Point-of-care test for tuberculosis: a boon in diagnosis

Submitted: January 17, 2023
Accepted: April 17, 2023
Published: April 28, 2023
Abstract Views: 1616
PDF: 629
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Rapid diagnosis of tuberculosis (TB) is an effective measure to eradicate this infectious disease worldwide. Traditional methods for screening TB patients do not provide an immediate diagnosis and thus delay treatment. There is an urgent need for the early detection of TB through point-of-care tests (POCTs). Several POCTs are widely available at primary healthcare facilities that assist in TB screening. In addition to the currently used POCTs, advancements in technology have led to the discovery of newer methods that provide accurate and fast information independent of access to laboratory facilities. In the present article, the authors tried to include and describe the potential POCTs for screening TB in patients. Several molecular diagnostic tests, such as nucleic acid amplification tests, including GeneXpert and TB-loop-mediated isothermal amplification, are currently being used as POCTs. Besides these methods, the pathogenic component of Mycobacterium tuberculosis can also be utilized as a biomarker for screening purposes through immunological assays. Similarly, the host immune response to infection has also been utilized as a marker for the diagnosis of TB. These novel biomarkers might include Mtb85, interferon-γ inducible protein-10, volatile organic compounds, acute-phase proteins, etc. Radiological tests have also been observed as POCTs in the TB screening POCT panel. Various POCTs are performed on samples other than sputum, which further eases the screening process. These POCTs should not require large-scale manpower and infrastructure. Hence, POCT should be able to identify patients with M. tuberculosis infection at the primary healthcare level only. There are several other advanced techniques that have been proposed as future POCTs and have been discussed in the present article.

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Price CP. Point of care testing. BMJ 2001;322:1285-8.
Heidt B, Siqueira WF, Eersels K, et al. Point of care diagnostics in resource-limited settings: a review of the present and future of PoC in its most needed environment. Biosensors (Basel) 2020;10:133.
World Health Organization. High‐priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting, 28-29 April 2014. Available from: https://apps.who.int/iris/handle/10665/135617.
Sreeramareddy CT, Panduru KV, Menten J, Van den Ende J. Time delays in diagnosis of pulmonary tuberculosis: a systematic review of literature. BMC Infect Dis 2009;9:91.
Nema V. Tuberculosis diagnostics: challenges and opportunities. Lung India 2012;29:259-66.
Das PK, Ganguly SB, Mandal B. Sputum smear microscopy in tuberculosis: it is still relevant in the era of molecular diagnosis when seen from the public health perspective. Biomed Biotechnol Res J 2019;3:77-9.
Ulukanligil M, Aslan G, Tasçi S. A comparative study on the different staining methods and number of specimens for the detection of acid fast bacilli. Mem Inst Oswaldo Cruz 2000;95:855-8.
Eddabra R, Ait Benhassou H. Rapid molecular assays for detection of tuberculosis. Pneumonia 2018;10:4.
Indian Council of Medical Research. India moving forward in research towards new tools for tuberculosis. Available from: https://www.tbonline.info/posts/2017/11/9/india-moving-forward-research-towards-new-tools-tb/.
Horne DJ, Kohli M, Zifodya JS, et al. Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev 2019;6:CD009593.
Chakravorty S, Simmons AM, Rowneki M, et al. The new Xpert MTB/RIF Ultra: improving detection of Mycobacterium tuberculosis and resistance to rifampin in an assay suitable for point-of-care testing. mBio 2017;8:e00812-7.
García-Elorriaga G, del Rey-Pineda G. Practical and laboratory diagnosis of tuberculosis: from sputum smear to molecular biology. Cham, Springer: 2015.
Ortega C, Wood R, Murton H, et al. Diagnosis of pulmonary tuberculosis by oral swab analysis (OSA): optimisation and development of non-sputum, point-of-care methods. Int J Tuber Lung Dis 2019;23:S211.
Byanyima P, Kaswabuli S, Musisi E, et al. Feasibility and sensitivity of saliva GeneXpert MTB/RIF Ultra for tuberculosis diagnosis in adults in Uganda. Microbiol Spectr 2022;10:e0086022.
World Health Organization. The use of loop-mediated isothermal amplification (TB- LAMP) for the diagnosis of pulmonary tuberculosis: policy guidance. 2016. Available from: https://apps.who.int/iris/handle/10665/249154.
Shete PB, Farr K, Strnad L, et al. Diagnostic accuracy of TB-LAMP for pulmonary tuberculosis: a systematic review and meta-analysis. BMC Infect Dis 2019;19:268.
Mori Y, Notomi T. Loop-mediated isothermal amplification (LAMP): a rapid, accurate, and cost-effective diagnostic method for infectious diseases. J Infect Chemother 2009;15:62-9.
Deng Y, Duan YF, Gao SP, Wang JM. Comparison of LAMP, GeneXpert, mycobacterial culture, smear microscopy, TSPOT. TB, TBAg/PHA ratio for diagnosis of pulmonary tuberculosis. Curr Med Sci 2021;41:1023-8.
Garg N, Ahmad FJ, Kar S. Recent advances in loop-mediated isothermal amplification (LAMP) for rapid and efficient detection of pathogens. Curr Res Microb Sci 2022;3:100120.
Cheng S, Pheng SH, Heng S, et al. Evaluation of loopamp assay for the diagnosis of pulmonary tuberculosis in Cambodia. BioMed Res Int 2020;2020:6828043.
Yadav R, Daroch P, Gupta P, et al. Diagnostic accuracy of TB-LAMP assay in patients with pulmonary tuberculosis... a case-control study in northern India. Pulmonology 2022;28:449-53.
Bulterys MA, Wagner B, Redard-Jacot M, et al. Point-of-care urine LAM tests for tuberculosis diagnosis: a status update. J Clin Med 2019;9:111.
Songkhla MN, Tantipong H, Tongsai S, Angkasekwinai N. Lateral flow urine lipoarabinomannan assay for diagnosis of active tuberculosis in adults with human immunodeficiency virus infection: a prospective cohort study. Open Forum Infect Dis 2019;6:ofz132.
Li Z, Tong X, Liu S, et al. The value of FujiLAM in the diagnosis of tuberculosis: a systematic review and meta-analysis. Front Public Health 2021:9:757133.
Cox JA, Lukande RL, Kalungi S, et al. Is urinary lipoarabinomannan the result of renal tuberculosis? Assessment of the renal histology in an autopsy cohort of Ugandan HIV- infected adults. PLoS One 2015;10:e0123323.
Simieneh A, Tadesse M, Kebede W, et al. Combination of Xpert® MTB/RIF and DetermineTM TB-LAM Ag improves the diagnosis of extrapulmonary tuberculosis at Jimma University Medical Center, Oromia, Ethiopia. PLoS One 2022;17:e0263172.
Shah M, Martinson NA, Chaisson RE, et al. Quantitative analysis of a urine-based assay for detection of lipoarabinomannan in patients with tuberculosis. J Clin Microbiol 2010;48:2972-4.
Zhou L, He X, He D, et al. Biosensing technologies for Mycobacterium tuberculosis detection: status and new developments. Clin Dev Immunol 2011;2011:193963.
Srivastava SK, Van Rijn CJ, Jongsma MA. Biosensor-based detection of tuberculosis. RSC Adv 2016;6:17759-71.
Joshi H, Kandari D, Maitra SS, Bhatnagar R. Biosensors for the detection of Mycobacterium tuberculosis: a comprehensive overview. Crit Rev Microbiol 2022;48:784-812.
Taufiq S, Waqar M, Sharif MN, Abbas SR. Towards portable rapid TB biosensor: detecting Mycobacterium tuberculosis in raw sputum samples using functionalized screen printed electrodes. Bioelectrochemistry 2023;150:108353.
Teixeira RC, Rodríguez M, de Romero NJ, et al. The potential of a portable, point-of- care electronic nose to diagnose tuberculosis. J Infect 2017;75:441-7.
Saktiawati AM, Triyana K, Wahyuningtias SD, et al. eNose-TB: a trial study protocol of electronic nose for tuberculosis screening in Indonesia. PLoS One 2021;16:e0249689.
Kulabhusan KP, Hussain B, Yüce M. Current perspectives on aptamers as diagnostic tools and therapeutic agents. Pharmaceutics 2020;12:646.
Lavania S, Das R, Dhiman A, et al. Aptamer-based TB antigen tests for the rapid diagnosis of pulmonary tuberculosis: potential utility in screening for tuberculosis. ACS Infect Dis 2018;4:1718-26.
Russell TM, Green LS, Rice T, et al. Potential of high-affinity, slow off-rate modified aptamer reagents for Mycobacterium tuberculosis proteins as tools for infection models and diagnostic applications. J Clin Microbiol 2017;55:3072-88.
Tang XL, Zhou YX, Wu SM, et al. CFP10 and ESAT6 aptamers as effective Mycobacterial antigen diagnostic reagents. J Infect 2014;69:569-80.
Pankhurst LJ, del Ojo Elias C, Votintseva AA, et al. Rapid, comprehensive, and affordable mycobacterial diagnosis with whole-genome sequencing: a prospective study. Lancet Respir Med 2016;4:49-58.
Colman RE, Mace A, Seifert M, et al. Whole-genome and targeted sequencing of drug- resistant Mycobacterium tuberculosis on the iSeq100 and MiSeq: a performance, ease- of-use, and cost evaluation. PLoS Med 2019;16:e1002794.
Messah AD, Pawitan JA. Next generation sequencing as rapid diagnosis of multidrug resistance tuberculosis. Adv Life Sci 2020;8:30-7.
Dookie N, Khan A, Padayatchi N, Naidoo K. Application of next generation sequencing for diagnosis and clinical management of drug-resistant tuberculosis: updates on recent developments in the field. Front Microbiol 2022;13:775030.
Goletti D, Petruccioli E, Joosten SA, Ottenhoff TH. Tuberculosis biomarkers: from diagnosis to protection. Infect Dis Rep 2016;8:6568.
Kashyap RS, Rajan AN, Ramteke SS, et al. Diagnosis of tuberculosis in an Indian population by an indirect ELISA protocol based on detection of Antigen 85 complex: a prospective cohort study. BMC Infect Dis 2007;7:74.
Rodríguez-Hernández E, Quintas-Granados LI, Flores-Villalva S, et al. Application of antigenic biomarkers for Mycobacterium tuberculosis. J Zhejiang Univ Sci B 2020;21:856-70.
Yoon C, Semitala FC, Atuhumuza E, et al. Point-of-care C-reactive protein-based tuberculosis screening for people living with HIV: a diagnostic accuracy study. Lancet Infect Dis 2017;17:1285-92.
Grace PS, Dolatshahi S, Lu LL, et al. Antibody subclass and glycosylation shift following effective TB treatment. Front Immunol 2021;12:679973.
Acharya MP, Pradeep SP, Murthy VS, et al. CD38+ CD27–TNF-α+ on Mtb-specific CD4+ T cells is a robust biomarker for tuberculosis diagnosis. Clin Infect Dis 2021;73:793-801.
Morris TC, Hoggart CJ, Chegou NN, et al. Evaluation of host serum protein biomarkers of tuberculosis in sub-Saharan Africa. Front Immunol 2021;12:639174.
Turner CT, Gupta RK, Tsaliki E, et al. Blood transcriptional biomarkers for active pulmonary tuberculosis in a high-burden setting: a prospective, observational, diagnostic accuracy study. Lancet Respir Med 2020;8:407-19.
Suliman S, Thompson EG, Sutherland J, et al. Four-gene pan-African blood signature predicts progression to tuberculosis. Am J Respir Crit Care Med 2018;197:1198-208.
Cliff JM, Lee JS, Constantinou N, et al. Distinct phases of blood gene expression pattern through tuberculosis treatment reflect modulation of the humoral immune response. J Infect Dis 2013;207:18-29.
Chendi BH, Jooste T, Scriba TJ, et al. Utility of a three-gene transcriptomic signature in the diagnosis of tuberculosis in a low-endemic hospital setting. Infect Dis 2023;55:44- 54.
Kulkarni V, Queiroz AT, Sangle S, et al. A two-gene signature for tuberculosis diagnosis in persons with advanced HIV. Front Immunol 2021;12:631165.
Binepal G, Agarwal P, Kaur N, et al. Screening difficult-to-reach populations for tuberculosis using a mobile medical unit, Punjab India. Public Health Action 2015;5:241- 5.
Philipsen RH, Sánchez CI, Maduskar P, et al. Automated chest-radiography as a triage for Xpert testing in resource-constrained settings: a prospective study of diagnostic accuracy and costs. Sci Rep 2015;5:12215.
World Health Organization. WHO consolidated guidelines on tuberculosis: module 2: screening: systematic screening for tuberculosis disease. Available from: https://www.who.int/publications/i/item/9789240022676.
Codlin AJ, Dao TP, Vo LN, et al. Independent evaluation of 12 artificial intelligence solutions for the detection of tuberculosis. Sci Rep 2021;11:23895.
Lopes UK, Valiati JF. Pre-trained convolutional neural networks as feature extractors for tuberculosis detection. Comput Biol Med 2017;89:135-43.
Jaeger S, Juarez-Espinosa OH, Candemir S, et al. Detecting drug-resistant tuberculosis in chest radiographs. Int J Comput Assist Radiol Surg 2018;13:1915-25.
Sekandi JN, Shi W, Zhu R, et al. Application of artificial intelligence to the monitoring of medication adherence for tuberculosis treatment in Africa: algorithm development and validation. JMIR AI 2023;2:e40167.
Zellweger JP, Sotgiu G, Corradi M, Durando P. The diagnosis of latent tuberculosis infection (LTBI): currently available tests, future developments, and perspectives to eliminate tuberculosis (TB). Med Lav 2020;111:170-83.
Pai M, Denkinger CM, Kik SV, et al. Gamma interferon release assays for detection of Mycobacterium tuberculosis infection. Clin Microbiol Rev 2014;27:3-20.
Carranza C, Pedraza-Sanchez S, de Oyarzabal-Mendez E, Torres M. Diagnosis for latent tuberculosis infection: new alternatives. Front Immunol 2020;11:2006.
Hur YG, Hong JY, Choi DH, et al. A feasibility study for diagnosis of latent tuberculosis infection using an IGRA Point-of-care platform in South Korea. Yonsei Med J 2019;60:375-80.
Miotto P, Goletti D, Petrone L. Making IGRA testing easier: first performance report of QIAreach QFT for tuberculosis infection diagnosis. Pulmonology 2022;28:4-5.
Girish S, Kinikar A, Pardesh G, et al. Utility of the interferon-gamma release assay for latent tuberculosis infection screening among Indian health-care workers. Indian J Commun Med 2021;46:281-4.
Morgan J, Muskat K, Tippalagama R, et al. Classical CD4 T cells as the cornerstone of antimycobacterial immunity. Immunol Rev 2021;301:10-29.
Halliday A, Whitworth H, Kottoor SH, et al. Stratification of latent mycobacterium tuberculosis infection by cellular immune profiling. J Infect Dis 2017;215:1480-7.
Mihret A, Abebe M. Cytokines and chemokines as biomarkers of tuberculosis. J Mycobac Dis 2013;3:2.
Wei Z, Li Y, Wei C, et al. The meta-analysis for ideal cytokines to distinguish the latent and active TB infection. BMC Pulm Med 2020;20:248.
Walzl G, Haks MC, Joosten SA, et al. Clinical immunology and multiplex biomarkers of human tuberculosis. Cold Spring Harb Perspect Med 2015;5:a018515.
Clifford V, Tebruegge M, Zufferey C, et al. Cytokine biomarkers for the diagnosis of tuberculosis infection and disease in adults in a low prevalence setting. Tuberculosis (Edinb) 2019;114:91-102.
Kumar NP, Hissar S, Thiruvengadam K, et al. Discovery and validation of a three- cytokine plasma signature as a biomarker for diagnosis of pediatric tuberculosis. Front Immunol 2021;12:653898.
Mutavhatsindi H, Van der Spuy GD, Malherbe ST, et al. Validation and optimization of host immunological bio-signatures for a point-of-care test for TB disease. Front Immunol 2021;12:607827.
Chegou NN, Sutherland JS, Malherbe S, et al. Diagnostic performance of a seven-marker serum protein biosignature for the diagnosis of active TB disease in African primary healthcare clinic attendees with signs and symptoms suggestive of TB. Thorax 2016;71:785-94.
Kumar NP, Hissar S, Thiruvengadam K, et al. Plasma chemokines as immune biomarkers for diagnosis of pediatric tuberculosis. BMC Infect Dis 2021;21:1055.
Dheda K, Ruhwald M, Theron G, et al. Point‐of‐care diagnosis of tuberculosis: past, present and future. Respirology 2013;18:217-32.
Engel N, Ganesh G, Patil M, et al. Barriers to point-of-care testing in India: results from qualitative research across different settings, users and major diseases. PLoS One 2015;10:e0135112.
Schito M, Peter TF, Cavanaugh S, et al. Opportunities and challenges for cost-efficient implementation of new point-of-care diagnostics for HIV and tuberculosis. J Infect Dis 2012;205:S169-80.
Sachdeva S, Davis RW, Saha AK. Microfluidic point-of-care testing: commercial landscape and future directions. Front Bioeng Biotechnol 2021;8:602659.

How to Cite

Tayal, Devika, Prabhpreet Sethi, and Prerna Jain. 2023. “Point-of-Care Test for Tuberculosis: A Boon in Diagnosis”. Monaldi Archives for Chest Disease 94 (1). https://doi.org/10.4081/monaldi.2023.2528.

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