The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Fastep Covid-19 IgG/IgM Rapid Test Device for use at the point-of-care.
Developed by Assure Tech, the Covid-19 test is allowed for use with fingerstick whole blood specimens at the point-of-care, at in-patient care settings operating under CLIA Certificate of Waiver.
The test can be used in doctor’s offices, hospitals, urgent care centres and emergency rooms, eliminating the need for sending samples to a central lab.
In July this year, the test was initially authorised to detect SARS-CoV-2 antibodies in venous whole blood, serum, and plasma samples, to identify individuals with Covid-19 infection.
In September, the US regulator expanded its authorisation for the 15-minute lateral flow test, to include point-of-care testing using finger-stick blood samples.
Fastep rapid Covid-19 IgG/IgM test authorised to detect SARS-CoV-2 antibodies
Fastep rapid Covid-19 IgG/IgM test has been authorised only for the presence of IgM and IgG antibodies, against SARS-CoV-2, not for any other viruses or pathogen.
The test has not been granted full approval by the FDA, and is only authorised for the duration of declaration pertaining the emergency use of in-vitro diagnostics.
Carolina Liquid Chemistries is engaged in supplying real-time PCR instruments, extraction systems and authorized test kits for SARS-CoV-2, which causes Covid-19, along with sample collection and transportation supplies.
In October, genomics company DxTerity Diagnostics secured the EUA from the FDA for a new at-home saliva-based Covid-19 test called SafeWorkDx.
The EUA status has been granted for the updated version of DxTerity’s SARS-CoV-2 RT-PCR test to conduct at home and workplace under supervision.
