Intended Use
SARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography) is to be used in conjunction with clinical manifestations and other laboratory test results to assist in the diagnosis of patients with suspected SARS-CoV-2 infection. The test
is only to be used by medical professionals. It provides only an initial screening test result and more specific alternative diagnosis methods should be performed in order to obtain the confirmation of SARS-CoV-2 infection. for professional use only.
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.
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Main Contents
Components provided are listed in the table.
| Component/REF |
XGKY-002 |
XGKY-002-5 |
XGKY-002-25 |
| Test Cassette |
1 test |
5 tests |
25 tests |
| Disposable paper cups |
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
1. Open the container. Make a “Kruuua” noise from the throat to clear the saliva from deep throat, then spit saliva (about 2 ml) into the container. Avoid any
saliva contamination of the outer surface of the container.
2. Optimal timing of specimen collection：After getting up and before brushing teeth, eating or drinking.
15 mins later, read the results visually. (Note: do NOT read the results after 20 mins!)
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 Saliva Antigen Rapid Detection kit (Latex Chromatography) |
XGKY-002 |
1test/kit |
Saliva |
18 Months |
2-30℃ / 36-86℉ |
| XGKY-002-5 |
5 tests/kit |
| XGKY-002-25 |
25 tests/kit |