Dataset Information

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.

ABSTRACT:

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.

SUBMITTER: Uettwiller-Geiger DL

PROVIDER: S-EPMC6396746 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Publications

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.

Uettwiller-Geiger Denise L DL Lessig Marvin M An Jie J Barsch Tara T Smith Susan S Walker Sharan S Riedel Alexander A Hao Yi Y Mohammad Amin A AA

American journal of clinical pathology 20190301 4

<h4>Objectives</h4>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).<h4>Methods</h4>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 ...[more]

PMID: 30423023

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Project description:Histoplasmosis is an important cause of mortality in people with advanced HIV, especially in countries with limited access to diagnostic assays. Histoplasmosis can be diagnosed using culture, histopathology, and antibody, antigen, and molecular assays. Several factors may affect the analytical performance of these laboratory assays, including sample type, clinical stage of the disease, and previous use of antifungal treatment, among others. Here we describe the results of a systematic literature review, followed by a meta-analysis of the analytical performances of the diagnostic laboratory assays employed. Our initial search identified 1631 references, of which 1559 references were excluded after title and abstract screening, leaving 72 references identified as studies relevant to the validation of histoplasmosis diagnostic assays. After evaluating the full text, 30 studies were selected for final review, including one paper not identified in the initial search. The meta-analysis for assay analytical performance shows the following results for the overall sensitivity (Sen) and specificity (Spe) of the various methods evaluated: Culture, Sen 77% (no data for specificity calculation); antibody detection assays, Sen 58%/Spe 100%; antigen detection assays, Sen 95%/Spe 97%; and DNA detection assays (molecular), Sen 95%/Spe 99%. Of the 30 studies reviewed, nearly half (n = 13) evaluated Histoplasma antigen assays, which were determined to be the most accurate methodology for diagnosis of progressive disseminated histoplasmosis in advanced HIV (inverse of the negative likelihood ratio was 13.2). Molecular assays appear promising for accurate diagnosis of histoplasmosis, but consensus on exact techniques is needed. Cultures showed variable sensitivity related to sample type and laboratory handling. Finally, antibody assays presented high specificity but low sensitivity. This poor sensitivity is most likely due the highly immunosuppressed state of this patient population. Diagnostic assays are crucial for accurate diagnosis of progressive disseminated histoplasmosis (PDH) with advanced HIV disease.

Dataset Information

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.

Objectives

Methods

Results

Conclusions

Publications

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.

Similar Datasets

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