[410293]
Transfusion of a west nile virus (wnv), nucleic acid test (nat)-reactive granulocyte component in 2005. Testing of the donation sample corresponding with the transfused component was performed at the american red cross national testing laboratory (ntl) using the gen-probe investigational tma reagents for wnv rna detection (product number 30113-02). Testing is performed under bb-ind 11036 (american red cross as the sponsor) cross referencing gen-probe's protocol in bb-ind 10920. The donation was tested without dilution (never pooled) and had a reactive wnv result (s/co = 2. 22) on master lot 405379 in 2005 (lot expiration not provided; lot manufactured on 2/15/04). Retesting performed using the same lot of wnv reagents in the next day yielded a nonreactive result (s/co = 0. 07). Per protocol, residual index sample has also been sent to national genetics institute (ngi) for wnv pcr. The tma testing was performed by trained operators using validated/qualified equipment/reagents. The tma lot used for the testing had been reported to the manufacturer and product distributor for elevated unresolved (false positive) reactive rates. The complaint was filed using standard complaint filing to chiron corporation (for whom the gen-probe investigational wnv reagents are distributed and supported). The historic use of lot 405379 in the ntl has resulted in a reactive rate (following one round of testing, or initial reactive rate) of 0. 10%; this was an elevation observed from the previous lot that had an initial reactive rate of 0. 02%. All red cross laboratories using lot 405379 have experienced similar elevations in reactive rates that have been attributed to the use of this lot. The manufacturer and distributor of the product have acknowledged that lot 405379 has significantly higher reactive rates than previous lots but state that the manufacture of this lot was within the product's manufacturing specifications.
Patient Sequence No: 1, Text Type: D, B5