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Journal of Clinical Microbiology, June 2002, p. 1938-1946, Vol. 40, No. 6
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.6.1938-1946.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Multicenter Evaluation of a New Automated Fourth-Generation Human Immunodeficiency Virus Screening Assay with a Sensitive Antigen Detection Module and High Specificity

Bernard Weber,1,2* Lutz Gürtler,3 Rigmor Thorstensson,4 Ulrike Michl,5 Annelies Mühlbacher,5 Philippe Bürgisser,6 Roberto Villaescusa,7 Adolfo Eiras,7 Christian Gabriel,8 Herbert Stekel,9 Srivilai Tanprasert,10 Sinenaart Oota,10 Maria-Jose Silvestre,11 Cristina Marques,11 Maria Ladeira,11 Holger Rabenau,2 Annemarie Berger,2 Urban Schmitt,12 and Walter Melchior12

Laboratoires Réunis Kutter-Lieners-Hastert, Junglinster, Luxembourg,1 Institut für Med. Virologie, Universitätskliniken Frankfurt, Frankfurt,2 Friedrich-Loeffler-Institute für Med. Microbiology, Ernst-Moritz-Arndt University Greifswald, Greifswald,3 R&D Infectious Diseases, Roche Diagnostics GmbH Laboratory Systems, Penzberg, Germany,12 Swedish Institute for Infectious Disease Control, Solna, Sweden,4 Blutzentrale der Landeskrankenanstalten Salzburg, Salzburg,5 Red Cross Transfusion Service Upper Austria,8 Allgemeines Krankenhaus Linz, Zentrallabor, Linz, Austria,9 Division d'Immunologie et d'Allergie, Département de Médecine Interne, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland,6 Centro de Transfusión de Galicia, Santiago de Compostela, Spain,7 National Blood Centre, Thai Red Cross Society, Bangkok, Thailand,10 Laboratorio Microbiologia, Hospital de Curry Cabral, Lisbon, Portugal,11

Received 24 October 2001/ Returned for modification 5 January 2002/ Accepted 13 February 2002

Fourth-generation assays for the simultaneous detection of human immunodeficiency virus (HIV) antigen and antibody that were available on the international market until now have antigen detection modules with relatively poor sensitivity and produce a higher rate of false-positive results than third-generation enzyme immunoassays (EIAs). The new Cobas Core HIV Combi EIA with an improved sensitivity for HIV p24 antigen was compared to alternative fourth- and third-generation assays, the p24 antigen test, and HIV type 1 (HIV-1) RNA reverse transcriptase PCR (RT-PCR). A total of 94 seroconversion panels (n = 709 sera), samples from the acute phase of infection after seroconversion (n = 32), anti-HIV-1-positive specimens (n = 730) from patients in different stages of the disease, 462 subtyped samples from different geographical locations, anti-HIV-2-positive sera (n = 302), dilutions of cell culture supernatants (n = 62) from cells infected with different HIV-1 subtypes, selected performance panels from Boston Biomedica Inc., 7,579 unselected samples from blood donors, 303 unselected daily routine samples, 997 specimens from hospitalized patients, and potentially interfering samples (n = 1,222) were tested with Cobas Core HIV Combi EIA. The new assay showed a sensitivity comparable to that of the Abbott HIV-1 AG Monoclonal A for early detection of HIV infection in seroconversion panels. The mean time delay of Cobas Core HIV Combi EIA (last negative sample plus 1 day) in comparison to that for HIV-1 RT-PCR for 87 panels tested with both methods was 2.75 days. The diagnostic window was reduced with Cobas Core HIV Combi EIA by between 3.6 and 5.7 days from that for third-generation assays. The specificities of Cobas Core HIV Combi EIA in blood donors were 99.84 and 99.85% (after repeated testing). Overall, 30 repeatedly reactive false-positive results out of 10,031 HIV-negative samples were obtained with Cobas Core HIV Combi EIA. Our results show that a fourth-generation assay with improved specificity such as Cobas Core HIV Combi EIA is suitable for blood donor screening because of its low number of false positives and because it detects HIV p24 antigen with a sensitivity comparable to that of single-antigen assays.

* Corresponding author. Mailing address: Laboratoires Réunis Kutter-Lieners-Hastert Centre, Langwies L-6131, Junglinster, Luxembourg. Phone: (352) 78 02 90 1. Fax: (352) 78 88 94. E-mail: web{at}labo.lu.

Journal of Clinical Microbiology, June 2002, p. 1938-1946, Vol. 40, No. 6
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.6.1938-1946.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.



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