Market penetration of Xpert MTB/RIF in high tuberculosis burden countries: A trend analysis from 2014 - 2016

Abstract

Background: Xpert® MTB/RIF, a rapid tuberculosis (TB) molecular test, was endorsed by the World Health Organization in 2010. Since then, 34.4 million cartridges have been procured under concessional pricing. Although the roll out of this diagnostic is promising, previous studies showed low market penetration. Methods: To assess 3-year trends of market penetration of Xpert MTB/RIF in the public sector, smear and Xpert MTB/RIF volumes for the year 2016 were assessed and policies from 2014-2016 within 22 high-burden countries (HBCs) were studied. A structured questionnaire was sent to representatives of 22 HBCs. The questionnaires assessed the total smear and Xpert MTB/RIF volumes, number of modules and days of operation of GeneXpert machines in National TB Programs (NTPs). Data regarding the use of NTP GeneXpert machines for other diseases and GeneXpert procurement by other disease control programs were collected. Market penetration was estimated by the ratio of total sputum smear volume for initial diagnosis divided by the number of Xpert MTB/RIF tests procured in the public sector. Results: The survey response rate was 21/22 (95%). Smear/Xpert ratios decreased in 17/21 countries and increased in four countries, since 2014. The median ratio decreased from 32.6 (Q1:14.3, Q3: 58.9) in 2014 to 6.0 (Q1: 1.6, Q3: 17.0) in 2016. Nineteen countries (19/19; 100%) were not using GeneXpert machines to their full capacity, however seven countries (7/19; 37%) were running tests for other diseases on their NTP-procured GeneXpert systems in 2017, such as HIV, hepatitis-C virus (HCV), Chlamydia trachomatis, and Neisseria gonorrhoeae. Five (5/15; 33%) countries reported GeneXpert procurement by HIV or HCV programs in 2016 and/or 2017. Conclusions: Our results show a positive trend for Xpert MTB/RIF market penetration in 21 HBC public sectors. However, GeneXpert machines were under-utilized for TB, and inadequately exploited as a multi disease technology.

Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults

“…The uptake has been much faster than for any other tuberculosis technology recommended by the WHO over the last 10 years. A recent survey of market penetration of Xpert MTB/RIF in high tuberculosis burden countries found greater use of Xpert MTB/RIF compared to smear microscopy for tuberculosis diagnosis ( Cazabon 2018 ).…”

Integrated use of the GeneXpert Platform for TB, HIV and EVD Testing in Liberia

“…A result of this integrated use, 3695 MTB/RIF tests were conducted during the study period. The utilization rate of MTB/RIF is very low in Liberia compared to the utilization rate of the 21-high burden countries [23].…”

Delayed recognition of Ebola virus disease is associated with longer and larger outbreaks

“…Utilization of the Gen-eXpert platform for EVD diagnostics is an example of a value-added approach, as a large network of these machines has been deployed through a WHOcoordinated effort for detection of multidrug-resistant TB, and is therefore also accessible for EVD diagnostics [77]. DRC began implementing GeneXperts for tuberculosis diagnostics at regional facilities in 2013, and hundreds of these instruments are already available and in use in numerous provinces across the country [78][79][80]. Furthermore, diagnosis of the first patients in the ongoing outbreak was accomplished with a GeneXpert, although this required shipment of the samples to the Institut National de Recherche Biomédicale in Kinshasha [81].…”