Multicenter evaluation of a new recombinant enzyme immunoassay for the combined detection of antibody to HIV-1 and HIV-2

Ayres, Laura Silveira; Avillez, Francisca; Garcia-Benito, Ana; Deinhardt, Friedrich; Gürtler, Lutz; Denis, François; Léonard, Guy; Ranger, Sylvie; Grob, Peter J.; Joller‐Jemelka, H. I.; Heß, Georg; Seidl, S.; Flacke, H; Simon, François; Brun‐Vézinet, Françoise; Sondag, D.; Albert, André Luís Mazzei; Hampl, H.; Schoen, Robert T.; Stramer, Susan L.; Troonen, Hugo

doi:10.1097/00002030-199002000-00006

Cited by 22 publications

(8 citation statements)

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“…HIV-2 has been found predominantly in West Africa and to a lesser extent in Portugal and France. Despite its rare occurrence in the United States, serological screening for HIV-2, in addition to serological screening for HIV-1, has been implemented in an effort to increase the safety of blood and blood products (5). Similarly, once the RNA assays are implemented, the requirement to test for both HIV-1 and HIV-2 RNAs could be imminent.…”

Section: Discussionmentioning

confidence: 99%

“…The first serological assay for detection of human immunodeficiency virus (HIV) type 1 (HIV-1) was implemented in 1985, 3 years after the recognition of HIV as the causative agent of AIDS (6,17,33). In 1986, a second HIV type, HIV-2, was isolated from patients with AIDS in West Africa (11), which led to the implementation of simultaneous screening for HIV-1 and HIV-2 (5,41). In the following years, continuous improvements of the serological assays, along with donor education and deferral procedures, have greatly reduced the risks of transfusion-acquired HIV infection (16,25,39,46).…”

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confidence: 99%

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Performance of a Multiplex Qualitative PCR LCx Assay for Detection of Human Immunodeficiency Virus Type 1 (HIV-1) Group M Subtypes, Group O, and HIV-2

et al. 2000

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Early detection of human immunodeficiency virus (HIV) in blood and blood products can be achieved by a sensitive nucleic acid amplification-based assay. We report on the performance of a PCR-based qualitative assay that detects both HIV type 1 (HIV-1) and HIV-2 with a sensitivity of 20 to 50 copies/ml. The assay has a specificity of 99.6% and an inhibition rate of 1.7%. One milliliter of sample is processed with a manifold system and Qiagen columns, and one-third of the extracted sample is used for PCR amplification. An internal control sequence, which is processed and amplified with each sample, monitors for amplification inhibition. Samples are reverse transcribed and are then amplified by reverse transcription-coupled PCR, after which HIV-1- and HIV-2-specific probes are hybridized to the amplified products. Following hybridization, samples are detected in the LCx instrument by microparticle enzyme immunoassay techniques. The detection system has an automated inactivation step that controls for PCR contamination. The HIV-1/2 qualitative RNA assay detects HIV-1 group M subtypes A, B, C, D, E, F, and G and group O. Testing of several HIV-1 seroconversion panels has demonstrated that the HIV-1/2 qualitative RNA assay detects HIV infection on the average of 6 days before p24 antigen can be detected and 11 days before antibodies can be detected.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

Performance of a Multiplex Qualitative PCR LCx Assay for Detection of Human Immunodeficiency Virus Type 1 (HIV-1) Group M Subtypes, Group O, and HIV-2

et al. 2000

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“…16 The desire to narrow this infectious window has led to consideration of adding to blood and organ donor-screening programs assays for direct detection of viral p24 antigen or nucleic acids (DNA and RNA).15. '7*' [8][9][10][11][12][13][14][15][16][17][18][19][20][21] Understanding of the duration of the antibody-negative window period, and of the relative sensitivities of antibody and direct viral assays for detection of evolving primary HIV-1 infections, is limited by a lack of optimally collected specimens with which to characterize this dynamic phase of infection. Analyses of serial samples from paid plasmapheresis donors who were later determined to have seroconverted have proven very useful for developing improved serologic assays and documenting their enhanced sen~itivity.~-~ However, because cryopreserved white cells were not available from these donors, these seroconversion panels have not allowed assessment of HIV-1 DNA detection techniques such as polymerase chain reaction (PCR).…”

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confidence: 99%

Time course of detection of viral and serologic markers preceding human immunodeficiency virus type 1 seroconversion: implications for screening of blood and tissue donors

et al. 1995

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“…The infectious window period defines the time during which an individual is both infected and infectious prior to seroconversion. While the sensitivities of HIV antibody detection assays have significantly improved since the tests were first licensed in 1985 (2,4,5,10,28), the infectious window period is still longer for the assays based on the detection of anti-HIV antibodies than for the assays based on the detection of viral nucleic acids. Indeed, the assays based on the detection of HIV-1 RNA by PCR gave positive results 7 to 11 days before the assays based on the detection of anti-HIV antibodies (4).…”

Section: Discussionmentioning

confidence: 99%

Detection of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in Pools of Sera Negative for Antibodies to HIV-1 and HIV-2

Morandi¹,

Schockmel²,

Yerly³

et al. 1998

J Clin Microbiol

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A total of 234 pools were prepared from 10,692 consecutive serum samples negative for antibodies to human immunodeficiency virus type 1 (HIV-1) and HIV-2 collected at five virological laboratories (average pool size, 45 serum samples). Pools were screened for the presence of HIV-1 RNA by a modified commercial assay (Amplicor HIV-1 Monitor test) which included an additional polyethylene glycol (PEG) precipitation step prior to purification of viral RNA (PEG Amplicor assay). The sensitivity of this assay for HIV-1 RNA detection in individual serum samples within pools matches that of standard commercial assays for individual serum samples, i.e., 500 HIV-1 RNA copies per ml. Five pools were identified as positive, and each one contained one antibody-negative, HIV-1 RNA-positive serum sample, corresponding to an average of 1 infected sample per 2,138 serum samples. Retrospective analysis revealed that the five HIV-1 RNA-positive specimens originated from individuals who had symptomatic primary HIV-1 infection at the time of sample collection and who were also positive for p24 antigenemia. We next assessed the possibility of performing the prepurification step by high-speed centrifugation (50,000 ×g for 80 min) of 1.5-ml pools containing 25 μl of 60 individual serum samples, of which only 1 contained HIV-1 RNA (centrifugation Amplicor assay). The sensitivity of this assay also matches the sensitivities of standard commercial assays for HIV-1 RNA detection in individual serum samples. The results demonstrate that both assays with pooled sera can be applied to the screening of large numbers of serum samples in a time- and cost-efficient manner.

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Multicenter evaluation of a new recombinant enzyme immunoassay for the combined detection of antibody to HIV-1 and HIV-2

Cited by 22 publications

References 0 publications

Performance of a Multiplex Qualitative PCR LCx Assay for Detection of Human Immunodeficiency Virus Type 1 (HIV-1) Group M Subtypes, Group O, and HIV-2

Performance of a Multiplex Qualitative PCR LCx Assay for Detection of Human Immunodeficiency Virus Type 1 (HIV-1) Group M Subtypes, Group O, and HIV-2

Time course of detection of viral and serologic markers preceding human immunodeficiency virus type 1 seroconversion: implications for screening of blood and tissue donors

Detection of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in Pools of Sera Negative for Antibodies to HIV-1 and HIV-2

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