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Guidelines for Mobile Laboratories for Molecular Diagnostic Testing of COVID-19

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초록

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.

Abstract

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.

참고문헌 (11)

  1. "Naming the coronavirus disease (COVID-19) and the virus that causes it" (2020)[URL]
  2. Ki Ho Hong, "Guidelines for Laboratory Diagnosis of Coronavirus Disease 2019 (COVID-19) in Korea", Annals of Laboratory Medicine, 40(5), pp.351~360 (2020), 대한진단검사의학회[DOI]
  3. Hong Ki Ho, "Update of Guidelines for Laboratory Diagnosis of COVID-19 in Korea", Annals of Laboratory Medicine, 42(4), pp.391~397 (2022), 대한진단검사의학회[DOI]
  4. "QuikLAB rapid COVID-19 testing lab" (2021)[URL]
  5. "CentoTruck, the mobile laboratory optimized for PCR tests" (2021)[URL]
  6. "Korean Law, Infectious Disease Control and Prevention Act. Article 16-2, paragraphs 1 and 2. Revised on August 11, 2020" (2021)[URL]
  7. "Korean Law, Medical Service Act. Article 33, paragraph 1, item 3, Revised on June 30, 2021" (2021)[URL]
  8. "Korean Law, Enforcement Rules of the Medical Service Act. Article 15. Revised on December 31, 2021" (2021)[URL]
  9. CLSI, "Laboratory design" (2007), Clinical and Laboratory Standards Institute
  10. "Special Measures for Safety Management of Waste Related to COVID-19" (2021)[URL]
  11. "Laboratory accreditation inspection checklist-laboratory management and molecular diagnostic test" (2021)[URL]

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