A rapid (10 minute) Cassette Test for the qualitative detection of IgG and IgM antibodies to 2019-nCov in human whole blood, serum, plasma specimens. Finger stick samples can be used for specimens collection.
Virus Covid-19 antibody test kits for professional medical use only
· This is
NOT a home Coronavirus test kit and is for professional medical use only.
· To order
Covid-19 antibody test kit you must be a licensed Medical Facility with an NPI
· We may
contact you prior to sending orders to verify your details.
25 x Healgen GCCOV-402A Rapid 2019-nCov (Covid-19) IgG / IgM on-site Coronavirus test kit.
Covid-19 whole blood/serum/plasma test cassette
· Qualitative lateral flow immunoassay for the detection of IgG and IgM antibodies to
results for IgM and IgG detection
professional in vitro diagnostic use only
· This is a
professional only medical diagnostic test kit intended solely for use by
healthcare professionals under the supervision of doctors.
at 2-30*C (36-86F) (accelerated stability studies suggest 24-month expiry stability)
to commercial PCR, offers a relative sensitivity of 100% for IgG and IgM. The relative specificity is 97.5% combined for IgG and IgM
Cross-reactivity with Influenza A, B, RSV or Adenovirus
for whole blood, serum, or plasma.
can be read at 10 minutes
· The Healgen GCCOV-402a screens for antibodies
specifically produced against Covid-19 and NOT virus antigenic material. A
negative test result does NOT exclude Covid-19 infection.
· Interpretation of results must always be
interpreted with consideration to the other clinical presenting information and
should not be used as the sole criteria for the diagnosis of 2019-nCoV
Clinical studies have shown IgM is detectable
at 3-5 days after the initial infection. This corresponds to the onset of
clinical symptoms in some patients. Antibody reactions can be delayed, making
this test an incomplete determinant for use in the acute diagnosis of active
· The role
of this test can also be used to identify recovered patients, confirming they
have had previous COVID-19 exposure and responded with antibody production.
antibodies are detectable 4-10 days after the onset of clinical symptoms.
access to PCR antigen testing is not available, negative tests should be
repeated in 72 hours where clinical symptoms persist.
· Not for
screening of donated blood.
Coronavirus Covid-19 Test pack contents
· 25 Covid-19
· 25 Blood
· 1 data
sheet instruction for use insert
· 1 vial
buffer solution to run tests with whole blood samples
Included that may be needed to perform Testing: