WHO Describes NPOC-NAATs as a New Diagnostic Class for TB Using Sputum and Tongue Swabs, Pluslife Named in WHO First-in-Class Test Description
The World Health Organization (WHO) has published a policy page describing near point-of-care nucleic acid amplification tests (NPOC-NAATs) as a new diagnostic class for tuberculosis (TB) detection using primary sputum or tongue swab samples. The page describes NPOC-NAATs as swab-based molecular tests that can produce results in less than one hour, using instruments that can be battery operated and do not require specialized infrastructure for use or storage.
WHO Recommendations for Use
For adults and adolescents with signs and symptoms of pulmonary TB, or who screen positive for pulmonary TB, the WHO guidance recommends:
Sputum: NPOC-NAATs on sputum as initial diagnostic tests for TB rather than smear microscopy (strong recommendation, moderate certainty of evidence).
Tongue swabs: When sputum cannot be obtained, NPOC-NAATs on tongue swabs as initial diagnostic tests for TB (strong recommendation, moderate certainty of evidence).
Policy Framing for Decentralized Settings
The WHO page highlights deployment across basic peripheral laboratories and decentralized settings, including health clinics, mobile units, and community sites without laboratories. It also indicates these tests can be performed by health care workers with basic technical skills, since they do not require laboratory methods such as precision pipetting.
Pluslife Named in WHO “First-in-Class” Test Description
In the section describing the first-in-class near point-of-care test, WHO identifies the MiniDock MTB Test as the product for which eligible data met the performance criteria used to establish the NPOC-NAAT class. The page summarizes the workflow involving sample lysis using heat and vortexing on a ThermoLyse instrument, followed by amplification on the Pluslife MiniDock instrument via the MTB test card. The class definition references results in less than one hour, and the Pluslife first-in-class description notes results are available in approximately 30 minutes.
Evidence Highlights Referenced by WHO
The WHO page summarizes that evidence on test accuracy included studies evaluating both sputum and tongue swabs against a microbiological reference standard. Compared with smear microscopy, it reports the Guideline Development Group judged NPOC-NAATs on sputum to be very accurate and NPOC-NAATs on tongue swabs to be accurate. It also reports that NPOC-NAATs on either sputa or tongue swabs would increase equity, be acceptable to end users, and be feasible to implement.
Commitment
Pluslife remains committed to helping close TB diagnostic gaps by bringing high-quality testing closer to patients in decentralized care pathways, supporting more equitable access to timely TB services, and strengthening efforts to help end TB.
