Principle
This kit uses immunochromatography for detection. The test strip consists of: 1) a burgundy colored conjugate pad containing mouse anti-novel coronavirus nucleoprotein monoclonal antibody conjugated with colloidal gold , 2) a n itrocellulose membrane strip containing one test lines (T lines) and a control line (C line) . The T line is pre-coated with antibodies for the detection of novel coronavirus nucleoprotein, and the C line is pre-coated with a control line antibody.
| Product name | COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit |
| Brand Name | GOLDEN TIME |
| Methodology | Colloidal gold |
| Specimen | Nasal swab,oropharyngeal swab or nasopharyngeal swab |
| Clinical sensitivity | 96.330% |
| Clinical specificity | 99.569% |
| Overall agreement | 98.79% |
| Packing | 1/5/20 tests/carton ,According to customer requirements. |
| Reading time | 10 mins |
| Service support | OEM/ODM |
Features
Easier: No special equipment needed; Easy to use; Intuitive visual interpretation.
Rapid: Results in 10 minutes.
Accurate: Results were validated by PCR and Clinical diagnosis.
Diversity: Works with oropharyngeal swab, nasal swab and nasopharyngeal swab.
Components
1.Individually sealed foil pouches containing:
a. One device
1) Novel coronavirus monoclonal antibody and rabbit IgG antibody for Recombined pad
2) Novel coronavirus monoclonal antibody for T line
3) Goat-anti-rabbit IgG antibody for C line
b. One desiccant
1)Sample Tubes (20) : Sample buffer（0.3ml/bottle)
2)Nasopharyngeal Swabs (20)
3) Quick Reference Instructions (1)
Storage and Stability
Store at 2℃~ 30℃ in a dry place and avoid direct sunlight. Do not freeze. It is valid for 24 months from date of manufacturing.
After the aluminum foil bag is unsealed, the test card should be used as soon as possible within one hour.
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