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Performance of three automated fourth-generation combined HIV antigen/antibody assays in large-scale screening of blood donors and clinical samples
Örebro University, School of Health and Medical Sciences. Örebro University Hospital, Örebro, Sweden.
Karolinska University Hospital, Solna, Sweden.
Örebro University Hospital, Örebro, Sweden; Swedish Institute for Infectious Disease Control, Stockholm, Sweden.
2009 (English)In: Transfusion Medicine, ISSN 0958-7578, E-ISSN 1365-3148, Vol. 19, no 2, 78-88 p.Article in journal (Refereed) Published
Abstract [en]

Since the introduction in the mid-1980s, HIV testing has gradually improved both in terms of sensitivity and specificity. The so-called fourth generation of tests, combined HIV antigen/antibody assays, has now been introduced. This study compares three automated combined assays with older third-generation antibody assays in large-scale screening. Serum samples from routine screening of blood and plasma donors and clinical samples were investigated for specificity evaluation. Three fourth-generation combination assays from one manufacturer were compared with three older third-generation antibody assays from the same manufacturer. More than 40 000 samples per assay were included. For sensitivity, selected panels of confirmed HIV-1- and HIV-2-positive samples as well as seroconversion samples (HIV-1) from commercial panels and also from patients who appeared during the evaluation were used. The specificities of the fourth-generation tests were 99.91% (AxSYM), 99.95% (ARCHITECT) and 99.97% (PRISM) after repeated testing. Some specificity variation between reagent batches was observed. All HIV-1-positive samples were reactive by the three fourth-generation systems. HIV-1 seroconversion samples and panels were reactive earlier than by antibody-only tests. As for HIV-2 samples, AxSYM failed to detect one (n = 40), whereas PRISM and ARCHITECT detected all (n = 16 for PRISM and n = 52 for ARCHITECT). The new HIV antigen/antibody combination assay systems were found to have high sensitivity and specificity. The instruments provided a rational and easy way of testing at large scale.

Place, publisher, year, edition, pages
2009. Vol. 19, no 2, 78-88 p.
National Category
Medical and Health Sciences Microbiology in the medical area
Research subject
Medicine
Identifiers
URN: urn:nbn:se:oru:diva-12085DOI: 10.1111/j.1365-3148.2009.00907.xISI: 000265377900004PubMedID: 19320855Scopus ID: 2-s2.0-65249166119OAI: oai:DiVA.org:oru-12085DiVA: diva2:355166
Available from: 2010-10-05 Created: 2010-10-05 Last updated: 2017-12-12Bibliographically approved
In thesis
1. Diagnostic strategies for blood borne infections in Sweden
Open this publication in new window or tab >>Diagnostic strategies for blood borne infections in Sweden
2015 (English)Doctoral thesis, comprehensive summary (Other academic)
Place, publisher, year, edition, pages
Örebro: Örebro university, 2015. 83 p.
Series
Örebro Studies in Medicine, ISSN 1652-4063 ; 124
Keyword
blood borne infections, screening assays, blood donors, HIV, HTVL-1/2, Hepatitis C, Syphilis
National Category
Microbiology in the medical area
Identifiers
urn:nbn:se:oru:diva-44303 (URN)978-91-7529-080-5 (ISBN)
Public defence
2015-05-29, Universitetssjukhuset, hörsal C1, Södra Grev Rosengatan, Örebro, 09:00 (Swedish)
Opponent
Supervisors
Available from: 2015-04-17 Created: 2015-04-17 Last updated: 2017-10-17Bibliographically approved

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Malm, Kerstin

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