Rapid Antigen Test COVID-19 Antigen Saliva Rapid Test Kit Single
Packing Self Testing Kit
Intended Use
- Qualitative detection of SARS-CoV-2 antigen in human saliva samples
from novel coronavirus suspected person with symptoms within 9 days
from onset.
- Positive result of the antigen test can be used for early triage
and rapid management of suspected populations.
- Negative results do not rule out SARS-CoV-2 infection and should
not be used as the sole basis for treatment or patient management
decisions.
- Nucleic acid detection should be carried out for suspected
population whose antigen test result is positive or negative.
Product Details
Item | Value |
Brand | Labnovation |
Name | SARS-CoV-2 Antigen Saliva Rapid Test Kit |
Package | 1 Test /Box |
Warranty | 24 Months |
Safty Standard | ISO13485, ISO9001 |
Specimen Type | Saliva |
Sample volume | 3 Full drops |
Test Speed | Within 15 minutes |
Use | For Self-test At Home |
Sensitivity | 94.29% |
Specificity | 99.00% |
Product Feature
- One-step Operation without extra step
- Individual Package, easy to carry
- Saliva specimen, easy to collect
- Unique design, simple and convenient
Test 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.
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. | Others |
PRECAUTION
- Waste should be treated in accordance with infectious substances
and should be discarded properly.
- If the saliva is not well mixed in the sample extraction tube,
false negative results may occur.
- Keep away from children. Any child under age 13 shouldn’t perform
the test without parental guidance, or professional aid.
- The test cassette should be used as soon as possible after removal
from aluminum foil bags. Avoid exposure to air for too long and
affecting test results due to dampness.