高级检索
当前位置: 首页 > 详情页

Comparative Performance of Four Nucleic Acid Amplification Tests for SARS-CoV-2 Virus

文献详情

资源类型:
WOS体系:

收录情况: ◇ SCIE

机构: [1]Guangzhou Univ Chinese Med, Guangdong Prov Key Lab Res Emergency TCM, Affiliated Hosp 2, Dept Lab Med, Guangzhou, Peoples R China [2]Guangzhou Univ Chinese Med, Clin Med Coll 2, Guangzhou, Peoples R China [3]Guangzhou Univ Chinese Med, Chinese Med Affiliated, Panyu Hosp, Dept Lab Med, Guangzhou, Peoples R China [4]Guangdong Hybribio Biotech Co Ltd, Mol Diagnost Engn Technol Res Ctr, Guangzhou, Peoples R China [5]Guangzhou Univ Chinese Med, Affiliated Hosp 2, Dept Lab Med, 111 Dade R, Guangzhou 510120, Peoples R China
出处:
ISSN:

关键词: severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 nucleic acid amplification test performance evaluation COVID-19

摘要:
Background: COVID-19 is caused by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), which was discovered in 2019 and spread around the world in a short time. SARS-CoV-2 nucleic acid amplification tests (NAATs) have been rapidly developed and quickly applied to clinical testing of COVID-19. Aim of this study was to evaluate the performance of four NAAT assays. Methods: Limit of detection (LOD), precision, accuracy, analytical specificity and analytical interference studies on four NAATs (Daan, Sansure, Hybribio, and Bioperfectus) were performed according to Clinical Laboratory Standards Institute protocols and guidelines. The four NAATs were compared using 46 clinical samples. Results: The LOD of the N gene for Daan, Sansure, and Hybribio was 500 copies/mL, and that for Bioperfectus was 1,000 copies/mL. The LOD of the ORF1ab gene for Daan, Bioperfectus, and Hybribio was 3,000 copies/mL, and that for Sansure was 2,000 copies/mL. A good precision was shown at the concentration above 20% of the LOD for all four NAATs, with all individual coefficients of variation below 3.6%. Satisfactory results were also observed in the accuracy, analytical specificity, and analytical interference tests. The results of the comparison test showed that Daan, Sansure, and Hybribio NAATs could detect the samples with a specificity of 100% (30/30) and a sensitivity of 100% (16/16), whereas Bioperfectus NAAT detected the samples with a specificity of 100% (30/30) and a sensitivity of 81.25% (13/16). However, no significant difference in sensitivity was found between Bioperfectus NAAT and the three other NAATs (p > 0.05). Conclusions: The four SARS-CoV-2 NAATs showed comparable performance, with the LOD of the N gene lower than the LOD of the ORF1ab gene.

语种:
WOS:
PubmedID:
中科院(CAS)分区:
出版当年[2020]版:
大类 | 4 区 医学
小类 | 4 区 医学实验技术
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 医学实验技术
JCR分区:
出版当年[2019]版:
Q4 MEDICAL LABORATORY TECHNOLOGY
最新[2023]版:
Q4 MEDICAL LABORATORY TECHNOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2019版] 出版当年五年平均 出版前一年[2018版] 出版后一年[2020版]

第一作者:
第一作者机构: [1]Guangzhou Univ Chinese Med, Guangdong Prov Key Lab Res Emergency TCM, Affiliated Hosp 2, Dept Lab Med, Guangzhou, Peoples R China [2]Guangzhou Univ Chinese Med, Clin Med Coll 2, Guangzhou, Peoples R China
推荐引用方式(GB/T 7714):
APA:
MLA:

资源点击量:2018 今日访问量:0 总访问量:645 更新日期:2024-07-01 建议使用谷歌、火狐浏览器 常见问题

版权所有©2020 广东省中医院 技术支持:重庆聚合科技有限公司 地址:广州市越秀区大德路111号