SARS-CoV-2 Antigen Saliva Rapid Test Kit Saliva Sample Virus
Antigen Rapid Diagnostic Single Packing Self Testing Use
Intend Use
The SARS-CoV-2 Antigen Saliva Rapid Test Kit is used to
qualitatively detect SARS-CoV-2 antigen in saliva samples of
suspected patients with new coronavirus. The positive result of the
antigen test can be used for early classification and rapid
management of suspected populations.
Product Details
Item | Value |
Name | SARS-CoV-2 Antigen Saliva Rapid Test Kit (Self Test) |
Warranty | 24 Months |
Safty Standard | ISO13485 |
Sample Type | Saliva specimen |
Sample volume | 3 Full drops |
Test Speed | Within 15 minutes |
Product Feature
- Quick Test: get the result in 15 minutes
- High Accuracy, sensitivity and specificity
- Simple to use
- Accurate and reliable
- Store at room temperature
Diagnostic Accuracy
SARS-CoV-2 Antigen Saliva Rapid Test Kit |
Sensitivity | Specificity | Total ACCURACY |
96.19% | 100.00% | 99.21% |
Main Components
- Test Cassette
- Saliva Collector
- Disposable Pipettes
- Sample Extraction Buffer (single dose)
- Instruction Insert
Use Step
- Take sample tube with prefilled sample extraction buffer and remove
the sealed film of the sample tube. Then put the tube into tube
stand (in the outer box).
- Open the tear hole of the aluminum foil bag, take out the
disposable pipette and test cassette, lay them flat.
- Put the saliva collection bag to lips and let
the saliva flow into the bag.
Place the tip of tongue against the upper or lower tooth root to
enrich saliva, and then swallow saliva to the throat without
ingesting saliva to esophagus, followed by returning saliva to the
mouth. Repeat the process for 5 times.
- Draw 2/3 dropper range(300ul)of saliva from saliva collection bag
with the help of pipette and transfer the entire contents into the
extraction buffer of the sample tube. And blow the liquid for 10
times, squeeze bottom of the sample tube to ensure the saliva is
thoroughly mixed.
- Close the cap of the sample tube.
Shake the specimen collection tube at least three times vigorously
to mix the saliva sample with extraction buffer. Attention: Please
avoid bubbles! - Add 3 full drops of the treated sample extraction buffer (about
70μL-100μL) vertically into the sample well of the test cassette.
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).
INVALID: No colored lines appear, or control line fails to appear,
indicating that the operator error or reagent failure.
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. | Omicron |
Other Information
- Not following the exact instructions can affect the outcome of the
test. The final diagnosis must be confirmed by a physician.
- Do not use the test if the packaging is damaged. Do not use broken
test components.
- All test components are only intended to be used for this test. Do
not reuse the test or test components.
- The test should be carried out immediately or within one hour after
opening the foil pouch (18-30°C, humidity <60%).
- Samples be processed as soon as possible after sample collection.
If the test cannot be performed immediately, the sample should be
stored in a sealed state, stored at 2~8°C for 8 hours. Long-term
storage is not recommended.