Standard Deliberation

Analysis of consideration on design, development and quality control of detection of SARS-CoV-2 by nucleic acid amplification methods based on ISO/TS 5798

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  • National Institutes for Food and Drug Control, Beijing 102629, China

Received date: 2022-11-04

  Online published: 2024-06-25

Abstract

The design, development and establishment of acceptable and high-quality severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) diagnostics based on nucleic acid detection methods is the important guarantee for the precise prevention and control of the epidemic of COVID-19. Studies had shown sample collection, transportation, storage, nucleic acid extraction during the pre-examination work process as well as selection and design of nucleic acid amplification method for detection were key factors affecting the accuracy of COVID-19 nucleic acid detection. In the development and routine application of test methods and kits, the comprehensive quality evaluation indexes of these processes should be further clarified. Based on the principle of SARS-CoV-2 detection by nucleic acid amplification as well as the whole process of SARS-CoV-2 molecular testing, the key points in the design, development and quality control of SARS-CoV-2 nucleic acid detection were summarized according to the “Requirements and recommendations for detection of SARS-CoV-2 by nucleic acid amplification methods” issued by the ISO. It can provide references for design of higher quality nucleic acid testing reagents and further improve the quality of nucleic acid testing in China.

Cite this article

TONG Yue, SUN Wei, YANG Ya-li, LIU Dong-lai, GUO Shi-fu, YANG Zhen . Analysis of consideration on design, development and quality control of detection of SARS-CoV-2 by nucleic acid amplification methods based on ISO/TS 5798[J]. Chinese Journal of Pharmaceutical Analysis, 2023 , 43(5) : 902 -907 . DOI: 10.16155/j.0254-1793.2023.05.22

References

[1] 侯颗. ISO发布首个新冠病毒核酸检测国际标准[N].中国纪检监察报,2022-06-09(3)
HOU K. ISO issued the first international standard for detection of SARS-CoV-2 by nucleic acid amplification methods[N].China Discipline Inspection and Supervision News, 2022-06-09(3)
[2] 李彩玉,陈梦媛,张师音,等.新型冠状病毒核酸检测假阴性原因分析及控制要点[J].厦门大学学报(自然科学版),2020,59(3):310
LI CY,CHEN MY,ZHANG SY, et al. Cause analysis and control points of false negative nucleic acid test for SARS-CoV-2[J].J Xiamen Univ(Nat Sci),2020,59(3):310
[3] 里进,叶光明,陈良君,等.新型冠状病毒核酸检测假阴性结果原因分析及对策[J].中华检验医学杂志,2020(3):221
LI J, YE GM,CHEN LJ, et al. Causes and countermeasures of false-negative results for SARS-CoV-2 nucleic acid test[J].Chin J Lab Med, 2020(3):221
[4] CHRISTENSEN BB, AZAR MM, TURBETT SE. Laboratory diagnosis for SARS-CoV-2 infection[J].Infect Dis Clin, 2022, 36(2): 327
[5] RAHBARI R, MORADI N, ABDI M. rRT-PCR for SARS-CoV-2: analytical considerations[J].Clin Chim Acta, 2021, 516: 1
[6] 袁桂清.全国首届医院临床实验室自动化学术峰会会议纪要[J].中华检验医学杂志,2005,28(11):1115
YUAN GQ. Minutes of the first national academic summit on hospital clinical laboratory automation[J].Chin J Lab Med,2005,28(11):1115
[7] ISO. In vitro Diagnostic Test Systems-Requirements and Recommendations for Detection of Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) by Nucleic Acid Amplification Methods[EB/OL].(2022-04)[2022-11-2].https://www.iso.org/standard/81712.html
[8] ASTUTI I, YSRAFI L. Evere acute respiratory syndrome coronavirus 2(SARS-CoV-2): an overview of viral structure and host response[J].Diabetes Metab Syndr, 2020, 14(4): 407
[9] ANDERSEN KG, RAMBAUT A, LIPKIN WI, et al. The proximal origin of SARS-CoV-2[J].Nat Med, 2020, 26(4): 450
[10] WRAPP D, WANG N, CORBETT KS, et al. Cryo-EM structure of the 2019-nCoV spike in the prefusion conformation[J].Science, 2020, 367(6483): 1260
[11] ORTIZ-PRADO E, SIMBAÖA-RIVERA K, GOMEZ-BARRENO L, et al. Clinical, molecular, and epidemiological characterization of the SARS-CoV-2 virus and the coronavirus disease 2019(COVID-19), a comprehensive literature review[J].Diagn Microbiol Infect Dis, 2020, 98(1): 115094
[12] YAN R, ZHANG Y, LI Y, et al. Structural basis for the recognition of SARS-CoV-2 by full-length human ACE2[J].Science, 2020, 367(6485): 1444
[13] GRALINSKI LE, MENACHERY VD. Return of the coronavirus: 2019-nCoV[J].Viruses, 2020, 12(2): 135
[14] WANG X, TAN L, WANG X, et al. Comparison of nasopharyngeal and oropharyngeal swabs for SARS-CoV-2 detection in 353 patients received tests with both specimens simultaneously[J].Int J Infect Dis, 2020, 94: 107
[15] GOLDFARB DM, TILLEY P, AL-RAWAHI GN, et al. Self-collected saline gargle samples as an alternative to health care worker-collected nasopharyngeal swabs for COVID-19 diagnosis in outpatients[J].J Clin Microbiol, 2021, 59(4): e02427
[16] MOHAMMADI A, ESMAEILZADEH E, LI Y, et al. SARS-CoV-2 detection in different respiratory sites: a systematic review and meta-analysis[J].eBioMedicine, 2020, 59: 102903
[17] TANG YW, SCHMITZ JE, PERSING DH, et al. Laboratory diagnosis of COVID-19: current issues and challenges[J].J Clin Microbiol, 2020, 58(6): e00512
[18] TEYMOURI M, MOLLAZADEH S, MORTAZAVI H, et al. Recent advances and challenges of RT-PCR tests for the diagnosis of COVID-19[J].Pathol Res Pract, 2021, 221: 153443
[19] HE X, LAU EHY, WU P, et al. Temporal dynamics in viral shedding and transmissibility of COVID-19[J].Nat Med, 2020, 26(5): 672
[20] ZOU L, RUAN F, HUANG M, et al. SARS-CoV-2 viral load in upper respiratory specimens of infected patients[J].N Engl J Med, 2020, 382(12): 1177
[21] FAJNZYLBER J, REGAN J, COXEN K, et al. SARS-CoV-2 viral load is associated with increased disease severity and mortality[J].Nat Commun, 2020, 11(1): 5493
[22] BERMEJO-MARTIN JF, GONZáLEZ-RIVERA M, ALMANSA R, et al. Viral RNA load in plasma is associated with critical illness and a dysregulated host response in COVID-19[J].Crit Care, 2020, 24(1): 691
[23] CHEN L, WANG G, LONG X, et al. Dynamics of blood viral load is strongly associated with clinical outcomes in coronavirus disease 2019(COVID-19) patients: a prospective cohort study[J].J Mol Diagn, 2021, 23(1): 10
[24] ZASADA AA, ZACHARCZUK K, WOZ′NICA K, et al. The influence of a swab type on the results of point-of-care tests[J].AMB Express, 2020, 10(1): 46
[25] WHO. Laboratory Testing for Coronavirus Disease 2019(COVID-19) in Suspected Human Cases: Interim Guidance[EB/OL].(2020-03-02 )[2022-11-02].https://apps.who.int/iris/handle/10665/331329
[26] RADBEL J, JAGPAL S, ROY J, et al. Detection of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) is comparable in clinical samples preserved in saline or viral transport medium[J].J Mol Diagn, 2020, 22(7): 871
[27] PERUMAL N, JAIN RK, SHRIVASTAVA R, et al. Stability of SARS-CoV-2 RNA in viral lysis buffer stored at different temperatures[J].J Lab Physicians, 2020, 12(4): 268
[28] PERCHETTI GA, HUANG ML, PEDDU V, et al. Stability of SARS-CoV-2 in phosphate-buffered saline for molecular detection[J].J Clin Microbiol, 2020, 58(8): e01094
[29] BURD EM. Validation of laboratory-developed molecular assays for infectious diseases[J].Clin Microbiol Rev,2010,23(3):550
[30] KUANG J, YAN X, GENDERS AJ, et al. An overview of technical considerations when using quantitative real-time PCR analysis of gene expression in human exercise research[J].PLoS One, 2018, 13(5): e0196438
[31] TAYLOR SC, NADEAU K, ABBASI M, et al. The ultimate qPCR experiment: producing publication quality, reproducible data the first time[J].Trends Biotechnol, 2019, 37(7): 761
[32] WHO. Real-Time RT-PCR Assays for the Detection of SARS-CoV-2[EB/OL].[2022-11-02]. https://www.who.int/docs/default-source/coronaviruse/whoinhouseassays.pdf
[33] KILIC T, WEISSLEDER R, LEE H. Molecular and immunological diagnostic tests of COVID-19: current status and challenges[J]. iScience, 2020, 23(8): 101406
[34] FDA. Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2-Letter to Clinical Laboratory Staff and Health Care Providers[EB/OL].(2021-01-08)[2022-11-02]. https://www.fda.gov/medical-devices/letters-health-care-providers/genetic-variants-sars-cov-2-may-lead-false-negative-results-molecular-tests-detection-sars-cov-2
[35] ARTESI M, BONTEMS S, GÖBBELS P, et al. A recurrent mutation at position 26340 of SARS-CoV-2 is associated with failure of the E gene quantitative reverse transcription-PCR utilized in a commercial dual-target diagnostic assay[J].J Clin Microbiol, 2020, 58(10): e01598
[36] KRALIK P, RICCHI M. A basic guide to real time PCR in microbial diagnostics: definitions, parameters, and everything[J].Front Microbiol, 2017, 8: 108
[37] KUANG J, YAN X, GENDERS AJ, et al. An overview of technical considerations when using quantitative real-time PCR analysis of gene expression in human exercise research[J].PLoS One, 2018, 13(5): e0196438
[38] GÜRTLER C, LAIBLE M, SCHWABE W, et al. Transferring a quantitative molecular diagnostic test to multiple real-time quantitative PCR platforms[J].J Mol Diagn, 2018, 20(4): 398
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