Abstract

To determine the seroprevalence of anti-hepatitis C virus antibodies (anti-HCV) in blood donors, and to describe the correlation between screening serological test results and confirmatory test. Epidemiological and laboratorial records of 10,090 blood donors of the blood unit in the city of Apucarana, Brazil, from January 1997 to December 1999 were assessed. Anti-HCV serum antibodies were detected using enzyme-linked immunosorbent assay (ELISA). Serum reactive samples were tested using RIBA (recombinant immunoblot assay). Statistical analysis was performed using Chi-square test, Fischer's test and Kappa index of agreement. The results showed that of all the donors, 2,461 (24.4%) were females, 7,629 (75.6%) were males, with ages ranging from 18 to 65 years old. Of 10,090 serum samples tested using ELISA, 88 were reactive to anti-HCV, a seroprevalence of 0.9% that showed no association with either age groups (p=0.197) or sex (p=0.323). When the samples were tested using RIBA, 11 (12.5%) were positive, 14 (15.9%) were indeterminate, and 38 (43.2%) were negative. Statistical analysis revealed a high correlation (kappa index 0.939) between ELISA and RIBA test results. Poorly reactive samples in ELISA showed a high correlation with negative results in RIBA, and samples highly reactive in ELISA showed a high correlation with positive results in RIBA. The results stress the need of confirmatory tests for all anti-HCV reactive samples in screening tests. HVC infection confirmation is paramount for clinical, laboratorial, and histological evaluation of blood donors.

Highlights

  • Gonçales et al[7] (2000) sugerem forte relação entre os resultados obtidos no teste de triagem de Elisa de segunda geração para pesquisa de anti-vírus da hepatite C (VHC) e positividade do RNA-HCV por RTnested PCR quando a relação entre a DO da amostra/cut-off obtida no enzyme-linked immunosorbent assay (ELISA) for maior ou igual a 3

  • Embora o valor preditivo positivo (VPP) do teste de enzyme-linked immunosorbent assay (ELISA) para anti-vírus da hepatite C (VHC) em doadores de sangue tenha melhorado significativamente com o uso de ELISA de segunda e terceira geração, soros que fornecem resultado reagente nos testes de triagem devem ser confirmados com testes suplementares multiantigênicos como o recombinant immunoblot assay (RIBA) ou pela amplificação do RNA viral por RT-PCR

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Summary

Methods

Epidemiological and laboratorial records of 10,090 blood donors of the blood unit in the city of Apucarana, Brazil, from January 1997 to December 1999 were assessed. Anti-HCV serum antibodies were detected using enzyme-linked immunosorbent assay (ELISA). Serum reactive samples were tested using RIBA (recombinant immunoblot assay). Statistical analysis was performed using Chi-square test, Fischer’s test and Kappa index of agreement

Results
Conclusions
Indeterminado Negativo Não RealizadoTotal
Negativo Não Realizado Total
Indeterminado Negativo Não Realizado Total
Teste confirmatório
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