Overview and Specifications:
Commodity Quality Certification : GS
Model Number : 2019-nCoV
Size : –
Material : ABS
Novel Coronavirus (2019-nCoV) Antibody Detection Kit is simple operation and high detection accuracy. You can do it at home.
[ Detection principle]
This kit adopts the principle of immunochromatography to detect novel coronavirus (2019-ncov) antibodies in human serum, plasma and venous whole blood by capture method When the sample contains antibodies to the novel coronavirus (2019-ncov) at concentrations higher than or equal to the minimum detection limit, the antibody binds to the antigen marker and the detected area(T) secondary antibody (anti-stranded antibody/anti-human IgG antibody) was captured to form a red reaction line, and the result was judged as positive; Otherwise, no band results were negative. Under the normal test circumstances, the quality control area (C shall be colored to indicate that the test is valid.
[ Storage conditions and expiry date]
Store at 2℃ ~30℃, valid for 6 months temporarily.
After the foil bag is opened, the test card should be used within 1 hour as soon as possible. The sample diluent should be covered immediately after being opened and kept in a cool place.
Please use it within the validity period Production date: see product labe Expiry date: see product label.
[ Inspection method]
Please read the instructions carefully before testing. Samples to be tested, test reagents andother test materials shall be balanced to room temperature, and the test shall be conducted at room temperature.
1. Open the tear mouth of the aluminum foil bag, take out the test card and lay it flat.
2. Add 10 L of serum/plasma/whole blood sample to the sample hole (orifice) of the test card, and then add about 80 L to the diluent sample hole (macropore) of the test card2 ~3 drops) sample diluent
3. The results show after 15 minutes of observation, while the results show after 20 minutes which had no clinical significance.
[ Interpretation of test results]
Invalid: when there is no red line in the quality control area (C), the test is invalid. It is recommended to re-test with a new test card at this time, especially paying attention to whether the sample quantity is enough;
Positive: two red lines, that is, one red line appears in each test area (T) and quality control area (C).
Negative: one red line, that is, only one red reaction line appears in the quality control area (C)．
[Clinical performance]: in guangzhou eighth people's hospital, guangdong second people's hospital, jiangmen wuyi hospital of traditional Chinese medicine, nanchang third hospital, xinyu people's hospital, clinical trials were conducted in six institutions at the wuhan Asian heart hospital. In vitro diagnostic reagent and clinical diagnostic criteria of novel coronavirus pneumonia were used to compare and verify the clinical performance of this product. There were 596 suspected cases of novel coronavirus infection, of which 361 were confirmed, 235 cases were excluded. In vitro diagnostic reagent was compared with the clinical diagnostic criteria of the new coronavirus pneumonia. The clinical sensitivity was 86.43% (95% CI :82.51%, 89.58%) and specificity was 99.57% (95% CI :97.63%, 99.92%). In addition, 172 patients were selected the homologous serum/plasma and whole blood samples (including 91 positive cases and 81 negative cases) were compared. The results showed the results of serum/plasma test as a reference, the positive coincidence rate of the whole blood test results was 93.41% (95% Cl:86.35% ~96.94%), and the negative coincidence rate was 100.00% (95%C: 95.47%~100%) . total agreement rate: 96.51% (95% Cl: 92.60% ~ 98.39%), After preliminary evaluation, it was basically confirmed that the clinical performance of the product could meet the urgent need of the epidemic situation.
[Package] Test card x 3, Sample diluent x 1 ( Not included blood needle )