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两种算法用于确认和鉴别最初对核酸扩增检测呈反应性的样本的比较。

Comparison of two algorithms to confirm and discriminate samples initially reactive for nucleic acid amplification tests.

作者信息

Tiwari Aseem Kumar, Dara Ravi C, Arora Dinesh, Aggarwal Geet, Rawat Ganesh, Raina Vimarsh

机构信息

Department of Transfusion Medicine, Medanta - The Medicity, Gurgaon, Haryana, India.

Laboratory Services and Transfusion Medicine, Medanta - The Medicity, Gurgaon, Haryana, India.

出版信息

Asian J Transfus Sci. 2017 Jul-Dec;11(2):140-146. doi: 10.4103/0973-6247.214330.

Abstract

BACKGROUND

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.

MATERIALS AND METHODS

Results of ID-NAT using two algorithms were analyzed.

RESULTS

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).

CONCLUSION

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.

摘要

背景

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。

材料与方法

分析了使用两种算法的ID-NAT结果。

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)。

结论

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。

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引用本文的文献

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本文引用的文献

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Evaluation of the Procleix Ultrio Plus ID NAT assay for detection of HIV 1, HBV and HCV in blood donors.
Asian J Transfus Sci. 2015 Jan-Jun;9(1):29-30. doi: 10.4103/0973-6247.150944.
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Automated nucleic acid amplification testing in blood banks: An additional layer of blood safety.
Asian J Transfus Sci. 2015 Jan-Jun;9(1):9-11. doi: 10.4103/0973-6247.150938.
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