Improved efficiency of national HIV, HCV, and HTLV antibody testing algorithms based on sequential screening immunoassays

Seed, Clive R.; Margaritis, Angelo R.; Bolton, Wayne; Kiely, Philip; Parker, Susan; Piscitelli, Lisa

doi:10.1046/j.1537-2995.2003.00304.x

Cited by 39 publications

(45 citation statements)

References 23 publications

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“…One could test simultaneously with two assays and exclude donors reactive with both since these subjects have the highest probability to be positive with NAT and/or Immunoblot (Choudhury et al, 2011). 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).…”

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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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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“…This algorithm has shown an elevated rate of inconclusive results and a high cost. The use of two EIA from different manufacturers for HTLV screening before confirmatory testing has been suggested in order to decrease false-reactive results [Rouet et al, 2001;Thorstensson et al, 2002;Seed et al, 2003;Jacob et al, 2007]. PCR is considered a gold standard for diagnosis of HTLV-1/2 because of its high sensitivity and specificity.…”

Section: Discussionmentioning

confidence: 99%

Long‐term serological follow‐up of blood donors with an HTLV‐Indeterminate Western Blot: Antibody Profile of Seroconverters and Individuals With False Reactions

Martins

Santos

Namen-Lopes

et al. 2010

Journal of Medical Virology

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The high proportion of indeterminate results of the screening test for human T-lymphotropic virus (HTLV) infection has been a challenge worldwide. In this study, 60 persons with seroindeterminate results for HTLV were followed until their serological status was defined. At least two independent serological tests (EIA and WB) from sequential samples were performed at an average interval of 4.4 years, totaling 141 serum samples tested. Seroconversion occurred in 12 individuals (reactive by EIA, positive by WB and PCR), and 48 were classified as false reactions (non-reactive EIA and negative PCR, but indeterminate WB). The seroconverter group had epidemiological features similar to those seen in HTLV-1 carriers, and the average time of follow-up for seroconversion was 4 years. In the group with false reactions, the most frequent indeterminate WB pattern in the samples was the presence of p24 alone. This pattern was absent in the seroconverter group, suggesting that p24 alone is an indicator of false reactivity. In contrast, the presence of p19 and p24 seems to be an indicator of true reactivity, since this pattern was frequent (66.7%) among the seroconverters and much less common (10.4% of the first samples) among the individuals with false reactions (P = 0.0001). Thus, HTLV infection may be suspected when reactivity to p19 and p24 is observed. Individuals with an indeterminate WB pattern should be followed-up and retested. The improvement of the HTLV algorithm screening of blood donors has been necessary to reduce inconclusive results and to avoid unnecessary follow-up to define the status of infection.

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“…The dual EIA algorithm we employed, which involves testing each sample that was repeat-reactive with the primary screening EIA using a different EIA, as previously suggested by Seed et al, 27 was shown to have high positive and negative predictive values, and could thus be utilized in blood services that usually do not perform confirmatory tests for HTLV due to the high cost of commercial WBs and unavailability of commercial HTLV PCR tests. This is the case for the majority of blood services in Brazil, where screening for HTLV is obligatory, but not the confirmation.…”

Section: Carneiro-proietti Et Almentioning

confidence: 99%

Human T-Lymphotropic Virus Type 1 and Type 2 Seroprevalence, Incidence, and Residual Transfusion Risk Among Blood Donors in Brazil During 2007–2009

Carneiro-Proietti

Sabino

Leão

et al. 2012

AIDS Research and Human Retroviruses

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Human T-lymphotropic virus type 1/2 (HTLV-1/2) infection is endemic in Brazil but representative donor prevalence and incidence data are lacking. All blood donations (2007)(2008)(2009)) from three blood centers in Brazil were studied. Samples reactive on one HTLV screening test (EIA) were retested with a different EIA; dual EIA reactivity correlated strongly with a confirmatory Western blot. Prevalence, incidence, and residual transfusion risk were calculated. Among 281,760 first-time donors, 363 were positive for HTLV on both EIAs (135 per 10 5 , 95% CI 122-150). Prevalence differed considerably by region, from 83 to 222 per 10 5 . Overall incidence rate was 3.6/10 5 person-years and residual transfusion risk was 5.0/10 6 per blood unit transfused. The logistic regression model showed significant associations with: age [adjusted odds ratio (aOR) = 5.23 for age 50 + vs. < 20], female sex (aOR = 1.97), black (aOR = 2.70 vs. white), and mixed skin colors (aOR = 1.78 vs. white), and inversely with education (aOR = 0.49, college vs. less than high school). HTLV testing with a dual-EIA strategy is feasible and can be useful in areas with low resources. Incidence and residual risk of HTLV-1 transmission by transfusion were relatively high and could be reduced by improving donor recruitment and selection in high prevalence areas. Blood center data may contribute to surveillance for HTLV infection.

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Improved efficiency of national HIV, HCV, and HTLV antibody testing algorithms based on sequential screening immunoassays

Cited by 39 publications

References 23 publications

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

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

Long‐term serological follow‐up of blood donors with an HTLV‐Indeterminate Western Blot: Antibody Profile of Seroconverters and Individuals With False Reactions

Human T-Lymphotropic Virus Type 1 and Type 2 Seroprevalence, Incidence, and Residual Transfusion Risk Among Blood Donors in Brazil During 2007–2009

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