ArticleAmerican journal of clinical pathology2019
Analytical and Clinical Performance Evaluation of the Elecsys HIV combi PT Assay on the cobas e 602 Analyzer for the Diagnosis of Human Immunodeficiency Virus.
Article in American journal of clinical pathology, 2019. 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, 7 citations in OpenAlex.
- Analytical and clinical performance evaluation of the Wantai chemiluminescence microparticle immunoassay on the Wan200 + analyzer for diagnosing HIV.Scientific reports · 2025Article
- HIV testing algorithm using fourth generation reagents reduces the false positive rate of screening tests.Scientific reports · 2025Article
- An Analysis of Predictive Sample-to-Cutoff Index for HIV Infection Confirmation Using Elecsys® HIV Combi PT Assay.International journal of clinical practice · 2022Article
- Data on the Relationships of Signal-To-Cutoff Ratios of Elecsys HIV Antigen/Antibody and Elecsys Syphilis Assays to Subsequent Confirmatory Testing at an Academic Medical Center.Data in brief · 2021Article
- Article
- The evaluation of low cut-off index values of ElecsysJournal of clinical laboratory analysis · 2020Article
Corrections and comments
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Authors and funding
9 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesWe evaluated the performance of the Elecsys HIV combi PT assay on the cobas e 602 analyzer for diagnosing human immunodeficiency virus (HIV; part of the US Food and Drug Administration [FDA] submission).
methodsThe HIV combi PT and reference (ARCHITECT HIV Ag/Ab Combo) assays were assessed at four independent clinical laboratories/one reference laboratory (United States; July 2014 to November 2015). Clinical performance was evaluated using four reagent lots. Analytical performance was evaluated per Clinical and Laboratory Standards Institute EP05-A3 guidelines. Serum/plasma samples from 18 clinical sites/vendors (United States and outside the United States) were tested.
resultsSensitivity (95% confidence interval [CI]) in HIV-1 antibody-positive individuals (United States and outside the United States; n = 1,460) was 100.00% (99.75%-100.00%). Specificity was 99.94% (95% CI, 99.85%-99.98%) in low-risk individuals (United States; n = 6,843), 98.19% (95% CI, 96.93%-99.04%) in high-risk individuals (United States and outside the United States; n = 758), and 97.43% (95% CI, 95.32%-98.76%) in pregnant women (United States and outside the United States; n = 440). Analytical performance was acceptable.
conclusionsWe demonstrate the robustness of the FDA-approved Elecsys HIV combi PT assay on the cobas e 602 analyzer for HIV testing in the United States.
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