Reliable Detection of Individuals Seropositive for the Human Immunodeficiency Virus (HIV) by Competitive Immunoassays Using Escherichia coli-Expressed HIV Structural Proteins

Dawson, George J.; Heller, J. S.; Wood, Charles; Gutierrez, Robin A.; Webber, Jessica; Hunt, Jeffrey C.; Hojvat, Sally; Senn, D.; Devare, Sushil G.; Decker, Richard H.

doi:10.1093/infdis/157.1.149

Cited by 29 publications

(15 citation statements)

References 31 publications

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“…The diagnostic tests for detection of HIV infection are developed based on this knowledge and over time, efforts are being made to improve sensitivity and specificity of screening and diagnostic assays. The first commercial test launched in 1985 for diagnosis of HIV infection test relied on detecting antibody to viral proteins [Barrett et al, 1986;Ward et al, 1986;Dawson et al, 1988]. With the knowledge that the viremia precedes antibody in virus-infected individuals, tests were developed for detection of HIV antigen Paul et al, 1987;Couroucé et al, 1988Couroucé et al, , 1992Busch et al, 1990;Couroucé, 1994].…”

Section: Introductionmentioning

confidence: 99%

Incremental detection of HIV infections by the HIV antigen/antibody combination assays: An Australian experience

et al. 2007

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Section: Introductionmentioning

confidence: 99%

Incremental detection of HIV infections by the HIV antigen/antibody combination assays: An Australian experience

et al. 2007

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“…Prior to the introduction of fourth-generation assays, commercial immunoassays for blood screening and diagnosis of HIV infection were based either on detection of HIV core (p24) protein (1,14,22) or on detection of HIV-specific antibodies, notably those antibodies directed against HIV transmembrane proteins (tmp). Antibodies against these proteins consistently appear during seroconversion of HIV-infected individuals and remain throughout the course of infection (2,3,7,19,24,26). Fourth-generation immunoassays have targeted reduction of the seronegative window period to achieve a continued decrease in the residual risk of transfusion-transmitted HIV infection (5, 6, 12, 15-17, 27, 30-32).…”

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Multicenter Evaluation of a New, Automated Enzyme-Linked Immunoassay for Detection of Human Immunodeficiency Virus-Specific Antibodies and Antigen

et al. 2004

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A collaborative multicenter study was conducted to evaluate the sensitivity, specificity, and precision of a three-step, fully automated, qualitative microparticle-based enzyme-linked immunoassay (AxSYM HIV Ag/Ab Combo; Abbott Laboratories), designed to simultaneously detect (i) antibodies against human immunodeficiency virus type 1 (HIV-1) and/or type 2 (HIV-2) and (ii) HIV p24 antigen. A significant reduction in the HIV seroconversion window was achieved by combining detection of HIV antibodies and antigen into a single assay format. For 22 selected, commercial HIV seroconversion panels, the mean time of detection with the combinedformat HIV antigen-antibody assay was reduced by 6.15 days compared to that with a similar third-generation single-format HIV antibody assay. The quantitative sensitivity of the combination assay for the p24 antigen (17.5 pg/ml by use of the p24 quantitative panel VIH SFTS96) was nearly equivalent to that of single-format antigen tests. The combination assay demonstrated sensitive (100%) detection of anti-HIV immunoglobulin in specimens from individuals in CDC stages A, B, and C and from individuals infected with different HIV-1 group M subtypes, group O, or HIV-2. The apparent specificity for hospitalized patients (n ‫؍‬ 1,938) was 99.90%. In a random population of 7,900 volunteer blood donors, the specificity (99.87%) was comparable to that of a third-generation single-format HIV antibody assay (99.92%) on the same donor specimens. In addition, the combination assay was robust to potential interfering specimens. The precision of the combination was high, with intra-and interrun variances of <9.3% for each precision panel specimen or assay control and <5.3% for the negative assay control.

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“…These assays used the solid phase coated with viral antigens and polyclonal antibodies to human immunoglobulins conjugated to an enzyme for detection of HIV-specific antibodies (1,24). The second-generation assays used HIV recombinant antigens instead of viral lysate as the source of antigen on the solid phase and also incorporated recombinant antigen for HIV-2 (6,10,11,12,13,16). These assays had improved specificity though the overall sensitivity remained similar to that of the first-generation assays.…”

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Seven Human Immunodeficiency Virus (HIV) Antigen-Antibody Combination Assays: Evaluation of HIV Seroconversion Sensitivity and Subtype Detection

Ly¹,

Martin

Daghfal

et al. 2001

J Clin Microbiol

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In this study, we evaluated the performance of two prototype human immunodeficiency virus (HIV) antigen-antibody (Ag-Ab) combination assays, one from Abbott Laboratories (AxSYM HIV Ag-Ab) and the other from bioMerieux (VIDAS HIV Duo Ultra), versus five combination assays commercially available in Europe. The assays were Enzygnost HIV Integral, Genscreen Plus HIV Ag-Ab, Murex HIV Ag-Ab Combination, VIDAS HIV Duo, and Vironostika HIV Uniform II Ag-Ab. All assays were evaluated for the ability to detect p24 antigen from HIV-1 groups M and O, antibody-positive plasma samples from HIV-1 groups M and O, HIV-2, and 19 HIV seroconversion panels. Results indicate that although all combination assays can detect antibodies to HIV-1, group M, subtypes A to G, circulating recombinant form (CRF) A/E, and HIV-1 group O, their sensitivity varied considerably when tested using diluted HIV-1 group O and HIV-2 antibody-positive samples. Among combination assays, the AxSYM, Murex, and VIDAS HIV Duo Ultra assays exhibited the best antigen sensitivity (at ∼25 pg of HIV Ag/ml) for detection of HIV-1 group M, subtypes A to G and CRF A/E, and HIV-1 group O isolates. However, the VIDAS HIV Duo Ultra assay had a lower sensitivity for HIV-1 group M and subtype C, and was unable to detect subtype C antigen even at 125 pg of HIV Ag/ml. The HIV antigen sensitivity of the VIDAS HIV Duo and Genscreen Plus combination assays was ∼125 pg of HIV Ag/ml for detection of all HIV-1 group M isolates except HIV-1 group O while the sensitivity of Vironostika HIV Uniform II Ag-Ab and Enzygnost HIV Integral Ag-Ab assays for all the group M subtypes was >125 pg of HIV Ag/ml. Among the combination assays, the AxSYM assay had the best performance for detection of early seroconversion samples, followed by the Murex and VIDAS HIV Duo Ultra assays

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Reliable Detection of Individuals Seropositive for the Human Immunodeficiency Virus (HIV) by Competitive Immunoassays Using Escherichia coli-Expressed HIV Structural Proteins

Cited by 29 publications

References 31 publications

Incremental detection of HIV infections by the HIV antigen/antibody combination assays: An Australian experience

Incremental detection of HIV infections by the HIV antigen/antibody combination assays: An Australian experience

Multicenter Evaluation of a New, Automated Enzyme-Linked Immunoassay for Detection of Human Immunodeficiency Virus-Specific Antibodies and Antigen

Seven Human Immunodeficiency Virus (HIV) Antigen-Antibody Combination Assays: Evaluation of HIV Seroconversion Sensitivity and Subtype Detection

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