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Validation and verification of the Abbott RealTime SARS-CoV-2 assay analytical and clinical performance.
J Clin Virol. 2020 08; 129:104474.JC

Abstract

BACKGROUND

High-throughput assays for the SARS-CoV-2 virus are critical to increasing test capacity and slowing the spread of COVID-19. Abbott Molecular developed and received emergency use authorization (EUA) to deploy the new RealTime SARS-CoV-2 assay, run on the automated m2000sp/rt system.

OBJECTIVE

To evaluate analytical and clinical performance of the RealTime SARS-CoV-2 assay compared to the SARS-CoV-2 CDC-based laboratory developed test (LDT) in clinical use by the University of Washington Clinical Virology Laboratory (UW Virology).

METHODS

RealTime SARS-CoV-2 assay limit of detection (LOD) was evaluated by testing two dilution panels of 60 replicates each. Cross-reactivity was evaluated by testing 24 clinical samples positive for various non‒SARS-CoV-2 respiratory viruses. Clinical performance was evaluated using 30 positive and 30 negative SARS-CoV-2 clinical samples previously tested using the UW Virology SARS-CoV-2 LDT.

RESULTS

Exceeding the 100 copies/mL LOD reported in the RealTime SARS-CoV-2 assay EUA product insert, 19 of 20 replicates were detected at 50 copies/mL and 16 of 20 replicates were detected at 25 copies/mL. All clinical samples positive for 24 non‒SARS-CoV-2 respiratory viruses were SARS-CoV-2 negative on the RealTime SARS-CoV-2 assay. The assay had high sensitivity (93%) and specificity (100%) for detecting SARS-CoV-2 in clinical samples. Two positive samples that tested negative with the RealTime SARS-CoV-2 assay had cycle numbers of 35.94 or greater and required dilution prior to testing. One of these samples was also inconclusive on the SARS-CoV-2 LDT.

CONCLUSION

The RealTime SARS-CoV-2 assay is acceptable for clinical use. With the high-throughput, fully automated m2000 system, this assay will accelerate the pace of SARS-CoV-2 testing.

Authors+Show Affiliations

Department of Laboratory Medicine, University of Washington, Seattle, Washington, United States.Department of Laboratory Medicine, University of Washington, Seattle, Washington, United States.Department of Laboratory Medicine, University of Washington, Seattle, Washington, United States; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States.Abbott Molecular, Des Plaines, Illinois, United States.Abbott Diagnostics, Abbott Park, Illinois, United States.Department of Laboratory Medicine, University of Washington, Seattle, Washington, United States; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States.Department of Laboratory Medicine, University of Washington, Seattle, Washington, United States; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States.Department of Laboratory Medicine, University of Washington, Seattle, Washington, United States; Department of Medicine, University of Washington, Seattle, Washington, United States. Electronic address: bcoombs@uw.edu.

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural
Validation Study

Language

eng

PubMed ID

32504946

Citation

Degli-Angeli, Emily, et al. "Validation and Verification of the Abbott RealTime SARS-CoV-2 Assay Analytical and Clinical Performance." Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, vol. 129, 2020, p. 104474.
Degli-Angeli E, Dragavon J, Huang ML, et al. Validation and verification of the Abbott RealTime SARS-CoV-2 assay analytical and clinical performance. J Clin Virol. 2020;129:104474.
Degli-Angeli, E., Dragavon, J., Huang, M. L., Lucic, D., Cloherty, G., Jerome, K. R., Greninger, A. L., & Coombs, R. W. (2020). Validation and verification of the Abbott RealTime SARS-CoV-2 assay analytical and clinical performance. Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, 129, 104474. https://doi.org/10.1016/j.jcv.2020.104474
Degli-Angeli E, et al. Validation and Verification of the Abbott RealTime SARS-CoV-2 Assay Analytical and Clinical Performance. J Clin Virol. 2020;129:104474. PubMed PMID: 32504946.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Validation and verification of the Abbott RealTime SARS-CoV-2 assay analytical and clinical performance. AU - Degli-Angeli,Emily, AU - Dragavon,Joan, AU - Huang,Meei-Li, AU - Lucic,Danijela, AU - Cloherty,Gavin, AU - Jerome,Keith R, AU - Greninger,Alexander L, AU - Coombs,Robert W, Y1 - 2020/05/28/ PY - 2020/04/28/received PY - 2020/05/18/revised PY - 2020/05/25/accepted PY - 2020/6/7/pubmed PY - 2020/8/12/medline PY - 2020/6/7/entrez KW - COVID-19 KW - Coronavirus KW - EUA KW - High-throughput assay KW - PCR KW - SARS-CoV-2 SP - 104474 EP - 104474 JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology JO - J Clin Virol VL - 129 N2 - BACKGROUND: High-throughput assays for the SARS-CoV-2 virus are critical to increasing test capacity and slowing the spread of COVID-19. Abbott Molecular developed and received emergency use authorization (EUA) to deploy the new RealTime SARS-CoV-2 assay, run on the automated m2000sp/rt system. OBJECTIVE: To evaluate analytical and clinical performance of the RealTime SARS-CoV-2 assay compared to the SARS-CoV-2 CDC-based laboratory developed test (LDT) in clinical use by the University of Washington Clinical Virology Laboratory (UW Virology). METHODS: RealTime SARS-CoV-2 assay limit of detection (LOD) was evaluated by testing two dilution panels of 60 replicates each. Cross-reactivity was evaluated by testing 24 clinical samples positive for various non‒SARS-CoV-2 respiratory viruses. Clinical performance was evaluated using 30 positive and 30 negative SARS-CoV-2 clinical samples previously tested using the UW Virology SARS-CoV-2 LDT. RESULTS: Exceeding the 100 copies/mL LOD reported in the RealTime SARS-CoV-2 assay EUA product insert, 19 of 20 replicates were detected at 50 copies/mL and 16 of 20 replicates were detected at 25 copies/mL. All clinical samples positive for 24 non‒SARS-CoV-2 respiratory viruses were SARS-CoV-2 negative on the RealTime SARS-CoV-2 assay. The assay had high sensitivity (93%) and specificity (100%) for detecting SARS-CoV-2 in clinical samples. Two positive samples that tested negative with the RealTime SARS-CoV-2 assay had cycle numbers of 35.94 or greater and required dilution prior to testing. One of these samples was also inconclusive on the SARS-CoV-2 LDT. CONCLUSION: The RealTime SARS-CoV-2 assay is acceptable for clinical use. With the high-throughput, fully automated m2000 system, this assay will accelerate the pace of SARS-CoV-2 testing. SN - 1873-5967 UR - https://www.unboundmedicine.com/medline/citation/32504946/Validation_and_verification_of_the_Abbott_RealTime_SARS_CoV_2_assay_analytical_and_clinical_performance_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1386-6532(20)30216-X DB - PRIME DP - Unbound Medicine ER -