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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.

Authors+Show Affiliations

Department of Laboratory Medicine, Konventhospital Barmherzige Brueder Linz and Ordensklinikum Linz Barmherzige Schwestern, Linz, Austria.Department of Laboratory Medicine, Konventhospital Barmherzige Brueder Linz and Ordensklinikum Linz Barmherzige Schwestern, Linz, Austria.Department of Laboratory Medicine, Konventhospital Barmherzige Brueder Linz and Ordensklinikum Linz Barmherzige Schwestern, Linz, Austria.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.Department of Internal Medicine, Konventhospital Barmherzige Brueder Linz, Linz, Austria.Department of Clinical Pathology, Hospital of Bolzano, Bolzano, Italy.Department of Laboratory Medicine, Konventhospital Barmherzige Brueder Linz and Ordensklinikum Linz Barmherzige Schwestern, Linz, Austria. Electronic address: benjamin.dieplinger@bs-lab.at.

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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0009-8981(20)30258-8 DB - PRIME DP - Unbound Medicine ER -