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.
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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.
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.
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.
There are two types of tests available for COVID-19 that can detect whether a person had it in the past (serology testing, which tests for antibodies against SARS-CoV-2, the virus that causes COVID-19), or whether they have it in the present (polymerase chain reaction (PCR) testing, which tests for active infection). This document is designed to explain the differences between PCR and serology testing, and when one test might be used over another.
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– Prof. Dantu
“You guys have been great, I’m excited to have found a group that can fit what we needed. We looked for a while”
– Matt
“I got it thank you so much. I can return to work… “
– Ana
Had great experience with BitCare few weeks back for COVID testing. Thanks to team for expedited results with their personal touch.
– Ajay
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