| A comprehensive evaluation of the proficiency testing program for the HIV-1 BED incidence assay. | |
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MedLine Citation:
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PMID: 21832016 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The HIV-1 BED incidence assay was developed at the Centers for Disease Control and Prevention and since 2005 has been available as a commercial kit for use in HIV-1 incidence surveillance. A BED-specific proficiency testing (PT) program was initiated in 2006 that included a panel of eight coded specimens (six unique and two duplicates) to participating laboratories. The number of participating laboratories increased from 12 to 38 from 2006 to 2009. Overall, 96.1% of the laboratories reported results, and 95.4% of those reporting achieved a 100% score. The observed mean normalized optical density (OD-n) values of all participants correlated well with the expected OD-n values for all specimens (R(2) = 0.98) used for seven PT rounds. BED testing demonstrated high reproducibility among all laboratories, with an agreement of 99.3% (574/578) between initial and confirmatory classification and regression statistics of R(2) = 0.96, slope = 1.022, and intercept = 0.0066. Reproducibility among duplicate specimens was very high during each PT round, with mean deviation of 1.8%. Analysis of controls and calibrator specimen for all 343 runs showed a coefficient of variation of ca. 20% for raw ODs in the dynamic range, which was reduced to <10% when the OD was normalized (OD-n). Most laboratories that failed the PT assessment had transcriptional errors, kit reagent problems, or specimen handling errors. Thus, the BED-specific PT program enabled us to track performance of different laboratories conducting the BED assay while identifying areas for improvements. This program will also serve as a template for future PT programs for new incidence assays as they become available. |
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Authors:
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Trudy Dobbs; Xin Liu; Rebecca Anderson; John Nkengasong; Bharat S Parekh |
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Publication Detail:
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Type: Evaluation Studies; Journal Article; Multicenter Study; Research Support, U.S. Gov't, P.H.S. Date: 2011-08-10 |
Journal Detail:
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Title: Journal of clinical microbiology Volume: 49 ISSN: 1098-660X ISO Abbreviation: J. Clin. Microbiol. Publication Date: 2011 Oct |
Date Detail:
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Created Date: 2011-09-30 Completed Date: 2012-01-23 Revised Date: 2012-04-02 |
Medline Journal Info:
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Nlm Unique ID: 7505564 Medline TA: J Clin Microbiol Country: United States |
Other Details:
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Languages: eng Pagination: 3470-3 Citation Subset: IM |
Affiliation:
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International Laboratory Branch, Division of Global HIV/AIDS, Centers for Disease Control and Prevention, 1600 Clifton Rd., Atlanta, GA 30329, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Clinical Laboratory Techniques
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methods*,
standards* HIV Antibodies / blood HIV Infections / diagnosis*, epidemiology* HIV-1 / genetics, isolation & purification* Humans Immunoenzyme Techniques / methods, standards Immunoglobulin G / blood Incidence Observer Variation Quality Control Reproducibility of Results Virology / methods*, standards* |
| Chemical | |
Reg. No./Substance:
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0/HIV Antibodies; 0/Immunoglobulin G |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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