Premier Biotech Fastep COVID-19 IgG/ IgM Rapid Antibody Test Cassette(Whole Blood/ Serum/ Plasma)-AZ COVID-19P

Premier Biotech Fastep COVID-19 IgG/ IgM Rapid Antibody Test Cassette(Whole Blood/ Serum/ Plasma)-AZ COVID-19P - 20/box

Description

The Fastep COVID-19 IgG/IgM Rapid Test Device is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. The Fastep COVID-19 IgG/IgM Rapid Test Device is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. 

Packing Info

• 20 tests/box

Reagents & Materials

• Individually packed test devices

• Disposable pipettes

• Buffer

• Package insert

Documents and Downloads

EUA

Procedure Guide

FS-Instructions For Use (PI)

Warnings and Precautions: 

• For in vitro Diagnostic Use Only.
• This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA
for use by laboratories certified under CLIA, that meet requirements to perform moderate or high
complexity tests.
• This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2,
not for any other viruses or pathogens. This test is only authorized for the duration of the declaration
that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for
detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and
Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
• Read the Package Insert prior to use. Directions should be read and followed carefully.
• Do not use kit or components beyond the expiration date.
• The device contains material of animal origin and should be handled as a potential biohazard. Do
not use if pouch is damaged or open.
• Test devices are packaged in foil pouches that exclude moisture during storage. Inspect each foil
pouch before opening. Do not use devices that have holes in the foil or where the pouch has not
been completely sealed.Erroneous result may occur if test reagents or components are improperly
stored.
• Do not use the Buffer if it is discolored or turbid. Discoloration or turbidity may be a sign of
microbial contamination.
• All patient specimens should be handled and discarded as if they are biologically hazardous. All
specimens must be mixed thoroughly before testing to ensure a representative sample prior to
testing.
• Failure to bring specimens and reagents to room temperature before testing may decrease assay
sensitivity. Inaccurate or inappropriate specimen collection, storage, and transport may yield
erroneous test result.
• Avoid skin contact with buffer containing sodium azide which is a skin irritant.
• If infection with SARS-CoV-2 is suspected based on current clinical and epidemiological screening
criteria recommended by public health authorities, specimens should be collected with appropriate
infection control precautions and sent to state or local health departments for testing.
• Humidity and temperature can adversely affect results