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Parvovirus B19 Transmission in Transfusion Recipients as Assessed in a Prospective Study (TRIPS). Yu MW, 1 Virata-Theimer ML, 1 Geng Y, 1 Schechterly CA, 2 Colvin CA, 3 Busch MP, 4 Alter HJ, 2 Luban NLC 3 1 CBER/FDA; 2 CC/NIH; 3 CNMC; 4 BSRI SoGAT XX, Warsaw, Poland 12-13 June 2007.

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parvovirus b19 transmission in transfusion recipients as assessed in a prospective study trips

Parvovirus B19 Transmission in Transfusion Recipients as Assessed in a Prospective Study (TRIPS)

Yu MW,1 Virata-Theimer ML,1 Geng Y,1 Schechterly CA,2 Colvin CA,3 Busch MP,4 Alter HJ,2 Luban NLC3

1CBER/FDA; 2CC/NIH; 3CNMC; 4BSRI

SoGAT XX, Warsaw, Poland

12-13 June 2007

trips transfusion related infections prospectively studied
TRIPSTransfusion Related Infections Prospectively Studied
  • A prospective study to investigate the transfusion risk of HIV, HBV, HCV, CMV, HHV-8, EBV, and parvovirus B19 by using both NAT and serological methods for detection in a cohort of transfusion recipients participating in a linked donor-recipient study
sample testing for b19 markers
Sample Testing for B19 Markers
  • Plasma or blood samples from 742 transfused patients enrolled between Nov 2001 and Nov 2006 were tested for:
    • B19 DNA, generally 4 and 8-wk post-transfusion (post-trn) samples by an in-house nested PCR (B19 DNA levels determined by limiting dilution)
    • Anti-B19 IgG, 12 and 24-wk post-trn samples by EIA (Biotrin)
    • If B19 DNA positive,
      • B19 DNA/anti-B19 IgM/anti-B19 IgG, pre-trn, post-trn, and associated donors’ plasma samples
      • DNA sequencing and phylogenetic analysis for causality assessment
blood and blood products transfused in trips
Blood and Blood Products Transfused in TRIPS
  • Cryoprecipitate
  • Platelets
  • Red Blood Cells (RBC)
  • Fresh Frozen Plasma
  • Frozen Deglycerolized RBC
  • Liquid Plasma
  • Stem Cells
b19 dna and anti b19 igg in recipients post transfusion
B19 DNA and Anti-B19 IgG in Recipients Post-Transfusion*

Testing # Pos/ # Recipients Tested (%)

B19 DNA 14/742 (1.9)

Anti-B19 IgG 385/632 (60.9)

* B19 DNA testing generally performed on 4 and 8 wk samples and anti-B19 IgG testing on 12 and 24 wk samples

14 b19 dna positive recipients
14 B19 DNA Positive Recipients
  • 11 (78.6%) recipients already pos for B19 DNA @ pre-trn
    • 6 + for low-level B19 DNA (≤ 63 IU/mL) and IgG
    • 3 + for DNA (≤ 2 x 107 IU/mL), IgM, and IgG
    • 1 + for DNA (> 2 x 1010 IU/mL) and IgM
    • 1 + for DNA only (63 IU/mL)
  • 1 recipient neg for all B19 markers @ pre- trn but pos for all @ post-trn
  • 1 recipient neg for all B19 markers @ pre-trn but had not seroconverted @ post-trn [the 4-wk DNA+ sample presumably false +]
  • 1 recipient with pending pre-trn testing
a b19 infected recipient after transfusion
A B19 Infected Recipient After Transfusion

Plasma B19 DNA Anti-B19

Testing (IU/mL) IgG IgM

Pre-trn Neg* Neg Neg

Post-trn:

2 wk 6 x 106 Neg Equiv

4 wk 20 Neg Neg

8 wk 630 Pos Pos

12 wk 140 Pos Pos

24 wk Neg Pos Neg

* <20 IU/mL of B19 DNA

b19 marker testing of donations received by the b19 infected recipient
B19 Marker Testing of Donations Received by the B19 Infected Recipient

Donor Trn B19 DNA Anti-B19

No. Date (IU/mL) IgG (IU/mL) IgM

1 Day 0a NTb NT NT

2 0 Neg Neg Neg

3 2 Neg Pos (15) Neg

4 2 5 x 109 Neg Neg

5 4 Neg Pos (79) Neg

6 4 Neg Pos (28) Neg

a RBC from 2 donors were transfused every other day starting on Day 0; 6 RBC units were used.

b Not tested; sample not available

summary i
Summary(I)
  • 1.9% (14/742) of transfusion recipients were parvovirus B19 DNA positive.
    • Majority (78.6%) of them were already infected with B19 before transfusion.
  • Only one seronegative recipient (0.1%, 1/742) was infected with B19 via transfusion.
  • The transmission case was confirmed by causality assessment based upon sequencing and phylogenetic analysis of the linked donor-recipient samples.
    • Both the donor and the recipient were infected with genotype 1 of B19.
summary ii
Summary(II)
  • The recipient was infected by receiving 1 unit of RBC having 5 x 109 IUof B19 DNA/mL plasma along with another 1 RBC unit positive for anti-B19 IgG (15 IU/mL plasma) within the same day and 2 other RBC units positive for anti-B19 IgG (79, 28 IU/mL) 2 days afterward.
    • Total infectious dose: 5 x 1010 IU of B19 DNA in the presence of anti-B19 IgG (150 or 1220 IU; presumably containing some B19 neutralizing antibodies)
      • Assuming 10 mL of residual plasma per unit of RBC
      • Assuming the RBC unit with no available sample was negative for all B19 markers
summary iii
Summary(III)
  • Transfusion transmission of B19 from an acutely infected donor to a susceptible recipient may not be a rare event.
  • Such a transmission might not have been detected without a prospective study.
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