Performance evaluation of a domestic human immunodeficiency virus type 1 nucleic acid quantitative detection kit

YANG Xiaohui, WEN Lan

Anhui Journal of Preventive Medicine ›› 2019, Vol. 25 ›› Issue (4) : 259-261.

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PDF(1446 KB)
Anhui Journal of Preventive Medicine ›› 2019, Vol. 25 ›› Issue (4) : 259-261.

Performance evaluation of a domestic human immunodeficiency virus type 1 nucleic acid quantitative detection kit

  • YANG Xiaohui, WEN Lan
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Abstract

Objective To evaluate the clinical application performance of a domestic human immunodeficiency virus type 1 (HIV-1) nucleic acid detection reagent. Methods A total of 209 clinical samples were collected and tested simultaneously with the HIV quantitative nucleic acid detection kit of Mérieux Company and Northeast Pharmaceutical Group.The relationship between the data obtained by the two reagents was analyzed.The consistency of the two reagents was analyzed by Kappa test, and the correlation between the two reagents was analyzed by Bland-Altman test and paired t test. Results The Kappa detection value of Northeast Pharmaceutical Group and Merier Company was 1.00, so the overall coincidence rate of the two companies was 100%.The correlation analysis of the quantitative test results of the two kits showed that the correlation between the two kits was high, and the test results were identical.The paired t test showed that the two kits were equivalent. Conclusion The results of HIV quantitative nucleic acid test kit of Northeast Pharmaceutical Group and HIV test kit of Mérieux Company for the same clinical sample are qualitatively consistent.At the same time, the quantitative results have a high degree of correlation and consistency.

Key words

Human immunodeficiency virus / Real-time PCR / Reagent evaluation

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YANG Xiaohui, WEN Lan. Performance evaluation of a domestic human immunodeficiency virus type 1 nucleic acid quantitative detection kit[J]. Anhui Journal of Preventive Medicine. 2019, 25(4): 259-261

References

[1] 刘欣萍.三种不同免疫检验方法检测抗HIV结果可靠性对比分析[J].中国现代药物应用,2016,10(23):22-23.
[2] Cao YF,Lei X,Ribeiro RM,et al.Probabilistic control of HIV latency and transactivation by the Tat gene circuit[J].Proceedings of the National Academy of Sciences, 2018,115 (49) :12453-12458.
[3] 李梅,王静. 某国产 HIV-1核酸定量检测试剂盒的应用性能评估[J].检验医学与临床,2014,11(16): 2220-2225.
[4] 董雪,赵曦,里天初,等.中国三版艾滋病检测技术工作规范的对比分析[J].中国艾滋病性病,2010,16(6): 595-598.
[5] 彭巧丽,李美忠,蒋强,等.不同 HIV-1 病毒载量定量检测方法的比较研究[J].中国艾滋病性病,2011,17(1): 4-7.
[6] 孙国清,闫江舟,薛秀娟,等.国内某人类免疫缺陷病毒 I 型( HIV-1) 核酸检测试剂盒的自动化应用性能评估[J] ,2015,25(18):3054-3055.
[7] 刘敏,陈秀英,梅少林,等.不同核酸提取方法检测HIV病毒载量和耐药基因的研究[J] ,2016,54(20):111-114.
[8] 李玉文.两种HIV抗体初筛试剂盒阳性率的比较分析[J].世界临床医学,2016,10(15):7.
[9] 陈志忠,李结敏,廖扬勋,等.某国产NAT试剂盒应用于血液筛查的评价与应用[J].分子诊断与治疗杂志,2016,8(3):192-195,211.
[10] 张娜,刘丽萍,易志强,等.LAg-Avidity EIA法用于HIV-1新发感染检测的性能评价研究[J].现代预防医学,2016,43(1):157-159,173.
[11] Bilgrami M,Okeefe P.Neurologic diseases in HIV-infected patients[J].Handb Clin Neurol,2014,121:1321-1344.
[12] 王述莲,戴立忠,陈曦,等.两种人类免疫缺陷病毒定量检测试剂的评价研究[J].中华医院感染学杂志,2014,24(22):5461-5464.
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