WHO prequalifies tuberculosis diagnostic test

Idowu Abdullahi

The World Health Organisation has prequalified the molecular diagnostic test for tuberculosis.

The test, Xpert® MTB/RIF Ultra, is the first test for TB diagnosis and antibiotic susceptibility testing that meets WHO’s pre qualification standards.

Tuberculosis is one of the world’s leading infectious disease killers, causing over a million deaths annually and imposing immense socio economic burdens, especially in low- and middle-income countries.

WHO described TB as a communicable disease that affects the lungs and is caused by a bacterium called Mycobacterium tuberculosis, which spreads through the air when an infected person coughs, sneezes, spits, or laughs with mouth open.

WHO noted that TB remains one of the world’s top infectious killer diseases with more than 10 million cases and one million deaths recorded annually.

According to the global health body, Nigeria has the highest burden of TB in Africa and ranks sixth among the 30 countries globally with the highest burden of the disease.

The WHO targets to end TB by 2030 by reducing its incidence by 80 per cent and deaths by 90 per cent.

Accurate and early detection of TB, especially drug-resistant strains, remains a critical and challenging global health priority. PUNCH Healthwise reports that the 2024 World TB Day was celebrated on March 24, with the theme, ‘’Yes! We can end TB!’

Reacting, the WHO Assistant Director-General for Access to Medicines and Health Products, Dr Yukiko Nakatani, said the prequalified test marks a significant win in the global health body’s effort in tackling tuberculosis.

“It underscores the importance of such groundbreaking diagnostic tools in addressing one of the world’s deadliest infectious diseases,” Nakatani said in a statement on WHO’s website.

“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,” Nakatani added.

Also, WHO Director for Regulation and Prequalification, Dr Rogerio Gaspar, said the development would aid effective tuberculosis care.

“High-quality diagnostic tests are the cornerstone of effective TB care and prevention,” said Gaspar, adding that “Prequalification paves the way for equitable access to cutting-edge technologies, empowering countries to address the dual burden of TB and drug-resistant TB.”

According to the statement, WHO prequalification of the test is expected to assure quality of diagnostic tests used to improve access to early diagnosis and treatment.

“It complements WHO’s endorsement approach, which is grounded in emerging evidence, diagnostic accuracy, and patient outcomes alongside considerations for accessibility and equity, with prequalification requirements on quality, safety, and performance.

“WHO’s assessment for prequalification is based on information submitted by the manufacturer, Cepheid Inc., and the review by Singapore’s Health Sciences Authority, the regulatory agency of record for this product.

“Designed for use on the GeneXpert® Instrument System, this nucleic acid amplification test (NAAT) Xpert® MTB/RIF Ultra detects the genetic material of Mycobacterium tuberculosis, the bacterium that causes TB, in sputum samples, and provides accurate results within hours. Simultaneously, the test identifies mutations associated with rifampicin resistance, a key indicator of multidrug-resistant TB.

“It is intended for patients who screen positive for pulmonary TB and who have either not started anti-tuberculosis treatment or received less than three days of therapy in the past six months,” the statement said.

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