ODM All People Saliva Self Test Kit SARS-CoV-2 RTK Antigen Home Test Kit
Rapid Test Kit SARS-CoV-2 Antigen Saliva Rapid Test Kit 1 Test For Self Testing Protable Rapid Antigen Test Kit
Intend Use
This rapid test kit is intended for the qualitative detection of SARS-CoV-2 antigen in human saliva sample from novel coronavirus suspected person with symptoms within 9 days from onset. The test result can be used for early detection and triage of people suspected of being infected.
Product Details
| Item | Value |
| Name | SARS-CoV-2 Antigen Saliva Rapid Test Kit (Self Test) |
| Model Number | LX-401602 |
| Type | 1 Test |
| Warranty | 18 Months |
| Power Source | Instruction Manual |
| Quality Certification | CE |
| Safty Standard | ISO13485 |
| Sample Type | Saliva |
| Sample volume | 3 Full drops |
| Test Speed | Within 15 minutes |
| Total Accuracy | Over 95% |
Product Feature
- Protable and convenient
- High Accuracy, Sensitivity and Specificity
- Excellent Performance, Strong test line and control line
- Easy for use, sample collected is very easy
Main Components
- 1 Test Cassette
- 1 Saliva Collectors With Collection Tube
- 1 Sample Extraction Buffer
- 1 Package Insert
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.
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. |
Precaution
- For IN VITRO diagnostic use only.
- Waste should be treated in accordance with infectious substances and should be discarded properly.
- The extraction reagent contains preservative agent which may be toxic if ingested. When disposed of through a sink, flush with a large volume of water.
- Do not use samples that have been placed for longer than one hour or contaminated.
- If the saliva is not well mixed in the sample extraction tube, false negative results may occur.
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