Journal
ANNALS OF LABORATORY MEDICINE
Volume 42, Issue 5, Pages 507-514Publisher
KOREAN SOC LABORATORY MEDICINE
DOI: 10.3343/alm.2022.42.5.507
Keywords
COVID-19; Mobile Laboratory; Guidelines; Diagnostic testing; Quality control
Categories
Funding
- [20210702DD4-00]
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This article provides guidelines for the operation, management, and quality control of mobile laboratories, specifically for the implementation and execution of COVID-19 molecular diagnostic testing. The guidelines cover various aspects including facility, preoperative evaluation, PCR testing, internal and external quality control, sample handling, reporting, laboratory personnel, biosafety level, and laboratory safety management. These guidelines are crucial for the maintenance and operation of mobile laboratories during normal circumstances as well as public health crises and emergencies.
With the rapid spread of the coronavirus disease (COVID-19), the need for rapid testing and diagnosis and consequently, the demand for mobile laboratories have increased. Despite this need, there are no clear guidelines for the operation, maintenance, or quality control of mobile laboratories. We provide guidelines for the operation, management, and quality control of mobile laboratories, and specifically for the implementation and execution of COVID-19 molecular diagnostic testing. These practical guidelines are primarily based on expert opinions and a laboratory accreditation inspection checklist. The scope of these guidelines includes the facility, preoperative evaluation, PCR testing, internal and external quality control, sample handling, reporting, laboratory personnel, biosafety level, and laboratory safety management. These guidelines are useful for the maintenance and operation of mobile laboratories not only in normal circumstances but also during public health crises and emergencies.
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