Performance comparison of the 4th generation Bio-Rad Laboratories GS HIV Combo Ag/Ab EIA on the EVOLIS™ automated system versus Abbott ARCHITECT HIV Ag/Ab Combo, Ortho Anti-HIV 1+2 EIA on Vitros ECi and Siemens HIV-1/O/2 enhanced on Advia Centaur

Mitchell, Elizabeth; Stewart, Gregory J.; Bajzik, Olivier; Ferret, Mathieu; Bentsen, Christopher; Shriver, M. Kathleen

doi:10.1016/j.jcv.2013.08.009

Cited by 49 publications

(35 citation statements)

References 20 publications

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“…HIV-RNA kann etwa 11 Tage nach Infektion im Blut über die NAT nachgewiesen werden. [114]. Selten können HIV-Infizierte mit einer durch HIV bedingten vollkommenen Immunsuppression anti-HIV-negativ sein -sie haben jedoch HIV-typische klinische Symptome und messbare Virustiter im Blut [115].…”

Section: Hiv-nachweismethodenunclassified

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Humanes Immunschwächevirus (HIV)

Gesundheit¹

2015

Bundesgesundheitsbl.

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Section: Hiv-nachweismethodenunclassified

“…Singuläre p24-Antigenteste oder kombinierte Antigen/Antikörperteste (sog 4. Generationsteste) sind zugelassen und kommerziell erhält-lich [114,119].…”

Section: Virusnachweisunclassified

Humanes Immunschwächevirus (HIV)

Gesundheit¹

2015

Bundesgesundheitsbl.

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“…Depending on the manufacturer, additional antigens derived from the reverse transcriptase and the p24 protein are included in the test systems [11,111,112,113]. Depending on the immune response and the antibody titre, an infection can be detected serologically after 3 weeks but usually after 4-5 weeks [114]. In rare cases, HIV-infected individuals with complete immunosuppression might be HIV antibody-negative, but they have HIV-typical clinical symptoms and measurable virus titres in the blood [115].…”

Section: Current Knowledge About the Pathogenmentioning

confidence: 99%

“…These assays enable the detection of HIV p24 with a sensitivity of 10 pg/ml (corresponding to about 10 5 virus particles/ml of blood). p24 antigen detection tests or combined antigen/antibody test systems (so-called 4th generation tests) are approved and commercially available [114,119]. …”

Section: Current Knowledge About the Pathogenmentioning

confidence: 99%

Human Immunodeficiency Virus (HIV)

2016

Transfus Med Hemother

249

101

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“…Identification of acute HIV infection requires detection of HIV nucleic acids or p24 antigens. New 4 th -generation laboratory-based assays for HIV-1 detect HIV-1 p24 antigenaemia as well as antibodies to HIV-1/2 [10][11][12][13][14].…”

Section: Introductionmentioning

confidence: 99%

Field accuracy of HIV rapid diagnostic tests for blood donors screening, Bukavu, Eastern Democratic Republic of the Congo

Kashosi

Kyambikwa

Mulongo

et al. 2018

J Infect Dev Ctries

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Introduction: Rapid diagnostic tests (RDTs) are widely used for point-of-care diagnosis of HIV infection in resource-limited settings. However, there are no data about their field diagnostic performance in Eastern Democratic Republic of the Congo (DRC), especially in the context of blood banks screening for transfusion safety purpose. Methodology: Blood specimens were collected from blood donors in Bukavu, Eastern DRC, from May the 1 st to June the 30 th , 2015, to evaluate the accuracy of Alere Determine HIV-1/2, Trinity Biotech Uni-Gold HIV, and DoubleCheckGold Ultra HIV 1&2 compared to the laboratorybased 4 th generation ELISA apDia HIV Ag/Ab assay. Sensitivity, specificity, positive and negative predictive values, and related 95% confidence intervals were calculated using MedCalc statistical software version 15.1. Reliability was evaluated using Cohen's Kappa Statistic, κ. Results: Of 312 participants who donated blood, 96/312 (30.7%) were female and the mean age (SD) was 31.7 years (± 8.1 years). Sensitivity for the three tests was 57.1% (95% CI: 18.4-90.1). The specificity was 99.7% (95% CI: 18.4-90.1) for Alere Determine HIV-1/2, 100% (95% CI: 98.8-100.0) for Uni-Gold HIV, and 100% (95% CI: 98.8-100.0) for DoubleCheckGold Ultra HIV 1&2. Cohen's Kappa Statistic showed moderate agreement between the 4 th generation ELISA apDia HIV Ag/Ab and either Alere Determine HIV-1/2 and Uni-Gold HIV (κ = 0.66; 95% CI: 0.55-0.76) but good agreement for DoubleCheckGold Ultra HIV1&2 (κ = 0.72; 95% CI: 0.61 -0.82). Conclusions: Compared to the laboratory-based ELISA apDia HIV Ag/Ab assay, the currently used 3 rd generation HIV RDTs showed poor field accuracy results for blood donor screening. These data support the need for 4 th generation Ag-Ab RDTs in transfusion blood qualification.

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Performance comparison of the 4th generation Bio-Rad Laboratories GS HIV Combo Ag/Ab EIA on the EVOLIS™ automated system versus Abbott ARCHITECT HIV Ag/Ab Combo, Ortho Anti-HIV 1+2 EIA on Vitros ECi and Siemens HIV-1/O/2 enhanced on Advia Centaur

Cited by 49 publications

References 20 publications

Humanes Immunschwächevirus (HIV)

Humanes Immunschwächevirus (HIV)

Human Immunodeficiency Virus (HIV)

Field accuracy of HIV rapid diagnostic tests for blood donors screening, Bukavu, Eastern Democratic Republic of the Congo

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