WHO to release negative policy recommendation over TB tests

According to a recent Lancet report, the World Health Organization is due to release its first negative policy recommendation after several inaccurate tuberculosis tests received negative reviews.

The Lancet has documented the health risks associated with inaccurate TB tests, but notes that manufacturers continue to claim their tests as effective and filling a diagnostic niche in high-burden countries, specifically in the sputum smear-negative patient groups.

"Everyone is aware of the consequences of bad drugs and vaccines, but nobody really thinks about bad diagnostics and what impact they can have," Madhukar Pai said, according to

Pai is the co-chair of the STOP-TB Partnership’s new diagnostic working group.

Pai’s group describes the adverse impact that misdiagnosis can have through wasted resources and health services. It recommends that the WHO continue with written guidance against serodiagnostic kits.

The Lancet recommends further targeted research be conducted as there is the potential to develop accurate serologic assays that could potentially fill the point-of-care niche.

For its part, the WHO is working to communicate it negative policy recommendations in a way designed not to stifle innovation and research on the subject.

Although commercial serodiagnostic kits are available worldwide, they are particularly useful in countries like India, where they are used on the 1.5 million people suspected to have TB every year.

Financial incentives for physicians have contributed to the use of risky tests, the Lancet reports, and WHO guidance might impact their sale and use in the private sector.