Product details
Intended Use
This product is intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens from anterior nasal swabs. It is inteneded as an aid in the diagnosis of cornavirus infection disease (COVID-19) for asymptomatic patients and/or symptomatic patients aged 2 years or older within 7 days after onset of symptoms, which is caused by SARS-CoV-2. For in vitro diagnostic use only. For self-testing use. Accroding to usability study on laymen user, the test can be correctly performed for anyone aged 18 and over. However, entire test procedure from specimen collection and specimen pre-treatment (swab, extraction solution, etc.) to reading of results of children under the age of 18 should be supported or under the supervision by an adult.
Test Principle
It is a lateral flow assay that qualitatively detects the presence of nucleocapsid (N) protein in upper respiratory samples. This lateral flow assay is designed with the Double-antibody sandwich immunoassay format.
Main Contents
Components provided are listed in the table.
| Component / REF |
B002CH-01 |
B002CH-05 |
B002CH-25 |
| Test Cassette |
1 test |
5 tests |
25 tests |
| Swab |
1 piece |
5 pcs |
25 pcs |
| Sample Lysis Solution |
1 tube |
5 tubes |
25 tubes |
| Specimen Transport Bag |
1 piece |
5 pcs |
25 pcs |
| Instructions For Use |
1 piece |
1 piece |
1 piece |
| Certificate of Conformity |
1 piece |
1 piece |
1 piece |
Operation Flow
Result Interpretation
Positive Result
Colored bands appear at both test line (T) and control line (C). It indicates apositive
result for the SARS-CoV-2 antigens in the specimen.
Negative Result
Colored band appear at control line (C) only. It indicates that the concentration of the SARS-CoV-2 antigens does not exist or below the detection limit of the test.
Invalid Result
No visible colored band appears at control line after performing the test. The
directions may not have been followed correctly or the test may have deteriorated. It
is recommended that the specimen be re-tested.
Order Information
| Product Name |
Cat. No |
Size |
Specimen |
Shelf Life |
Trans. & Sto. Temp. |
| SARS-CoV-2 Antigen Rapid Detection kit (Latex Chromatography) For Self-testing |
B002CH-01 |
1test/kit |
Nasal Swab |
18 Months |
2-30℃ / 36-86℉ |
| B002CH-05 |
5 tests/kit |
| B002CH-25 |
25 tests/kit |
