Comparative Evaluation and Measure of Accuracy of ELISAs, CLIAs, and ECLIAs for the Detection of HIV Infection among Blood Donors in China

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.

Enzyme-Linked Immunosorbent Assay versus Chemiluminescent Immunoassay: A General Overview

“…Both ELISA and CLIA were more specific and accurate [12] Comparison of CLIA, ELISA and passive agglutination for diagnosis of Mycoplasma pneumoniae infection.…”

Nine-month course of SARS-CoV-2 antibodies in individuals with COVID-19 infection

“…Unlike IgG antibody and total antibody tests, IgM antibody and IgA antibody tests generally have a specificity of less than 99 percent [ 16 ]. The anti-N and anti-S tests used in our study work with the ECLIA method and can be considered reliable since they show high sensitivity and specificity rates and a relatively narrow confidence interval [ 11 , 15 , 16 ]. Regarding the COVID-19 antibody tests, the Infectious Diseases Society of America (IDSA) recommends using IgG only or total antibody tests since their accuracy is higher, instead of IgM only or IgA only tests [ 10 , 16 ].…”

Comparison of three serological chemiluminescence immunoassays for SARS-CoV-2, and clinical significance of antibody index with disease severity

“…quantification, could be one of the causes of these discrepancies. In general, it has been reported that CLIA has higher specificity and accuracy than quantitative methods such as ELISA and agglutinin for the detection of many viruses [19][20][21]. The quantitative values calculated by automated chemiluminescence instruments could be more consistent and wider than those measured by ELISA in earlier studies and would achieve a better correlation with clinical features.…”

“…For all specimens, 0.3 mL was aliquoted into microtubes and stored at -70˚C before testing. The median number of samples per patient was 6.0 (95% CI = 3.35-6.0), and the median follow-up period was 17 days (95% CI = [15][16][17][18][19][20][21]. This study was approved by the Institutional Review Board (IRB) of Kangnam Sacred Heart Hospital of Hallym University (IRB No.…”