Human immunodeficiency virus Type-1 (HIV-1)

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Record number: 
Adverse Occurrence type: 
MPHO Type: 
Estimated frequency: 
This case, which dates back to more than 10 years ago, is the only case of HIV transmission reported to date since the development and use of methylene blue inactivation. Methylene blue treated plasma has been in clinical use for 22 years (2015).
Alerting signals, symptoms, evidence of occurrence: 
HIV infection was diagnosed in a 24-year-old patient with T-cell acute lymphoblastic leukemia who had received blood components from 77 donors in Spain, 4 years prior to the diagnosis (September 2005 to April 2006). The paper does not describe the reason for testing nor does it give clinical details.
Demonstration of imputability or root cause: 
A look back exercise identified one donor who was HIV-1 antibody and RNA positive; the donor had been diagnosed with HIV infection approximately 1 month after his last donation, which was the implicated donation. Red blood cells (RBCs), Methylene blue FFP (MB-FFP), and buffy coat platelet concentrate (BC-PLT) had been manufactured. At the time of donation in 2005, HIV-1RNA was not detected by PCR in a 44 Mini Pool format. The cellular components from this donation had been leukoreduced. In 2009, HIV seroconversion was detected in the BC-PLT and MB-FFP recipients. The recipient of RBC patient did not show any evidence of HIV infection. The HIV strains from the two infected recipients and the donor were sequenced across 720 nucleotides in the pol gene; a mean nucleotide identity of 99.3% (range, 99.0%-99.7%) was observed, whereas identity to unrelated control sequences was 94.2% (range,91.9%-96.8%). It is not mentioned, whether or not the recipients were seronegative prior to the transfusions. The described findings support donor-derived infection but does not give evidence of root cause. The paper did not explore the possible explanations for the transmission and did not address system failure against process failure. The retrospectively measured viral load in the archived index donation showed 135 copies/ml HIV-1 RNA by Cobas Amplicor.
Imputability grade: 
Not Assessable
Suggest new keywords: 
Methylene blue
pathogen reduction
pathogen inactivation
Reference attachment: 
Suggest references: 
Manuel Alvarez, Mar Luis-Hidalgo, Marıa Alma Bracho, et al. Transmission of human immunodeficiency virus Type-1 by fresh-frozen plasma treated with methylene blue and light. TRANSFUSION 2015;00;00–00. doi:10.1111/trf.13409
Expert comments for publication: 
The paper does not describe all relevant points in great detail and there is missing information. There is no discussion regarding the likelihood of the Theraflex technology per se to fail to inactivate HIV-1 present at the described level of 135 copies/ml. There is some discussion regarding the possibility of under quantification of plasma viraemia but the issue of inactivation failure against process errors was not explored.