ArticleVox sanguinis2022
High false discovery rate of the Architect anti-HCV screening test in blood donors in Uganda and evaluation of an algorithm for confirmatory testing.
Article in Vox sanguinis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed, 11 citations in OpenAlex.
- Prevalence trends of transfusion-transmitted infections at a tertiary private hospital blood bank in Uganda: a retrospective 6-year review (2017-2022).BMC infectious diseases · 2025Article
- Mindray CL-900i assay: An effective assay for hepatitis B surface antigen screening with superior specificity.IJID regions · 2025Article
- The Issue of Screening for Transfusion-Transmitted Infections in Sub-Saharan Africa Presents Several Challenges: A Review.Advances in hematology · 2025Review
- High false hepatitis C antibody positivity rate in a regionally-inclusive population of non-renumerated blood donors in Uganda.African health sciences · 2024Article
- Glycylglycine promotes the solubility and antigenic utility of recombinant HCV structural proteins in a point-of-care immunoassay for detection of active viremia.Microbial cell factories · 2024Article
- A new double-antigen sandwich test based on the light-initiated chemiluminescent assay for detecting anti-hepatitis C virus antibodies with high sensitivity and specificity.Frontiers in cellular and infection microbiology · 2023Article
- High false discovery rate of the Architect anti-HCV screening test in blood donors in Uganda and evaluation of an algorithm for confirmatory testing.Vox sanguinis · 2022Article
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9 authors at 4 institutions in 3 countries.
Funding
Abstract
BACKGROUND AND
objectivesAdequate supplies of donor blood remain a major challenge in sub-Saharan Africa. This is exacerbated by a lack of confirmatory testing for transfusion-transmitted infections by blood transfusion services (BTS), leading to significant blood disposal owing to putatively high seroprevalence rates amongst Ugandan blood donors. We aimed to ascertain the false discovery rate of the Architect anti-hepatitis C virus (HCV) screening assay and categorize screen-reactive samples into three groups: presumed false positive, active and past infection, and develop an algorithm for confirmatory testing. MATERIALS AND
methodsA total of 470 screen-reactive HCV blood donations were retested using the Architect anti-HCV assay, an alternative antibody test (SD Biosensor) and a core antigen (cAg) test. signal-to cut-off (S/CO) ratios and pre-analytical factors (centrifugation speed, haemolysis check, time between collection and testing) were recorded. Based on the S/CO ratio evaluation, we propose a testing algorithm to guide supplemental tests.
resultsThe false discovery rate of the Architect anti-HCV assay was 0.84 as 395/470 (84%) screen-reactive samples had no evidence of HCV infection (SD Biosensor and cAg negative) (presumed false positive), 38/470 (8.1%) were antigenaemic, and 32/470 (6.8%) had evidence of past infection. The median S/CO ratios of the presumed false-positive and active infection samples were 1.8 and 17.3, respectively. The positive predictive value of HCV positivity in samples with ratios above 12 was 91.8%. On retesting, 104/470 (22.1%) samples became negative.
conclusionThe Architect anti-HCV assay has a very high false discovery rate in Ugandan BTSs, leading to excessive blood disposal. Pre-analytical factors likely contribute to this. An introduction of confirmatory testing using an algorithm based on S/CO ratio evaluation could limit unnecessary blood wastage and donor deferral.
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