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1.
Transfusion ; 47(9): 1686-90, 2007 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-17725735

RESUMO

BACKGROUND: The hepatitis C virus antibody (anti-HCV) can be identified with third-generation immunoassays. The purpose of this study was to define the correlation or agreement between first and second reactive results of anti-HCV microparticle-based enzyme immunoassay (MEIA) and of chemiluminescence assays (ChLIAs) in blood donors, to determine whether repeat testing is necessary. STUDY DESIGN AND METHODS: Commercially available assays, third-generation HCV MEIA (Abbott), third-generation HCV ChLIA (Ortho), and third-generation HCV ChLIA (Abbott), were used to evaluate anti-HCV repeatedly reactive blood obtained from donations made at 23 Mexican blood centers over a period of 1 year. The intraassay correlation between first and second reactive anti-HCV tests with the Pearson r test and the coefficient of variation (CV) were determined. RESULTS: The intraassay correlation of 565 anti-HCV repeatedly reactive samples was 0.996 for the Abbott third-generation HCV MEIA, 0.995 for the Ortho third-generation HCV ChLIA, and 0.993 for the Abbott third-generation HCV ChLIA. The CVs of these assay systems were 2.82, 5.33, and 5.69 percent, respectively. CONCLUSION: A highly significant intraassay correlation between anti-HCV duplicates was found. Specimens with a single reactive anti-HCV result with the Abbott third-generation HCV MEIA, Ortho third-generation HCV ChLIA, and Abbott third-generation HCV ChLIA assays should be considered as positive and need not be retested. Such a change in the algorithm for blood donor screening is feasible because of the availability of highly automated platforms.


Assuntos
Anticorpos Anti-Hepatite C/sangue , Anticorpos Anti-Hepatite C/imunologia , Imunoensaio/métodos , Hepacivirus/genética , Humanos , RNA Viral/genética , Reprodutibilidade dos Testes
2.
Transfusion ; 44(9): 1344-9, 2004 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-15318859

RESUMO

BACKGROUND: Hepatitis C virus (HCV) represents a viral pandemic that is five times as widespread as human immunodeficiency virus. Blood transfusion posed a major risk of HCV infection in developed countries before 1990, but the introduction of improved blood-screening measures has decreased the risk of transfusion-associated HCV infection, which may now be even lower since the introduction of screening of pooled samples by nucleic acid testing (NAT). Unfortunately, NAT is not affordable in most developing countries. The goal of this work is to assess the usefulness of both screening measures, the medical history, and the self-exclusion form to distinguish between high-risk and low-risk populations of HCV-carrier blood-donor candidates in Mexico. STUDY DESIGN AND METHODS: From February 2002 to April 2003, 4174 consecutive candidates were enrolled in a prospective, nonrandomized and comparative study. In total, 4158 candidates were included in the analysis and divided in two groups: Group A consisted of 3101 accepted donors and Group B consisted of 1057 deferred donors according to a complete medical history and self-exclusion form. The only exclusion criteria was the lack of a signed consent form to enter the study. All candidates from both groups underwent anti-HCV detection by third-generation enzyme immunoassay (EIA). Those who had either a positive or gray-zone signal-to-cutoff ratio underwent polymerase chain reaction and a second EIA test. If the second EIA test resulted in either a positive or gray-zone signal-to-cutoff ratio, a recombinant immunoblot assay test was performed. The chi-square test was used for statistical analysis, and a p value less than 0.05 was considered significant. RESULTS: Anti-HCV prevalence by the EIA method was as follows: 0.61 percent for Group A and 1.32 percent for Group B (p = 0.0243); whereas with recombinant immunoblot assay the prevalence was 0.19 percent for Group A and 0.47 percent for Group B (p = 0.1265). When we analyzed the polymerase chain reaction test results, the prevalence in Group A was 0.10 percent (95% confidence interval, 0.089-0.110) and in Group B was 0.47 percent (95% confidence interval, 0.439-0.500) (p = 0.0159). CONCLUSIONS: The medical history of blood donors in conjunction with serologic screening tests helps to improve blood transfusion safety. This measure is recommended in blood banks of those countries where NAT is still unaffordable.


Assuntos
Doadores de Sangue , Hepatite C/epidemiologia , Programas de Rastreamento/métodos , Prontuários Médicos , Autorrevelação , Adulto , Doadores de Sangue/psicologia , DNA Viral/sangue , Feminino , Hepatite C/diagnóstico , Humanos , Immunoblotting , Técnicas Imunoenzimáticas , Consentimento Livre e Esclarecido , Masculino , Pessoa de Meia-Idade , Reação em Cadeia da Polimerase , Valor Preditivo dos Testes , Estudos Prospectivos , Estudos Soroepidemiológicos , Inquéritos e Questionários , Viremia/diagnóstico , Viremia/epidemiologia
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