Tiwari Aseem Kumar, Dara Ravi C, Arora Dinesh, Aggarwal Geet, Rawat Ganesh, Raina Vimarsh
Department of Transfusion Medicine, Medanta - The Medicity, Gurgaon, Haryana, India.
Laboratory Services and Transfusion Medicine, Medanta - The Medicity, Gurgaon, Haryana, India.
Asian J Transfus Sci. 2017 Jul-Dec;11(2):140-146. doi: 10.4103/0973-6247.214330.
Blood centers in India have published individual donor nucleic acid testing (ID-NAT) data based on an algorithm (Algorithm A) where serologically negative, NAT reactive sample was subsequently tested with discriminatory NAT (d-NAT), and on the basis of d-NAT, initial reactive samples were classified as "NAT yield" or inconclusive. We followed Algorithm B based on replicate testing and Ultrio Plus assay and compared the results with Algorithm A with Ultrio assay.
Results of ID-NAT using two algorithms were analyzed.
A total of 88,583 (31,844 with Algorithm A and 56,739 with Algorithm B) samples were tested. Among serology nonreactive donations, NAT inconclusive results came down from 95.2% in Algorithm A to 73.1% in Algorithm B ( = 0.0001). Discriminated yield (DY) rate went up from 4.7% in Algorithm A to 21.9% in Algorithm B ( = 0.001).
The study data suggest that replicate testing strategy and Ultrio Plus reduce the number of "inconclusive results" seen with earlier commonly used algorithm. We recommend a replicate testing strategy in ID-NAT testing since it will increase the DY and will eliminate the unnecessary discriminatory tests.
印度的血液中心已根据一种算法（算法A）公布了个体供者核酸检测（ID-NAT）数据，该算法中，血清学阴性但核酸检测反应性的样本随后用鉴别性核酸检测（d-NAT）进行检测，并根据d-NAT将最初反应性样本分类为“核酸检测阳性率”或不确定。我们采用了基于重复检测和Ultrio Plus检测的算法B，并将结果与使用Ultrio检测的算法A进行比较。
分析了使用两种算法的ID-NAT结果。
共检测了88583个样本（算法A检测31844个，算法B检测56739个）。在血清学无反应的献血样本中，核酸检测不确定结果从算法A中的95.2%降至算法B中的73.1%（P = 0.0001）。鉴别阳性率（DY）从算法A中的4.7%升至算法B中的21.9%（P = 0.001）。
研究数据表明，重复检测策略和Ultrio Plus检测减少了早期常用算法中出现的“不确定结果”数量。我们建议在ID-NAT检测中采用重复检测策略，因为它将提高DY并消除不必要的鉴别检测。
