Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0021051 (immunodeficiency)
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A total of 152 sera from African subjects were tested for presence of antibody to human immunodeficiency virus using four enzyme immunoassays (EIA) marketed by Abbott Diagnostics, Organon Teknika, Wellcome and Diagnostics Pasteur respectively, an indirect immunofluorescence assay (IFA) and an immunoblot assay (IBA) as reference test. The sensitivity (95% confidence limits, CL) of the EIAs and the IFA ranged between 80.9% and 99.1%. The specificity of the Abbott EIA was lower (95% CL: 38.1-72%) than that of the other assays (95% CL: 83.5-100%). The use of an IFA or the Wellcome competitive EIA as confirmatory test on initially EIA positive sera yielded a specificity of 85.5-100% (95% CL) compared with the IBA. The costs of screening by an EIA, followed by confirmatory testing of reactive sera with IFA or the Wellcome EIA and IBA on discrepant test results was similar for all combinations with the exception of initial screening with the Abbott EIA which was more expensive. Using a limited number of sera from African subjects no one test system yielded a significantly superior degree of specificity or sensitivity.
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PMID:Comparison of enzyme immunoassays and an immunofluorescence test for detection of antibody to human immunodeficiency virus in African sera. 329 80

Paired serum and oral fluid specimens (n = 287) were collected with the Omni-Sal device and were assayed for the presence of antibodies to human immunodeficiency virus type 1 (HIV-1). Enzyme immunoassays (EIAs)--Abbott 3A11, an Organon Teknika Corporation research-use-only test, and the Murex GACELISA--were used per the manufacturers' inserts or were modified slightly to accommodate the oral fluid specimens. Compared with serum Western blot (immunoblot) results, each EIA had a sensitivity of 100% and the specificities were 89.6% for the Abbott 3A11 EIA, 96.5% for the GACELISA, and 97.8% for the Organon Teknika Corporation EIA. Specificities based on specimens that were repeatedly reactive were 99.3% for all EIAs. A miniaturized Western blot technique used for confirmatory testing of both the serum and oral fluid specimens found 149 of the 287 samples to be HIV-1 antibody positive in both sample types. The Western blot banding patterns observed for the serum and oral fluid specimens were essentially identical. Immunoglobulin G concentrations were determined for all oral fluid specimens and ranged from < 0.5 to > 40.0 micrograms/ml. Immunoglobulin G concentrations did not correlate with the ability of any of the EIAs to detect HIV-1-specific antibody or with the ability of the modified Western blot to detect HIV-1 protein-specific antibodies.
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PMID:Oral fluid as a specimen for detection and confirmation of antibodies to human immunodeficiency virus type 1. 758 12

The performance of four enzyme immunoassays, manufactured by Abbott, Diagnostics Pasteur, Genetic Systems, and Organon Teknika, for the combined detection of anti-human immunodeficiency virus type 1 (HIV-1) and anti-HIV-2, was examined in a multisite evaluation. The collaborative efforts of 7 Australian Red Cross Blood Transfusion and 12 Australian Public Health Laboratories minimized potential biases in data by providing large numbers of anti-HIV-1-negative and -positive samples. Sensitivity was estimated using samples that were positive for anti-HIV-1 from individuals known to be infected and seroconversion samples. Sensitivity estimates in the four assays were 99.71, 99.94, 99.49, and 99.68%, respectively. Specificity was measured using fresh, sequential blood donations and samples with previous false-positive reactions in other assays. Specificity estimates from blood donations were 99.92, 99.46, 99.67, and 99.85%, respectively. The data were analyzed further using the delta statistic, which distinguishes the performance of assays of similar sensitivity and specificity by providing a measure of how well results in a population of positive or negative samples are removed from the assay's cutoff value.
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PMID:Multisite evaluation of four anti-HIV-1/HIV-2 enzyme immunoassays. Australian HIV Test Evaluation Group. 788 8

A new modular automated enzyme immunoassay (EIA) (Enzymun-Test HIV Ag: Boehringer Mannheim) for quantitative human immunodeficiency virus (HIV) antigen detection was evaluated by testing a panel of 1,506 serum samples, including seroconversions, dilution series, follow-up samples from patients under antiretroviral therapy, single serum specimens from HIV-seropositive individuals in different stages of infection, potentially cross-reactive samples, and sera from HIV-negative hospitalized patients. The Abbott HIV type 1 (HIV-1) antigen monoclonal antibody assay served as the reference assay, and nucleic acid sequence-based amplification (Organon Teknika) for quantitative amplification of HIV-1 RNA was used for follow-up of patients under antiretroviral chemotherapy. The Boehringer Mannheim and Abbott EIAs showed concordant results for the early detection of HIV antigen in all the seroconversion panels. The follow-up samples from 29 HIV-infected individuals under antiretroviral therapy gave divergent results between both antigen tests. For the detection of HIV antigen in single serum samples from HIV-infected patients in different stages of HIV infection, a higher number of positive samples was detected with the Abbott HIV-1 antigen monoclonal antibody assay in samples from patients in stages II and III of HIV infection. The Enzymun-Test detected three or more positive samples than did the Abbott assay among the samples of patients with AIDS. The concordance on a sample-to-sample basis between the Boehringer Mannheim and Abbott EIAs was 98.6%. The sensitivity of the Enzymun-Test in comparison to the reference assay was 97.2%; the specificity was 98.8%. Although no close correlation could be found between the amount of viral RNA in serum detected by nucleic acid sequence-based amplification and the concentration of HIV antigen, a high HIV-1 RNA copy number was mostly associated with high levels of HIV antigen. In conclusion, the Enzymun-Test permits accurate HIV antigen detection and offers, in contrast to previous assays, the possibility of completely automated detection.
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PMID:Quantitative detection of human immunodeficiency virus (HIV) antigen by the Enzymun-Test: comparison with alternative assays and nucleic acid sequence-based amplification of HIV type 1 RNA. 873 95

Three procedures for the quantification of human immunodeficiency virus type 1 (HIV-1) RNA from plasma were compared at three laboratories. The comparison involved the Quantiplex branched DNA assay (version 1.0) by Chiron Diagnostics, the NASBA-QT assay by Organon Teknika, and the Amplicor Monitor assay by Roche Molecular Systems. The laboratories performed each of the three assays with the same sets of reconstructed HIV-1-infected human plasma samples, cross-sectionally collected clinical plasma samples and longitudinally collected plasma samples from patients starting zidovudine therapy. Analysis of the reconstruction panel results for interlaboratory variation demonstrated that no laboratory differences in results were detected for any of the assays. A comparison of the reproducibilities of duplicate samples analyzed by batch and in separate assay runs demonstrated that the reproducibilities of the test results were similar within one assay and appeared to be independent of the HIV-1 concentration. The best reproducibility was obtained with the Quantiplex assay, but all three assays demonstrated equal reliability, which was independent of batched or unbatched analysis of replicate samples. Differences in the absolute concentrations calculated were observed for the assays, in particular in the analysis of reconstructed samples. In all assays, similar changes in plasma HIV-1 RNA concentrations were determined for longitudinally collected clinical samples.
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PMID:Multicenter comparison of three commercial methods for quantification of human immunodeficiency virus type 1 RNA in plasma. 894 Apr 41

Three kits (Roche AMPLICOR human immunodeficiency virus type 1 [HIV-1] Monitor, Chiron enhanced-sensitivity bDNA, and Organon Teknika NASBA HIV-1 QT) and two in-house assays (from National Genetics Institute and Baylor College of Medicine) were compared with a blinded panel. The results were evaluated as to intra-assay sensitivity, precision, and ability to detect differences in a dilution series.
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PMID:Intra-assay performance characteristics of five assays for quantification of human immunodeficiency virus type 1 RNA in plasma. 950 27

An enzyme-linked immuno-sorbent assay (ELISA) for the detection of human immunodeficiency virus type 1 (HIV-1) and simian immunodeficiency virus (SIVcpz/SIVmnd) antigens was designed using immunoreagents from naturally infected individuals, and compared to the commercially available Vironostika HIV-1 Antigen Microelisa System (Organon Teknika). The in-house assay proved to be specific for HIV-1 isolates belonging to group M (A-H) and group O and for SIVcpz and SIVmnd isolates, but was less sensitive than the Vironostika HIV-1 Antigen Microelisa System, except for SIVmnd. For the strains belonging to HIV-2, SIVmac and SIVagm, the in-house assay could not detect antigen to an appreciable degree. This study shows that a considerably less expensive but sufficiently accurate HIV-1 antigen capture assay can be developed to monitor HIV-1 (group M and O), SIVcpv and SIVmnd antigen in the supernatants of virus cultures.
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PMID:Design and evaluation of an in-house HIV-1 (group M and O), SIVmnd and SIVcpz antigen capture assay. 970 76

We compared the performance of Organon Teknika's NucliSens and Roche Diagnostic Systems' Monitor quantitative human immunodeficiency type 1 RNA assays. Both had similar linearity and sensitivity over most of the dynamic range of the assays, although the Monitor assay was superior at the low range of RNA values while the NucliSens assay was more consistent at higher RNA values. NucliSens generally showed less interassay variability.
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PMID:Comparison of NucliSens and Roche Monitor assays for quantitation of levels of human immunodeficiency virus type 1 RNA in plasma. 988 40

In order to determine whether commercial assays presently in use for the quantification of plasma human immunodeficiency virus type 1 (HIV-1) RNA levels detect different genetic viral subtypes with the same reliability, a panel of 38 samples corresponding to 22 HIV-1-infected patients, representing non-B subtypes A-F, was examined. One to three plasma samples belonging to each individual were tested by the second-generation HIV-1 branched DNA (bDNA) assay (Chiron, Spain), the Nuclisens assay (Organon-Teknika, Spain), the Amplicor Monitor reverse transcriptase polymerase chain reaction assay (Roche, Spain), and the Ultradirect Monitor (Roche) using primers specifically designed to amplify non-B HIV-1 subtypes. Each of the different methods for measuring viral load showed a distinct sensitivity for non-B HIV-1 subtypes. Values higher than the assay detection limit were obtained in 22 (57.9%), 33 (86.8%), and 37 (93.3%) samples using the bDNA, Nuclisens, and Monitor assays, respectively. Significantly different values (>0.5 logs) were found in 55.3%, 81.6%, and 71.1% of specimens comparing results provided by bDNA and Nuclisens, bDNA and Monitor, and Nuclisens and Monitor, respectively. Quantitative values provided by the Ultradirect Monitor test using non-B primers were particularly discordant with the other tests. Overall, 44.7% of samples yielded higher viral load values with this assay than with the regular Monitor assay, reflecting its enhanced sensitivity for non-B subtypes; however, the reproducibility of this test was low. These results support the recommendation of always using the same assay when monitoring plasma viraemia.
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PMID:Comparison of three different commercial methods for measuring plasma viraemia in patients infected with non-B HIV-1 subtypes. 1038 13

Amplification of human immunodeficiency virus type 1 (HIV) reverse transcriptase (RT) and protease (PT) sequences from plasma is difficult when HIV RNA levels are low, and it usually cannot be accomplished in samples with <1,000 HIV RNA copies/ml. Because the RNA extraction step is critical for the success of subsequent amplifications and sequence analyses, two RNA extraction methods were compared to study plasma samples with low HIV RNA levels. Forty-four plasma samples containing <500 HIV RNA copies/ml in a branched-DNA (bDNA) assay (Quantiplex HIV RNA assay version 2.0 [Chiron Corp., Emeryville, Calif.]) were studied. RNA was extracted by using two commercial kits (QIAamp Viral RNA kit [Qiagen, Hilden, Germany] and NucliSens kit [Organon Teknika, Boxtel, The Netherlands]). Fragments (1,144 bp) encompassing HIV PT and RT sequences were amplified by nested PCRs. Amplified products were sequenced by using a commercial kit (Applied Biosystems). HIV RNA was recovered from a total of 21 plasma samples, including 20 samples after extraction by the NucliSens method, and 8 samples after extraction by the QIAamp method (P < 0.05). Mean HIV RNA levels in these samples, measured by an ultrasensitive bDNA assay (Quantiplex HIV RNA assay version 3.0; Chiron Corp., Emeryville, Calif.), were 848 copies/ml (median, 666; range, 154 to 2,606 copies/ml). Analysis of RT and PT sequences in five samples demonstrated an average of 3.8 and 2.4 resistance mutations in these regions, respectively. The NucliSens RNA extraction kit is a valuable method for obtaining HIV RNA for genotypic studies from plasma fractions of individuals with low HIV RNA levels.
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PMID:Recovery and analysis of human immunodeficiency virus type 1 (HIV) RNA sequences from plasma samples with low HIV RNA levels. 1061 6


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