The current status of nucleic acid amplification technology in transfusion‐transmitted infectious disease testing

Abstract

Fully automated multiplex nucleic acid amplification technology (NAT) enabling individual‐donation (ID) or minipool of 6 (MP6) screening for HIV, HCV and HBV is provided by two major commercial players (Grifols/Hologic and Roche). In August 2014, Roche released the cobas MPX assay performed on the high‐throughput cobas 8800 and 6800 instruments. Grifols recently released their Ultrio Elite assay which includes detection of HIV‐2 and is performed on the Panther platform and allows random access of sample and reagent loading during processing, which streamlines functionality and improves turnaround time. At the end of June 2015, 61 countries perform NAT to screen the blood supply. Of these, 16 and 18 countries screen entirely with NAT systems either from Roche or from Grifols, respectively, and the remaining 27 countries use a combination of both methods in their country. Twenty countries screen entirely using ID‐NAT and the remaining 41 countries use either MP or a combination of MP and ID‐NAT. The cobas MPX Roche assay has a 95% limit of detection (LOD) of 25·7 IU/ml (CI 21·1–32·8), 7·0 IU/ml (CI 5·9–8·6) and 1·4 IU/ml (CI 1·2–1·7) for HIV‐1, HCV and HBV, respectively. The Ultrio Elite Grifols assay has a LOD of 18 IU/ml (15–23·5), 3·0 IU/ml (2·5–3·9) and 4·3 IU/ml (CI 3·8–5·0) for HIV, HCV and HBV, respectively. There have been 4 anecdotal cases of proven ID‐NAT breakthrough transmission cases of both window period (WP) and occult HBV infection (OBI) highlighting the importance of selective donor recruitment in addition to state‐of‐the‐art screening.

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