Reliable, accessible, cost-effective, & easy (RACE) diagnostic modality: A key for elimination of tuberculosis

Radio-imaging modalities

The conventional age-old X-ray chest examination still remains the most commonly used method for screening and preliminary diagnosis as well as for follow up of the pulmonary tuberculosis (PTB patients on anti-tuberculous treatment (ATT). In many forms of extra pulmonary tuberculosis (EPTB) such as Bone TB, role of X-ray cannot be undermined. However, technology has limited specificity. Newer radiographic tools including the use of digital plates and digital radiography obviating the need of dark rooms and more recently the computer-aided diagnosis (CAD) have revolutionized the TB diagnosis and management^13,14. In a recent study, newer versions of five commercial AI algorithms: the ‘qXR’’ ‘CAD4TB’, ‘L unit INSIGHT CXR’, ‘JF CXR-1’, and ‘InferRead DR’, were compared to find their sensitivity and specificity. These advances helped precise and early identification of parenchymal lesions or enlargement of mediastinal lymph nodes (LN) and to determine the disease activity. All the five AI algorithms, as mentioned above, reduced the need of Xpert/MTB-Rif tests by 50 per cent while the sensitivity of more than 90 per cent was maintained. However, AI algorithms performed poorly among the older age groups and people with a past history of TB¹⁹. Qin et al²⁰ further evaluated 12 CAD products available in the market of South Africa and found that ‘Lunit’, ‘Nexus’, ‘JF CXR-2’, and ‘qXR’ maintained high sensitivity of >90 per cent for pulmonary TB requiring confirmatory diagnostic testing in only a few cases. However, all products including the WHO endorsed products showed poor performance in older individuals, people with previous TB, and people living with HIV (PLWH)²⁰.

Recently, sequential pulmonary ‘¹⁸F-2-fluoro-deoxy-D-glucose (¹⁸F-FDG) positron emission tomography (PET)’ was compared with the ‘high-resolution-computed-tomography (HRCT)’ and the results were encouraging. This non-invasive method was found useful in monitoring the disease activity and responses to ATT. It is well known that F-FDG accumulates in the metabolically active cells, including the inflammatory cells including macrophages, neutrophils, and lymphocytes, are typically involved in active lesions of TB. Combining ‘¹⁸F-FDG positron emission tomography (PET)’ with CT imaging (PET/CT) has a bright future in TB treatment monitoring. Although expensive, this technique could be useful for the management of patients with dreaded form of TB such as MDR and XDR-TB. Data from multiple cohorts have demonstrated that PET glycolytic activity decreases in response to effective TB treatment which means that it can predict the treatment outcome with high precision²¹.

India has made several breakthroughs in the field of TB, and a software developed by Qure.ai^®22 is another breakthrough which India can boast. An Artificial Intelligence (AI) solution disrupting the conventional methods of radiodiagnosis has been developed by enhancing the image accuracy and thereby improving the health outcomes. With ever improving machine-learning tools, accuracy is expected to increase further. Qure.ai uses ‘deep-learning’ technology to provide automated interpretation of radio-imaging platforms like X-rays, CTs and ultrasounds scans enabling faster diagnosis and speedy treatment²². Efforts are underway by Indian Council of Medical Research (ICMR), FIND and Stop TB Partnership to compile a database of paediatric X-rays to develop CAD algorithms for children and to validate the accuracy of CAD. ‘Artificial intelligence and Machine Learning (AI and ML)’ tools have been developed jointly by ICMR, Department of Health Research and Department of Atomic Energy, Government of India for screening of pulmonary TB and other lung diseases using CxR images, with high accuracy in differentiating pulmonary TB and other diseases (personal communication). Once these tools and software are validated on patients of TB and other diseases, added with portable X-ray machines, can be the game changer. The literature suggests that CAD systems could be highly useful tools for TB screening programmes in difficult-to-reach areas where physical access to expert radiologists may be a limiting factor. However, more large-scale prospective studies, preferably random clinical trials (RCTS) are needed to address long awaited questions especially the operational feasibility of the CAD systems. The WHO, in the year 2021 recommended the use of CAD tools for TB screening among adults but did not include children in this recommendation due to low evidence of diagnostic accuracy among children.

Sample collection, processing and smear microscopy

Collection, storage and transportation of clinical samples is of paramount importance. In the previous decade various solid substrate such as glass slides, FTA cards, and Geno Cards have been evaluated for preserving the morphology and /or nucleic acids for molecular testing with similar detection rates as from fresh samples²³.The molecular testing has also been found highly useful in archived samples, if stored at sub-zero temperature, where detection of MTB using conventional phenotypic methods was not possible when the sample was collected²⁴.The morphological demonstration of the Mycobacteria has been possible with microscopic aids and even after a century, microscopy remains a rapid, cost-effective and easy method for diagnosing TB. However, there are two major concerns. One that microscopy cannot differentiate between the MTB from other non-tuberculous mycobacteria (NTM) and second that it lacks sensitivity (requiring 5000-10000 bacilli /mL of sample to get the positive results), giving false negative results, with low diagnostic yield, in paucibacillary situations^11,12. The sensitivity of the smear-microscopy for the detection of acid-fast-bacilli (AFB) has marginally improved with fluorochromes like Auramine-rhodamine¹¹.

Artificial-intelligence and machine-learning (AI and ML) in smear microscopy

AI-ML technologies are now being tried in the field of medicine with exponential number of applications particularly the image analysis or in the microscopy. In recent years, the ‘operator independent sputum smear-microscopy based on the ZEISS AxioScan®’ and other AI-ML based systems have been evaluated to detect and count the AFB automatically with 97 per cent sensitivity and 86 per cent specificity²⁵.The scope is increasing every day and neural network software are being developed to develop algorithms for diagnosis and treatment prescription based on signs and symptoms entered in the system. However, such developments may not be very useful for resource limited countries and settings due to low literacy rate and inaccurate data entry, which may lead to wrong algorithmic output.

Culture and phenotypic drug susceptibility testing (pDST)

The culture isolation of MTB remains a highly sensitive diagnostic method, that permits practically 10 colony forming units (CFU) or live mycobacteria to grow to a visible colony on solid medium. In liquid cultures theoretically as low as single Mycobacterium can grow to give a positive signal, albeit with longer incubation period. The positive mycobacterial growth means almost 100 per cent specificity. Mycobacteria were first cultivated by Lowenstein in 1931 on egg base with malachite green along with other nutritional supplements and one year later Jensen made some modification in the medium after which the medium is renamed as Lowenstein-Jensen (L-J) medium. A few more modifications have been made in the composition of the medium, but the base still remains the whole egg or its yolk. The cultivation of Mycobacteria and doing anti-mycobacterial drug susceptibility on solid culture medium remained backbone of TB diagnosis for almost a century, but the process is time-consuming taking as long as six wk thus providing limited clinical value.

In 2007, WHO endorsed liquid cultures for the mycobacterial culture and drug susceptibility. Though there are a number of commercial liquid culture systems but BACTEC-MGIT960 system remains the gold-standard for the diagnosis of TB and drug susceptibility testing (DST)^{4,15,18,19,21,24}.The MGIT 960 is also endorsed by the WHO. However, the culture based diagnosis has limitations of improved yet undesirably long turn-around-time (TAT) for 11-42 days, requirement of trained personnel, and level 3 biosafety laboratory environment^15,18,19,21. A number of non-commercialized culture based methods have reported for drug susceptibility testing. These tests are useful in the early stages of mass screening and testing of new drugs, when the WHO endorsed culture based or molecular tests are yet endorsed by the WHO. However, these tests require biosafety precaution and cannot be used in peripheral laboratories. Some of the well-studied and reported tests in this category are ‘Microscopic Observation of Drug Susceptibility (MODS)’, ‘Nitrate Reductase Assay (NRA)’, ‘Calorimetric Redox Indicator (CRI)’, Fast-Flaque and thin-layer agar (TLA). Except the last two, these tests have been recommended by WHO provided stringent quality control, and only in reference laboratories⁹.

Polymerase chain reaction (PCR)

This technology has been used for the diagnosis of TB since early 1990s²⁶. In recent years various forms of PCR have been developed including multiplex PCR, that can detect genus and species specific amplicons, thereby differentiating MTB and NTM, in a single tube^5,27. The conventional PCR requires agarose gel for detection of amplified products, and this limitation has been overcome by the development of real time PCR, in which the DNA amplification reaction could be monitored on the LED screen as the PCR runs on a real-time basis^15,19,28. The quantitative real-time PCR (qRT-PCR) could be used for amplifying the DNA, but also for the RNA using the reverse-transcription technology. The technology provides quantification of the pathogen load in the given sample. There are several commercially available PCR kits, such as Cobas-TaqMan-based PCR, and these PCR platforms have shown high sensitivity and specificity for TB detection, and additionally detection of various other species of the mycobacteria, which is not possible by GeneXpert/MTB-Rif²⁹.The details of these PCR systems are published extensively elsewhere.

GeneXpert^®/MTB-RIF or Xpert^®/MTB-RIF

During the terror threats in USA, the envelopes containing suspected anthrax, required identification of the pathogen with minimal manipulation of the samples. For this ‘Cepheid™ Inc. (USA)’ developed a new technology known as ‘cartridge-based-nucleic-acid-amplification test (CBNAAT)’ or GeneXpert²⁹. These systems were deployed by the United States Postal Service in postal sorting facilities to detect anthrax in postal envelops. Because of possibility of bioterrorism, the application had to be an integrated, self-contained, and automated that could be operated with minimal technical expertise. Sputum samples from PTB patients also require separate processing of each sample for mycobacterial DNA extraction. The sample processing remains a major challenge for all types of PCRs. To overcome this challenge M/s Cepheid Inc. (USA) and Foundation for Innovative New Diagnostics (FIND), with financial support from the ‘National Institutes of Health (NIH), USA’, modified the technology and first time applied and evaluated for the diagnosis of TB on clinical samples in 2010³⁰.The unique features of this system include sample processing and DNA amplification in a single closed cartridge. The results are reported in 90 min, In addition, the system not only detects the MTB DNA in the sample with high accuracy, it also detects rifampicin resistance simultaneously. Here onward, Xpert/MTB-Rif would be used instead of GeneXpert/MTB-Rif, for convenience purposes.

The Xpert MTB/RIF was endorsed by WHO in 2010 for the diagnosis of TB and simultaneous rifampicin resistance detection¹⁶. After this endorsement the Xpert-MTB /Rif was rolled out by various national TB control programmes. The Indian Government rolled in the national TB control programme in 2013. Since than more than 4000 systems have been installed in Government and private sector laboratories with exceptional performance in PTB¹⁷ albeit low to very low (11%) in the paediatric PTB and in adult EPTB samples, especially in plural fluid³¹ the ascitic fluid³², CSF from suspected cases of TB menigitis³³. The ‘lower limit of detection (LOD)’ of Xpert-MTB /Rif is estimated to be 113 ‘CFU/mL’ of the sample.

Truenat^®

India has developed a cartridge based test for the diagnosis of PTB. The manufacturers of this product (M/s Molbio Diagnostics, Goa, India) started with one basic test and later it has developed three improved versions called Truenat MTB, MTB-Plus and MTB-RIF Dx. These tests are intended to be used in the health system as suggested for Xpert MTB/RIF. The WHO, 2020 recommended the Truenat MTB and Truenat MTB Plus assays as the initial diagnostic tests for TB. The WHO also recommended these tests “to be run along with the Truenat MTB-RIF-Dx for detection of rifampicin resistance on sample that are found positive in Truenat-MTB or TruenatMTB-Plus results. After its endorsement by WHO, the test has undergone extensive evaluation, nationally and globally. The sensitivity of Truenat MTB-Plus is found to be 91 per cent as compared to Xpert/MTB-Rif (90%). In HIV-TB coinfected patients its reported sensitivity was 85 per cent compared to 81 per cent for Xpert/MTB-Rif. The specificity of Truenat MTB Plus was, however, slightly lower (96%) than GeneXpert(99%)⁴⁵. However, the older versions had a limitation that for drug resistance detection another module has to be used. The manufacturers have developed a fourth version, called Truenat MTB Ultima. Abdulgader et al⁴⁶ compared Truenat MTB Ultima, Truenat MTB Plus, and Xpert MTB-Rif Ultra and showed that Truenat MTB Ultima, Truenat MTB Plus, and Xpert MTB Ultra had sensitivities of 90, 84, and 92 per cent, respectively and specificities of 85, 95, and 95 per cent, respectively.

Line probe assays

In last three decades when more emphasis was given on TB and its control, several innovations took place, including liquid cultures and development of molecular tests. In the early years of this century two crucial molecular tests were developed, one was real-time PCR based technology, the Xpert/MTB-Rif and the other was reverse hybridization of mycobacterial DNA on the strips, known as line probe assay (LPA). The origin and other details of this technology are covered by us elsewhere³⁹.The earlier versions were developed only for detecting the mutations which confer resistance to first line (FL) drugs i.e. Rifampicin (Rif) and isoniazid (INH) resistance. The new-generation LPAs have been developed with improved sensitivity, and cover more genetic mutations that confer resistance to second line (SL) drugs. These include Genotype MTBDRsl version 2.0 (Hain Lifesciences-Bruker) for second line drugs. Genotype MTBDRsl V2.0 showed higher sensitivity for detection of fluoroquinolones (FQ) and XDR-TB isolates over Genotype MTBDRsl V1.0^47,48. Emerging novel mutations conferring drug resistance in MTB isolates have limited the use of this assay because it does not include the probes corresponding to mutations that are associated with MDR and XDR- TB. In addition, longer turnaround time (TAT), high cost, biosafe laboratory environment and tedious nature of the west remains an issue.

LAMP (loop-mediated isothermal amplification)

Loop-mediated isothermal amplification (LAMP) is based on isothermal PCR amplification method that can be performed in a standard-BSL-2 level molecular biology setting. The LAMP-based TB test has been recommended by WHO since 2016, as a potential replacement for smear microscopy. Its average sensitivity (89.6%) and specificity (94%) are reported to be lower than GeneXpert/MTB-Rif. However, its analytical sensitivity has been reported as 5 fg of mycobacterial DNA, which is equivalent to one mycobacterial cell⁴⁹. The test has been developed for various applications including to detect and differentiate MTB and NTM in single tube^39,50. Moreover, the test is cumbersome, involving multiple steps and BSL-2 or higher laboratory infrastructure.

Next-generation sequencing

In 1998 the whole genome of MTB was sequenced. After the availability of whole genome sequence (WGS) data targeted next-generation sequencing (tNGS) or Sanger’s sequencing method can allow us to sequence millions of fragments in each run simultaneously and undertake profiling of the MTB for drug resistance, lineages detection and also to detect novel mutations³⁹. In 2023, WHO issued an advisory encouraging tNGS for the detection of DR-TB. The tNGS allows us to test new drugs and novel molecules against MTB. The traditional sequencing of MTB was dependent on bacterial culture but newer tNGS platforms provide opportunity to carry out directly onthe clinical samples obviating the process of bacterial culture^11,51. There are at least three platforms, the Illumina, Ion Torrent and Oxford Nanopore. However, the technology requires skilled manpower with experience in bioinformatics, beside the comparatively high cost for resource constrained regions. Hence this technology can best be utilized by pooling the human and laboratory resources in a centralised place. In a recent study conducted in Bangladesh, tNGS results show higher sensitivities for rifampicin (99.3%), isoniazid (96.3%), fluoroquinolones (94.4%), and very high to aminoglycosides (100%) but comparatively lower for ethambutol (76.6%), streptomycin (68.7%), ethionamide (56.0%) and pyrazinamide (50.7%) when compared with pDST⁵⁰.While the tNGS primarily has clinical application, for deeper insight of the pathogen whole genome sequence (WGS) has to be carried, which can unravel new information on the genomic data and regional or lineage specific genetic variations. The WGS can also help understand the new mechanisms of survival, fitness, and DNA repair mechanisms adopted by the pathogen under specific conditions^51,52.

With the rapid development in the field of molecular biology detection technologies, CRISPR/Cas system is more widely being used in clinical practice for pathogen detection⁵¹. Recent studies show that if the trans cleavage ability of CRISPR-Cas12a against the single-stranded DNA is combined with hybridization steps and chemiluminescence to establish an imaging sensor for the supersensitive detection of MTBDNA, this technology can be a game changer. Qiao et al⁵³ reported a linear relationships between the concentration of MTBDNA and the output signal in the ranges of 10 to 200 pM and 200 to 800 pMDNA. The lowest limit of detection (LOD) was as low as 0.83 pM of MTB genomic DNA, and a plasmid containing MTB-specific sequence was detected at one copy per μL, which is a very high analytical sensitivity. A detection sensitivity of 100 per cent was achieved by analysing the MTB-DNA isolated from sputum samples of TB patients. This study shows new hopes for TB detection and broadens the application of CRISPR-Cas12a based sensors in clinical diagnosis.

Tuberculin skin test

Tuberculin skin test (TST), also known as Mantoux test or PPD (purified protein derivative) test evaluates the cell mediated (Type IV) immunity. It was developed more than 104 years back and is still used as an initial screening test in some of the industrialized countries, which are TB non-endemic, to detect MTB exposure. It has several limitations specially its poor specificity. The TST has low sensitivity especially in immunocompromised individuals. There are also variations in the composition of purified protein which is the basis of this test. Therefore, in recent years several advances have been made to prepare a more standardized protein substrate. In early years of this century Staten’s Serum Institute, Copenhagen, Denmark prepared an ovel Skin Test (C-Tb) which consists of recombinant antigens–ESAT-6 and CFP-10, that are included in the IGRAs also. The C-Tb test has been reported to be highly specific skin test for the detection of LTBI and it also addresses some of the drawbacks of TST and IGRAs. C-Tb is done in the same manner as the TST. In a recently published study sensitivity of C-Tb, TST and QuantiFERON-TB-Gold-In-Tube (QFT) were found to be 72 per cent vs. 75 per cent vs. 73 per cent, respectively. Although, all the three tests showed similar sensitivity in HIV-TB co-infected participants, but the positivity rates were found low when CD4 counts were <100 cells/μL. Among the asymptomatic paediatric contacts, 32 per cent tested positive with C-Tb and 32 per cent (28/87) with TST with a concordance rate of 89 per cent. Overall, the C-Tb and TST showed a similar safety profile⁵⁴. Now the Staten’s Serum Institute has collaborated with Serum Institute of India and other manufacturing units globally to market these antigens to replace the PPD based TST.

QuantiFERON-TB /IGRA tests

The QuantiFERON-TB-Gold-In-Tube (QFT) or IGRA is an interferon gamma (IFN-γ) release assay is used to replace the TST. The use of IGRA is recommended in individuals who cannot come for the reading of the TST on 3^rd day, or who are known to have had exposure to MTB, HIV infection, or other immunocompromised conditions. There are a number of variants of the test, viz QuantiFERON, QuantiFERON-Gold and QuantiFERON GoldPlus⁵⁵. It has several advantages over the TST including its non-reactivity with non-tuberculous mycobacteria, high specificity, but high cost is the major limitation of its wider use in resource constrained settings. The QFT is reported to be more specific than TST, as the QFT has ESAT-6 and CFP-10, which are specific only to MTB complex and does not cross react with NTM exposure^11,19,21. Despite clear instructions from all manufactures, QFT gold is often misused to diagnose the active TB while its best utility is for latent TB and past exposure to TB.

Serological diagnostic methods

Serological tests refer to blood based in-vitro tests which detect humoral immune responses, antibodies to MTB antigens. These tests offer several advantages such as: (i) rapid results (within minutes), (ii) easy to perform (iii) can be truly point of care tests and (iv) in cases of extrapulmonary tuberculosis (EPTB), paucibacillary TB and where the appropriate samples is difficult to obtain or the site of pathology is not identifiable, a blood test may be more practical; because immune response is not site-specific but systemic.

The International Standards for TB Care do not recommend the use of serological tests in routine practice. After finding the performance of the tests which were in the market before 2010, very poor, in 2011 WHO banned these test kits. Subsequently Government of India also banned antibody detection kits marketed at thattime⁵⁶. Although the intention behind the ban was validated and desired to avoid false positive as well as false negative results, the nuanced language in WHO policy statement regarding new research has become a point of confusion for various researchers, kit developers as well as for funding bodies. The WHO guidelines do mention that further research to identify new/alternative point-of-care tests for TB diagnosis and/or serological tests with improved accuracy is strongly encouraged. The document also mentions that “such research should be based on adequate study design including quality principles such as representative suspected populations, prospective follow up and adequate and explicit blinding. The report strongly recommended that proof of-principle studies be followed by evidence produced from prospectively implemented and well-designed evaluation and demonstration studies, including assessment of patient impact. Unfortunately, the report was misunderstood as complete ban on commercialized as well as on developing new serological tests, specially by the administrative ministries and local policy makers, rather than encouraging innovating novel antigens and point of care triage tests. After this ban the research on finding novel serological tests has completely stopped and only rarely such studies are being published in recent years^57-64. Even though these guidelines did not ban any future research, a wrong message is gone in, which needs to clarification from WHO and national TB Elimination programme managers, so that funding for innovative research can be encouraged. In another review article several proteomics platforms, developed for the detection of host immune responses, have been covered. These include timeline of proteomic technologies and protein database development, such as mass spectrometry (MS); two-dimensional polyacrylamide gel electrophoresis (2D-PAGE), matrix-assisted laser desorption/ionization (MALDI), electrospray ionization (ESI), peptide mass fingerprinting (PMF), isotope-coded affinity tag (ICAT), difference-gel 2D-electrophoresis (DIGE), surface-enhanced laser desorption/ionization time of flight (SELDI-TOF), Human Proteome Organization (HUPO), and Human Protein Atlas (HPA)⁵⁹.There are several antigens which have been evaluated for the diagnosis of pulmonary and other forms of TB. After WHO ban on TB serology in 2011, between January 2012 to till May 2025, more than 634 articles are published in PubMed. Of these 354 were on humans, and only 37 were on antibody-based diagnostic tests, averaging less than four articles per year. Further, only 12 studies were based in vitro diagnostic tests, of which 10 studies analysed the antibodies against various antigen in the plasma or serum while in two studies novel monoclonal antibodies were used to detect circulating antigens. The researchers used various test platforms and various antigens. Baumann et al⁶⁰, used antigen Apa, HSP 16.3, HSP20, PE35 and lipoarabinomannan (LAM) to stimulate the host cells. They found sensitivity of 71 per cent and specificity of 86 per cent. In 2015, Chen et al⁶¹ from China in a multicentric study used MTB-specific antigens Ag14-16kDa, Ag32kDa, Ag38kDa and Ag85B in protein array system but found very low sensitivity ranging from 28 per cent to 55 per cent and specificity ranging from 93 per cent to 100 per cent, of various antigens singly or even in combination. In 2017, Zhao et al⁶² from Japan evaluated the utility of 11 antigens in differentiating MTB infection, caused by Beijing and non-Beijing lineages. They used Rv0679c142Asn, Rv0679c142Lys, Ag85B, Ag85A, ARC, TDM-M, TDM-K, HBHA, MDP-1, LAM, and TBGL antigens in an ELISA platform, but the results were not encouraging. In 2019, two studies were published: one from Thailand and the other from China^63-64.These authors used several antigens including B: I-TAC, I-309, MIG, Granulysin, FAP, MEP1B, Furin and LYVE-1and multiple platforms. Yang et al⁶³ used a protein array and by using the combination algorithm of these eight antigens, reported a sensitivity of 74-100 per cent and specificity of 71-100 per cent. Recently Mahmood et al⁶⁴ from Pakistan used chimera of two antigens Rv3874 and Rv3875 in ELISA platform and concluded that chimera of these antigens gave better results than individual antigen assays. Nonetheless, for the first time, Singh et al¹⁰ demonstrated that novel antigens they have developed could be used as a point of care test using the immunochromatographic flow through assay in 10 min. Gupta et al⁵⁷ advanced the previous study and developed novel monoclonal antibodies to detect MTB specific antigens in the clinical samples. The monoclonal antibodies can be used in various platform like direct fluorescence test on biopsies and fine needle aspiration cytology samples, ELISA, or in a ICT based rapid POC tests.

Recent studies show high potential of novel antigens to develop flow-through or lateral flow immunochromatography based rapid tests, that can be used in remotest areas requiring no equipment, no electricity and no skilled manpower. We hope that if emphasis is given on innovative research and developing novelantigens¹⁰ or monoclonal antibodies⁵⁴ using recombinant DNA technology, as is given on developing molecular technologies or vaccine development by the funding and licencing authorities, the innovative technologies will help TB elimination mission possible. Nevertheless, the point of care tests should be used with care and preferably as triage tests, and an algorithmic combination of serological triage tests and confirmatory molecular with or without standard microbiological tests (Figure) should be developed for elimination of TB.

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Figure.

A proposed algorithm for diagnostic approach using triage strategy. The antibody detection based lateral flow or flow through immunochromatographic point of care tests (IC-POCT) can revolutionize the management strategy of Tuberculosis and may help in timely elimination of Tuberculosis. These POCs can be applied for mass population screening as well as for the symptomatic cases. A triage test with very high sensitivity can rule out any form of tuberculosis and test negative subjects, will not be require further investigations. Those who are found POC test positive will be required to get investigated further using standard microbiological, molecular, histopathological or radio-imaging investigation depending on the suspected site of infection and the clinical criteria.

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