FEASIBILITY OF SCALING UP OF GENE X-PERT MTB/RIF ASSAY FOR DIAGNOSIS OF TB IN NEPAL: AN IMPLEMENTATION RESEARCH

Basant Joshi, Prof. dr. Adi Utarini, MSc., MPH., PhD.; dr. Trisasi Lestari, M.Med.Sc.

2017 | Tesis | S2 Ilmu Kesehatan Masyarakat

Background Tuberculosis is major public health problem in low and middle-income countries. Early detection and enrolment of missing cases of TB is challenge for National tuberculosis program. Optimum utilization of novel diagnostic tool, gene X-pert MTB/RIF can contribute for increased TB detection. Objective To describe the results and challenges of gene X-pert MTB/RIF diagnosis in eligible presumptive TB patients within Nepal NTP. Design Descriptive, mixed method (explanatory sequential design) implementation research conducted between March and June 2017, collecting secondary data and in-depth interviews with patients, NTP focal persons and partners. Focus group discussion with stakeholders. Results A total of 23,075 gene X-pert tests with 22,288 people tested by both gene X-pert and sputum microscopic method between 17 July 2015 and 16 July 2016. Among these, 77% of the of the patients have same results (positive or negative for TB) from both diagnostic tools. The two diagnostic methods have fair agreements for test results. (Kappa score, 0.3). Test failure rates ranged from 2.6% to 13.4% and positivity rate from 6.5-49%. Number of cartridge needed for one positive case to diagnose ranged from 2.3 to 10.2. Nearly 17% of smear negative samples were detected positive by gene X-pert technology. Lack of effective supply chain management and maintenance from NTC as well as problem in stock verification for timely demand of cartridge by the gene X-pert centers was found to be the main reason for effective implementation of gene X-pert MTB/RIF in Nepal. Similarly, poor laboratory infrastructure for running gene X-pert equipment was also challenge for proper implementation and scale up. Conclusion Expansion and improvement of existing gene X-pert centers is necessary in Nepal to minimize the missing cases from smear microscopy and increasing TB case detection.

Background Tuberculosis is major public health problem in low and middle-income countries. Early detection and enrolment of missing cases of TB is challenge for National tuberculosis program. Optimum utilization of novel diagnostic tool, gene X-pert MTB/RIF can contribute for increased TB detection. Objective To describe the results and challenges of gene X-pert MTB/RIF diagnosis in eligible presumptive TB patients within Nepal NTP. Design Descriptive, mixed method (explanatory sequential design) implementation research conducted between March and June 2017, collecting secondary data and in-depth interviews with patients, NTP focal persons and partners. Focus group discussion with stakeholders. Results A total of 23,075 gene X-pert tests with 22,288 people tested by both gene X-pert and sputum microscopic method between 17 July 2015 and 16 July 2016. Among these, 77% of the of the patients have same results (positive or negative for TB) from both diagnostic tools. The two diagnostic methods have fair agreements for test results. (Kappa score, 0.3). Test failure rates ranged from 2.6% to 13.4% and positivity rate from 6.5-49%. Number of cartridge needed for one positive case to diagnose ranged from 2.3 to 10.2. Nearly 17% of smear negative samples were detected positive by gene X-pert technology. Lack of effective supply chain management and maintenance from NTC as well as problem in stock verification for timely demand of cartridge by the gene X-pert centers was found to be the main reason for effective implementation of gene X-pert MTB/RIF in Nepal. Similarly, poor laboratory infrastructure for running gene X-pert equipment was also challenge for proper implementation and scale up. Conclusion Expansion and improvement of existing gene X-pert centers is necessary in Nepal to minimize the missing cases from smear microscopy and increasing TB case detection.

Kata Kunci : TB, X-pert, NTP, IR, microscopy, TB detection, Barriers