Xpert MTB/RIF Ultra, produced by US-based molecular diagnostics company Cepheid, “is the first test for TB diagnosis and antibiotic susceptibility testing that meets WHO’s prequalification standards”, the UN health agency said.

WHO prequalification aims to ensure that key health products meet global standards for quality, safety and efficacy.

The WHO already recommended the test, but prequalification means that UN agencies such as UNICEF, or others like the Gavi vaccine alliance, have a simpler pathway to procure and distribute a product in countries with limited resources.

“This first prequalification of a diagnostic test for tuberculosis marks a critical milestone in WHO’s efforts to support countries in scaling up and accelerating access to high-quality TB assays that meet both WHO recommendations and its stringent quality, safety and performance standards,” said Yukiko Nakatani, a WHO assistant director-general.

“It underscores the importance of such groundbreaking diagnostic tools in addressing one of the world’s deadliest infectious diseases,”

A preventable and curable disease, TB is caused by bacteria and most often affects the lungs. It is spread through the air when people with lung TB cough, sneeze or spit.

In October, the WHO said a record 8.2 million new tuberculosis cases were diagnosed worldwide in 2023 – the highest number since it began global TB monitoring in 1995.

And with 1.25 million related deaths, TB probably returned to being the world’s leading cause of death from a single infectious agent, following three years in which it was replaced by Covid-19, the WHO added.

The test detects the genetic material of the bacterium that causes TB in spit samples, and provides an accurate result within hours.

The WHO says the accurate and early detection of TB, especially drug-resistant strains, is a critical global health priority.

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“High-quality diagnostic tests are the cornerstone of effective TB care and prevention,” said Rogerio Gaspar, the WHO’s regulation and prequalification director.

The disease disproportionately affects 30 high-burden countries.

Five countries – India, Indonesia, China, Philippines and Pakistan – account for more than half of the global TB burden, with more than a quarter of the cases found in India alone.