Abstract
Background Enzyme-linked immunosorbent assay (ELISA) is the only serological method approved for blood screening in China. Automated chemiluminescence immunoassay (CLIA) and electrochemiluminescence immunoassay (ECLIA) had been used in clinical laboratories but not applied to screen HIV among blood donors. This study aimed to evaluate the performance of ELISA, CLIA, and ECLIA, focusing on the feasibility of CLIA/ECLIA for blood screening. Method 1029 blood donations from 14 blood centers screened by ELISA were enrolled in the study. All plasma samples were tested by eight ELISA assays in 16 blood centers, followed by the detection of CLIA and ECLIA methods in the National Center for Clinical Laboratories (NCCL), further confirmed by nucleic acid testing (NAT) and Western blot (WB). Results Of 1029 samples, 136 were confirmed as HIV positive. CLIA and ECLIA assay had similar sensitivities with ELISAs but showed higher specificity (CLIA: 99.1%, 885/893; ECLIA: 99.0%, 884/893), concordance rate (CLIA: 99.2%, 1021/1029; ECLIA: 99.1%, 1020/1029), and positive predictive value (PPV) (CLIA: 94.4%, 136/144; ECLIA: 93.8%, 136/145) than most of ELISA kits (>5 ELISAs) (P < 0.05). Kappa values of CLIA (0.967) and ECLIA (0.963) were the highest among all the serologic assays. Among 451 samples with initial ELISA reactivity, 315 were negatives, of which 307 (97.5%) and 306 (97.1%) were detected as nonreactive by CLIA (8 nonspecific reactions) and ECLIA (9 nonspecific reactions), respectively. Conclusion Compared with ELISA, CLIA and ECLIA are more specific and accurate in detecting HIV antibody/antigen and can keep more nonspecifically reactive donors detected by ELISA. CLIA and ECLIA can be used for the improvement of serological blood screening strategy to avoid the unnecessary loss of blood donors.
Highlights
Enzyme-linked immunosorbent assay (ELISA) is the only serological method approved for blood screening in China
From March 2015 to September 2015, 1029 blood donations detected as HIV reactive using one or two ELISAs which were collected from 14 blood centers or blood banks and were screened for HIV. e number of blood donations was equal to the number of blood donors
No significant differences found in sensitivity and negative predictive value (NPV) between 8 ELISAs and chemiluminescence immunoassay (CLIA)/electrochemiluminescence immunoassay (ECLIA) (P < 0.05); Kappa values of CLIA (0.967) and ECLIA (0.963) were the highest among all the serologic assays
Summary
Enzyme-linked immunosorbent assay (ELISA) is the only serological method approved for blood screening in China. Automated chemiluminescence immunoassay (CLIA) and electrochemiluminescence immunoassay (ECLIA) had been used in clinical laboratories but not applied to screen HIV among blood donors. All plasma samples were tested by eight ELISA assays in 16 blood centers, followed by the detection of CLIA and ECLIA methods in the National Center for Clinical Laboratories (NCCL), further confirmed by nucleic acid testing (NAT) and Western blot (WB). Compared with ELISA, CLIA and ECLIA are more specific and accurate in detecting HIV antibody/antigen and can keep more nonspecifically reactive donors detected by ELISA. CLIA and ECLIA can be used for the improvement of serological blood screening strategy to avoid the unnecessary loss of blood donors. ELISA is the only approved serological assay for HIV screening among blood donations in China. Antibody or antigen concentration is determined by the emitted light of antigenantibody reaction and measured using light reader [6,7]
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