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Evaluation of the EDI enzyme linked immunosorbent assays for the detection of SARS-CoV-2 IgM and IgG antibodies in human plasma.
Clin Chim Acta. 2020 Oct; 509:79-82.CC

Abstract

BACKGROUND

Besides SARS-CoV-2 RT-PCR testing, serological testing is emerging as additional option in COVID-19 diagnostics. Aim of this study was to evaluate novel immunoassays for detection of SARS-CoV-2 antibodies in human plasma.

METHODS

Using EDITM Novel Coronavirus COVID-19 Enzyme Linked Immunosorbent Assays (ELISAs), we measured SARS-CoV-2 IgM and IgG antibodies in 64 SARS-CoV-2 RT-PCR confirmed COVID-19 patients with serial blood samples (n = 104) collected at different time points from symptom onset. Blood samples from 200 healthy blood donors and 256 intensive care unit (ICU) patients collected before the COVID-19 outbreak were also used.

RESULTS

The positivity rates in the COVID-19 patients were 5.9% for IgM and 2.9% for IgG ≤ 5 days after symptom onset; Between day 5 and day 10 the positivity rates were 37.1% for IgM and 37.1% for IgG and rose to 76.4% for IgM and 82.4% for IgG after > 10-15 days. After 15-22 days the "true" positivity rates were 94.4% for IgM and 100% for IgG. The "false" positivity rates were 0.5% for IgM and 1.0% for IgG in the healthy blood donors, 1.6% for IgM and 1.2% for IgG in ICU patients.

CONCLUSIONS

This study shows high "true" vs. low "false" positivity rates for the EDITM SARS-CoV-2 IgM and IgG ELISAs.

Links

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Authors+Show Affiliations

Bundschuh C
Department of Laboratory Medicine, Konventhospital Barmherzige Brueder Linz and Ordensklinikum Linz Barmherzige Schwestern, Linz, Austria.
Egger M
Department of Laboratory Medicine, Konventhospital Barmherzige Brueder Linz and Ordensklinikum Linz Barmherzige Schwestern, Linz, Austria.
Wiesinger K
Department of Laboratory Medicine, Konventhospital Barmherzige Brueder Linz and Ordensklinikum Linz Barmherzige Schwestern, Linz, Austria.
Gabriel C
Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, Graz, Austria; Ludwig Boltzmann Institute for Experimental and Clinical Traumatology Vienna, Vienna, Austria.
Clodi M
Department of Internal Medicine, Konventhospital Barmherzige Brueder Linz, Linz, Austria.
Mueller T
Department of Clinical Pathology, Hospital of Bolzano, Bolzano, Italy.
Dieplinger B
Department of Laboratory Medicine, Konventhospital Barmherzige Brueder Linz and Ordensklinikum Linz Barmherzige Schwestern, Linz, Austria. Electronic address: benjamin.dieplinger@bs-lab.at.

MeSH

AgedAged, 80 and overAntibodies, ViralBetacoronavirusCOVID-19Coronavirus InfectionsEnzyme-Linked Immunosorbent AssayFemaleHumansImmunoglobulin GImmunoglobulin MMaleMiddle AgedPandemicsPneumonia, ViralSARS-CoV-2Serologic Tests

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32526218

Citation

Bundschuh, Christian, et al. "Evaluation of the EDI Enzyme Linked Immunosorbent Assays for the Detection of SARS-CoV-2 IgM and IgG Antibodies in Human Plasma." Clinica Chimica Acta; International Journal of Clinical Chemistry, vol. 509, 2020, pp. 79-82.
Bundschuh C, Egger M, Wiesinger K, et al. Evaluation of the EDI enzyme linked immunosorbent assays for the detection of SARS-CoV-2 IgM and IgG antibodies in human plasma. Clin Chim Acta. 2020;509:79-82.
Bundschuh, C., Egger, M., Wiesinger, K., Gabriel, C., Clodi, M., Mueller, T., & Dieplinger, B. (2020). Evaluation of the EDI enzyme linked immunosorbent assays for the detection of SARS-CoV-2 IgM and IgG antibodies in human plasma. Clinica Chimica Acta; International Journal of Clinical Chemistry, 509, 79-82. https://doi.org/10.1016/j.cca.2020.05.047
Bundschuh C, et al. Evaluation of the EDI Enzyme Linked Immunosorbent Assays for the Detection of SARS-CoV-2 IgM and IgG Antibodies in Human Plasma. Clin Chim Acta. 2020;509:79-82. PubMed PMID: 32526218.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of the EDI enzyme linked immunosorbent assays for the detection of SARS-CoV-2 IgM and IgG antibodies in human plasma. AU - Bundschuh,Christian, AU - Egger,Margot, AU - Wiesinger,Kurt, AU - Gabriel,Christian, AU - Clodi,Martin, AU - Mueller,Thomas, AU - Dieplinger,Benjamin, Y1 - 2020/06/08/ PY - 2020/04/25/received PY - 2020/05/26/revised PY - 2020/05/27/accepted PY - 2020/6/12/pubmed PY - 2020/9/1/medline PY - 2020/6/12/entrez KW - Antibody testing KW - COVID-19 KW - ELISA KW - SARS-CoV-2 KW - Serological test SP - 79 EP - 82 JF - Clinica chimica acta; international journal of clinical chemistry JO - Clin Chim Acta VL - 509 N2 - BACKGROUND: Besides SARS-CoV-2 RT-PCR testing, serological testing is emerging as additional option in COVID-19 diagnostics. Aim of this study was to evaluate novel immunoassays for detection of SARS-CoV-2 antibodies in human plasma. METHODS: Using EDITM Novel Coronavirus COVID-19 Enzyme Linked Immunosorbent Assays (ELISAs), we measured SARS-CoV-2 IgM and IgG antibodies in 64 SARS-CoV-2 RT-PCR confirmed COVID-19 patients with serial blood samples (n = 104) collected at different time points from symptom onset. Blood samples from 200 healthy blood donors and 256 intensive care unit (ICU) patients collected before the COVID-19 outbreak were also used. RESULTS: The positivity rates in the COVID-19 patients were 5.9% for IgM and 2.9% for IgG ≤ 5 days after symptom onset; Between day 5 and day 10 the positivity rates were 37.1% for IgM and 37.1% for IgG and rose to 76.4% for IgM and 82.4% for IgG after > 10-15 days. After 15-22 days the "true" positivity rates were 94.4% for IgM and 100% for IgG. The "false" positivity rates were 0.5% for IgM and 1.0% for IgG in the healthy blood donors, 1.6% for IgM and 1.2% for IgG in ICU patients. CONCLUSIONS: This study shows high "true" vs. low "false" positivity rates for the EDITM SARS-CoV-2 IgM and IgG ELISAs. SN - 1873-3492 UR - https://www.unboundmedicine.com/medline/citation/32526218/Evaluation_of_the_EDI_enzyme_linked_immunosorbent_assays_for_the_detection_of_SARS_CoV_2_IgM_and_IgG_antibodies_in_human_plasma_ DB - PRIME DP - Unbound Medicine ER -