Riesgo estimado de infección viral en 10 de un sistema...Disposition, and Donor Deferral and...
Transcript of Riesgo estimado de infección viral en 10 de un sistema...Disposition, and Donor Deferral and...
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Riesgo estimado de infecciRiesgo estimado de infeccióón viral en 10n viral en 1077
donaciones estudiadasdonaciones estudiadas
VentanaVentana VariantesVariantes SeroconversiSeroconversióón Errorres den Errorres de
AtAtíípica pica laboratorio laboratorio
HIVHIV 15(93.7%)15(93.7%) <0.6(<3.7%) <0.1(<0.6%) 0.4(2.5%)<0.6(<3.7%) <0.1(<0.6%) 0.4(2.5%)
HCVHCV 80(72.180(72.1--87.9%)87.9%) <1(<1.1<1(<1.1--<0.9%)<0.9%) 00--20(020(0--21.9%) (1.2(021.9%) (1.2(0--21.9%)21.9%)
HBV HBV 6363--150(41.2150(41.2--98%) <0 (0%) 1(0.698%) <0 (0%) 1(0.6--1.5%) 11.5%) 1--3(0.63(0.6--4.5%)4.5%)
Busch y col. Applications of molecular biology to blood TransfusBusch y col. Applications of molecular biology to blood Transfusion. ion.
AABB,1997:123AABB,1997:123--7676
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Dodd et al. Transfusion, 2002
INFECCIINFECCIÓÓNN
RIESGO RESIDUAL A PARTIR DERIESGO RESIDUAL A PARTIR DE
DADORES DADORES REPETITIVOSREPETITIVOS
TODOS LOS TODOS LOS DONANTESDONANTES
HBVHBV 1:205.0001:205.000 1:144.0001:144.000
HCV (s/NAT)HCV (s/NAT) 1:276.0001:276.000 1:199.0001:199.000
HCV (c/NAT)HCV (c/NAT) 1:1.935.0001:1.935.000 1:1.390.0001:1.390.000
RIESGO RESIDUAL
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Alter MJ. Epidemiology of viral hepatitis and HIV co-infection. J Hepatol 2006; 44 Suppl: S6-S9.
3,7 108 infectados por HBV
1,3 108 infectados por HCV
4,0 107 infectados por HIV
Pacientes infectados por HIV 2-4 106 coinfectados por HBV
4-5 106 coinfectados por HCV
La distribución de datos es variable
Coinfectados por HBV = 6-14 % (67% incluyendo Core/Ag)
Coinfectados por HCV = 25-30 %
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SEROLOGSEROLOGÍÍAA NATNAT
% %
COINCIDENCIACOINCIDENCIA
HIV/P24HIV/P24 99 44 4444
HBsAgHBsAg 22
33 4,64,6HBc y HBsAgHBc y HBsAg 55
HBcHBc 5858
HCVHCV 2727 1111 4141
HIVHIV HBsAgHBsAg HBcHBc HCVHCV
NAT PNAT P NAT NNAT N NAT PNAT P NAT NNAT N NAT PNAT P NAT NNAT N NAT PNAT P NAT NNAT N
RPRP 2020 3,93,9 38,338,3 11,911,9 0,200,20 0,320,32 8,618,61 2,652,65
DSDS 00 2,92,9 2,362,36 13,713,7 0,020,02 0,170,17 1,011,01 1,571,57
nn 44 55 33 44 33 6060 1111 1616
Comparativos de RP
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Mejora logísticaMejora 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
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Informe al DonanteInforme al Donante
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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
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Reentry for Donors Deferred Because of Reactive HIV-1/2 Test Results
GROUP INAT ReactiveAnti-HIV 1/2 Test NegativeHIV-1 p24 EIA Negative
GROUP IINAT Non Reactive or Not DoneAnti-HIV 1/2 Test RRHIV-1 WB or IFA Indeterminate, Unreadable, Negative or Not DoneHIV-1 p24 EIA Negative
GROUP IIINAT Non Reactive or Not DoneAnti-HIV 1/2 Test NegativeHIV-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 RRID-NAT ReactiveAnti-HIV-1/2 Test Negative
ID-NAT Non ReactiveAnti-HIV-1/2 Test RR
ID-NAT Non ReactiveAnti-HIV-1/2 Test Negative
DEFER DONOR PERMANENTLY
DEFER DONOR PERMANENTLY
REENTER DONOR (Donor Eligible for Future Donation,Provided Donor Meets Elegibility Criteria)
DEFER DONOR AND CONTINUE FOLLOW-UP
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Reentry for Donors Deferred Because of Reactive HCV Test Results
GROUP ANAT ReactiveAnti-HCV Test Negative
GROUP BNAT Non Reactive or Not DoneAnti-HCV Test RR
AFTER 6 MONTHS
TEST FOLLOW-UP SAMPLE USING
HCV ID-NAT AND ANTI-HCV TEST
ID-NAT Reactive
Anti-HCV Test RRID-NAT ReactiveAnti-HCV Test Negative
ID-NAT Non ReactiveAnti-HCV Test RR
ID-NAT Non ReactiveAnti-HCV Test Negative
DEFER DONOR PERMANENTLY
DEFER DONOR PERMANENTLY
REENTER DONOR (Donor Eligible for Future Donation,Provided Donor Meets Elegibility Criteria)
DEFER DONOR AND CONTINUE FOLLOW-UP
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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)
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Reemplazo de muestra seropositiva
Liberar unidades
SERONEGATIVAS
ID- NAT de SEROPOSITIVO
MP-NATPOSITIVO
SEROLOGIA POSITIVA
Todas las unidades bloqueadas MP-NAT 2
NEGATIVO POSITIVO
MP-NATPOSITIVO
SEROLOGIA NEGATIVA
POSITIVO NEGATIVO
Descartar unidad
Diferimiento permanente
MP-NATNEGATIVO
SEROLOGIA POSITIVA
1
2
1 y 2 deben testearse en paralelo
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Todas las unidades liberadas
MP-NATNEGATIVO
SEROLOGIA NEGATIVA
MP-NATNEGATIVO
SEROLOGIA POSITIVA
Donante de
reposición
Donante
repetitivo
HIV RP> 4
HCV RP> 3
HBV (Ag) RP> 12
Repetir
ID-NAT
DESCARTAR UNIDAD
INFORME AL DONANTE
Repetir
ID-NAT
DESCARTAR UNIDAD
INFORME AL DONANTE
PROGRAMA DE
REINGRESO
DIFERIMIENTO
TEMPORARIO
DIFERIMIENTO
PERMANENTE
+-
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ID-NAT positivos
Apertura de pool en muestra individual
MP-NATPOSITIVO
SEROLOGIA NEGATIVA
Todas las unidades bloqueadas
ID-NAT negativos
Unidadesliberadas
Repetición de serología por
2 kits
Diferimiento permanente donante
(-)Discordancia
Revisión métodos
Descarte y reetiquetado de las unidades
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Dr. Alejandro Otero FHBA [email protected]