Multi-Platform Comparison of SARS-CoV-2 Serology Assays for the Detection of COVID-19

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 exp...

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Published inThe Journal of Applied Laboratory Medicine Vol. 5; no. 6; p. 1324
Main Authors Suhandynata, Raymond T, Hoffman, Melissa A, Kelner, Michael J, McLawhon, Ronald W, Reed, Sharon L, Fitzgerald, Robert L
Format Journal Article Web Resource
LanguageEnglish
Published England Oxford University Press 01.11.2020
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Abstract 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. 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. 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%. 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.
AbstractList 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. 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. 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%. 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.
Author Reed, Sharon L
Hoffman, Melissa A
Suhandynata, Raymond T
Kelner, Michael J
Fitzgerald, Robert L
McLawhon, Ronald W
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Keywords COVID-19
prevalence
diagnosis
SARS-CoV-2
predictive values
serology
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Snippet 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...
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SubjectTerms Antibodies, Viral - blood
Antibodies, Viral - immunology
Antibodies, Viral - isolation & purification
Betacoronavirus - immunology
Betacoronavirus - isolation & purification
Clinical Laboratory Techniques - instrumentation
Clinical Laboratory Techniques - statistics & numerical data
Coronavirus Infections - blood
Coronavirus Infections - diagnosis
Coronavirus Infections - immunology
Coronavirus Infections - virology
COVID-19
COVID-19 Testing
False Negative Reactions
False Positive Reactions
Humans
Immunoglobulin G - blood
Immunoglobulin G - immunology
Immunoglobulin G - isolation & purification
Longitudinal Studies
Pandemics
Pneumonia, Viral - blood
Pneumonia, Viral - diagnosis
Pneumonia, Viral - immunology
Pneumonia, Viral - virology
Predictive Value of Tests
Reagent Kits, Diagnostic - statistics & numerical data
SARS-CoV-2
Serologic Tests - instrumentation
Serologic Tests - statistics & numerical data
Time Factors
Title Multi-Platform Comparison of SARS-CoV-2 Serology Assays for the Detection of COVID-19
URI https://www.ncbi.nlm.nih.gov/pubmed/32766840
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