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Multi-Platform Comparison of SARS-CoV-2 Serology Assays for the Detection of COVID-19.
Suhandynata, Raymond T; Hoffman, Melissa A; Kelner, Michael J; McLawhon, Ronald W; Reed, Sharon L; Fitzgerald, Robert L.
  • Suhandynata RT; Department of Pathology, UC San Diego Health, San Diego, CA.
  • Hoffman MA; Department of Pathology, UC San Diego Health, San Diego, CA.
  • Kelner MJ; Department of Pathology, UC San Diego Health, San Diego, CA.
  • McLawhon RW; Department of Pathology, UC San Diego Health, San Diego, CA.
  • Reed SL; Department of Pathology, UC San Diego Health, San Diego, CA.
  • Fitzgerald RL; Department of Pathology, UC San Diego Health, San Diego, CA.
J Appl Lab Med ; 5(6): 1324-1336, 2020 11 01.
Article in English | MEDLINE | ID: covidwho-696756
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Serologic Tests / Coronavirus Infections / Clinical Laboratory Techniques / Betacoronavirus / Antibodies, Viral Type of study: Cohort study / Diagnostic study / Observational study / Prognostic study Limits: Humans Language: English Journal: J Appl Lab Med Year: 2020 Document Type: Article Affiliation country: Jalm

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Serologic Tests / Coronavirus Infections / Clinical Laboratory Techniques / Betacoronavirus / Antibodies, Viral Type of study: Cohort study / Diagnostic study / Observational study / Prognostic study Limits: Humans Language: English Journal: J Appl Lab Med Year: 2020 Document Type: Article Affiliation country: Jalm