Assuntos
Fármacos Dermatológicos/economia , Custos de Medicamentos/legislação & jurisprudência , Seguro de Serviços Farmacêuticos/economia , Assistência Farmacêutica/economia , Fármacos Dermatológicos/uso terapêutico , Medicamentos Genéricos/economia , Medicamentos Genéricos/uso terapêutico , Gastos em Saúde , Humanos , Seguro de Serviços Farmacêuticos/legislação & jurisprudência , Medicaid/economia , Medicare/economia , Avaliação das Necessidades , Estados Unidos , United States Food and Drug Administration/economia , United States Food and Drug Administration/legislação & jurisprudênciaRESUMO
BACKGROUND AND OBJECTIVES: To reduce the risk of transfusion-transmissible viruses entering the blood supply, the nucleic acid amplification testing (NAT) was implemented to screen Scottish and Northern Irish blood donations in minipools. After 5 years of NAT for hepatitis C virus (HCV) and 2 years for human immunodeficiency virus-1 (HIV-1), the yield of serologically negative, nucleic acid positive 'window donations' and cost-benefit of NAT is under review. MATERIALS AND METHODS: When the Scottish National Blood Transfusion Service (SNBTS) implemented NAT in 1999, a fully automated 'black box' system was not available. Therefore, an 'in-house' assimilated NAT assay was developed, validated and implemented. The system is flexible and allows testing for additional viral markers to be introduced with relative ease. RESULTS: The HCV and HIV NAT assays have 95% detection levels of 7.25 IU/ml and 39.8 IU/ml, respectively, as determined by probit analysis. One HCV (1 in 1.9 million) and one HIV (1 in 0.77 million) window donation have been detected in 5 and 2 years, respectively, of NAT. CONCLUSION: The SNBTS NAT assays are robust and have performed consistently over the last 5 years. The design of the in-house system allowed HIV NAT to be added in 2003 at a relatively small additional cost per sample, although for both assays, the royalty fee far exceeds the cost of the test itself. Clearly NAT has a benefit in improving the safety of the blood supply although the risks of transfusion-transmitted viral infections, as reported in the Serious Hazards of Transfusion (SHOT) report, are extremely low. Also, in UK the yield of HCV antibody negative, NAT positive donations is far lower than predicted although the early detection of an HIV window period donation and the increase of HIV in the blood donor and general populations may provide a stronger case for HIV NAT. SUMMARY SENTENCE: The yield of HCV and HIV NAT in UK is significantly less than that anticipated from statistical models.
Assuntos
Doadores de Sangue , Transfusão de Sangue/normas , Infecções por HIV/diagnóstico , Hepatite C/diagnóstico , Técnicas de Amplificação de Ácido Nucleico/normas , Adulto , Transfusão de Sangue/economia , Transfusão de Sangue/métodos , Análise Custo-Benefício , Feminino , Soronegatividade para HIV , Humanos , Irlanda , Masculino , Pessoa de Meia-Idade , Técnicas de Amplificação de Ácido Nucleico/economia , Técnicas de Amplificação de Ácido Nucleico/estatística & dados numéricos , Escócia , Sensibilidade e Especificidade , Testes SorológicosRESUMO
Samples from 1828 donations were screened for anti-HBc at seven sites in the UK using kits supplied by 10 manufacturers. Only 10 (0.55%) donations were considered to have true anti-HBc reactivity and these were detected by all 10 kits. Additional markers of HBV infection were found in nine of these 10 donations. Additional reactives were found by all kits, the number ranging from 1 to 43. In the four more specific kits, the 10 true reactives were clearly distinguished from the 'false reactives' by the strength of the reaction. It is concluded that the reliance on a single ELISA test for anti-HBc diagnosis is unwise. The use of a second test known to be more specific than the screening ELISA is recommended.