Journal of Diagnostics Concepts & Practice >
Practice and exploration of novel coronavirus nucleic acid detection in designated hospitals
Received date: 2022-05-25
Online published: 2022-04-25
Objective: To explore the related problems and solutions in nucleic acid detection of COVID-19 patients at the present stage, and to provide reference for clinical laboratories. Methods: A total of 462 patients admitted from April 1 to April 10 were selected and their basic Ct values and time changes were analyzed. The false-negative test results caused by sample collection from March 20 to March 31 and from April 1 to April 10 were statistically analyzed, respectively. A total of 213 clinical samples were selected for parallel detection using reagents A and B to compare the differences between them. According to relevant documents, make the reinspection standard operation procedure (SOP) document of suspicious samples. According to the quality control method of quantitative test, weak-positive control was prepared and tested 5 batches every day for 4 days, and 20 groups of data were obtained and used as the initial data to make quality control charts. Results: The median Ct values of ORF1ab and N gene in 462 patients were 24.50 (20.58-32.10) and 23.38 (19.43-31.24), respectively. In 184 patients with Ct value less than 30, the median time for Ct value to rise above 30 was 6 days (4-8 days). The sampling unqualified rates were 12.4% and 2.4% in the early and late stages, respectively, and the difference was statistically significant (P<0.01). The consistency of the two reagents was good in the detection of samples with Ct values less than 30, but decreased in the detection of samples with Ct values between 30 and 40. The Ct values of ORF1ab and N gene in weak-positive control were 35.17±0.55 and 35.23±0.88, respectively, which can better monitor the detection of clinically concerned samples with Ct values within the range of 35. Conclusions: For COVID-19 patients with basic Ct value less than 30, the frequency of nucleic acid test can be set to once every 3 or 4 days. The difference between the two regents in detection of the smple with Ct value less than 30 is minor, but for the sample with Ct value 30-40, the difference is apparently large. Laboratories should establish the standards and procedures for sample re-test, and the quality monitoring at the level of Ct value 35 should be strengthened to ensure the consistency of COVID-19 nucleic acid test results.
CHEN Changqiang, MENG Jun, JIN Peipei, DAI Jing, et al . Practice and exploration of novel coronavirus nucleic acid detection in designated hospitals[J]. Journal of Diagnostics Concepts & Practice, 2022 , 21(02) : 143 -149 . DOI: 10.16150/j.1671-2870.2022.02.008
[1] | 国家卫生健康委办公厅. 新型冠状病毒肺炎诊疗方案(试行第九版)[EB/OL]. [2022-03-14]. http://www.gov.cn/zhengce/zhengceku/2022-03/15/5679257/files/49854a49c7004f4ea9e622f3f2c568d8.pdf. |
[1] | General Office of National Health Commission. Diagnosis and treatment plan for novel coronavirus pneumonia (trial version 9)[EB/OL].[2022-03-14]. http://www.gov.cn/zhengce/zhengceku/2022-03/15/5679257/files/49854a49c7004f4ea9e622f3f2c568d8.pdf. |
[2] | 黄斐, 张春燕, 郭玮, 等. SARS-CoV-2核酸检测的现状和问题[J]. 检验医学, 2021, 36(5):554-559. |
[2] | Huang F, Zhang CY, Guo W, et al. Current situation and problems of sars-cov-2 nucleic acid detection[J]. Lab Med, 2021, 36(5):554-559. |
[3] | 张瑞, 李金明. 如何减少新型冠状病毒核酸检测的假阴性[J]. 中华医学杂志, 2020, 100(11):801-804. |
[3] | Zhang R, Li JM. How to reduce false negatives in nucleic acid detection of novel coronavirus[J]. Natl Med J Chin, 2020, 100(11):801-804. |
[4] | 莫茜, 秦炜, 傅启华, 等. 正确认识新型冠状病毒核酸检测的影响因素[J]. 中华检验医学杂志, 2020, 43(3):213-216. |
[4] | Mo Q, Qin W, Fu QH, et al. Correctly understand the influencing factors of nucleic acid detection of novel coronavirus[J]. Chin J Lab Med, 2020, 43(3):213-216. |
[5] | Younes N, Al-Sadeq DW, Al-Jighefee H, et al. Challenges in laboratory diagnosis of the novel coronavirus SARS-CoV-2[J]. Viruses. 2020 May 26; 12(6):582. |
[6] | Rabaan AA, Tirupathi R, Sule AA, et al. Viral dynamics and real-time RT-PCR Ct values correlation with disease severity in COVID-19[J]. Diagnostics(Basel), 2021, 11(6):1091. |
[7] | Singanayagam A, Patel M, Charlett A, et al. Duration of infectiousness and correlation with RT-PCR cycle threshold values in cases of COVID-19, England, January to May 2020[J]. Euro Surveill, 2020, 25(32):2001483. |
[8] | 熊丹, 阚丽娟, 王萌萌, 等. 七种国产新型冠状病毒核酸检测试剂盒的一致性和检出能力评价研究[J]. 中华检验医学杂志, 2020, 43(8):787-793. |
[8] | Xiong D, Kan LJ, Wang MM, et al. Evaluation of consistency and detection ability of seven domestic novel coronavirus nucleic acid detection kits[J]. Chin J Lab Med, 2020, 43(8):787-793. |
[9] | Evans D, Cowen S, Kammel M, et al. The Dangers of Using Cq to Quantify Nucleic Acid in Biological Samples: A Lesson From COVID-19[J]. Clin Chem, 2021, 68(1):153-162. |
[10] | Xiao S, Yue J, Zhang T, et al. Laboratory Management and Quality Control Practice of SARS-CoV-2 Nucleic Acid Detection[J]. Lab Med, 2021, 52(1):e8-e14. |
/
〈 |
|
〉 |