Product Details
Rapid Test Kit Antigen Saliva Rapid Test Kit 20 Tests Kit High
Accuracy For Professional Test Use
Intend Use
This rapid test kit is intended for the 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, but it cannot be used as
diagnosis basis of SARS-CoV-2 infection. 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. 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-401603 |
Specificity | 99.00% |
Sensitivity | 94.29% |
Type | 20 Tests / Kit |
Sample Type | Saliva |
Warranty | 24 Months |
Quality Certification | CE, MSDS |
Safty Standard | ISO13485, ISO9001 |
Sample volume | 3 Full drops |
Test Speed | <15 minutes |
Product Feature
- Fast results as soon as 10-15 minutes
- Facilitates patient treatment decisions quickly
- Simple, time-saving procedure
- Little specimens, only few saliva sample
- All necessary reagents provided & no equipment needed
- High sensitivity and specificity
Advantage
- Accurate: the product has a high accurate, specificity and
sensitivity
- Easy to administer and read results: no need for instrument or
other equipment during the test
- Fast detection: the result appears in 15 minutes, can be used for
testing on a massive scale.
- No specific storage requirement: room temperature (2-30ºC)
Main Components
- Test Cassettes
- Saliva Collectors With Collection Tubes
- Sample Extraction Buffer
- Tube stand
- Package Insert
Notic
- 30 minutes before sampling, please do not eat, smoke, drinking
alcohol or drinks.
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. | |
FAQ
- What about the order payment methods and delivery time?
30~70% T/T advance, balance before delivery, D/A, D/P, etc.
Delivery time usually 3-10 days after receiving the deposit.
- Can you do the ODM OR OEM?
Yes, as a manufacturer, we can accept OEM/ODM
- Will you help me register the products in my country ?
Sure, we will provide all you documents and samples you need for
register.
- How to deal with the products regarding the quality and quantity?
LABNOVATION TECHNOLOGIES,INC is a professional supplier for the
medical products for many years and we have stric QC departement.
- Can i have a phone call directly with your sales if some urgent
questions?
Yes, of course, that is wonderful to save the time and catch the
key point easily. If you have any questions, you can call us or
send us by email.
Certificate
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.