Lookback on donors who are repeatedly reactiveon first‐generation hepatitis C virus assays:justification and rational implementation

Tobler, Leslie H.; Tegtmeier, Gary; Stramer, Susan L.; Quan, Stella; Dockter, Janel; Giachetti, Cristina; Busch, MP

doi:10.1046/j.1537-2995.2000.40010015.x

Cited by 17 publications

(16 citation statements)

References 10 publications

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“…A recombinant immunoblot assay (RIBA HCV 2.0 strip immunoblot assay; Chiron, Emeryville, CA) was used to confirm the specificity of highly positive EIA. In a separate subset of 75 specimens with signal-to-cutoff ratios of 13, 70 (90%) were positive by recombinant immunoblot assay (authors' unpublished data), which is consistent with the findings of others [42,43].…”

Section: Methodssupporting

confidence: 88%

Genetic Epidemiology of Hepatitis C Virus throughout Egypt

et al. 2000

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Hepatitis C virus (HCV) infection is a major health problem in Egypt, where the seroprevalence is 10-20-fold higher than that in the United States. To characterize the HCV genotype distribution and concordance of genotype assessments on the basis of multiple genomic regions, specimens were obtained from blood donors in 15 geographically diverse governorates throughout Egypt. The 5' noncoding, core/E1, and NS5B regions were amplified by reverse transcription-polymerase chain reaction and analyzed by both restriction fragment length polymorphism (RFLP) and phylogenetic tree construction. For the 5' noncoding region, 122 (64%) of 190 specimens were amplified and analyzed by RFLP: 111 (91%) were genotype 4, 1 (1%) was genotype 1a, 1 (1%) was genotype 1b, and 9 (7%) could not be typed. Phylogenetic analyses of the core/E1 and NS5B regions confirmed the genotype 4 preponderance and revealed evidence of 3 new subtypes. Analysis of genetic distance between isolates was consistent with the introduction of multiple virus strains 75-140 years ago, and no clustering was detected within geographic regions, suggesting widespread dispersion at some time since then.

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Section: Methodssupporting

confidence: 88%

Genetic Epidemiology of Hepatitis C Virus throughout Egypt

et al. 2000

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“…al., 2001 [24] indicated that only 5% of positive samples have a S/CO ratio less than 5. This is supported by Centres for Disease Control and Prevention Atlanta USA (CDC) and the Microbiological Diagnostics Assessment Service UK (MiDAS) [20], [43]. Their results suggest using S/CO ratio values to predict HCV-RNA positives, those that have been exposed but have cleared, and false-positive infections.…”

Section: Methodsmentioning

confidence: 99%

Infection Frequency of Hepatitis C Virus and IL28B Haplotypes in Papua New Guinea, Fiji, and Kiribati

et al. 2013

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It has been estimated that there are more than 60 million Hepatitis C virus (HCV) carriers in the World Health Organisation's Western Pacific region (WHO-WPR), where liver cancer is among the top three causes of cancer death. WHO and the US Centres for Disease Control and Prevention report the prevalence of HCV in the South Pacific islands (countries within the WHO-WPR) to be high (5–10% and >2% respectively). However, since HCV is not tested for in many of these countries, there is sparse data available to support this assertion. We screened ∼2000 apparently healthy individuals from Papua New Guinea, Fiji and Kiribati and found a sero-prevalence of 2.0%, 0.1% and 0%, respectively. All sero-positive samples tested negative for HCV RNA. Curious as to why all the sero-positive individuals were negative for HCV-RNA, we also screened them for the HCV protective IL28B SNP markers rs12979860 and rs8099917. All antibody-positive participants bar one had HCV protective haplotypes. Our results suggest that HCV is present in these Pacific island countries, albeit at a prevalence lower than previous estimates. As none of our participants had undergone antiviral treatment, and therefore must have cleared infection naturally, we hypothesise that genotypes 1 and/or 4 are circulating in South Pacific Island people and that these peoples are genetically predisposed to be more likely to spontaneous resolve HCV infection than to become chronic carriers.

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“…Several CDC-sponsored and other anti-HCV seroprevalence studies have indicated that reactive S/Co ratios could be used to predict supplemental positive results (2,(5)(6)(7)11); most of these studies used EIAs (2,5,6,11). In the present report, the first fully automated random access diagnostic test approved by the FDA for the detection of HCV antibody, the VITROS anti-HCV assay, was utilized.…”

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confidence: 95%

Efficiency of the Ortho VITROS Assay for Detection of Hepatitis C Virus-Specific Antibodies Increased by Elimination of Supplemental Testing of Samples with Very Low Sample-to-Cutoff Ratios

et al. 2005

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The clinical significance of specimens with low sample-to-cutoff (S/Co) ratios in the Ortho VITROS chemiluminescence assay (CIA) for detection of antibodies to hepatitis C virus (HCV) was evaluated. In one study of 482 CIA-reactive samples, none of the 83 samples with S/Co ratios of <5 was HCV RNA positive. In a subsequent study, 332 samples with S/Co ratios of between 1 and 20 were tested with the recombinant immunoblot assay (RIBA). None of the 163 samples with S/Co ratios of <5 was RIBA positive, 83% were RIBA negative, and 28 samples (18%) were RIBA indeterminate. HCV RNA and/or clinical evidence of hepatitis was not found in the 27 indeterminate cases examined. These results show that over 99% of samples with very low S/Co ratios (<5) have no evidence of HCV infection. Therefore, we suggest that the HCV antibody testing algorithm for the VITROS assay might be modified to eliminate supplemental testing of samples with very low S/Co ratios.Assays for the detection of hepatitis C virus (HCV) antibodies have high false-positive rates, particularly in low-prevalence populations. Therefore, other tests such as recombinant immunoblot assay (RIBA) or HCV RNA PCR are used to confirm positive HCV antibody screening tests. To facilitate usage of the supplemental testing, the Centers for Disease Control and Prevention (CDC) published guidelines that incorporate anti-HCV assay signal-to-cutoff (S/Co) ratios into reflex testing algorithms for HCV antibody testing, in order to provide a more systematic approach for the laboratory diagnosis of HCV and minimize the number of specimens that require supplemental testing (2). Data obtained with three anti-HCV screening assays were used for these recommendations: two enzyme immunoassays (EIAs) (Abbott HCV EIA 2.0 and ORTHO HCV version 3.0 enzyme-linked immunosorbent assay) and one enhanced chemiluminescence immunoassay (CIA) (VITROS anti-HCV assay; Ortho-Clinical Diagnostics).The VITROS anti-HCV CIA has recently been shown to be at least as specific and sensitive as conventional EIAs (7, 9), and use of this CIA has been increasing. However, detailed studies of the CIA S/Co ratio value predictive of a positive supplemental HCV test have been limited (7, 9). The CDC guidelines have suggested reflex supplemental testing for samples with S/C ratios of Ͻ8.0 in the VITROS anti-HCV assay based on the evaluation of a total of 1,326 reactive samples, with only 142 of these specimens having S/Co ratios of Յ7.9 (2).We started using the VITROS anti-HCV assay shortly after its Food and Drug Administration approval in August 2001 and have prospectively applied reflex supplemental testing to all samples with S/Co ratios of between 1.00 and 20.0 in the setting of a population of U.S. veterans (8). The objectives of the present study were (i) to determine the S/Co ratio predictive of detectable HCV RNA; (ii) to evaluate, in samples with low S/Co ratios (between 1 and 20), the relationship between S/Co ratios and the number and types of bands detected by RIBA; (iii) to assess, for samples with i...

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Lookback on donors who are repeatedly reactiveon first‐generation hepatitis C virus assays:justification and rational implementation

Cited by 17 publications

References 10 publications

Genetic Epidemiology of Hepatitis C Virus throughout Egypt

Genetic Epidemiology of Hepatitis C Virus throughout Egypt

Infection Frequency of Hepatitis C Virus and IL28B Haplotypes in Papua New Guinea, Fiji, and Kiribati

Efficiency of the Ortho VITROS Assay for Detection of Hepatitis C Virus-Specific Antibodies Increased by Elimination of Supplemental Testing of Samples with Very Low Sample-to-Cutoff Ratios

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