Coronavirus Disease 2019, or COVID-19, is a novel respiratory disease that has characterized as a pandemic by the World Health Organization.
On March 16, 2020, the FDA updated its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency to included guidance for serology tests that identify antibodies (e.g., IgM, IgG) to SARS-CoV-2 from clinical specimens; allowing healthcare entities to perform testing at the point-of-care.
Rapid screening of individuals with this virus is vital in addressing this escalating public health issue. Recent studies suggest that a high percentage of patients show no clinical symptoms of the SARS-CoV-2 virus, thus screening patients is vitally important.
Features & Benefits:
BitCare Rapid IgM-IgG Combined Antibody Test for COVID-19 is used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro.
Works with whole blood, serum, & plasma
Tests for both IgM and IgG antibodies
Validated using PCR
10-15 minutes per test
Intuitive visual interpretation
No special equipment needed
The COVID-19 IgM/IgG Rapid Test is ideally suited for hospitals, clinics, care facilities, laboratories, and mobile clinics. The test can potentially be effectively deployed in schools, airports, seaports, businesses, community centers, senior living, nursing homes, care facilities, etc., giving it the potential to become a compelling force in the fight against this pandemic.
General Population Screening
Allows rapid examination and diagnosis near the point of care
Hospitals, Physician Offices, Laboratories
Can screen carriers who are asymptomatic
Can determine if the patient recently affected by the virus, even if the virus is no longer present
NOTE: Updated USFDA guidance issued on March 16, 2020, allows the distribution of this product for diagnostic use in laboratories or by healthcare workers at the point-of-care. The updated policy can be viewed by clicking here. Please see FAQ’s below for more detailed information.