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COVID-19 IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)
COVID-19 IgG/IgM Rapid Test Kit (Whole Blood/Serum/Plasma) For Professional Use
INTENDED USE:
COVID-19 IgG/IgM Rapid Test Kit (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the
rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirusi in human whole blood,
serum or plasma. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19
IgG/IgM Rapid Test kit (Whole Blood/Serum/Plasma) must be confirmed with alternative testing method(s) and clinical
findings
INTRODUCTION
Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds and
that cause respiratory, enteric, hepatic, and neurologic diseases. Seven coronavirus species are known to cause human
disease. Four viruses – 229E, OC43, NL63, and HKU1 – are prevalent and typically cause common cold symptoms in
immunocompetent individuals.4 The three other strains – severe acute respiratory syndrome coronavirus (SARS-CoV),
Middle East respiratory syndrome coronavirus (MERS-CoV) and 2019 Novel Coronavirus (COVID-19) – are zoonotic in
origin and have been linked to sometimes fatal illness. IgG and IgM antibodies to 2019 Novel Coronavirus can be
detected with 2-3 weeks after exposure. IgG remains positive, but the antibody level drops overtime.
SPECIMEN COLLECTION
1. COVID-19 IgG/IgM Rapid Test kit (Whole Blood/Serum/Plasma) can be performed using either whole blood, serum or
2. Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed
specimens.
3. Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature
for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage,
specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to
be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be
tested immediately.
4. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well
prior to testing. Specimens should not be frozen and thawed repeatedly.
5. If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation
of etiologic agents.
TEST PROCEDURE
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