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Overview: Founded in 2013, Wells Bio, Inc. is a Korean firm which develops and manufactures in vitro diagnostic tests based on immunochemical, biochemical, and molecular technology.
Test Name: CareUS™ COVID-19 IgM/IgG
Testing Type: Qualitative rapid diagnostic antibody test
Technology: The careUS™ COVID-19 IgM/IgG is an in vitro rapid immunochromatographic diagnostic test using colloidal gold for the qualitative detection of IgM/IgG antibodies against SARS-CoV-2 directly from human whole blood, serum or plasma. Storage temperature needs to be 1-30 degrees Celsius.
Test Sample Type: 10 micro liter human whole blood, serum or plasma
Time to Result: 10-15 minutes
Testing Location: Home/hospital/POC
Complementary Products: Kit components: Test cassettes (25 each per pack), Disposable capillary pipette (25 each per pack), Assay buffer vial, Instructions for use
Effectiveness: Using 97 test samples, the sensitivity was 93.6% and specificity: 98%. A total of 47 positive and 50 negative specimens were collected from subjects and confirmed by commercially available SARS- CoV-2 RT-PCR as a comparator method. The clinical performance of the careUSTM COVID-19 IgM/IgG was compared to the comparator method.
Current Status: Commercially available. The company obtained the Conformite Europeenne (CE) mark for its diagnostic kit on March 3. Cat. No. is RCO-M02582
Business Model: 25 tests/kit and minimum order of 100,000. Weekly production capacity of 500,000
Organization: Wells Bio is a subsidiary of Access Bio, an American company. It is currently engaging in a joint initiative with the government funded by the Korea Research Institute of Chemical Technology. The current Chairman is Young Ho Choi.
Other: The Immuno Chromatography Technology (ICT) aspect of Wells Bio ensures its products are able to retain the highest levels of accuracy and sensitivity as part of R&D efforts.