Establishing proof of concept for utility of Trueprep®-extracted DNA in line-probe assay testing.

BACKGROUND AND OBJECTIVES: With an increased demand for rapid, diagnostic tools for TB and drug resistance detection, Truenat® MTB-RIF assay has proven to be a rapid point of care molecular test. The present study aimed to establish a proof of concept of using Trueprep-extracted DNA for line-probe assay (LPA) testing.METHODS: A total of 150 sputum samples (MTB-positive at Truenat sites) were divided into two aliquots. One aliquot was used for DNA extraction using the Trueprep device and MTB testing. The second aliquot of the sample was subjected to GenoLyse® DNA extraction. DNA from both the Trueprep and GenoLyse methods was subjected to first-line (FL) and second-line (SL) LPA testing.RESULTS: Of 139 Trueprep-extracted DNA, respectively 135 (97%) and 105 (75%) had interpretable results by FL and SL-LPA testing. Of 128 GenoLyse-extracted DNA, all 128 (100%) had interpretable FL-LPA results and 114 (89%) had interpretable SL-LPA results.CONCLUSION: The results obtained in this study indicate that Trueprep-extracted DNA can be used in obtaining valid LPA results. However, the study needs to be conducted on a larger sample size before our recommendations can be used for policy-making decisions.

Strengthened capacity of India´s bedaquiline Conditional Access Programme for introducing new drugs and regimens.

BACKGROUND: Addressing TB in India is critical to meeting global targets. With the scale-up of diagnostic networks and the availability of new TB drugs, India had the opportunity to improve the detection and treatment outcomes in drug-resistant TB (DR-TB).OBJECTIVE: To document how the introduction of new drugs and regimens is helping India improve the care of DR-TB patients.DESIGN: In 2016, India´s National TB Programme (NTP) introduced bedaquiline (BDQ) under a Conditional Access Programme (BDQ-CAP) at six sites after providing extensive training and strengthening laboratory testing, pre-treatment evaluation, active drug safety monitoring and management (aDSM) and follow-up systems.RESULTS: An interim analysis reflected earlier and better culture conversion rates: 83% of the 620 patients converted within a median time of 60 days. However, 248 serious adverse events were reported, including 73 deaths (12%) and 100 cardiotoxicity events (16.3%). Encouraged by the evidence of safety and efficacy of BDQ, the NTP took steps to systematically expand its access to cover the entire population by 2018.CONCLUSION: The cautious yet focused approach used to introduce BDQ under BDQ-CAP paved the way for the rapid introduction of delamanid, as well as the shorter treatment regimen and the all-oral regimen for DR-TB.

Is bleach-sedimented smear microscopy an alternative to direct microscopy under programme conditions in India?

This cross-sectional multi-centric study compared the yield of and potential benefit for detecting smear-positive pulmonary tuberculosis (PTB) by bleach sedimentation (2% sodium-hypochlorite) versus direct microscopy under programme conditions in India. Among 3168 PTB suspects, 684 (21.6%) were detected by bleach sedimentation vs. 625 (19.7%) by direct microscopy, with a proportional overall agreement of 96% (κ = 0.88). While 594 patients were smear-positive with both methods, 31 patients detected by direct microscopy were missed and an additional 90 patients were detected by bleach sedimentation. Overall, bleach sedimentation increased the yield of smear-positive TB detection; however; it also increased the time to results.

Cette étude transversale multicentrique a comparé, dans les conditions du programme en Inde, le rendement et les avantages potentiels de la détection des tuberculoses pulmonaires (TBP) à frottis positif par la sédimentation à l'eau de Javel (2% d'hypochlorite de sodium) par comparaison avec l'examen microscopique direct. Parmi 3168 sujets suspects de TBP, 684 (21,6%) ont été détectés par la sédimentation à l'eau de Javel par rapport à 625 (19,7%) par l'examen microscopique direct, avec donc une proportion de 96% de concordance globale (κ = 0,88). Alors que les résultats des frottis étaient positifs chez 594 patients par les deux méthodes, l'examen microscopique direct a raté la détection chez 31 patients et la sédimentation à l'eau de Javel a détecté 90 patients de plus. Au total, la sédimentation à l'eau de Javel a augmenté le rendement de la détection des TB à frottis positif, mais a prolongé la durée avant obtention des résultats.

En un estudio transversal multicéntrico se comparó el rendimiento y la posible utilidad de la detección de la tuberculosis (TB) con baciloscopia positiva mediante la concentración del esputo con hipoclorito de sodio (2%) y se comparó esta técnica con el examen microscópico directo, en las condiciones del programa nacional de la India. En los 3168 pacientes con presunción clínica de TB se detectaron 684 casos (21,6%) por el método de la sedimentación con lejía y 625 casos (19,7%) mediante la microscopia directa, lo cual ofrece una concordancia global del 96% (índice κ = 0,88). Quinientos noventa y cuatro pacientes presentaron baciloscopias positivas con ambas técnicas; con la técnica de sedimentación se pasaron por alto 31 de los pacientes diagnosticados por microscopia directa y la concentración con lejía permitió el diagnóstico de 90 pacientes suplementarios. En términos generales, la sedimentación con lejía aumentó el rendimiento de la detección de casos de tuberculosis con baciloscopia positiva, pero prolongó el lapso hasta la obtención de los resultados.