Cepheid's Xpert MTB/XDR TB Drug Resistance Test Receives WHO Prequalification
Cepheid
Molecular Diagnostics Product Developer
Danaher
Product Design and Manufacturer
Reprint#IVD Tool Person
Cepheid, a subsidiary of Danaher, announced that its Xpert MTB/XDR tuberculosis drug resistance test kit has received World Health Organization (WHO) Prequalification (WHO PQ). This means the test meets WHO standards for quality, safety, and performance and can be procured by international organizations.
This test can directly identify resistance to multiple first-line and second-line tuberculosis drugs from patient samples, including isoniazid, fluoroquinolones, amikacin, etc.,Results available in approximately 90 minutes.The WHO guidelines show that using this test can accelerate drug resistance detection, increase the proportion of patients receiving timely treatment, reduce the risk of missed diagnosis, and improve survival rates.
Cepheid President Vitor Rocha stated,This test provides rapid and reliable drug resistance information for clinical use, especially in high-burden areas, helping doctors make more precise treatment decisions. The reagent runs on the GeneXpert real-time PCR system, and Cepheid also offers several WHO pre-qualified Xpert tests.
Last year, Cepheid reduced the price of the Xpert MTB/RIF Ultra test to $7.97 per test under the Global Access Program to improve accessibility in low-income countries. With the rollout of Xpert MTB/XDR, it is expected to accelerate the diagnosis and treatment of drug-resistant tuberculosis globally, providing support for public health control.
WHO PQ
WHO Prequalification: A Key Quality Benchmark in Global Public Health
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