Objective This study aimed to evaluate the impact of combined use of chemiluminescent immunoassay CLIA and nucleic acid amplification testing NAAT to improve transfusion transmitted Hepatitis B Virus HBV, Hepatitis C virus HCV and Human Immunodeficiency Virus–1 HIV–1 among blood donors in Pakistan Design Retrospective, single center observational Setting Regional blood center at tertiary care hospital in urban Pakistan Participants All adults of 18 years or above who were eligible to donate blood after meeting the pre-donation screening criteria during the study period (26,778) Outcome Measures Primary outcome measure was to estimate the incremental yield of HBV, HCV, and HIV–1 infections using combined CLIA and NAAT compared to CLIA alone per 100,000 donations Secondary outcome was to calculate inter-test agreement and discordance between CLIA and NAAT methods Results Among 26,778 donors, the combined CLIA and NAAT testing detected a total of 2,423·6 viral infections per 100,000 donations, NAAT alone contributed 739·7 per 100,000 of these For HBV, NAAT uniquely detected 489/100,000 additional cases missed by CLIA, the combined detection rate was 1,561 per 100,000. For HCV, NAAT only yield was lower 247 per 100,000, with total detection of 825·3 per 100,000. HIV–1 was rare in the donor pool, incremental NAAT yield was 3·7 per 100,000, with a combined detection rate of 37·3per 100,000. Agreement between tests was substantial for HBV (κ–0·63) and moderate to fair for HCV (κ–0·47) and HIV–1 (κ–0·40). The discordant cases detected by NAAT alone for HBV, HCV and HIV–1 were 183, 431 and 37 respectively. McNemar test showed statistically significant differences across all markers, with large effect sizes for HIV–1 (0·92, 95percent CI: 0·80–1·00) and HCV (0·69, 95percent CI: 0·65–0·73). Conclusion Integrating CLIA with NAAT enhanced the detection of HBV, including occult and window period infections, and refined estimates of active HCV and HIV–1 infections which significantly improved blood transfusion safety.
Ata et al. (Wed,) studied this question.