• The first prequalification of a diagnostic test for tuberculosis marks a critical milestone in scaling up and accelerating access to high-quality TB assays that meet WHO recommendations as well as quality, safety, and performance standards.

• It assures the quality of tests used to improve access to early diagnosis and treatment

• The assessment is based on information submitted by the manufacturer, Cepheid Inc., and reviewed by Singapore’s Health Sciences Authority (HSA), the regulatory agency of record for this product.

• This Nucleic Acid Amplification Test (NAAT) detects the genetic material of Mycobacterium tuberculosis, which causes TB, in sputum and provides accurate results in hours. 

• It also identifies mutations associated with its rifampicin resistance, a key indicator of multidrug-resistant TB.

• It is intended for those who screen positive for pulmonary TB and either have not started anti-tuberculosis treatment or have received less than three days of therapy in the last six months.

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