Product Details
SARS-CoV-2 Antigen Saliva Rapid Test Kit Antigen Saliva Rapid
Diagnostic Test Self Test Antigen Rapid Test Kit
Intend Use
The Labnovation SARS-CoV-2 antigen saliva rapid test kit is
intended for the qualitative detection of SARS-CoV-2 infection.
Product Details
Item | Value |
Name | SARS-CoV-2 Antigen Saliva Rapid Test Kit |
Warranty | 24 Months |
Sample Type | Saliva Sample |
Sample volume | 3 Full drops |
Test Time | Within 15 minutes |
Store temperature | Store 2-30 ℃ |
Product Feature
- No pre-processing required, simple operation, do not need any extra
instrument
- Rapid test, easy to interpert the result within 15 minutes.
- The effective supplement of antigen test window period.
- Transported and stored at room temperature
Diagnostic Accuracy
- Sensitivity: 96.19%
- Specificity: 100.00%
- Total Accuracy: 99.21%
Main Components
- Saliva Collector
- Disposable Pipettes
- Sample Extraction Buffer (single dose)
- Instruction Insert
- Test Cassette
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 |
Application
- People with symtoms in the early stage
- Regular screening
- Hospital / Clinic
- Office
- High-risk congregate
- School
Other Infromation
- This kit is a qualitative detection, which cannot determine the
exact content of antigen.
- 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%).
Company Profile
Labnovation Technologies, Inc. is an original manufacturer
established in Shenzhen, China since 2001. We are dedicated in
developing and manufacturing IVD instruments and reagents including
HbA1c analyzer and reagents, rapid test reader & reagents,
hematology reagents, clinical chemistry reagents, electrolyte
reagents, wash solution and urine test reagents.
Labnovation products are developed in house, tested extensively in
clinics and passed strict quality controls. All of our products are
CE marked and approved by SFDA. In the past 15 years, our products
have been exported to 110 different countries and used in 8000
hospitals worldwide. We provide both ready-to-use final products
and bulk OEM reagents, including ready-to-use reagents,
concentrated, and powder.
With an investment of 10% of our annual sales into R&D, we
release new products every years. We win more and more domestic and international cooperation by
company reputation and products quality while we actively take part
in fairs like MEDICA,AACC, ARBA HEALTH and so on through which we
are well-known by the companies in this field.