ISO Cov-19 Portable Antigen Rapid Test Device Saliva Test Kit Approved By KKM
Rapid Test Kit Cov-19 Antigen Saliva Rapid Test Kit High Specificity 1 Test Professional Antigen Saliva Rapid Test Kit
Intend Use
SARS-CoV-2 antigen saliva rapid test kit is intended for detection SARS-CoV-2 antigen in human saliva sample. The test kit is an qualitative detection rapid test kit for professional use. About the test result, the positive result can be used forearly triage and rapid management of suspected populations, further nucleic acid detection should be carried out for suspected population whose antigen test result is positive or negative.
Product Details
| Item | Value |
| Name | SARS-CoV-2 Antigen Saliva Rapid Test Kit |
| Model Number | LX-401601 |
| Type | 1 Tests/Kit |
| Warranty | 18 Months |
| Quality Certification | CE, MSDS |
| Safty Standard | ISO13485 |
| Sample Type | Saliva |
| Sample volume | 3 Full drops |
| Test Speed | Within 10-15 minutes |
| Specificity | 99.00% |
| Sensitivity | 94.29% |
| Total Accuracy | >95% |
Product Advantage
- Short test time, read the result within 10-15 mins
- Excellent performance, Strong Test line and Control line
- Lower cost with high effciency
- Reliable safety without extra instument
- More comfortable, convenience and protable
Main Components
- 1 Test Cassettes
- 1 Saliva Collectors With Collection Tubes
- 1 Sample Extraction Buffer
- 1 Instruction Manual
Use Step
- Open the cap of the collection tube and istall saliva collector.
- Put the collection tube with saliva collector close to lips and let the saliva flow into the collection tube. Tje volum of saliva needs to be half of 0.5 scal mark(0.25).
- Screw the sample extraction buffer carefully.
- Add all sample extration buffer to the collection tube. Discard the saliva collector, tighten the cap onto the specimen collection tube.
- Shake the specimen collection tube at least three time vigorously to mix the saliva and the extraction buffer. Squeeze bottom of the collection tube ensure the saliva is thoroughly mixed.
- Add 3 full drops of the solution to the sample well(S). Read the result at 15 minutes. Do not interpret the result after 20 minutes.
Result Interpretation
-
POSITIVE: Two (2) distinct colored lines appear. One line should be in the control region (C) and the other line should be in the test region (T).
-
NEGATIVE: One (1) colored line appears in the control region(C). No apparent colored line appears in the test region (T). The negative result does not indicate the absence of analytes in the sample, it only indicates the level of tested analytes in the sample is less than the minimum detection limit.
-
INVALID: No colored lines appear, or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.
Principle
- This kit is an immunochromatography assay. According to the gold immunochromatographic test principle, double antibody sandwich method was used to detect SARS-CoV-2 nucleocapsid antigen in the samples. If there is antigen in the sample, complex can be formed at the detection line, and red band is shown, indicating negative result. If there is no antigen in the sample, complex cannot be formed at the detection line, and no red band is shown, indicating negative result.
- Whether the sample contains antigen or not, the gold monoclonal antibody will bind to the enveloped antibody at the quality control line, form a compound and condense into a red band.
Application
- Center for Disease Control and Prevention
- Primary Health Care Institution
- School
- Prison / Detention Center etc.
Virus Sources
| Global high frequency mutation | Alpha / B.1.1.7(U.K.) | Beta I B.1.351(South Africa) |
| Gemma I P.1(Brazil) | Kappa I B.1.617.1(India) | Delta I B.1.617.2(India) |
| C.37,ect | Alpha I B.1.17(U.K.) | B.1.36.16.etc |
| A.2.5,etc | A.23.1 | Alpha I B.1.17(U.K.) |
| B.1.1.33.etc | C.1.1.etc. | etc. |
Stroage And Expiry
Store as packaged in the sealed pouch at 2-30℃, avoid heat and sunshine, dry place, valid for 24 months. Do not freeze. Do not open the inner packaging until ready, it must be used within one hour if opened (Humidity≤60%, Temp: 20℃-30℃). Please use immediately when the humidity>60%.
Certificate
FAQ
- MOQ
We have the MOQ limit, which is 10000 pieces.
- Shipment
Air Cargo, Ocean Cargo or by Express
- Payment
Business to Business account
- Contact
Whatsapp, E-mail or Phone.
- Delivery Date
After order confirmed, we will arrange your order immediately,and offer you an estimated delivery date.
OEM Or ODM Accept
Yes, We accept OEM / ODM order.
Get in Touch
Have questions about our products or want to discuss a custom order? Our team is ready to help you.






