Evaluation of the analytical sensitivity of twenty-eight respiratory pathogen nucleic acid detection kits based on different types of human adenovirus
10.3760/cma.j.cn112866-20210714-00120
- VernacularTitle:基于不同型别腺病毒标准品的呼吸道病原体核酸试剂最低检测限性能评价
- Author:
Haiwei ZHOU
1
;
Donglai LIU
;
Tingting MA
;
Sihong XU
Author Information
1. 中国食品药品检定研究院传染病诊断试剂二室，北京 100050
- Keywords:
Human adenovirus;
Respiratory pathogen nucleic acid detection kit;
Standard;
Limit of detection
- From:
Chinese Journal of Experimental and Clinical Virology
2021;35(5):494-499
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the analytical sensitivity of twenty-eight respiratory pathogen nucleic acid detection kits based on different types of human adenovirus.Methods:According to the EP17-A2 document of the Clinical and Laboratory Standards Institute, probit regression analysis of 95% hit rates was performed to evaluate the limit of detection (Lod) of 28 respiratory pathogen nucleic acid detection kits. The differences between claimed Lod and measured Lod, and between different adenovirus types were compared.Results:The data showed that the claimed Lod for 50% (12/24) of the manufacturers can be accurately evaluated. There was a poor consistency in 12 kits, and the difference in 4 kits was not significant (measured Lod<5×claimed Lod), however, the difference in the other 8 kits was significant (measured Lod>5×claimed Lod, 24 000-fold increase for the most significant). The difference of measured Lod concentration between different kits was more than 10 6 orders of magnitude (the lowest and the highest were 20 copies/ml and 4.8×10 7copies/ml, respectively). An analysis of different types of adenovirus detected by the same kit revealed a wide range of measured Lod, spanning 10 4 orders of magnitude differences (the lowest and the highest were 5.0×10 3copies/ml and 4.8×10 7copies/ml, respectively). Conclusions:It is showed that there is a lack of accuracy in evaluation of the analytical sensitivity for some respiratory pathogen nucleic acid detection kits, so it is particularly necessary to use a variety of pathogen types or subtypes for performance evaluation.
