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

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

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 %

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

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

Informe al DonanteInforme 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 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

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

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)

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

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

+-

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

Dr. Alejandro Otero FHBA aotero@hemobaires.org.ar