High Accuracy Serum Plasma Whole Blood IgG/IgM Rapid Test Kit
For professional and in vitro diagnostic use only.
| Product Name | High Accuracy Serum Plasma Whole Blood IgG/IgM Rapid Test Kit |
| 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.
[PRINCIPLE OF THE TEST]
This test uses double-antibody sandwich to legally detect the
antigen of novel coronavirus (2019-nCoV) in saliva samples. During
detection, the gold labeled anti-2019-nCoV monoclonal antibody in
the labeling pad binds to the 2019-nCoV antigen in the sample to
form a complex, and the reaction complex moves forward along the
nitrocellulose membrane under the action of chromatography, it is
captured by the anti-2019-nCoV monoclonal antibody pre-coated by
the detection zone (T) on the nitrocellulose membrane, and finally
a red color reaction line is formed in the T zone. If the sample
does not contain 2019-nCoV antigen, a red color reaction line
cannot be formed in the T zone. Regardless of whether the sample to
be tested contains 2019-nCoV antigen, a red reaction line will
always form in the quality control area (C).
[SUMMARY]
The novel coronaviruses belong to the β genus. COVID-19 is an acute
respiratory infectious disease. People are generally susceptible.
Currently, the patients infected by the novel coronavirus are the
main source of infection; asymptomatic infected people can also be
an infectious source. Based on the current epidemiological
investigation, the incubation period is 1 to 14 days, mostly 3 to 7
days. The main manifestations include fever, fatigue and dry cough.
Nasal congestion, runny nose, sore throat, myalgia and diarrhea are
found in a few cases.
