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WHO Finds High Diagnostic Accuracy in Three Classes of MDx Technologies for TB Testing, Resistance

NEW YORK ─ The World Health Organization on Wednesday announced that it has found high diagnostic accuracy for three classes of molecular diagnostic technologies for tuberculosis testing in advance of an update to its guidelines for TB diagnostic tests expected later this year.

The technologies are moderate-complexity, automated nucleic acid amplification tests (NAATs) for detection of TB and resistance to rifampicin and isoniazid; low-complexity, automated NAATs for the detection of resistance to isoniazid and second-line anti-TB agents; and high-complexity, hybridization-based NAATs for the detection of resistance to pyrazinamide.

The WHO convened a meeting of a Guideline Development Group in December 2020 to address challenges associated with the diagnosis of TB and related drug-resistance, and described findings from the meeting in a Rapid Communication report.

According to the report, products included in the evaluation of the moderate-complexity, automated NAATs included Abbott's RealTime MTB and RealTime MTB RIF/NIH tests; Hain Lifescience's FluoroType MTBDR and FluoroType MTB tests; Becton Dickinson's BD Max MDR-TB test; and Roche's Cobas MTB and Cobas MTB-RIF/IHN tests.

For low-complexity, automated NAATs, the products evaluated included Danaher's Cepheid Xpert MTB/XDR, and for high-complexity, hybridization-based NAATs the group evaluated Nipro's Genoscholar PZA-TB II test.

"The diagnostic options for people with TB and drug-resistant TB are increasing thanks to the engagement of manufacturers and to research that is generating new evidence," Tereza Kasaeva, director of the WHO Global TB Programme, said in a statement.

The WHO said it has released the Rapid Communication in advance of its updated guidelines expected later in 2021 to inform national TB programs and other stakeholders about new developments for the diagnosis of TB and drug resistance and to allow for rapid transition and planning at a country level.

Late in January, the WHO announced that it published the latest edition of its essential diagnostics list of recommended in vitro diagnostic tests that should be available at the point of care and in laboratories in all countries to increase timely and lifesaving diagnoses, and it urged countries to prioritize investments in testing.

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