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Two Pandemics, One Challenge-Leveraging Molecular Test Capacity of Tuberculosis Laboratories for Rapid COVID-19 Case-Finding.

ABSTRACT: In many settings, the ongoing coronavirus disease (COVID-19) pandemic coincides with other major public health threats, in particular tuberculosis. Using tuberculosis (TB) molecular diagnostic infrastructure, which has substantially expanded worldwide in recent years, for COVID-19 case-finding might be warranted. We analyze the potential of using TB diagnostic and research infrastructures for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing. We focused on quality control by adapting the 12 Quality System Essentials framework to the COVID-19 and TB context. We conclude that diagnostic infrastructures for TB can in principle be leveraged to scale-up SARS-CoV-2 testing, in particular in resource-poor settings. TB research infrastructures also can support sequencing of SARS-CoV-2 to study virus evolution and diversity globally. However, fundamental principles of quality management must be followed for both TB and SARS-CoV-2 testing to ensure valid results and to minimize biosafety hazards, and the continuity of TB diagnostic services must be guaranteed at all times.

SUBMITTER: Homolka S

PROVIDER: S-EPMC7588527 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Two Pandemics, One Challenge-Leveraging Molecular Test Capacity of Tuberculosis Laboratories for Rapid COVID-19 Case-Finding.

Homolka Susanne S Paulowski Laura L Andres Sönke S Hillemann Doris D Jou Ruwen R Günther Gunar G Claassens Mareli M Kuhns Martin M Niemann Stefan S Maurer Florian P FP

Emerging infectious diseases 20200921 11

In many settings, the ongoing coronavirus disease (COVID-19) pandemic coincides with other major public health threats, in particular tuberculosis. Using tuberculosis (TB) molecular diagnostic infrastructure, which has substantially expanded worldwide in recent years, for COVID-19 case-finding might be warranted. We analyze the potential of using TB diagnostic and research infrastructures for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing. We focused on quality control by a ...[more]

PMID: 32956612

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Project description:BackgroundFluoroquinolones and second-line injectable drugs are the backbone of treatment regimens for multidrug-resistant tuberculosis, and resistance to these drugs defines extensively drug-resistant tuberculosis. We assessed the accuracy of an automated, cartridge-based molecular assay for the detection, directly from sputum specimens, of Mycobacterium tuberculosis with resistance to fluoroquinolones, aminoglycosides, and isoniazid.MethodsWe conducted a prospective diagnostic accuracy study to compare the investigational assay against phenotypic drug-susceptibility testing and DNA sequencing among adults in China and South Korea who had symptoms of tuberculosis. The Xpert MTB/RIF assay and sputum culture were performed. M. tuberculosis isolates underwent phenotypic drug-susceptibility testing and DNA sequencing of the genes katG, gyrA, gyrB, and rrs and of the eis and inhA promoter regions.ResultsAmong the 308 participants who were culture-positive for M. tuberculosis, when phenotypic drug-susceptibility testing was used as the reference standard, the sensitivities of the investigational assay for detecting resistance were 83.3% for isoniazid (95% confidence interval [CI], 77.1 to 88.5), 88.4% for ofloxacin (95% CI, 80.2 to 94.1), 87.6% for moxifloxacin at a critical concentration of 0.5 μg per milliliter (95% CI, 79.0 to 93.7), 96.2% for moxifloxacin at a critical concentration of 2.0 μg per milliliter (95% CI, 87.0 to 99.5), 71.4% for kanamycin (95% CI, 56.7 to 83.4), and 70.7% for amikacin (95% CI, 54.5 to 83.9). The specificity of the assay for the detection of phenotypic resistance was 94.3% or greater for all drugs except moxifloxacin at a critical concentration of 2.0 μg per milliliter (specificity, 84.0% [95% CI, 78.9 to 88.3]). When DNA sequencing was used as the reference standard, the sensitivities of the investigational assay for detecting mutations associated with resistance were 98.1% for isoniazid (95% CI, 94.4 to 99.6), 95.8% for fluoroquinolones (95% CI, 89.6 to 98.8), 92.7% for kanamycin (95% CI, 80.1 to 98.5), and 96.8% for amikacin (95% CI, 83.3 to 99.9), and the specificity for all drugs was 99.6% (95% CI, 97.9 to 100) or greater.ConclusionsThis investigational assay accurately detected M. tuberculosis mutations associated with resistance to isoniazid, fluoroquinolones, and aminoglycosides and holds promise as a rapid point-of-care test to guide therapeutic decisions for patients with tuberculosis. (Funded by the National Institute of Allergy and Infectious Diseases, National Institutes of Health, and the Ministry of Science and Technology of China; ClinicalTrials.gov number, NCT02251327 .).

Project description:BackgroundThere was a 'missing millions' gap between the incidence of tuberculosis (TB) cases and the notified cases. In many TB high-burden countries, only about 25% of household contacts (HHCs) completing household TB evaluation and 20-89% of eligible contacts did not adhere to TB screening. The study was conducted to assess the yield of door-to-door TB household contact investigation among household contact of bacteriologically confirmed pulmonary TB cases in central Ethiopia.MethodsThis cross-sectional study was carried out in selected health facilities of central Ethiopia from January 1, 2023 to December 3, 2023.All sequential voluntary bacteriologically confirmed TB patients and their HHCs without discrimination by age were included in the study. Xpert Ultra assay and TB culture were used to investigate active TB from sputum sample. Spearman's correlation analysis was used to determine the correlation between the index case cycle threshold value and the corresponding HHCs. Multivariable logistic regression analysis was done to investigate the associated risk factors for active TB in HHCs.ResultsAmong 967 HHCs claimed by 303 index cases (259 drug susceptible TB (DS-TB) and 44 multi-drug resistance TB (MDR/RR-TB)), 902(93.07%) HHCs had received baseline symptom-based TB evaluation. Presumptive TB was identified in 20.17% (182) of the evaluated HHCs and 13(1.44%) were diagnosed with active TB. Eleven HHCs (7.24%; 95% CI: 3.85-12.9%) from DS-TB index case contacts and 2 (6.67%; 95% CI: 1.16-23.51) from MDR/RR-TB indexes HHCs were found to be MTB detected Rifampicin resistance not detected cases. The Xpert ultra assay results revealed an 84.62% (95% CI: 57.77-95.68) Rifampicin drug resistance concordance between the index case and the corresponding HHC. Active TB was significantly associated with night sweating and sharing a bed with the index patient, P-value < 0.05.ConclusionHome-to-home TB contact screening have high active TB yield and implementable in both rural and urban areas of the nation only by mentoring and motivating the health extension workers. Proximity to bacteriologically confirmed TB patient for long time exposes household contacts for active TB. Scheduling convenient times and last-mile service delivery to contacts is very important to address the missed active TB cases in the community.

Dataset Information

Two Pandemics, One Challenge-Leveraging Molecular Test Capacity of Tuberculosis Laboratories for Rapid COVID-19 Case-Finding.

Publications

Two Pandemics, One Challenge-Leveraging Molecular Test Capacity of Tuberculosis Laboratories for Rapid COVID-19 Case-Finding.

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