Evaluation of the mindray CL900i CLIA HIV Ag/Ab combo assay for sensitive and specific HIV screening compared to established methods

Autor: Gheyath K. Nasrallah, Nadin Younes, Hadiya M. Khalid, Jawaher A. Al-Emadi, Salma Younes, Mazen Najib Abouassali, Manal Abdelmutaal Elshaikh, Ibrahim Wisam Karime, Mohammed Abdelfatah Ibrahim, Mutaz Mohamed Ali, Ibrahim Al Shaar, Na Liu, Houssein Ayoub, Hadi M. Yassine, Laith J. Abu-Raddad, Ahmed Ismail
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Scientific Reports, Vol 14, Iss 1, Pp 1-8 (2024)
Druh dokumentu: article
ISSN: 2045-2322
DOI: 10.1038/s41598-024-78271-z
Popis: 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.
Databáze: Directory of Open Access Journals
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