of immunogenicity versus the PstS1, PstS3 antigens (18% positive results for lipoglycan versus 4% positive results for the PstS1, PstS3 antigens), OR = 4.968; 95% CI 1.603-15.392; p=0.003).

1. Abilbaeva A.A., Tarabaeva A.S., Bitanova E.Zh., Erbolat D., Tuyebaeva B.T., Shuralev E.A. Efficiency of Mycobacterium Tuberculosis antigens in the diagnosis of tuberculosis using immunochromatographic rapid testing. Vestnik KazNMU, 2019, no. 4, pp. 110-114. (In Russ.)

2. Aulock S.V., Deininger S., Draing C., Gueinzius K., Dehus O,. Hermann C. Gender difference in cytokine secretion on immune stimulation with LPS and LTA. J. Interferon Cytokine Res., 2006, vol. 26, no. 12, pp. 887-892. https://doi.org/10.1089/jir.2006.26.887

3. Bothamley G.H. Male sex bias in immune biomarkers for tuberculosis. Front. Immunol., 2021, no. 12, pp. 640903. https:// doi.org/10.3389/fimmu.2021.640903

4. Chavez K., Ravindran R., Dehnad A., Khan I.H. Gender biased immune-biomarkers in active tuberculosis and correlation of their profiles to efficacy of therapy. Tuberculosis (Edinb), 2016, no. 99, pp. 17-24. https://doi.org/10.1016/j.tube.2016.03.009

5. Chopra K.K., Sidiq Z., Hanif M., Dwivedi K.K. Advances in the diagnosis of tuberculosis- Journey from smear microscopy to whole genome sequencing. Indian J. Tuberc., 2020, vol. 67, no. 4S, pp. S61-S68. https://doi.org/10.1016/j.ijtb.2020.09.026

6. Commercial Serodiagnostic Tests for Diagnosis of Tuberculosis: Policy Statement. Geneva, World Health Organization, 2011. Available: https://www.who.int/publications/i/item/9789241502054 Accessed October 10, 2024

7. Cudahy P., Shenoi S.V. Diagnostics for pulmonary tuberculosis. Postgrad. Med. J., 2016, vol. 92, no. 1086, pp. 187-93. https:// doi.org/10.1136/postgradmedj-2015-133278

8. de Martino M., Lodi L., Galli L., Chiappini E. Immune response to Mycobacterium tuberculosis: a narrative review. Front Pediatr., 2019, vol. 27, no. 7, pp. 350. https://doi.org/10.3389/fped.2019.00350

9. Dias S.P., Brouwer M.C., van de Beek D. Sex and gender differences in bacterial infections. Infect. Immun., 2022, vol. 90, no. 10, pp. e0028322. https://doi.org/10.1128/iai.00283-22

10. Jacqueline M.A., Elisabeth J.-A., Xian Y., Susanne B., Eric L., Patrick W.B., Steven C.A., Arturo C., Suman L. Antibodies against immunodominant antigens of Mycobacterium tuberculosis in subjects with suspected tuberculosis in the United States compared by HIV status. Clinical and Vaccine Immunology, 2010, vol. 17, no. 3, pp. 384-392. https:// doi.org/10.1128/CVI.00503-09

11. Klein S.L., Marriott I., Fish E.N. Sex-based differences in immune function and responses to vaccination. Trans. R. Soc. Trop. Med. Hyg., 2015, vol. 109, no. 1, pp. 9-15. https://doi.org/10.1093/trstmh/tru167

12. Kostinov P.M., Zhuravlev I.P., Filatov N.N., Kostinova M.А., Polishchuk B.V., Shmitko D.A., Mashilov V.C., Vlasenko E.A., Ryzhov A.A., Kostinov M.А. Gender differences in the level of antibodies to measles virus in adults. Vaccines, 2021, vol. 9, no. 5, pp. 494. https://doi.org/10.3390/vaccines9050494

13. La Manna M.P., Tamburini B., Orlando V., Badami G.D., Di Carlo P., Cascio A., Singh M., Dieli F., Caccamo N. LIODetect®TB-ST: Evaluation of novel blood test for a rapid diagnosis of active pulmonary and extra-pulmonary tuberculosis in IGRA confirmed patients. Tuberculosis (Edinb.), 2021, no. 130, pp. 102119. https://doi.org/10.1016/j.tube.2021.102119.

14. McLean M.R., Lu L.L., Kent S.J., Chung A.W. An inflammatory story: antibodies in tuberculosis comorbidities. Front. Immunol., 2019, no. 10, pp. 2846. https://doi.org/10.3389/fimmu.2019.02846

15. Ruggieri A., Anticoli S., D'Ambrosio A., Giordani L., Viora M. The influence of sex and gender on immunity, infection and vaccination. Ann. Ist. Super. Sanita, 2016, vol. 52, no. 2, pp. 198-204. https://doi.org/10.4415/ANN_16_02_11

16. Urassa W.K., Mbena E.M., Swai A.B., Gaines H., Mhalu F.S., Biberfeld G. Lymphocyte subset enumeration in HIV seronegative and HIV-1 seropositive adults in Dar es Salaam, Tanzania: determination of reference values in males and females and comparison of two flow cytometric methods. J. Immunol. Methods, 2003, no. 277 (1-2), pp. 65-74. https://doi.org/10.1016/s0022-1759(03)00174-1

17. Tsverava L., Chitadze N., Chanturia G., Kekelidze M., Dzneladze D., Imnadze P., Gamkrelidze A., Lagani V., Khuchua Z., Solomonia R. Antibody profiling reveals gender differences in response to SARS-COVID-2 infection//medRxiv 2021. Available at: https://www.researchgate.net/publication/352153446_Antibody_profiling_reveals_gender_differences_in_response_to_SARS-COVID-2_infection [Accessed 01.12.2024]

18. Vancolen S., Sébire G., Robaire B. Influence of androgens on the innate immune system // Andrology. – 2023. – Vol. 11, № 7. – Р. 1237-1244. https://doi.org/10.1111/andr.13416

19. Yu X., Prados-Rosales R., Jenny-Avital E.R., Sosa K., Casadevall A., Achkar J.M. Comparative evaluation of profiles of antibodies to mycobacterial capsular polysaccharides in tuberculosis patients and controls stratified by HIV status // Clin Vaccine Immunol. – 2012. – Vol. 19, № 2. –Р. 198-208. https://doi.org/10.1128/CVI.05550-11