Confirmatory testing of hepatitis C virus–positive enzyme immunoassay results in limited‐resource countries: should it be attempted?

Nelson, Kenrad E.; Shan, Hua

doi:10.1111/j.1537-2995.2008.01696.x

Cited by 8 publications

(8 citation statements)

References 29 publications

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“…In the study performed by the CDC, in three different population arms whose HCV prevalence was either low (2%), medium (9·5%) or high (25%), it was demonstrated that when the S/CO ratio of a repeat reactive sample was ≥3·8, the true positivity rate with the confirmatory test was 95% (when tested with Abbott second generation EIA and Ortho third generation ELISA). In a similar study performed in China, it was stated that true positivity rate with the use of RIBA or NAT was 96·1% for EIA samples whose S/CO ratio was ≥3·8 with Ortho third generation EIA (Nelson & Shan, 2008). In another study correlation was also noticed with high false‐positive rates for sample S/CO ratios below the value of 3·8 (Contreras et al , 2007).…”

Section: Discussionmentioning

confidence: 99%

The significance of repeat testing in Turkish blood donors screened with HBV, HCV and HIV immunoassays and the importance of S/CO ratios in the interpretation of HCV/HIV screening test results and as a determinant for further confirmatory testing

Acar¹,

Kemahlı

Altunay³

et al. 2010

Transfusion Medicine

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The purpose of this study was to investigate the intra-assay correlations amongst initial reactive and repeat screening results used in enzyme immunoassays (EIAs) for hepatitis B virus (HBV), hepatitis C virus (HCV) and HIV in blood donors. This study evaluated the value of using the power of the signal to cut-off (S/CO) ratio index for confirming anti-HCV/HIV reactive screening results, thereby touching upon the utility of S/CO indices in determining whether further confirmatory testing was necessary. Screening test results of the 72,695 blood donors were evaluated over a 1-year period. Correlation analysis among each initial test and retests was done by Pearson r test. Appropriate S/CO values to determine the need of the confirmation testing was investigated by ROC analyses. EIA intra-assay correlations were of statistical significance and were determined as follows: 0.948 for anti-HCV, 0.827 for anti-HIV and 0.948 for HBsAg. The threshold S/CO ratio values which predicted more than 95% of the confirmation test result were 3.8 for HCV and 5.6 for HIV. We were able to demonstrate a strong level of intra-assay correlation amongst EIAs, thereby eliminating the need for repetition of the screening test. Hence, we suggest that repeat screening should only be limited to HBV and HIV tests with low EIA S/CO ratios. Thus, using the power of the S/CO ratio in determining the need for HCV confirmation testing can be a cost-effective measure, especially if the S/CO value is >or=3.8.

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Section: Discussionmentioning

confidence: 99%

The significance of repeat testing in Turkish blood donors screened with HBV, HCV and HIV immunoassays and the importance of S/CO ratios in the interpretation of HCV/HIV screening test results and as a determinant for further confirmatory testing

Acar¹,

Kemahlı

Altunay³

et al. 2010

Transfusion Medicine

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“…A number of reports have shown that relatively high sample‐to‐cutoff (s/co) ratios on screening immunoassays (IAs) for antibodies to hepatitis C virus (anti‐HCV) are predictive of confirmed‐positive results in both blood donor 1‐8 and nondonor populations 9‐16 . As well, it has been suggested that an anti‐HCV status can be assigned solely on the basis of screening IA s/co ratios 17,18 . The purpose of this study was to compare the s/co ratio distributions of biologic false‐reactive (BFR) with confirmed‐positive results for four chemiluminescent immunoassays (ChLIAs) in a blood donor population.…”

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confidence: 99%

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

et al. 2010

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Although high s/co ratios were predictive of confirmed-positive results in all four assays, a number of confirmed-positive samples gave low values while some biologic false-positive samples showed high values. As the s/co ratio distributions for BFR and confirmed-positive results overlapped for all four PRISM assays, this study highlights the importance of serologic confirmatory testing and the need for caution when using screening IA results to assign a final donor status.

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“…HBV DNA level measured using poly merase chain reaction (PCR) is a good diagnostic assay for the diagnosis of HBV, however, due to its high cost in many countries and regions, especially low-income countries, ELISA is still used without further confirming viral titer with PCR. Significantly, many HBeAg (−) patients show chronic active HBV in further screening by PCR and vice versa (Nelson and Shan 2008). Therefore, it is important to identify new reliable serum markers as indicators of the active status of HBeAg (−) CHB.…”

Section: Introductionmentioning

confidence: 99%

Serum Decoy Receptor 3 Is a Useful Predictor for the Active Status of Chronic Hepatitis B in Hepatitis B e Antigen-Negative Patients

Hou

Lou

et al. 2013

Tohoku J. Exp. Med.

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Hepatitis B virus (HBV) infection is a global public health problem, because patients with chronic hepatitis B (CHB) may progress to liver cirrhosis and eventually evolve into hepatocellular carcinoma. Decoy receptor 3 (DcR3) is a soluble receptor of the tumor necrosis factor receptor superfamily, and has been implicated in anti-apoptotic and anti-inflammatory pathways. In this study, we explored the clinical value of serum DcR3 in predicting the active status of CHB in hepatitis B e antigen-negative patients (active HBeAg (−) CHB), which was determined with ELISA. The serum level of DcR3 in active HBeAg (−) CHB patients (1.92 ± 0.68 ng/ml) was higher than that in healthy controls (0.80 ± 0.25 ng/ml, p < 0.0001) and that in inactive status of HBeAg (−) CHB (inactive hepatitis B surface antigen carrier, HBsAg-IaC) patients (0.95 ± 0.26 ng/ml, p < 0.0001). DcR3 level was correlated with HBV DNA level (r = 0.819, p < 0.0001) and alanine transaminase level (ALT, r = 0.704, p < 0.0001) in active HBeAg (−) CHB patients. The area under the Receiver Operating Characteristics curve of DcR3 for detecting the active status of HBeAg (−) CHB patients was 0.914 (95% confidence interval, 0.851-0.977). The optimal cut-off value for DcR3 to predict active HBeAg (−) CHB was 1.22 ng/ml, which had a sensitivity of 87.5% and a specificity of 84.4%. These results suggest that serum DcR3 level may be useful for detecting HBeAg (−) CHB in the active stage, which requires medical treatment.

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Confirmatory testing of hepatitis C virus–positive enzyme immunoassay results in limited‐resource countries: should it be attempted?

Abstract: ABBREVIATIONS: CIA = chemiluminescence assay; S/C = signal-to-cutoff (ratio).

Cited by 8 publications

References 29 publications

The significance of repeat testing in Turkish blood donors screened with HBV, HCV and HIV immunoassays and the importance of S/CO ratios in the interpretation of HCV/HIV screening test results and as a determinant for further confirmatory testing

The significance of repeat testing in Turkish blood donors screened with HBV, HCV and HIV immunoassays and the importance of S/CO ratios in the interpretation of HCV/HIV screening test results and as a determinant for further confirmatory testing

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

Serum Decoy Receptor 3 Is a Useful Predictor for the Active Status of Chronic Hepatitis B in Hepatitis B e Antigen-Negative Patients

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