Performance Evaluation for the HBVAND HCV Detection Protocols That Are Used By the Medical Commission Diagnostic Laboratory in Qatar

Abstract

Background: Viral Hepatitis is regarded as a serious concern to human wellbeing, affecting millions of individuals yearly. The leading cause of this disease is the infection of Hepatitis A, B, C, D, and E. Consequently, leading to several complications, including liver cirrhosis and tumor formation. The World Health Organization (WHO) estimated that one in three people around the globe have been infected by either HBV or HCV. Objectives: We aim to achieve the highest level of accuracy and reliability of our testing, and to evaluate the primary and secondary tests used to diagnose HBV and HCV at the medical commission of Qatar. Methods: This retrospective study was conducted based on recorded laboratory results for hepatitis B (n=1061) and hepatitis C (n=1399) during the period of January 1, 2019, to December 31, 2019. The obtained data for hepatitis B included ARCHITECT immunoassay; while the hepatitis C data included ARCHITECT immunoassay, INNOLIA (line immune Assay), and Polymerase chain reaction (PCR). Results: A total of 334.313 HBV and 334.312 HCV cases were analyzed in Medical commission during 2019. Data analysis was done on a total of 1061 and 1399 positive individuals who were previously screened for HBV and HCV, respectively. Our HBV results showed high reproducibility and reliability of the Architect assay as indicated by the 100% overall percent agreement and positive percent agreements between the different runs of the test as well as different Architect analyzers. Regarding HCV results, our analysis indicated that Architect did not show a high percent agreement with those of PCR (overall percent agreement and PPV was 5.77%). Conclusion: The study illustrated that the agreement percentage was the highest for Ant-HBS and Anti-HCV with excellent performance for the Architect system. It demonstrated high specificity and 99.91% overall agreement with different Architect analyzers. and 100% positive predictive agreement. Yet, Architect had 67.20% overall agreement between HBsAg round 2 final positive and Architect neutralization test. Regarding HCV testing, the Architect demonstr ated high specificity with a 100% overall agreement between round 1 and round 2 of anti-HCV testing. Besides, it showed a 100% positive predictive agreement between Architect anti-HCV round 2 and PCR as well as Architect anti-HCV round 2 and INNO-LIA HCV. Yet, the overall agreement were 5.77% and 28.32%, respectively. In addition, the evaluation of INNO-LIA HCV and PCR showed a 100% positive predictive value with 79.22% overall agreement. The results showed that the procedures of the Medical commission testing platform gives precise and reproducible results. Therefore, there is no advantage gained from repeating Architect analysis, and it is recommended to healthcare facilities in Qatar to use Architect only one time. In this manner, we would be able to successfully save our limited resources while reducing cost and time for future testing procedures.