Kit of 25 antibody tests COVID-19 approved by Health Canada.
The kit includes:
25 disposable pipettes
25 individually packaged test devices
2x 7ml bottles
Lasecurity certificates, talcohol ampons and timer are not included.
Manufacturer: BTNX Inc.
Brand: Rapid Response
The Rapid Response™ COVID-19 IgG/IgM rapid test device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in blood human whole (including blood and capillary whole blood), serum or plasma. At the point of care, this test is only allowed with fingerstick whole blood samples.
This test is intended to be used as an aid in identifying people with an adaptive immune response to SARS-CoV-2, indicating recent or previous infection. The Rapid Response™ COVID-19 IgG/IgM rapid test device should not be used to screen patients or to diagnose or exclude acute SARS-CoV-2 infection.
At present, it is not known how long antibodies persist after infection and whether the presence of antibodies confers protective immunity.
A negative or non-reactive result for an individual subject indicates the absence of detectable antibodies to the COVID-19 virus. However, a resting negative or non-reactive result does not rule out the possibility of exposure to or infection with the COVID-19 virus. False positive results may occur due to cross-reactivity of pre-existing antibodies or other possible causes.
Due to the risk of false positive results, confirmation of positive results should be confirmed using a second, different IgG/IgM detection method. Laboratories are required to report all results to the appropriate public health authorities. The test is for professional use only. This test is not intended for home testing (or self-testing).
The Rapid Response™ COVID-19 IgG/IgM rapid test device can detect a response to vaccination.