Hangzhou Aichek Medical Technology Co.,Ltd |
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For professional and in vitro diagnostic use only.
Product Name | Professional CoV-19 Antibody iggigm Rapid test double check for patient |
Formats | Strip(3mm)Device(4mm) uncut sheet |
Place of Origen | China |
Specimen | Blood |
Read Time | 15 minutes |
Shelf life | 2 years |
Package | 25 device/box |
Storage | 2℃-30℃ |
[INTENDED USE]
COVID-19 IgG/IgM Antibody Rapid Test Kit is a rapid test intended
for the qualitative detection of the IgM and IgG antibodies to
SARS-CoV-2 in human serum, plasma or whole blood sample from
patients suspected of COVID-19 infection. The test Kit for
professional use only. It is an aid in the diagnosis of the
patients with suspected SARS-CoV-2 infection in conjunction with
clinical presentation and results of other laboratory tests. But to
be attention the test Results from this test kit should not be used
as the sole basis for diagnosis. The test provides preliminary test
results.
[LIMITATIONS]
• The COVID-19 IgG/IgM Rapid Test device is limited to provide a qualitative detection. The intensity of the test line does not necessarily correlate to the concentration of the antibody in the blood.
• The results obtained from this test are intended to be an aid in diagnosis only. Each physician must interpret the results in conjunction with the patient’s history, physical findings, and other diagnostic procedures.
• A negative test result indicates that antibodies to Novel coronavirus are either not present or at levels undetectable by the test.
[STORAGE AND STABILITY]
• Store as packaged in the sealed pouch at the temperature (2-30 ℃ or 36-86 ℉). The kit is stable within the expiration date printed on the labeling.
• Once open the pouch, the test should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration.
• The lot number and the expiration date were printed on the labeling.