Are Lessons Learned in Setting Cut Points for Detection of Anti-Drug Antibodies Also Useful in Serology Assays for Robust Detection of SARS-CoV-2 Reactive Antibodies?

Bowsher, Ronald R; Devanarayan, Viswanath

Bowsher, Ronald R; Devanarayan, Viswanath.

Bowsher RR; B2S Life Sciences llc, 97 East Monroe Street, Franklin, Indiana, 46131, USA. Ron.Bowsher@B2SLifeSciences.com.
Devanarayan V; GlaxoSmithKline, 1250 South Collegeville Road, Collegeville, Pennsylvania, 19426, USA.

AAPS J ; 22(6): 127, 2020 10 06.

Article in English | MEDLINE | ID: covidwho-835909

Subject(s)

Antibodies, Viral/blood; Antigens, Viral/immunology; Betacoronavirus/immunology; Clinical Laboratory Techniques/methods; Coronavirus Infections/diagnosis; Endpoint Determination/methods; Enzyme-Linked Immunosorbent Assay/methods; Pandemics; Pneumonia, Viral/diagnosis; Spike Glycoprotein, Coronavirus/immunology; Antibodies/blood; Antibodies, Viral/immunology; COVID-19; COVID-19 Testing; Drug Hypersensitivity/blood; Drug Hypersensitivity/diagnosis; Endpoint Determination/standards; Enzyme-Linked Immunosorbent Assay/standards; False Negative Reactions; False Positive Reactions; Humans; Normal Distribution; Point-of-Care Testing; Reproducibility of Results; SARS-CoV-2; Sensitivity and Specificity

Keywords

COVID-19; cut point; diagnostics; immunogenicity; serology; statistics

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Enzyme-Linked Immunosorbent Assay / Coronavirus Infections / Clinical Laboratory Techniques / Endpoint Determination / Pandemics / Spike Glycoprotein, Coronavirus / Betacoronavirus / Antibodies, Viral / Antigens, Viral Type of study: Diagnostic study / Prognostic study Limits: Humans Language: English Journal: AAPS J Journal subject: Pharmacology / Drug Therapy Year: 2020 Document Type: Article Affiliation country: S12248-020-00510-8

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