Xpert MTB/RIF assay for the diagnosis of Mycobacterium tuberculosis and its Rifampicin resistance at Felege Hiwot and Debre Tabor Hospitals, Northwest Ethiopia: A preliminary implementation research

Abstract

Abstract
Background: The World Health Organization endorsed GeneXpert MTB/RIF (Xpert) assay for the diagnosis of tuberculosis (TB) and multidrug resistant tuberculosis (MDR-TB) in 2010. However, the practice of using this novel diagnostic method is still limited in a high TB and human immunodeficiency virus (HIV) burden settings, including Ethiopia. Therefore, we conducted this study aimed at describing the first implementation status of Xpert assay in the diagnosis of TB and MDR-TB at Felege Hiwot Referral Hospital (FHRH) and Debre Tabor General Hospital (DTGH), Northwest Ethiopia.
Methods: We analyzed the records of 1922 (FHRH=544 and DTGH=1378) presumptive TB patients diagnosed using Xpert test from 1 November 2015 to 30 April 2016 at FHRH and DTGH, Northwest Ethiopia. All patients who had registered data on their sex, age, HIV status, presumptive MDR-TB status and Xpert results were included for analysis. Data were retrieved directly from GeneXpert result registration log book using data extraction sheet. Data were entered, cleaned, and analyzed using SPSS statistical software package; p < 0.05 was considered to be significant.
Results: Overall Xpert assay properly diagnosed 14.6% of the cases (258/1922). Among these, rifampicin (RIF) resistance was detected at 9.3% (24/258). In the studied settings, clinical data showed that 81.0% (1556/1922) of the cases were MDR- TB. Among the study subjects, 888 (46.2 %) of them were HIV positive. However, TB-HIV co-infection rate was at 41.9% (108/258). Of the total patients registered, 1005 (52.3%) of whom were males. The mean age of patients was 31.1 years with SD of 17.5. Significant predictors of the Xpert test were: age (p=0.000), sex (p=0.009), HIV status (p=0.003) and presumptive MDR-TB (p=0.000).
Conclusions: In the studied areas, large proportion of clinically TB suspected patients were wrongly diagnosed with MDR-TB. Therefore, the use of Xpert assay in health settings with no culture facility will decrease the unnecessary use of anti-TB drugs and improve rapid TB, and MDR-TB detection and proper management of the cases. [Ethiop. J. Health Dev. 2016;30(2):60-65]
Key Words: TB, GeneXpert, MTB/RIF assay, Northwest Ethiopia.