Abstract:
BACKGROUND : Developing countries experience limited access to HCV laboratory tests for different reasons.
Providing near to real–time HCV testing and results especially to at–risk populations including those in rural
settings for timely initiation to treatment is key. Within a rural Myanmar setting, we compared HCV diagnostic
detection and quantification of the GeneXpert, and Advanced Biological Laboratories UltraGene–HCV assays
against the gold standard and reference method Roche real–time HCV in Myanmar.
METHODS : Blood samples from 158 high–risk individuals were assessed using three different methods at baseline.
Results were checked for normality and log transformed. Log differences and bias between methods were
calculated and correlated. Pearson’s correlation coefficient was used to determine the association of HCV viral
loads across all methods. The level of agreement with the standard method (Roche real time HCV) was assessed
using Bland–Altman analyses.
RESULTS : There was a strong positive correlation coefficient between all three methods with GeneXpert and Roche
having the strongest, r = 0.96, (p<0.001). Compared to Roche, ABL (mean difference, 95 % limits of agreement;
-0.063 and -1.4 to 1.3 Log10IU/mL) and GeneXpert (mean difference, 95 % limits of agreement; -0.28 and -0.7 to
1.8 Log10IU/mL) showed a good level of agreement with the GeneXpert being slightly superior.
CONCLUSION : We demonstrate the excellent performance and no-inferiority, in terms of levels of agreements of both
GeneXpert and ABL compared to the Roche platform and supporting the use of the POC assays as alternative a
cost-effective methods in HCV detection and diagnosis in developing and low resource settings countries.
