A comparative analysis between NAT and chemiluminescence in detection of transfusion transmitted viruses in two main university blood transfusion centers

Abstract Nucleic acid amplification Testing (NAT) is expected to minimize the potential risk of transfusion transmitted infections (TTIs) which escaped the detection by serologic screening. Therefore, the aim was to assess the seroprevalence of TTIs (HCV, HBV and HIV) in voluntary blood donors and to verify the accuracy of chemiluminescence (CLIA) test versus NAT as confirmatory test for more safe blood donations in two main university (Mansoura and Assiut) blood transfusion centers in Egypt. A retrospective analysis was done for 87,620 specimens from healthy voluntary blood donors by NAT and CLIA techniques in Mansoura (12,464) and Assiut (75,156) blood transfusion centers. The prevalence of viral reactivity by CLIA was 2.49% (0.77%, 1.69% and 0.03% for HBV, HCV and HIV respectively) and by NAT was 2.25% (HBV 0.71%, HCV 1.52% and HIV 0.02%). The CLIA seroreactivity for HBV was found in 676 samples versus 621 by NAT (589 true positive, 87 false positive and 32 false negative). HCV reactivity was detected in 1477 by CLIA versus 1328 by NAT (1305 true positive, 172 false positive and 23 false negative). HIV results showed (CLIA/NAT) 22 versus 19 reactive samples (19 true positive, 3 false positive and 0.0 false negative). Comparison of CLIA and NAT results as regards the accuracy revealed 99.86% ,99.78%, and 100% for HBV, HCV, and HIV respectively. The CLIA and NAT techniques showed perfect agreement for detection of HCV (kappa = 0.929), HBV detection (kappa = 0.907) and HIV detection (kappa = 0.900). NAT implementation with CLIA increased blood transfusion safety with the advantage of direct sequence specific detection of virus genome. Therefore, it is a critical role to adopt NAT technology in all blood transfusion centers in Egypt.