ArticleScientific reports2024
Evaluation of the mindray CL900i CLIA HIV Ag/Ab combo assay for sensitive and specific HIV screening compared to established methods.
Article in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed.
- Comparative Evaluation of CLIA and ELISA Serological Assays for HSV-1 IgG With Western Blot Confirmation in a Clinical Cohort: A Cross-Sectional Study.Health science reports · 2026Article
- Strengthening STD Screening Programs: Comprehensive Evaluation of High-Throughput Immunoassays for HIV and Syphilis Detection.Microorganisms · 2026Article
- Understanding indeterminate HIV serology through antigen-band pattern analysis of INNO-LIA and recomLine HIV confirmatory assays.Scientific reports · 2026Article
- Consistent performance of cytomegalovirus IgG assays across platforms contrasts with marked IgM variability, supporting IgG avidity-based infection classification in a high-prevalence population.Scientific reports · 2026Article
- Advancing HIV Diagnostics: Comparative Evaluation of Multisure HIV-1/2 Rapid Confirmatory Test Against Geenius and Traditional Reference Assays Within a CDC-Aligned Diagnostic Framework.Microorganisms · 2026Article
- Accre 8 emerging point of care CLIA system for vitamin B12 assessment compared with three established assays.Scientific reports · 2025Article
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Authors and funding
16 authors.
Funding
Abstract
Architect-HIV Ag/Ab combo chemiluminescence assay is globally recognized for its sensitivity but has a notable false-positive rate. In this study, we aim to evaluate the performance of a new cost-effective screening alternative, the chemiluminescence Ag/Ab combo assay (CL-900i-HIV) from Mindray, China. We selected 195 archived samples categorized according to the INNO-LIA™ HIV I/II, the gold standard confirmatory assay. These samples included true positive (n = 38; positive by Architect-HIV & INNO-LIA-HIV), true negative (n = 101; negative by Architect-HIV & INNO-LIA-HIV), false positive (n = 20; positive by Architect-HIV & negative by INNO-LIA-HIV), and indeterminate results (n = 26). We tested all samples using the Mindray CL-900i-HIV and all positive Architect-HIV samples (n = 80) were confirmed by PCR. Compared to INNO-LIA™ HIVI/II line immunoassay confirmatory assay, Mindray CL-900i-HIV demonstrated a sensitivity of 100% (95% CI 90.7-100), specificity of 100% (95% CI 97.0-100), overall percent agreement (OPA) of 100% (95% CI 97.7-100.0), and perfect agreement with the INNO-LIA confirmatory assay (κ = 1.00). Additionally, Mindray's CL-900i-HIV exhibited a significantly lower false-positive rate (8.75%) compared to Architect-HIV's (55%). Mindray CL900i demonstrated high sensitivity and very low false-positive rate, thus, has the potential to serve as an excellent, cost-effective surrogate for HIV screening, overcoming the limitations of existing automated assays.
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