Estimating the False-Positive Rate of Highly Automated SARS-CoV-2 Nucleic Acid Amplification Testing

doi:10.1128/JCM.01080-21

. 2021 Jul 19;59(8):e0108021.

doi: 10.1128/JCM.01080-21. Epub 2021 Jul 19.

Estimating the False-Positive Rate of Highly Automated SARS-CoV-2 Nucleic Acid Amplification Testing

Christopher M Chandler¹, Lori Bourassa¹, Patrick C Mathias^{1

2}, Alexander L Greninger^{1

3}

Affiliations

¹ Department of Laboratory Medicine and Pathology, University of Washington School of Medicine, Seattle, Washington, USA.
² Department of Biomedical Informatics and Medical Education, University of Washington School of Medicine, Seattle, Washington, USA.
³ Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.

PMID: 33972455
PMCID: PMC8288255
DOI: 10.1128/JCM.01080-21

Estimating the False-Positive Rate of Highly Automated SARS-CoV-2 Nucleic Acid Amplification Testing

Christopher M Chandler et al. J Clin Microbiol. 2021.

. 2021 Jul 19;59(8):e0108021.

doi: 10.1128/JCM.01080-21. Epub 2021 Jul 19.

Authors

Christopher M Chandler¹, Lori Bourassa¹, Patrick C Mathias^{1

2}, Alexander L Greninger^{1

3}

Affiliations

¹ Department of Laboratory Medicine and Pathology, University of Washington School of Medicine, Seattle, Washington, USA.
² Department of Biomedical Informatics and Medical Education, University of Washington School of Medicine, Seattle, Washington, USA.
³ Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.

PMID: 33972455
PMCID: PMC8288255
DOI: 10.1128/JCM.01080-21

No abstract available

Keywords: Hologic; Roche; SARS-CoV-2; false positive; high-throughput.

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References

1. Burd EM. 2010. Validation of laboratory-developed molecular assays for infectious diseases. Clin Microbiol Rev 23:550–576. doi:10.1128/CMR.00074-09. - DOI - PMC - PubMed
1. Lieberman JA, Pepper G, Naccache SN, Huang M-L, Jerome KR, Greninger AL. 2020. Comparison of commercially available and laboratory developed assays for in vitro detection of SARS-CoV-2 in clinical laboratories. J Clin Microbiol 58:e00821-20. doi:10.1128/JCM.00821-20. - DOI - PMC - PubMed
1. Tsuboi H, Kasamatsu Y, Matsubara S, Sasao A, Kunimitsu K, Munakata N, Ito T, Tsuchido Y, Yamawaki M, Fujita N. 2020. Two cases of novel coronavirus infection (COVID-19) with transient viral elevation using semi-quantitative real-time reverse transcription PCR and symptom relapse after completion of 10 days of favipiravir treatment. J Infect Chemother doi:10.1016/j.jiac.2020.12.018. - DOI - PMC - PubMed
1. Lin L, Carlquist J, Sinclair W, Hall T, Lopansri BK, Bennett ST. 2021. Experience with false-positive test results on the TaqPath real-time reverse transcription-polymerase chain reaction coronavirus disease 2019 (COVID-19) testing platform. Arch Pathol Lab Med 145:259–261. doi:10.5858/arpa.2020-0612-LE. - DOI - PubMed

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[1] Burd EM. 2010. Validation of laboratory-developed molecular assays for infectious diseases. Clin Microbiol Rev 23:550–576. doi:10.1128/CMR.00074-09. - DOI - PMC - PubMed

[2] Burd EM. 2010. Validation of laboratory-developed molecular assays for infectious diseases. Clin Microbiol Rev 23:550–576. doi:10.1128/CMR.00074-09. - DOI - PMC - PubMed

[3] Lieberman JA, Pepper G, Naccache SN, Huang M-L, Jerome KR, Greninger AL. 2020. Comparison of commercially available and laboratory developed assays for in vitro detection of SARS-CoV-2 in clinical laboratories. J Clin Microbiol 58:e00821-20. doi:10.1128/JCM.00821-20. - DOI - PMC - PubMed

[4] Lieberman JA, Pepper G, Naccache SN, Huang M-L, Jerome KR, Greninger AL. 2020. Comparison of commercially available and laboratory developed assays for in vitro detection of SARS-CoV-2 in clinical laboratories. J Clin Microbiol 58:e00821-20. doi:10.1128/JCM.00821-20. - DOI - PMC - PubMed

[5] Tsuboi H, Kasamatsu Y, Matsubara S, Sasao A, Kunimitsu K, Munakata N, Ito T, Tsuchido Y, Yamawaki M, Fujita N. 2020. Two cases of novel coronavirus infection (COVID-19) with transient viral elevation using semi-quantitative real-time reverse transcription PCR and symptom relapse after completion of 10 days of favipiravir treatment. J Infect Chemother doi:10.1016/j.jiac.2020.12.018. - DOI - PMC - PubMed

[6] Tsuboi H, Kasamatsu Y, Matsubara S, Sasao A, Kunimitsu K, Munakata N, Ito T, Tsuchido Y, Yamawaki M, Fujita N. 2020. Two cases of novel coronavirus infection (COVID-19) with transient viral elevation using semi-quantitative real-time reverse transcription PCR and symptom relapse after completion of 10 days of favipiravir treatment. J Infect Chemother doi:10.1016/j.jiac.2020.12.018. - DOI - PMC - PubMed

[7] Lin L, Carlquist J, Sinclair W, Hall T, Lopansri BK, Bennett ST. 2021. Experience with false-positive test results on the TaqPath real-time reverse transcription-polymerase chain reaction coronavirus disease 2019 (COVID-19) testing platform. Arch Pathol Lab Med 145:259–261. doi:10.5858/arpa.2020-0612-LE. - DOI - PubMed

[8] Lin L, Carlquist J, Sinclair W, Hall T, Lopansri BK, Bennett ST. 2021. Experience with false-positive test results on the TaqPath real-time reverse transcription-polymerase chain reaction coronavirus disease 2019 (COVID-19) testing platform. Arch Pathol Lab Med 145:259–261. doi:10.5858/arpa.2020-0612-LE. - DOI - PubMed

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Estimating the False-Positive Rate of Highly Automated SARS-CoV-2 Nucleic Acid Amplification Testing

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Estimating the False-Positive Rate of Highly Automated SARS-CoV-2 Nucleic Acid Amplification Testing

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