Introduction
To help stop the spread of Coronavirus, Singclean Medical has developed two kinds of COVID-19 Antigen Test Kits, nasopharyngeal swab and saliva swab.
Intended Use
Singclean COVID-19 Antigen Test kit (Colloidal Gold) is a solid phase immunochromatographic assay for the rapid, qualitative detection of antigen to 2019 Novel Coronavirus in human saliva. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 Antigen Test kit (Colloidal Gold) must be confirmed with alternative testing method (s) and clinical findings.
Main Symptoms of COVID-19
Fever, fatigue, cough, shortness of breath
Features
•Quick: Results ready in 15 minutes, help with the global shortage of swabs and PPE
•Non-invasive: More comfortable than COVID-19 nasopharyngeal swab
•Safe: Will not require health care workers to be put at risk. Sampling can be done by patients
•Accurate: With a high level of accuracy that’s comparable to nasopharyngeal swab testing
Product Information
Product Name | Singclean COVID-19 Antigen Test Kit |
Test Principle | Colloidal Gold Method |
Sample Type | Saliva Swab |
Sample Volume | 3 Drops of Extracted Solution (100µl) |
Qualitative/Quantitative | Qualitative |
Test Time | 15 mins |
Operation Temperature | 15-30°C |
Storage Temperature | 4-30°C |
Shelf Life (Unopened) | 24 months |
Specification
1 test/box
20 tests/box
50 tests/box
100 tests/box
Materials Supplied
Test Cassette
Cotton Swab
Antigen Extraction Buffer
Antigen Extraction Tube
Paper Workbench
Instruction for Use
Material Required but Not Provided
Timer
Storage and Stability
The kit can be stored at room temperature or refrigerated (4-30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use.
DO NOT FREEZE.
Do not use beyond the expiration date.
After opening the sealed pouch, use the test as soon as possible within 60 minutes.
Test Procedures
1.DO NOT eat, drink, smoke, brush teeth for 30 minutes before collecting saliva. Remove the swab package, keep the sponge tip on the tongue until the tip being fully soaking by saliva (at least two minutes).
2. Place the antigen extraction tube on the workbench. Insert the swab into the extraction tube pre-added with 12 drops of extraction buffer.
3. Rotate the swab about 10 times while pressing the swab head against the tube wall to release the antigen.
4. Leave the swab in the extraction tube for 1 minute.
5. Remove the swab while squeezing the tip of the swab so that as much liquid in the swab can be discharged as possible.
6. Press the dropper tip tightly onto the tube and let it stand for about 1 minute.
7. Apply 3 drops of extracted solution (about 100µl) to each of the specimen well of the test device.
8. Read the test result in 15 minutes.
Result Interpretation
Positive:
lf both control line (C) and test line (T) appear, the result indicates the presence of COVID-19 antigen in the specimen. The result is COVID-19 positive.
Negative:
lf only control line(C)appears, the result indicates that no COVID-19 antigens are detected in the specimen. The result is COVID-19 negative.
Invalid:
Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
Limitations:
1. Use fresh samples whenever possible.
2. Optimal assay performance requires strictly adherence to the assay procedure described in Instruction for use. Deviations may lead to aberrant results.
3. A positive result does not rule out bacterial infection or co-infection with other viruses.
4. A negative result for an individual subject indicates absence of detectable COVID-19 antigen. However, a negative test result does not preclude the possibility of exposure to or infection with COVID-19.
5. A negative result can occur if the quantity of the COVID-19 antigen present in the specimen is below the detection limits of the assay, or failed to collect the COVID-19 antigen in the saliva of the patient.
6. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
