- Pack Size
- 50 Tests per kit
- Expected Usage
This kit is used to qualitatively detect 2019-nCov IgM/IgG antibody in human serum & plasma sample in vitro. It only can be used as a supplementary testing of 2019-nCov in suspected cases. It can’t be used to make a definite diagnosis of 2019-nCov disease, still needs to work together with nucleic acid testing.
Product is for medical organization use only.
Positive result still needs further testing, negative result can’t exclude the possibility of infection.
This kit can’t be used as a routine clinical diagnostic reagent. The testing result is only for clinical diagnosis reference.
For safety reasons, the laboratory that performs the testing must have a relevant qualification.
- Principle of Detection
- The product was detected by solid phase immunochromatography using capture method. The test sample (blood/plasma) diffuses upward by capillary force, when passes through the marker pad, the 2019-nCov IgM/IgG antibody will react with the 2019-nCoV antigen colloidal gold complex. The new formed colloidal gold labeled antigen-IgM complex and colloidal gold labeled antigen IgG complex will diffuse onto the nitrocellulose membrane together with sample, then react with the mouse anti-human IgM antibody which is coated on the T1 line (detection line), then T1 line turns red. The non-react colloidal gold immune complex continues to move up and is blocked by T2 line (detection line) which coated with the mouse anti-human IgG antibody, then T2 line turns red. Finally, the remaining un-intercepted colloidal gold conjugates continued to move up and combine with the C line (quality control line), indicating that the whole process is finished.
- Product Components
Foil bag, Desiccant, Test Strip and plastic card.
1.0mg/ml mouse anti-human IgM antibody coated on T1 line
1.0mg/ml mouse anti-human IgG antibody coated on T2 line
1.0mg/ml internal reference protein C coated on C-line (qc line)
The marker pad contain 40 OD recombinant 2019-nCov antigen- Colloidal Gold complex
HEPES buffer containing Casein(0.1M), 5mL/bottle
50 pieces per kit
P.S: You can’t mix components from different batches.
6 months at 4-30℃.
After the reagent card is opened (temperature 4-30℃, humidity less than 65%), the period of validity is 1h.The diluent is valid for 28 days after being opened.