Article Text
Abstract
Background Rapid detection of resistance to key drugs such as fluoroquinolones (FQ) and bedaquiline (BDQ) is essential for appropriate management of multi-drug resistant tuberculosis (MDR-TB). . Molecular tests available require either infrastructures not available in peripheral laboratories in low resource countries, or do not detect resistance to BDQ. Recently, two tests have been developed: GeneXpert MTB/XDR (Cepheid, USA) detecting resistance to isoniazid (INH), FQ and ethionamide (ETH), and TrueNat XDR (Molbio Diagnostics, India) for detection of resistance to INH, FQ and BDQ.
Methods In the EDCTP-funded project (DIAMA) aimed at developing culture free approaches for diagnosis and management of MDR-TB patients, we assessed the performances of these tests in field conditions compared to phenotypic drug-susceptibility testing (pDST) and whole genome sequencing (WGS) using 1711 unique samples consecutively collected in the Sub-Saharan African region (Benin, Cameroon, DRC, Ethiopia, Guinea, Mali, Nigeria, Rwanda and Senegal).
Results Using a composite reference standard comprising pDST and WGS, Xpert-XDR showed a sensitivity of 87.3% for INH, 37.8% for ETH and 66.7% for FQ, with a respective specificity of 96.5%, 98.3% and 99.7%. For TrueNat, the sensitivity was 88.1% for INH and 47.4% for FQ, with a specificity of 85.7% for INH, 97.7% for FQ and 98.5% for BDQ.
Conclusion These tests showed promising results, particularly as screening test for detection of resistance to FQ and BDQ.