Update of Guidelines for Laboratory Diagnosis of COVID-19 in Korea

Hong, Ki Ho; Kim, Gab Jung; Roh, Kyoung Ho; Sung, Heungsup; Lee, Jaehyeon; Kim, So Yeon; Kim, Taek Soo; Park, Jae Sun; Huh, Hee Jae; Park, Younhee; Kim, Jae‐Seok; Kim, Hyo Soo; Seong, Moon Woo; Ryoo, Nam Hee; Song, Suk-yoon; Lee, Hyukmin; Kwon, Gye Cheol; Yoo, Cheon-Kwon

doi:10.3343/alm.2022.42.4.391

Cited by 24 publications

(23 citation statements)

References 75 publications

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“…Self-sampling is an excellent approach in these situations, as it allows for more samples to be collected and screened in less time. Self-collection of upper respiratory tract samples via the nasal cavity (such as NS) or oral cavity (such as saliva, OS, or mouthwash) is, therefore, being investigated as a minimally invasive technique, which poses less risk of infection to HCWs, and does not require the use of expensive personal protective equipment [ 10 , 11 , 33 ]. Thus, self-collection could be easily conducted at home or in the community in cases where close contact is required with patients having SARS-CoV-2 infection for rapid screening and detection of the virus during mass infection, thereby, eliminating close interaction of HCWs individuals with SARS-CoV-2 infection.…”

Section: Discussionmentioning

confidence: 99%

“…The virus has been detected in numerous clinical specimens, including nasopharyngeal swabs (NPS), oropharyngeal swabs (OPS), nasal swabs (NS), and oral swabs (OS); as well as in sputum, urine, stools, and blood [ 9 , 10 ]. Current surveillance relies on established sampling techniques, such as the collection of NPS by trained healthcare workers (HCWs) [ 11 , 12 , 13 ]. However, a shortage of HCWs has strained the NPS sampling system, especially when the incidence of infections increases rapidly [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

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Performance Analysis of Self-Collected Nasal and Oral Swabs for Detection of SARS-CoV-2

Lim

Baek²,

Park³

et al. 2022

Diagnostics

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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the third highly pathogenic human coronavirus and is rapidly transmitted by infected individuals regardless of their symptoms. During the COVID-19 pandemic, owing to the dearth of skilled healthcare workers (HCWs) to collect samples for early diagnosis, self-collection emerged as a viable alternative. To evaluate the reliability of self-collection, we compared the virus detection rate using 3990 self-collected swabs and HCW-collected swabs, procured from the same individuals and collected immediately after the self-collection. The results of multiplex reverse-transcription quantitative polymerase chain reaction revealed that the viral load in the HCW-collected swabs was marginally (18.4–28.8 times) higher than that in self-collected swabs. Self-collection showed no significant difference in sensitivity and specificity from HCW-collection (κ = 0.87, McNemar’s test; p = 0.19), indicating a comparable performance. These findings suggest that self-collected swabs are acceptable substitutes for HCW-collected swabs, and that their use improved the specimen screening efficiency and reduced the risk of SARS-CoV-2 infection among HCWs during and after the COVID-19 pandemic.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Performance Analysis of Self-Collected Nasal and Oral Swabs for Detection of SARS-CoV-2

Lim

Baek²,

Park³

et al. 2022

Diagnostics

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“…The laboratory should be equipped with a UPS. The recommended indoor temperature and humidity for mobile laboratories are 18–26°C and 30–70%, respectively [ 9 ]. Thermometers and hygrometers must be available in mobile laboratories, and the temperature and humidity must be recorded daily.…”

Section: Management Of Mobile Laboratoriesmentioning

confidence: 99%

“…Korean Society for Laboratory Medicine (KSLM) and the Korea Disease Control and Prevention Agency (KDCA) have published guidelines for diagnosing COVID-19 in clinical laboratories in Korea [ 2 , 3 ]. These guidelines were mainly for laboratories in healthcare facilities; therefore, we discuss the limitations pertaining to mobile laboratories.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2022

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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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“…Dear Editor, Point-of-care (POC) molecular assays are vital in diagnosing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in acute care settings [1]. As various POC molecular assays with widely varying performance are used worldwide, performance validation is important [2,3].…”

mentioning

confidence: 99%