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Rapid Antigen Test Kit Antigen Saliva Detection CoV-19 Antigen Saliva Rapid Test 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.
The test 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.
To be attention the 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
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)
Advantage
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
Main Components
20 Test Cassettes
20 Saliva Collectors With Collection Tubes
20 Sample Extraction Buffer
1 Tube stand
1 Instruction for use
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.
Application
Center for disease control and prevention
Primary health care institution
School
Prison / Detention Center / Drug Rehabilitation Center
Government Department / Public Institution / State-Owned Enterprise / Large Company
Industrial Production Enterprise
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 Details
Bronze Gleitlager
,
Bronze Sleeve Bushings
and
Graphite Plugged Bushings
from Quality China Factory
Business Type:
Manufacturer
Year Established:
2001
Total Annual:
10000000-50000000
Employee Number:
100~600
Ecer Certification:
Active Member
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 reagent... 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 reagent...