Riesgo estimado de infección n viral en 10 7 donaciones estudiadas Ventana Variantes Seroconversión n Errorres de Atípica laboratorio HIV 15(93.7%) <0.6(<3.7%) <0.1(<0.6%) 0.4(2.5%) HCV 80(72.1-87.9%) 87.9%) <1(<1.1-<0.9%) <0.9%) 0-20(0-21.9%) 21.9%) (1.2(0-21.9%) 21.9%) HBV 63-150(41.2 150(41.2-98%) <0 (0%) 1(0.6-1.5%) 1.5%) 1-3(0.61 3(0.6-4.5%) Busch y col. Applications of molecular biology to blood Transfusion. AABB,1997:123-76 76
RIESGO RESIDUAL INFECCIÓN RIESGO RESIDUAL A PARTIR DE DADORES REPETITIVOS TODOS LOS DONANTES HBV 1:205.000 1:144.000 HCV (s/nat) 1:276.000 1:199.000 HCV (c/nat) 1:1.935.000 1:1.390.000 Dodd et al. Transfusion, 2002
3,7 10 8 infectados por HBV 1,3 10 8 infectados por HCV 4,0 10 7 infectados por HIV Pacientes infectados por HIV 2-4 10 6 coinfectados por HBV 4-5 10 6 coinfectados por HCV La distribución de datos es variable Coinfectados por HBV = 6-14 % (67% incluyendo Core/Ag) Coinfectados por HCV = 25-30 % Alter MJ. Epidemiology of viral hepatitis and HIV co-infection. J Hepatol 2006; 44 Suppl: S6-S9.
% COINCIDENCIA SEROLOGÍA NAT HIV/P24 9 4 44 HBsAg 2 HBc y HBsAg 5 3 4,6 HBc 58 HCV 27 11 41 Comparativos de RP HIV HBsAg HBc HCV NAT P NAT N NAT P NAT N NAT P NAT N NAT P NAT N RP 20 3,9 38,3 11,9 0,20 0,32 8,61 2,65 DS 0 2,9 2,36 13,7 0,02 0,17 1,01 1,57 n 4 5 3 4 3 60 11 16
Mejora logística OPTIMIZACION DE LOS TIEMPOS DE ENTREGA DE RESULTADOS Demora de Procesamiento 6 a 10 horas vs mínimo de 24 horas OPERATIVIDAD PARA TRABAJO EN POOLES Esquema de reemplazo de muestra seropositiva DEFINICION DE ZONAS GRISES ACOTADAS A LA VARIABILIDAD DEL REACTIVO
Informe al Donante
1992: Revised Recommendations for the Prevention of Human Inmmunodeficiency Virus (HIV-1) Transmission by Blood and Blood Products 1993: Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) 1995: Recommendations for Donor Screening whit a Licensed Test for HIV-1 Antigen 2005: Draft Guidance: Recommendations for reentry of donors deferred because of anti-hiv test result and anti-hcv test result 2010: Guidance: Nucleic Acid Testing (NAT) for Human Inmodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
Reentry for Donors Deferred Because of Reactive HIV-1/2 Test Results GROUP I NAT Reactive Anti-HIV 1/2 Test Negative HIV-1 p24 EIA Negative GROUP II NAT Non Reactive or Not Done Anti-HIV 1/2 Test RR HIV-1 WB or IFA Indeterminate, Unreadable, Negative or Not Done HIV-1 p24 EIA Negative GROUP III NAT Non Reactive or Not Done Anti-HIV 1/2 Test Negative HIV-1 p24 EIA RR AFTER 8 WEEKS TEST FOLLOW-UP SAMPLE USING HIV-1 ID-NAT AND ANTI-HIV-1/2 TEST ID-NAT Reactive Anti-HIV-1/2 Test RR ID-NAT Reactive Anti-HIV-1/2 Test Negative ID-NAT Non Reactive Anti-HIV-1/2 Test RR ID-NAT Non Reactive Anti-HIV-1/2 Test Negative DEFER DONOR PERMANENTLY DEFER DONOR PERMANENTLY DEFER DONOR AND CONTINUE FOLLOW-UP REENTER DONOR (Donor Eligible for Future Donation,Provided Donor Meets Elegibility Criteria)
Reentry for Donors Deferred Because of Reactive HCV Test Results GROUP A NAT Reactive Anti-HCV Test Negative GROUP B NAT Non Reactive or Not Done Anti-HCV Test RR AFTER 6 MONTHS TEST FOLLOW-UP SAMPLE USING HCV ID-NAT AND ANTI-HCV TEST ID-NAT Reactive Anti-HCV Test RR ID-NAT Reactive Anti-HCV Test Negative ID-NAT Non Reactive Anti-HCV Test RR ID-NAT Non Reactive Anti-HCV Test Negative DEFER DONOR PERMANENTLY DEFER DONOR PERMANENTLY DEFER DONOR AND CONTINUE FOLLOW-UP REENTER DONOR (Donor Eligible for Future Donation,Provided Donor Meets Elegibility Criteria)
REQUALIFICATION PROCESS FOR DONORS DEFERRED BECAUSE OF REPEATEDLY REACTIVE TEST RESULTS FOR ANTI-HBc Donors previously deferred solely because of repeatedly reactive (RR) anti-hbc test on more than one occasion After a minimum of 8 weeks following the last repeatedly reactive anti-hbc test result, test a follow-up sample using FDA-licensed HBsAg and anti-hbc tests, and HBV NAT HBsAg RR or Anti-HBc RR or HBV NAT Reactive All tests negative Defer donor indefinitely Reenter donor (Donor eligible for future donations, provided donor meets eligibility criteria)
MP-NAT POSITIVO SEROLOGIA POSITIVA Reemplazo de muestra seropositiva POSITIVO ID- NAT de SEROPOSITIVO 2 NEGATIVO Todas las unidades bloqueadas MP-NAT 2 1 Descartar unidad Diferimiento permanente MP-NAT NEGATIVO SEROLOGIA POSITIVA NEGATIVO POSITIVO Liberar unidades SERONEGATIVAS MP-NAT POSITIVO SEROLOGIA NEGATIVA 1 y 2 deben testearse en paralelo
MP-NAT NEGATIVO SEROLOGIA NEGATIVA Todas las unidades liberadas Donante de reposición HIV RP> 4 HCV RP> 3 HBV (Ag) RP> 12 Repetir ID-NAT DESCARTAR UNIDAD INFORME AL DONANTE MP-NAT NEGATIVO SEROLOGIA POSITIVA - Donante repetitivo Repetir ID-NAT DESCARTAR UNIDAD INFORME AL DONANTE PROGRAMA DE REINGRESO DIFERIMIENTO TEMPORARIO + DIFERIMIENTO PERMANENTE
MP-NAT POSITIVO SEROLOGIA NEGATIVA Apertura de pool en muestra individual ID-NAT positivos Todas las unidades bloqueadas ID-NAT negativos Descarte y reetiquetado de las unidades Repetición de serología por 2 kits Unidades liberadas Discordancia Revisión métodos (-) Diferimiento permanente donante
Dr. Alejandro Otero FHBA aotero@hemobaires.org.ar