Abbott Laboratories Inc.

Business Name: Abbott Laboratories Inc.
Business Genre:
Business Description:

global healthcare company in over 160 countries, product portfolio focuses on diagnostics, medical devices, generic medicines, and nutritionals [1]

City: Abbott Park
State: IL
Country: USA
Data/Evidence of Effectiveness: Many claims in health care provider fact sheet that false positive and false negatives may occur [4]. Control and calibration samples are available to increase robustness of test [3]. U of Washington published in J Clin Microbiol that test had “99.9% specificity and 100% sensitivity for detecting the IgG antibody in patients 17 days or more after symptom began.” [5]
Complimentary Products Needed to Perform Test: serum separator tube (serum) or lithium heparin in separator tube (plasma) and ARCHITECT i1000SR or i2000SR systems (Abbott instruments) [3], SARS-CoV-2 IgG calibrator and control kit (sold separately), instructions available at
Setting of Care: authorizied laboratories (required to report results to healthcare providers and public health authorities) [3]
Current Status / Clinical Development Stage / Expected Milestones: NOT FDA cleared/approved; FDA approved to meet EUA criteria [3]. Under EUA, cGMP requirements have been waived [3]; for in vitro diagnostic use ONLY [3]; currently available for purchase [2]
Funding & Ownership : Public (Market Cap $158.5B) [7]
Business Model: sale of medical products focused on cardiovascular, diabetes care, neuromodulation, nutrition, and diagnostics and consumer products including some popular brands such as ENSURE protein drinks, ZONEPERFECT bars, PEDIALYTE and PEDIASURE [1]
History & Origins : Company has extensive experience in creating diagnostic tests. Previous focus includes immunosassays, hematology assays, photometric and potentiometric assays. [1]
Date EUA Issued: 4/26/2020 [3]
Sources: [1]; [2]; [3]; [4]; [5]; [6] [7]
Organization: Robert B. Ford (President/CEO); Miles D. White (Executive Chairman); Executive VPs for diagnostics (John Ginascol, Andrea Wainer, Jaime Contreras, Christopher Scoggins) [6]
Time to Result: 29 minutes for 1 result; 4000 results in 24hr [2]
Test Sample Type: serum or plasma [3]
Technology Overview: detects adaptive immune response using a two-step immunoassay using chemiluminescent microparticle immunoassay (CMIA) technology [2-3]
Testing Type: qualitative IgG antibody test [3]
Test Category: SEROLOGY
Test Name: SARS-CoV-2- IgG assay [2]
Clinical Application & Need: detect current, recent, or prior infection [3]

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