WHO Expands IVD Prequalification Scope to Support TB Diagnosis

TB and drug-resistant TB remain underdiagnosed globally. In response, WHO has expanded its Prequalification of in vitro diagnostics (IVDs) to include rapid diagnostic tests for detecting mycobacterial LAM antigen in urine—a key tool for diagnosing TB in people living with HIV and children.

This aligns with updated WHO guidelines and supports access to quality-assured diagnostics for vulnerable populations. Manufacturers are invited to contact WHO at diagnostics@who.int for pre-submission guidance.