Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus

doi:10.3389/fcimb.2021.755508

Review

. 2021 Oct 13:11:755508.

doi: 10.3389/fcimb.2021.755508. eCollection 2021.

Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus

Xi Mo¹, Xueliang Wang², Zhaoqin Zhu³, Yuetian Yu⁴, Dong Chang⁵, Xinxin Zhang⁶, Dong Li⁷, Fenyong Sun⁸, Lin Zhou⁹, Jin Xu¹⁰, Hong Zhang¹¹, Chunfang Gao¹², Ming Guan¹³, Yanqun Xiao², Wenjuan Wu¹⁴

Affiliations

¹ Pediatric Translational Medicine Institute, Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
² Department of Molecular Biology, Shanghai Centre for Clinical Laboratory, Shanghai, China.
³ Department of Laboratory Medicine, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
⁴ Department of Critical Care Medicine, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
⁵ Department of Laboratory Medicine, Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center, Shanghai, China.
⁶ Department of Infectious Diseases, Research Laboratory of Clinical Virology, Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
⁷ Department of Laboratory Medicine, Shanghai Tongji Hospital, School of Medicine, Tongji University, Shanghai, China.
⁸ Department of Clinical Laboratory Medicine, Shanghai Tenth People's Hospital of Tongji University, Shanghai, China.
⁹ Department of Laboratory Medicine, Changzheng Hospital, Naval Medical University, Shanghai, China.
¹⁰ Department of Clinical Laboratory, Children's Hospital of Fudan University, Shanghai, China.
¹¹ Department of Clinical Laboratory, Shanghai Children's Hospital, Shanghai, China.
¹² Clinical Laboratory Medicine Center, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine Shanghai, Shanghai, China.
¹³ Department of Laboratory Medicine, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.
¹⁴ Department of Laboratory Medicine, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.

PMID: 34722341
PMCID: PMC8548827
DOI: 10.3389/fcimb.2021.755508

Review

Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus

Xi Mo et al. Front Cell Infect Microbiol. 2021.

. 2021 Oct 13:11:755508.

doi: 10.3389/fcimb.2021.755508. eCollection 2021.

Authors

Affiliations

¹ Pediatric Translational Medicine Institute, Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
² Department of Molecular Biology, Shanghai Centre for Clinical Laboratory, Shanghai, China.
³ Department of Laboratory Medicine, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
⁴ Department of Critical Care Medicine, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
⁵ Department of Laboratory Medicine, Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center, Shanghai, China.
⁶ Department of Infectious Diseases, Research Laboratory of Clinical Virology, Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
⁷ Department of Laboratory Medicine, Shanghai Tongji Hospital, School of Medicine, Tongji University, Shanghai, China.
⁸ Department of Clinical Laboratory Medicine, Shanghai Tenth People's Hospital of Tongji University, Shanghai, China.
⁹ Department of Laboratory Medicine, Changzheng Hospital, Naval Medical University, Shanghai, China.
¹⁰ Department of Clinical Laboratory, Children's Hospital of Fudan University, Shanghai, China.
¹¹ Department of Clinical Laboratory, Shanghai Children's Hospital, Shanghai, China.
¹² Clinical Laboratory Medicine Center, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine Shanghai, Shanghai, China.
¹³ Department of Laboratory Medicine, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.
¹⁴ Department of Laboratory Medicine, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.

PMID: 34722341
PMCID: PMC8548827
DOI: 10.3389/fcimb.2021.755508

Abstract

COVID-19 continues to circulate globally in 2021, while under the precise policy implementation of China's public health system, the epidemic was quickly controlled, and society and the economy have recovered. During the pandemic response, nucleic acid detection of SARS-CoV-2 has played an indispensable role in the first line of defence. In the cases of emergency operations or patients presenting at fever clinics, nucleic acid detection is required to be performed and reported quickly. Therefore, nucleic acid point-of-care testing (POCT) technology for SARS-CoV-2 identification has emerged, and has been widely carried out at all levels of medical institutions. SARS-CoV-2 POCT has served as a complementary test to conventional polymerase chain reaction (PCR) batch tests, thus forming an experimental diagnosis platform that not only guarantees medical safety but also improves quality services. However, in view of the complexity of molecular diagnosis and the biosafety requirements involved, pathogen nucleic acid POCT is different from traditional blood-based physical and chemical index detection. No guidelines currently exist for POCT quality management, and there have been inconsistencies documented in practical operation. Therefore, Shanghai Society of Molecular Diagnostics, Shanghai Society of Laboratory Medicine, Clinical Microbiology Division of Shanghai Society of Microbiology and Shanghai Center for Clinical Laboratory have cooperated with experts in laboratory medicine to generate the present expert consensus. Based on the current spectrum of major infectious diseases in China, the whole-process operation management of pathogen POCT, including its application scenarios, biosafety management, personnel qualification, performance verification, quality control, and result reporting, are described here. This expert consensus will aid in promoting the rational application and robust development of this technology in public health defence and hospital infection management.

Keywords: expert consensus; nucleic acid; pathogen; point-of-care testing; whole-process operation management.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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References

1. Basile K., Kok J., Dwyer D. E. (2018). Point-Of-Care Diagnostics for Respiratory Viral Infections. Expert Rev. Mol. Diagn. 18, 75–83. doi: 10.1080/14737159.2018.1419065 - DOI - PMC - PubMed
1. Centers for Disease Control and Prevention (U.S.) (2015). Center for Surveillance, Epidemiology, and Laboratory Services, Division of Laboratory Systems, Centers for Medicare & Medicaid Services (U.S.). Developing an Individualized Quality Control Plan: A Step-by-Step Guide.
1. Clinical and Laboratory Standards Institute (2018). Validation and Verification of Multiplex Nucleic Acid Assays, 2nd Edition. MM17.
1. Harris J., AbdelWareth L. O., Lari S., Callaghan K. O., Anderson P., Mirza I. (2018). Setting Up a Point-Of-Care Testing Service in a Greenfield, Quaternary Hospital: An Implementation Review. Arch. Pathol. Lab. Med. 142, 1223–1232. doi: 10.5858/arpa.2017-0507-RA - DOI - PubMed
1. Health Industry Standard of the People's Republic of China (2017). General Biosafety Standard for Causative Bacteria Laboratories (WS 233-2017).

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[1] Basile K., Kok J., Dwyer D. E. (2018). Point-Of-Care Diagnostics for Respiratory Viral Infections. Expert Rev. Mol. Diagn. 18, 75–83. doi: 10.1080/14737159.2018.1419065 - DOI - PMC - PubMed

[2] Basile K., Kok J., Dwyer D. E. (2018). Point-Of-Care Diagnostics for Respiratory Viral Infections. Expert Rev. Mol. Diagn. 18, 75–83. doi: 10.1080/14737159.2018.1419065 - DOI - PMC - PubMed

[3] Centers for Disease Control and Prevention (U.S.) (2015). Center for Surveillance, Epidemiology, and Laboratory Services, Division of Laboratory Systems, Centers for Medicare & Medicaid Services (U.S.). Developing an Individualized Quality Control Plan: A Step-by-Step Guide.

[4] Centers for Disease Control and Prevention (U.S.) (2015). Center for Surveillance, Epidemiology, and Laboratory Services, Division of Laboratory Systems, Centers for Medicare & Medicaid Services (U.S.). Developing an Individualized Quality Control Plan: A Step-by-Step Guide.

[5] Clinical and Laboratory Standards Institute (2018). Validation and Verification of Multiplex Nucleic Acid Assays, 2nd Edition. MM17.

[6] Clinical and Laboratory Standards Institute (2018). Validation and Verification of Multiplex Nucleic Acid Assays, 2nd Edition. MM17.

[7] Harris J., AbdelWareth L. O., Lari S., Callaghan K. O., Anderson P., Mirza I. (2018). Setting Up a Point-Of-Care Testing Service in a Greenfield, Quaternary Hospital: An Implementation Review. Arch. Pathol. Lab. Med. 142, 1223–1232. doi: 10.5858/arpa.2017-0507-RA - DOI - PubMed

[8] Harris J., AbdelWareth L. O., Lari S., Callaghan K. O., Anderson P., Mirza I. (2018). Setting Up a Point-Of-Care Testing Service in a Greenfield, Quaternary Hospital: An Implementation Review. Arch. Pathol. Lab. Med. 142, 1223–1232. doi: 10.5858/arpa.2017-0507-RA - DOI - PubMed

[9] Health Industry Standard of the People's Republic of China (2017). General Biosafety Standard for Causative Bacteria Laboratories (WS 233-2017).

[10] Health Industry Standard of the People's Republic of China (2017). General Biosafety Standard for Causative Bacteria Laboratories (WS 233-2017).

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Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus

Affiliations

Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus

Authors

Affiliations

Abstract

Conflict of interest statement

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