Curebase has supported InBios International in securing US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its SCoV-2 Detect IgG Rapid Test.
The company collaborated with InBios to test its Covid-19 rapid test, which is an in-vitro lateral flow chromatographic immunoassay.
The device is designed to detect IgG antibodies of SARS-CoV-2 in human serum, plasma, venous whole blood and fingerstick whole blood.
It is developed to identify individuals with an adaptive immune response to SARS-CoV-2, which indicates recent or prior infection.
Curebase noted that the IgG Rapid Test should not be used to identify or exclude acute SARS-CoV-2 infection.
A clinical study was conducted using Curebase solution on individuals who were 15 days or more post symptom onset.
In this trial, the SCoV-2 Detect IgG Rapid Test showed 96.9% (PPA) of those who were positive and 100% of those who were negative (NPA) for SARS-CoV-2 IgG antibodies.
The new Covid-19 test also includes all reagents and controls which are needed to perform 50 test specimens with results in about 20 minutes.
Curebase founder and CEO Tom Lemberg said: “By locally activating points of care in the community to collect clinical data, such as drive-through testing sites, we can more conveniently and quickly obtain data for the FDA’s requirements.”
The company noted the InBios’s SCoV-2 Detect IgG Rapid Test has only been authorised for emergency use by the FDA for use by authorised laboratories and has not been FDA cleared or approved.
It has been approved only to detect the IgG antibodies presence of SARS-CoV-2, not for the detection of any other viruses or pathogens.
The product’s authorisation is only for the duration of the declaration that circumstances exist which justifies the EUA of vitro diagnostics to detect and/or diagnose Covid-19.