This week WAidid suggets the reading of an article from WHO. Based on the outcomes of the FIND-coordinated study, WHO extends its recommendations for the use of Hain Version 1 assay to the Hain version 2 and Nipro assays, for the rapid detection of rifampicin conferring mutations in AFB smear-positive samples and positive cultures. This recommendation does not apply to other LPAs available on the market. WHO does not recommend the use of LPAs in AFB smear-negative samples.
WHO has approved the use of two alternative line probe assays (LPAs) which are rapid DNA based tests which simultaneously confirm the presence of tuberculosis (TB) and detect resistance to rifampicin and isoniazid. This follows the 2008 recommendation by WHO on the use of LPAs for the rapid detection of rifampicin resistance. At that time, the evidence assessed was for the LPA technology, Hain Version 1 assay.
The two LPAs are:
GenoType® MTBDRplus assay, Hain Lifescience (Hain Version 2 assay)
Nipro Assay, Nipro Corporation
For new versions of technologies that WHO has already recommended, WHO requires a head-to-head comparison with the existing technology. Hain Version 1 assay was used as the head-to-head comparison for the new assays to demonstrate their equivalent performance.
In 2014 and 2015, FIND coordinated a multi-center, blinded cross-sectional study of the diagnostic accuracy of these two newly-available tests, to compare their performance against that of the Hain Version 1 assay. A composite reference standard including phenotypic drug susceptibility testing (DST) and DNA sequencing was used. The study had two phases. Phase 1 was designed to evaluate the performance of the newer assays on a wide range of clinical isolates and Phase 2 to evaluate their performance on sputum specimens from patients with pulmonary TB.
The study demonstrated equivalence of the newer LPA assays (Hain Version 2 and Nipro) with the Hain version 1 assay. These assays showed comparable performance for the detection of M. tuberculosis and rifampicin resistance conferring mutations in acid-fast bacilli (AFB) smear-positive samples and isolates of M. tuberculosis.
To read the article online click HERE