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

被引:6
|
作者
Uettwiller-Geiger, Denise L. [1 ]
Lessig, Marvin [2 ]
An, Jie [3 ]
Barsch, Tara [1 ]
Smith, Susan [4 ]
Walker, Sharan [4 ]
Riedel, Alexander [5 ]
Hao, Yi [5 ]
Mohammad, Amin A. [3 ]
机构
[1] Mather Hosp Northwell Hlth, Port Jefferson, NY 11777 USA
[2] Nationwide Lab Serv, Boca Raton, FL USA
[3] Baylor Scott & White Hlth, Temple, TX USA
[4] Roche Diagnost, Indianapolis, IN USA
[5] Roche Diagnost, Penzberg, Germany
关键词
Specificity; Sensitivity; HIV-1; HIV-2; HIV p24 antigen; HIV immunoassay; ANTIBODY; ANTIGEN;
D O I
10.1093/ajcp/aqy153
中图分类号
R36 [病理学];
学科分类号
100104 ;
摘要
Objectives We 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). Methods The 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. Results Sensitivity (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. Conclusions We 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.
引用
收藏
页码:377 / 385
页数:9
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