High Accuracy Ncp Atrips COVID-19 Corona Virus Antibody Rapid Test
IGG IGM CE FDA CDC Test
| Name | COVID-19 Test Kit |
| Certification | CDC,CE,ISO,FDA |
| Storage | Keep in a dry place away from light. |
| Test Kit | Do not freeze |
| Expiry date: | 24 months. |
| Stored Temperature | 4-30°C |
Product Feature:
1. The specimen: serum, plasma, whole blood;
2. Rapid screening for coronavirus infection within 15 minutes;
3. Equipment is not required, suitable for all kinds of field
screening;
4. Reduce the risk of sampling infection;
5. Early diagnosis, early treatment, shorten the course of disease;
6. The kit is transported and stored at room temperature;
7. Reduce the workload of epidemic situation designated hospitals;
Intended Use
COVID-19(SARS-CoV-2)IgG/IgM Test is used for qualitative detection
of novel coronavirus IgG/IgM antibodies in human serum, plasma and
whole blood. After infection with the novel coronavirus, the common
signs include respiratory symptoms, fever, cough, wheezing and
dyspnea, etc. In more severe cases, the infection can lead to
pneumonia, severe acute respiratory syndrome, kidney failure and
even death. Coronaviruses can be expelled from the body through
respiratory secretions, transmitted by oral fluids, sneezing,
contact, and by airborne droplets.
Warnings and precautions
1. For in vitro diagnostic use only. Operation should be carried
out in strict accordance with the instructions, do not use expired
or damaged products.
2. Only the diluent in the package can be used, and diluent in
different batches cannot be mixed.
3. Do not use tap water, purified water and distilled water as
negative controls.
4. The test device should be used within 1 hour after unsealing. If
the ambient temperature is higher than 30°C or more humid, use
immediately after tearing.
5. If there is no liquid migration in the test window within 30
seconds after adding the detection solution, add another 1 drop of
detection solution.
6. Pay attention to the possibility of virus infection when
collecting specimens, wear disposable gloves, masks, etc., after
washing hands.
7. The test device is disposable. The test device and specimen
after use shall be regarded as medical waste with biological
infection risk and properly disposed of according to relevant
national regulations.
Interpretation of Result
Positive:1. Two or three distinct lines appear. One line should
always appear in the control line region (C), and
another one or two apparent colored line(s) should appear in the
test line region(s) (T1 and T2).
2. If a line appears on the quality control line, a line appears on
the test line T1, and no sline appears on the test line
T2, it indicates that IgG antibody is present in the sample and no
IgM antibody is present.
3. If a line appears on the quality control line, a line appears on
the test line T2, and no sline appears on the test line
T1, it indicates that IgM antibody is present in the sample and no
IgG antibody is present.
Negative: One colored line appears in the control region (C). No
Apparent colored lines appear in the test lines
regions (T1 and T2).
Invalid: Control line(C) fails to appear. Insufficient specimen
volume or incorrect procedural technologies are the
most likely reasons for control line failure. Review the procedure
and repeat the test with a new test device. If the
problem persists, discontinue using the test kit immediately and
contact your local distributor.
Note: The red line in the test line (T) can show different shades
of color. However, even a very weak line
should be judged as a positive result during the specified
observation period, regardless of the color of the
line
Specimen:
COVID-19(SARS-CoV-2) IgM Test can be performed used on Whole Blood/
Serum/ Plasma.
Testing should be performed immediately after specimen collection.
Use only clear non-hemolyzed specimens.
