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Multi-Platform Comparison of SARS-CoV-2 Serology Assays for the Detection of COVID-19.
J Appl Lab Med. 2020 11 01; 5(6):1324-1336.JA

Abstract

BACKGROUND

COVID-19 is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a novel beta-coronavirus that is responsible for the 2019 coronavirus pandemic. Acute infections should be diagnosed by polymerase chain reaction (PCR) based tests, but serology tests can demonstrate previous exposure to the virus.

METHODS

We compared the performance of the Diazyme, Roche, and Abbott SARS-CoV-2 serology assays using 179 negative participants to determine negative percentage agreement (NPA) and in 60 SARS-CoV-2 PCR-confirmed positive patients to determine positive percentage agreement (PPA) at 3 different time frames following a positive SARS-CoV-2 PCR result.

RESULTS

At ≥15 days, the PPA (95% CI) was 100 (86.3-100)% for the Diazyme IgM/IgG panel, 96.0 (79.7-99.9)% for the Roche total Ig assay, and 100 (86.3-100)% for the Abbott IgG assay. The NPA (95% CI) was 98.3 (95.2-99.7)% for the Diazyme IgM/IgG panel, 99.4 (96.9-100)% for the Roche total Ig assay, and 98.9 (96.0-99.9)% for the Abbott IgG assay. When the Roche total Ig assay was combined with either the Diazyme IgM/IgG panel or the Abbott IgG assay, the positive predictive value was 100% while the negative predictive value remained greater than 99%.

CONCLUSIONS

Our data demonstrates that the Diazyme, Roche, and Abbott SARS-CoV-2 serology assays have similar clinical performances. We demonstrated a low false-positive rate across all 3 platforms and observed that false positives observed on the Roche platform are unique compared to those observed on the Diazyme or Abbott assays. Using multiple platforms in tandem increases the PPVs, which is important when screening populations with low disease prevalence.

Authors+Show Affiliations

Department of Pathology, UC San Diego Health, San Diego, CA.Department of Pathology, UC San Diego Health, San Diego, CA.Department of Pathology, UC San Diego Health, San Diego, CA.Department of Pathology, UC San Diego Health, San Diego, CA.Department of Pathology, UC San Diego Health, San Diego, CA.Department of Pathology, UC San Diego Health, San Diego, CA.

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

32766840

Citation

Suhandynata, Raymond T., et al. "Multi-Platform Comparison of SARS-CoV-2 Serology Assays for the Detection of COVID-19." The Journal of Applied Laboratory Medicine, vol. 5, no. 6, 2020, pp. 1324-1336.
Suhandynata RT, Hoffman MA, Kelner MJ, et al. Multi-Platform Comparison of SARS-CoV-2 Serology Assays for the Detection of COVID-19. J Appl Lab Med. 2020;5(6):1324-1336.
Suhandynata, R. T., Hoffman, M. A., Kelner, M. J., McLawhon, R. W., Reed, S. L., & Fitzgerald, R. L. (2020). Multi-Platform Comparison of SARS-CoV-2 Serology Assays for the Detection of COVID-19. The Journal of Applied Laboratory Medicine, 5(6), 1324-1336. https://doi.org/10.1093/jalm/jfaa139
Suhandynata RT, et al. Multi-Platform Comparison of SARS-CoV-2 Serology Assays for the Detection of COVID-19. J Appl Lab Med. 2020 11 1;5(6):1324-1336. PubMed PMID: 32766840.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multi-Platform Comparison of SARS-CoV-2 Serology Assays for the Detection of COVID-19. AU - Suhandynata,Raymond T, AU - Hoffman,Melissa A, AU - Kelner,Michael J, AU - McLawhon,Ronald W, AU - Reed,Sharon L, AU - Fitzgerald,Robert L, PY - 2020/07/07/received PY - 2020/07/27/accepted PY - 2020/8/9/pubmed PY - 2020/12/2/medline PY - 2020/8/9/entrez KW - COVID-19 KW - SARS-CoV-2 KW - diagnosis KW - predictive values KW - prevalence KW - serology SP - 1324 EP - 1336 JF - The journal of applied laboratory medicine JO - J Appl Lab Med VL - 5 IS - 6 N2 - BACKGROUND: COVID-19 is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a novel beta-coronavirus that is responsible for the 2019 coronavirus pandemic. Acute infections should be diagnosed by polymerase chain reaction (PCR) based tests, but serology tests can demonstrate previous exposure to the virus. METHODS: We compared the performance of the Diazyme, Roche, and Abbott SARS-CoV-2 serology assays using 179 negative participants to determine negative percentage agreement (NPA) and in 60 SARS-CoV-2 PCR-confirmed positive patients to determine positive percentage agreement (PPA) at 3 different time frames following a positive SARS-CoV-2 PCR result. RESULTS: At ≥15 days, the PPA (95% CI) was 100 (86.3-100)% for the Diazyme IgM/IgG panel, 96.0 (79.7-99.9)% for the Roche total Ig assay, and 100 (86.3-100)% for the Abbott IgG assay. The NPA (95% CI) was 98.3 (95.2-99.7)% for the Diazyme IgM/IgG panel, 99.4 (96.9-100)% for the Roche total Ig assay, and 98.9 (96.0-99.9)% for the Abbott IgG assay. When the Roche total Ig assay was combined with either the Diazyme IgM/IgG panel or the Abbott IgG assay, the positive predictive value was 100% while the negative predictive value remained greater than 99%. CONCLUSIONS: Our data demonstrates that the Diazyme, Roche, and Abbott SARS-CoV-2 serology assays have similar clinical performances. We demonstrated a low false-positive rate across all 3 platforms and observed that false positives observed on the Roche platform are unique compared to those observed on the Diazyme or Abbott assays. Using multiple platforms in tandem increases the PPVs, which is important when screening populations with low disease prevalence. SN - 2576-9456 UR - https://www.unboundmedicine.com/medline/citation/32766840/Multi_Platform_Comparison_of_SARS_CoV_2_Serology_Assays_for_the_Detection_of_COVID_19_ L2 - http://jalm.aaccjnls.org/cgi/pmidlookup?view=long&pmid=32766840 DB - PRIME DP - Unbound Medicine ER -