West Nile virus testing experience in 2007: evaluation of different criteria for triggering individual-donation nucleic acid testing

Abstract

Background: In 2007, clients served by Blood Systems Laboratories used variable approaches for triggering West Nile virus (WNV) RNA individual-donation (ID) nucleic acid testing (NAT). These included two minipool (MP) NAT-reactive donations and a greater than 1:1000 rate in a 7-day interval (primary trigger), criteria based on one MP-NAT-reactive donation when there was WNV activity in overlapping and/or adjacent geographic areas (neighbor trigger), or zero MP-NAT-reactive donation (self-trigger).

Study design and methods: The Procleix WNV assay was used in either a 16-sample MP or an ID format. NAT-repeat reactivity or anti-immunoglobulin M (IgM) positivity defined true positives (TPs). TPs that were negative on 1:16 dilution testing were considered ID-NAT yield cases.

Results: WNV NAT performed on 1,217,929 donations identified 162 TPs; 87 were detected by MP (rate of 0.008%) and 75 by ID (rate of 0.10%; p < 0.0001). There were 34 ID-NAT yield cases, including 4 IgM/immunoglobulin G (IgG)-negative and 9 IgM-positive/IgG-negative donations. Rates of yield cases by primary, neighbor, and self-triggering were 0.077, 0.052, and 0.004% (p = 0.0003). None of 11 ID-NAT yield cases detected by the neighbor trigger would have been detected if the primary trigger had been used.

Conclusions: Primary triggering criteria identified 21 viremic donations that would have been missed by MP testing; however, 11 other low-level viremic donations required more stringent criteria (e.g., neighbor trigger) for detection. It is reasonable to adopt more stringent ID-NAT triggers, including elimination of the rate criterion and triggering on one NAT-reactive donation for regions adjacent to centers which have already triggered.