Shortening of the diagnostic window with a new combined HIV p24 antigen and anti-HIV-1/2/O screening test

被引:56
作者
Brust, S
Duttmann, H
Feldner, J
Gürtler, L
Thorstensson, R
Simon, F
机构
[1] Dade Behring Vertriebs GmbH & Co, D-65835 Liederbach, Germany
[2] Dade Behring Marburg GmbH, Marburg, Germany
[3] Max Von Pettenkofer Inst Hyg & Med Microbiol, Munich, Germany
[4] Swedish Inst Infect Dis Control, Stockholm, Sweden
[5] Grp Hosp Bichat Claude Bernard, Paris, France
关键词
combined antigen/antibody test; seroconversion; HIV-1; subtypes; genetic variability; AIDS;
D O I
10.1016/S0166-0934(00)00229-9
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
Because antibodies to the human immunodeficiency virus (HIV) are absent in the very early phase of HIV infection, there remains a slight residual risk for HIV transmission by blood donations by viremic but antibody negative donations. To shorten the diagnostic window between infection and the detection of antibodies, Enzygnost(R) HIV Integral (Dade Behring, Germany) was developed. With this new test, HIV p24 antigen and HIV antibodies can be detected simultaneously in a single test. Tn a multicenter study the new screening assay has been compared with various tests that detect only HIV antibodies or HIV p24 antigen and with assays which permit a simultaneous detection of HIV antigen and HIV antibodies. The new assay showed 100% sensitivity for the detection of antibodies to HIV-1, groups M (n= 1102) and O (n= 55), and HIV-2 (n = 289). In 23 out of 52 seroconversion panels, seroconversion was detected 2-18 days earlier with the new combined antigen/antibody test compared to single antibody tests. All samples from a viral load panel (n = 451), all samples containing p24 antigen (n = 302), and all but one of the cell culture supernatants (n = 38) infected with various HIV-1 subtypes or HIV-2 were identified reliably by the new test. The specificity of the assay for 4002 unselected blood donors was 99.78% initially and 99.80% after retesting. Potentially interfering factors had no systematic influence on specificity. By testing for p24 antigen, which is present prior to the onset of antibody production in some cases of recent HIV infection, the new assay reduces the diagnostic window as compared to third generation screening assays, thus permitting an earlier diagnosis of HIV infection. (C) 2000 Elsevier Science B.V. All rights reserved.
引用
收藏
页码:153 / 165
页数:13
相关论文
共 12 条
[1]  
BACHMANN P, 1995, INFECTION, V5, P322
[2]   Performance of the Amplicor human immunodeficiency virus type 1 PCR and analysis of specimens with false-negative results [J].
Barlow, KL ;
Tosswill, JHC ;
Parry, JV ;
Clewley, JP .
JOURNAL OF CLINICAL MICROBIOLOGY, 1997, 35 (11) :2846-2853
[3]   ISOLATION AND PARTIAL CHARACTERIZATION OF AN UNUSUAL HUMAN IMMUNODEFICIENCY RETROVIRUS FROM 2 PERSONS OF WEST-CENTRAL AFRICAN ORIGIN [J].
DELEYS, R ;
VANDERBORGHT, B ;
VANDENHAESEVELDE, M ;
HEYNDRICKX, L ;
VANGEEL, A ;
WAUTERS, C ;
BERNAERTS, R ;
SAMAN, E ;
NIJS, P ;
WILLEMS, B ;
TAELMAN, H ;
VANDERGROEN, G ;
PIOT, P ;
TERSMETTE, T ;
HUISMAN, JG ;
VANHEUVERSWYN, H .
JOURNAL OF VIROLOGY, 1990, 64 (03) :1207-1216
[4]   Origin of HIV-1 in the chimpanzee Pan troglodytes troglodytes [J].
Gao, F ;
Bailes, E ;
Robertson, DL ;
Chen, YL ;
Rodenburg, CM ;
Michael, SF ;
Cummins, LB ;
Arthur, LO ;
Peeters, M ;
Shaw, GM ;
Sharp, PM ;
Hahn, BH .
NATURE, 1999, 397 (6718) :436-441
[5]   Reduction of the diagnostic window with a new combined p24 antigen and human immunodeficiency virus antibody screening assay [J].
Gürtler, L ;
Mühlbacher, A ;
Michl, U ;
Hofmann, H ;
Paggi, GG ;
Bossi, V ;
Thorstensson, R ;
Villaescusa, RG ;
Eiras, A ;
Hernandez, JM ;
Melchior, W ;
Donie, F ;
Weber, B .
JOURNAL OF VIROLOGICAL METHODS, 1998, 75 (01) :27-38
[6]  
GURTLER LG, 1994, J VIROL, V68, P1581
[7]  
*LEGR TRAV RETR SO, 1999, GAZETTE TRANSFUS, V155, P4
[8]   Identification of a new human immunodeficiency virus type 1 distinct from group M and group O [J].
Simon, F ;
Mauclère, P ;
Roques, P ;
Loussert-Ajaka, I ;
Müller-Trutwin, MC ;
Saragosti, S ;
Georges-Courbot, MC ;
Barré-Sinoussi, F ;
Brun-Vézinet, F .
NATURE MEDICINE, 1998, 4 (09) :1032-1037
[9]   Persistently negative HIV-1 antibody enzyme immunoassay screening results for patients with HIV-1 infection and AIDS: serologic, clinical, and virologic results [J].
Sullivan, PS ;
Schable, C ;
Koch, W ;
Do, AN ;
Spira, T ;
Lansky, A ;
Ellenberger, D ;
Lal, RB ;
Hyer, C ;
Davis, R ;
Marx, M ;
Paul, S ;
Kent, J ;
Armor, R ;
McFarland, J ;
Lafontaine, J ;
Mottice, S ;
Cassol, SA ;
Michael, N .
AIDS, 1999, 13 (01) :89-96
[10]   Evaluation of 14 commercial HIV-1/HIV-2 antibody assays using serum panels of different geographical origin and clinical stage including a unique seroconversion panel [J].
Thorstensson, R ;
Andersson, S ;
Lindbäck, S ;
Dias, F ;
Mhalu, F ;
Gaines, H ;
Biberfeld, G .
JOURNAL OF VIROLOGICAL METHODS, 1998, 70 (02) :139-151