Product Details
Rapid Test Kit COVID-19 Antigen Saliva Rapid Test Kit 1 Test Self
Testing Simple Operation High Accuracy Easy Use Test Kit
Intend Use
SARS-CoV-2 antigen saliva rapid test kit is intended for the
qualitative detection of SARS-CoV-2 antigen in human saliva sample
from novel coronavirus suspected person with symptoms within 9 days
from onset. The test result can be used for early detection and
triage of people suspected of being infected.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 (Self Test) |
Model Number | LX-401602 |
Type | 1 Test / Box |
Warranty | 18 Months |
Quality Certification | CE |
Safty Standard | ISO13485 |
Sample Type | Saliva |
Sample volume | 3 Full drops |
Test Speed | Within 10-15 minutes |
Total Accuracy | Over 95% |
Sensitivity | 94.29% |
Specificity | 99.00% |
Product Feature
- Non-invasive
- Simple to use
- Self Testing, not need extra instrument
- Saliva Sample, more comfortable than others
Advantage
- Can be used in a wide variety of non-laboratory settings
- Test results in 15 minutes
- Stable, with high accuracy
- Safety and reliable, high accuracy, specificity and sensitivity
Main Components
- 1 Test Cassette
- 1 Saliva Collectors With Collection Tube
- 1 Sample Extraction Buffer
- 1 Instruction Manual
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. | |
Precaution
- For IN VITRO diagnostic use only.
- Waste should be treated in accordance with infectious substances
and should be discarded properly.
- This kit is a qualitative detection, which cannot determine the
exact content of antigen
- The extraction reagent contains preservative agent which may be
toxic if ingested. When disposed of through a sink, flush with a
large volume of water.
- False negative results may be caused by unreasonable sample
collection, transport and treatment, and low viral load in samples.
- The kit is a disposable rapid test kit, which is only used for the
detection of human saliva samples. The operation should be carried
out strictly according to the instructions. Do not use expired or
damaged products.
FAQ
- Manufacturer or Trade Company?
We' re manufacturer, we have our own factoty. Dust-free workshops
with advanced machines and professional workers.
- Register your products in our country?
Yes welcome. We can offer full files for you to register.
It depends on the specification of the products. For big orders, we
can produce 100k-250k per day.
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.