Analysis of sample‐to‐cutoff ratios on chemiluminescent immunoassays used for blood donor screening highlights the need for serologic confirmatory testing

Kiely, Philip; Walker, Kyall; Parker, Susan; Cheng, Anthea

doi:10.1111/j.1537-2995.2009.02572.x

Cited by 27 publications

(30 citation statements)

References 31 publications

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“…Our results indicate that it is possible to define S/CO values for each ARCHITECT assay with a PPV that nears 100%, as already demonstrated by Kiely et al and by Acar et al for other assay systems. However, if these S/CO values were used to discriminate confirmed positive samples from BFP without confirmatory testing, a substantial percentage of specimens would be incorrectly classified.…”

Section: Discussionsupporting

confidence: 86%

Comparison Between Screening and Confirmatory Serological Assays in Blood Donors in a Region of South Italy

Sommese

Iannone

Cacciatore

et al. 2014

J. Clin. Lab. Anal.

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Supplemental testing on samples with high signal by screening assays seems to add little information. GZ settings and confirmatory testing for positive screening results should be designed taking in account several factors, including difference in the natural history among blood-borne infections, the characteristics of first- and second-level tests, and, when available, the results of nucleic acid amplification testing.

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Section: Discussionsupporting

confidence: 86%

Comparison Between Screening and Confirmatory Serological Assays in Blood Donors in a Region of South Italy

Sommese

Iannone

Cacciatore

et al. 2014

J. Clin. Lab. Anal.

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“…The weak anti-HCV reactivity in the nine samples may very well be non-specific. Weak signals (S/CO < 3) in a chemiluminescent anti-HCV immunoassay are associated with false-positive reactivity [11]. In addition, comparing the signals in the stored and fresh samples, the archived samples show elevated background reactivity, below and around the cut-off value (Fig.…”

Section: Resultsmentioning

confidence: 99%

Hepatitis C virus infection among transmission-prone medical personnel

Zaaijer

Appelman

Frijstein

2011

Eur J Clin Microbiol Infect Dis

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Hepatitis C virus (HCV)-infected physicians have been reported to infect some of their patients during exposure-prone procedures (EPPs). There is no European consensus on the policy for the prevention of this transmission. To help define an appropriate preventive policy, we determined the prevalence of HCV infection among EPP-performing medical personnel in the Academic Medical Center in Amsterdam, the Netherlands. The prevalence of HCV infection was studied among 729 EPP-performing health care workers. Serum samples, stored after post-hepatitis B virus (HBV) vaccination testing in the years 2000–2009, were tested for HCV antibodies. Repeat reactive samples were confirmed by immunoblot assay and the detection of HCV RNA. The average age of the 729 health care workers was 39 years (range 18–66), suggesting a considerable cumulative occupational exposure to the blood. Nevertheless, only one of the 729 workers (0.14%; 95% confidence interval [CI]: <0.01% to 0.85%) was tested and confirmed to be positive for anti-HCV and positive for HCV RNA, which is comparable to the prevalence of HCV among Amsterdam citizens. Against this background, for the protection of personnel and patients, careful follow-up after needlestick injuries may be sufficient. If a zero-risk approach is desirable and costs are less relevant, the recurrent screening of EPP-performing personnel for HCV is superior to the follow-up of reported occupational exposures.

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“…Nevertheless, two tests increase the cost of the screening unless a sequential screening strategy is used (Seed et al, 2003). Another solution would be to use the strength of antibody reactivity as predictive marker of true-positive results and viremia in asymptomatic HCV infected people (Acar et al, 2010; Contreras et al, 2010; Kiely et al, 2010; Stramer et al, 2012). Our results, from an admittedly small study, are in accordance with this last report since mean s/co ratios were significantly higher in viremic subjects.…”

Section: Discussionmentioning

confidence: 99%

Screening for hepatitis C virus infection in a high prevalence country by an antigen/antibody combination assay versus a rapid test

Tagny

Mbanya

Murphy

et al. 2014

Journal of Virological Methods

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In low-income-countries, screening for hepatitis C virus (HCV) infection is often based on rapid tests (RT). Their lower sensitivity compared to enzyme immunoassay (EIA) suggests that newer HCV Antigen/Antibody (Ag/Ab) combination assays might have a role in such countries. To test this idea, 1998 blood donors were tested at the University Teaching Hospital blood bank in Yaoundé, Cameroon simultaneously with a RT (HCV rapid test, Human Diagnostics, Berlin, Germany) according to standard practice (S1) and with an Ag/Ab assay (Monolisa HCV Ag/Ab Ultra, Biorad, France) (S2). All discordant, borderline and reactive samples were submitted to confirmatory testing by immunoblot and/or HCV-RNA. Of the 86 (4.3%) samples positive with one or both strategies, 29 were confirmed negative, 37 positive and 20 were false positive or resolved infection. There was a significant difference in test sensitivity (p = 0.01) between S1 (70.3%) and S2 (91.9%) but not in test specificity (99.4% and 98.6%, respectively). The benefit of the Ag/Ab assay in the detection of recent HCV seronegative infections could not be evaluated since no Antigen-only donations were identified. However, better Ag/Ab test sensitivity compared to RT supports the implementation of these newer immunoassays for HCV screening in the African blood bank setting.

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Analysis of sample‐to‐cutoff ratios on chemiluminescent immunoassays used for blood donor screening highlights the need for serologic confirmatory testing

Cited by 27 publications

References 31 publications

Comparison Between Screening and Confirmatory Serological Assays in Blood Donors in a Region of South Italy

Comparison Between Screening and Confirmatory Serological Assays in Blood Donors in a Region of South Italy

Hepatitis C virus infection among transmission-prone medical personnel

Screening for hepatitis C virus infection in a high prevalence country by an antigen/antibody combination assay versus a rapid test

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