Variability in the Cycle Threshold Values of SARS-CoV-2 Real-Time Reverse Transcription Polymerase Chain Reaction Test: A Review of the Nationwide Proficiency Testing Survey in Korea Article Swipe
Kuenyoul Park
,
Heungsup Sung
,
Mi‐Na Kim
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.15263/jlmqa.2023.45.4.166
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.15263/jlmqa.2023.45.4.166
Background: A nationwide proficiency test result for the severe acute respiratory syndrome coronavirus 2 real-time reverse transcription polymerase chain reaction (rRT-PCR) was analyzed to investigate the intraand interlaboratory variations in the cycle threshold (Ct) values.Methods: Four different types of contrived samples, including five positive samples with three different concentrations and two negative samples, were sent to participating laboratories in March/October 2022.This study examined the variations in the extraction kits and PCR reagents used in the laboratories.Results: Overall, 278 and 301 laboratories responded to each challenge.In the first challenge, five laboratories (1.8%) provided incorrect resultsthree false positives and two false negatives from one positive and one weak-positive sample.In the second challenge, only two laboratories (0.7%) provided incorrect results-one false positive and one false negative from one positive sample.The intralaboratory variations of the Ct values in the first and second challenges were deemed unacceptable (Ct >1.66) in 7 (2.5%) and 14 (4.7%) laboratories, respectively; one laboratory showed unacceptable intralaboratory variations for both positive and weak-positive samples in the second challenge.The interlaboratory variability of the Ct values for two commonly used rRT-PCR reagents was remarkable, with a difference of up to eight cycles observed for the same specimen.Conclusions: The overall performance and intralaboratory variability of the test were acceptable in most participating laboratories.However, caution should be exercised when interpreting the results from other institutions due to the remarkable interlaboratory variability of the Ct values.
Related Topics
Concepts
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Coronavirus disease 2019 (COVID-19)
Reverse transcription polymerase chain reaction
2019-20 coronavirus outbreak
Real-time polymerase chain reaction
Reverse transcriptase
Polymerase chain reaction
Medicine
Virology
Biology
Genetics
Internal medicine
Infectious disease (medical specialty)
Disease
Gene
Messenger RNA
Outbreak
Metadata
- Type
- review
- Language
- en
- Landing Page
- https://doi.org/10.15263/jlmqa.2023.45.4.166
- https://www.jlmqa.org/journal/download_pdf.php?doi=10.15263/jlmqa.2023.45.4.166
- OA Status
- hybrid
- Cited By
- 1
- References
- 14
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4390266912
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4390266912Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.15263/jlmqa.2023.45.4.166Digital Object Identifier
- Title
-
Variability in the Cycle Threshold Values of SARS-CoV-2 Real-Time Reverse Transcription Polymerase Chain Reaction Test: A Review of the Nationwide Proficiency Testing Survey in KoreaWork title
- Type
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reviewOpenAlex work type
- Language
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enPrimary language
- Publication year
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2023Year of publication
- Publication date
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2023-12-27Full publication date if available
- Authors
-
Kuenyoul Park, Heungsup Sung, Mi‐Na KimList of authors in order
- Landing page
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https://doi.org/10.15263/jlmqa.2023.45.4.166Publisher landing page
- PDF URL
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https://www.jlmqa.org/journal/download_pdf.php?doi=10.15263/jlmqa.2023.45.4.166Direct link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
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hybridOpen access status per OpenAlex
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https://www.jlmqa.org/journal/download_pdf.php?doi=10.15263/jlmqa.2023.45.4.166Direct OA link when available
- Concepts
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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Coronavirus disease 2019 (COVID-19), Reverse transcription polymerase chain reaction, 2019-20 coronavirus outbreak, Real-time polymerase chain reaction, Reverse transcriptase, Polymerase chain reaction, Medicine, Virology, Biology, Genetics, Internal medicine, Infectious disease (medical specialty), Disease, Gene, Messenger RNA, OutbreakTop concepts (fields/topics) attached by OpenAlex
- Cited by
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1Total citation count in OpenAlex
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2025: 1Per-year citation counts (last 5 years)
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10Other works algorithmically related by OpenAlex
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