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5 protocols using elecsys hiv combi pt

1

Automated HIV Screening with Cobas E 411

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Cobas E 411 (Roche Diagnostics GmbH, Mannheim, Germany) is a fully automated immunoassay analyzer which uses electro-chem-iluminescence immunoassay (ECLIA) technology to detect HIV-1 and HIV-2 in human serum. The analyzer had sample loading chambers, a touch-screen monitor and a printer. This study used Elecsys HIV combi PT (Roche Diagnostics GmbH, Mannheim, Germany) as reagents. This reagent is a fourth generation qualitative immunoassay for the determination of HIV-1 p24 antigens and antibodies to HIV-1, including group O, and HIV-2 in serum. Test results were produced within 30 min after loading samples.
Samples with cutoff index (COI) <0.9 were considered non-reactive (negative) and those with COI ≥1.0 considered reactive (positive). There were no observed COI readings in the range ≥0.9 to <1.0 (borderline) among the samples, HIV RNA test was therefore not needed.
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2

Validation of HIV Rapid Diagnostic Tests

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DHC results were classified as true or false with reference to results of the laboratory assays which are standard of care in this setting: fourth generation HIV screening immunoassay (Architect HIV Ag/Ab Combo, Abbott Diagnostics, Wiesbaden, Germany; or Elecsys HIV Combi PT, Roche Diagnostics, Mannheim, Germany), supplementary HIV antibody (Serodia HIV-1 Antibody particle agglutination assay, Fujirebio, Tokyo, Japan; or Genscreen HIV 1&2 Antibody EIA, Bio-Rad Laboratories, Redmond, WA), HIV p24 antigen immunoassay (Genscreen HIV-1 p24 Antigen, Bio-Rad Laboratories, Redmond, WA) and HIV Western blot (HIV Western Blot 2.2, MP Diagnostics, Singapore). In men diagnosed HIV-positive, HIV RNA (HIV Cobas Taqman 48 v2.0, Roche Diagnostics, Branchburg, NJ), CD4 T-cell count (Canto II flow cytometer, Becton Dickenson, San Jose, CA) and genotype (Vircotype HIV-1, Janssen Diagnostics, Beerse, Belgium) tests were performed.
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3

Comprehensive Diagnostic Assays for Viral Infections

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Blood counts were determined at the Central Laboratory of the University Hospital Essen according to routine procedures. For HIV-1/2 diagnostics, the screening tests Architect HIV Ag/Ab Combo (chemiluminescent microparticle immunoassay (CMIA); Abbott, Wiesbaden, Germany) and Elecsys HIV combi PT (electrochemiluminescence immunoassay; Roche Diagnostics, Rotkreuz, Switzerland) were utilized. Further, the confirmatory test INNO-LIA HIV I/II Score (line-immunoassay; Fujirebio, Hannover, Germany) and RealTime HIV-1 m2000sp (qPCR; Abbott, Wiesbaden, Germany) were employed. The presence of an EBV infection was assessed using the chemiluminescence immunoassays (CLIAs) Liaison EBV IgM, VCA IgG, and EBNA IgG (all DiaSorin, Dietzenbach, Germany). SARS-CoV-2-specific Abs were measured using the SARS-CoV-2 S1/S2 IgG ELISA (DiaSorin) and the CLIA Liaison SARS-CoV-2 TrimericS IgG assay (DiaSorin) for spike-specific Abs (IgG S), while the CMIA SARS-CoV-2 IgG assay (Abbott) was used for nucleocapsid (N)-specific Abs (IgG N).
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4

Multimodal Hepatitis Infection Screening

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All serum samples were tested for HBsAg, anti‐HCV, and anti‐HIV using the CLIA on the Cobas® 6000 analyzer (Elecsys® HBsAg II, Elecsys® Anti‐HCV II, Elecsys® HIV combi PT; Roche Diagnostics). Total anti‐HBc were tested on samples randomly selected using CMIA (Elecsys® Anti‐HBc II; Roche Diagnostics). HBV‐DNA and HCV‐RNA viral loads (VLs) were quantified respectively on HBsAg and anti‐HCV‐reactive samples using the Roche Molecular System (COBAS AmpliPrep/COBAS Taqman HBV Test Version 2.0; COBAS AmpliPrep/COBAS Taqman HCV Test Version 2.0). To detect possible occult hepatitis B infection, HBV‐DNA‐VL was quantified in HBsAg‐negative samples randomly selected (COBAS AmpliPrep/COBAS Taqman HBV Test Version 2.0). The manufacturer's reported limits of detection for HBsAg, HIV (p24 antigen), HBV DNA, and HCV RNA were 0.1 (0.88ng/ml), ≤2, 20, and 15 IU/ml, respectively. As for Elecsys® Anti‐HCV II, the sensitivity and specificity were 100% and 99.9%, respectively, and 100% for both for Elecsys® Anti‐HBc II. With respect to the cost of testing, serological markers have been estimated to cost approximately $7.00 per test, and approximately $25.00 for molecular testing. All tests were performed according to the manufacturer's instructions.
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5

Cross-sectional HIV testing study

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Between 1 January and 31 December 2013, we conducted a cross-sectional study in eight NSW sites with high MSM caseloads (five public HIV or sexual health services, two general practices and one community clinic). Eligible participants were aged 18 years or older, consented to testing with one ORT plus a confirmatory fourth-generation EIA (either an Elecsys HIV Combi PT [Roche Diagnostics] or Architect HIV Ag/Ab Combo [Abbott Diagnostics] assay, depending on the local laboratory).
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