Laboratory evaluation of rapid test kits to detect hepatitis C antibody for use in predonation screening in emergency settings
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Le résumé fourni par la source
BACKGROUND: Emergency whole blood transfusion is a lifesaving procedure employed on modern battlefields. Rapid device tests (RDTs) are frequently used to mitigate transfusion-transmitted infection risks. STUDY DESIGN AND METHODS: A limited evaluation of the RDT formerly used on battlefields was performed using 50 donor plasma samples and commercially available panels. Five hepatitis C virus (HCV) RDTs with sufficient stated sensitivity and thermostability were assessed using 335 HCV-positive and 339 HCV-negative donor plasma samples, 54 seroconversion panel plasma samples, and 84 HCV-positive and 84 HCV-negative spiked whole blood under normal, hot, and cold storage conditions and normal and hot test conditions, plus an ease-of-use survey. RESULTS: BioRapid HCV test sensitivity on donor plasma was 84% (95% confidence interval [CI], 70.9%-92.8%). Using all positive plasma samples, OraQuick HCV sensitivity exceeded all comparators (99.4%, 95% CI, 98.0%-99.9%, p<0.05). Specificity was consistently high, led by OraQuick HCV at 99.7% (95% CI, 98.6%-100%), statistically superior only to Axiom HCV (p<0.05). Using seroconversion panels, only OraQuick HCV showed equivalent or earlier HCV detection compared to the gold standard. Using spiked whole blood, specificity was consistently high, and sensitivity ranged significantly from 34.5% (95% CI, 25.0%-45.1%) for CORE HCV to 98.8% (95% CI, 94.3%-99.9%) for OraQuick HCV. All comparator RDTs were significantly less sensitive than OraQuick HCV at one or more stress condition. CONCLUSION: This HCV RDT comparison identified significant sensitivity differences, particularly using whole blood under extreme storage and testing conditions. These data support OraQuick HCV superiority and illustrate the value of RDT evaluation under simulated field conditions.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Laboratory evaluation of rapid test kits to detect hepatitis C antibody for use in predonation screening in emergency settings
- Date Crossref
- 23/07/2012
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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United States Department of the Army pays non établi dans la noticeOrganisme public
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American Red Cross pays non établi dans la noticeOrganisation à but non lucratif
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U.S. Army Medical Center of Excellence pays non établi dans la noticeOrganisme public
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Walter Reed Army Institute of Research pays non établi dans la noticeOrganisme public
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the Department of Blood Research pays non établi dans la noticeInstitution
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the US Armed Services Blood Program pays non établi dans la noticeInstitution
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the US Army Blood Program pays non établi dans la noticeInstitution
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the US Army Medical Department Center and School pays non établi dans la noticeInstitution
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the US Military HIV Research Program pays non établi dans la noticeInstitution
United States Department of the Army, American Red Cross et U.S. Army Medical Center of Excellence, avec 6 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.