Point-of-Care Diagnostic Tests for Tuberculosis Disease

A special issue of Diagnostics (ISSN 2075-4418). This special issue belongs to the section "Point-of-Care Diagnostics and Devices".

Deadline for manuscript submissions: closed (31 October 2023) | Viewed by 6041

Special Issue Editors


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Guest Editor
All India Institute of Medical Sciences, Nagpur 441108, India
Interests: epidemiologic studies; epidemiological statistics; clinical epidemiology; tuberculosis; health; community health; health services research; public health; epidemiologic methods; TB-HIV

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Guest Editor
All India Institute of Medical Research, Bangalore, India
Interests: infectious disease epidemiology; tuberculosis; child health; infectious diseases; epidemiology; HIV; treatment; diabetes; drug resistance; Mycobacterium tuberculosis

Special Issue Information

Dear Colleagues, 

Rapid TB diagnosis is one of the key strategies to end tuberculosis (TB) globally. Point-of-care tests (POCTs) facilitate early detection, help to provide immediate treatment, and halt the transmission of TB disease. The TB community has always dreamt of having state-of-the-art point-of-care tests which are simple, feasible for field implementation, and yet specific. The development of a second simple, rapid, point-of-care test is a major step forward for advancing tuberculosis diagnostics and could save lives as a result of early detection and treatment. In fact, in the patient care cascade, POCT reduces the length of time for diagnosis and treatment significantly.  The aim of this Special Issue is to provide a platform to exchange knowledge, novel research findings, and experiences between epidemiologists, clinician-scientists, laboratory scientists, academicians, public health program managers, and other health professionals on the thematic area of ‘Point-of-Care Diagnostic Tests for Tuberculosis Disease’. These POCTs may include newer nucleic acid amplification tests, antigen-based detection, antibody detection, novel biomarkers or enzymes, low-cost portable chest-X-ray technologies, AI-based or other novel detection platforms or technologies. In addition to the development of these POCTs, experiences of implementation of these tests in real-world field settings for detection of the disease would be vital. Field-based studies to evaluate the feasibility, validity, clinical impact, and cost-effectiveness of newer tests are also encouraged.

Dr. Jaya Prasad Tripathy
Dr. Sharath Nagaraja
Guest Editors

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Keywords

  • point-of-care test
  • rapid TB diagnosis
  • implementation research
  • cost-effectiveness
  • diagnostic test validity
  • AI-based algorithms

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Published Papers (2 papers)

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Research

11 pages, 783 KiB  
Article
Experience of “One Stop TB Diagnostic Solution” Model in Engaging a Private Laboratory for End-to-End Diagnostic Services in the National TB Elimination Program in Hisar, India
by Rajesh Raju, Banuru Muralidhara Prasad, Umesh Alavadi, Sanjeev Saini, Mukesh Sabharwal, Akshay Duhan, Sridhar Anand, Manohar Lal, Harpreet Kaur, Neerja Arora, Jyoti Jaju, Moe Moore, Ranjani Ramachandran, Nishant Kumar and Rajendra P. Joshi
Diagnostics 2023, 13(17), 2823; https://doi.org/10.3390/diagnostics13172823 - 31 Aug 2023
Cited by 1 | Viewed by 2501
Abstract
The complete diagnostic evaluation of tuberculosis based on its drug-resistance profile is critical for appropriate treatment decisions. The TB diagnostic landscape in India has been transformed with the scaling-up of WHO-recommended diagnostics, but challenges remain with specimen transportation, completing diagnostic assessment, turnaround time [...] Read more.
The complete diagnostic evaluation of tuberculosis based on its drug-resistance profile is critical for appropriate treatment decisions. The TB diagnostic landscape in India has been transformed with the scaling-up of WHO-recommended diagnostics, but challenges remain with specimen transportation, completing diagnostic assessment, turnaround time (TAT), and maintaining laboratories. Private laboratories have demonstrated efficiencies for specimen collection, transportation, and the timely testing and issue of results. A one-stop TB diagnostic model was designed to assess the feasibility of providing end-to-end diagnostic services in the Hisar district of Haryana state, India. A NTEP-certified private laboratory was engaged to provide the services, complementing the existing public sector diagnostic services. A total of 10,164 specimens were collected between May 2022 and January 2023 and these were followed for the complete diagnostic assessment of Drug-Susceptible TB (DS-TB) and Drug-Resistant TB (DR-TB) and the time taken for issuing results. A total of 2152 (21%) patients were detected with TB, 1996 (93%) Rifampicin-Sensitive and 134 (6%) with Rifampicin-Resistant TB. Nearly 99% of the patients completed the evaluation of DS-TB and DR-TB within the recommended TAT. The One-Stop TB/DR-TB Diagnostic Solution model has demonstrated that diagnostic efficiencies could be enhanced through the strategic purchase of private laboratory services. Full article
(This article belongs to the Special Issue Point-of-Care Diagnostic Tests for Tuberculosis Disease)
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12 pages, 941 KiB  
Article
Rapid Detection of Mycobacterium Tuberculosis Using a Novel Point-of-Care BZ TB/NTM NALF Assay: Integrating LAMP and LFIA Technologies
by Ha Nui Kim, Junmin Lee, Soo-Young Yoon, Woong Sik Jang and Chae Seung Lim
Diagnostics 2023, 13(8), 1497; https://doi.org/10.3390/diagnostics13081497 - 21 Apr 2023
Cited by 2 | Viewed by 2690
Abstract
Tuberculosis (TB) is one of the leading causes of infectious mortality from a single infectious agent, Mycobacterium tuberculosis (MTB). This study evaluated the performance of the newly developed BZ TB/NTM NALF assay, which integrated loop-mediated isothermal amplification and lateral flow immunochromatographic assay technologies, [...] Read more.
Tuberculosis (TB) is one of the leading causes of infectious mortality from a single infectious agent, Mycobacterium tuberculosis (MTB). This study evaluated the performance of the newly developed BZ TB/NTM NALF assay, which integrated loop-mediated isothermal amplification and lateral flow immunochromatographic assay technologies, for the detection of MTB. A total of 80 MTB-positive samples and 115 MTB-negative samples were collected, all of which were confirmed by TB real-time PCR (RT-PCR) using either AdvanSureTM TB/NTM RT-PCR Kit or Xpert® MTB/RIF Assay. The performance of the BZ TB/NTM NALF assay was evaluated by calculating its sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) in comparison to those of the RT-PCR methods. Compared to the RT-PCR, the sensitivity, specificity, PPV, and NPV of BZ TB/NTM NALF assay were 98.7%, 99.1%, 98.7%, and 99.1%, respectively. The concordance rate between BZ TB/NTM NALF and RT-PCR was 99.0%. Rapid and simple detection of MTB is essential for global case detection and further elimination of TB. The performance of the BZ TB/NTM NALF Assay is acceptable with a high concordance with RT-PCR, indicating that it is reliable for use in a low-resource environment. Full article
(This article belongs to the Special Issue Point-of-Care Diagnostic Tests for Tuberculosis Disease)
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