Active Member
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Address: Vanke Tianyu Garden,B2-1010, Unit B, Building 9 Longcheng Street Longgang District Shenzhen, China
Contact name:Zhang
Shenzhen Wensidun Technology Co., Ltd. |
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SARS-CoV-2 Antigen Swab Test Kit 10 Tests/Kit CE for Nasal Swab
COVID-19 Contagiousness
1. Transmission through respiratory droplets and close contact is the main route of transmission.
2. Contact with virus-contaminated items can also cause infection.
3. In a relatively closed environment, it is transmitted by aerosols.
Susceptible Population
The population is generally susceptible. Some immunity can be obtained after infection or after receiving the COVID-19 vaccine, but the duration is not clear.
Materials Provided
| Component | Description | Specification |
| 10 test/kit | ||
| Test cassette | Foil ouched test device containing one reactive strip. | 10 |
| Sterile swab | For sample collection and transfer. | 10 |
| Inside page | Instructions for use. | 1 |
| Extraction buffer | Dissolve the sample | 10 |
| The certificate of conformity | 1 | |
| Packages with holes | Be used as tube stand (optional). | 1 |
Detection Limit
The limit of detection (LOD) for the SARS-CoV-2 Antigen Rapid Test
is 4 x 102 TCID50/mL.
| Matrix | LOD Concentration TCID50/mL | Number of Positive/ Total | %Detected |
A viral sample inactivated by gamma irradiation | 4 x 102TCID50/mL | 20/20 | 100% |
Interference
The following interfering substances have no impact on SARS-CoV-2
Antigen Rapid Test (Colloidal Gold).
| No. | Interfering Substance | Final Test Concentration |
| 1 | Mucin | 0.54% |
| 2 | Menthol | 1.4 mg/mL |
| 3 | Whole Blood | 5% |
| 4 | Triamcinolone acetonide | 1 ng/mL |
| 5 | Tobramycin | 5 μg/mL |
| 6 | Levofloxacin | 1.5 μg/mL |
| 7 | Mupirocin | 12 mg/mL |
| 8 | Oxymetazoline | 9%v/v |
| 9 | Nasal Spary | 16%v/v |
| 10 | Dexamethasone | 0.5 μg/mL |
Hook Effect
No high dose hook effect was observed when tested with up to a concentration of 1.3 x 106 TCID50/mL of heat inactivated SARS-CoV-2 virus.
Warnings And Important Information
1. The test is designed for external use outside human body only. Please do not ingest. Avoid skin and eye contact with the buffer liquid.
2. Failure to follow the instructions may affect the test result. The final diagnosis should be confirmed by a physician.
3. Keep it out of reach of children.
4. Persons with reduced vision or mobility should ask for assistance.
5. Do not use the test if test components are damaged.
6. Use only the materials supplied with this test. Do not reuse the test or test components.
7. The test should be performed immediately, latest one hour after opening the foil pouch (at 20-30°C, humidity<60%).
Positive Test Result
If a colored line is visible in the test line region (T) and a
colored line is visible in the control line region (C), indicating
positive test result. This means that SARS CoV-2 antigens are
detectable in your nasal sample and indicates with high probability
of COVID-19 infection.
Please stay home and call your doctor or local health department.
Follow local self-isolation guidelines and take a PCR confirmation
test.
* Note: Line thickness is irrelevant; any reddish lines in the test
line (T) should be interpreted as a positive test result. Positive
test results must be confirmed by molecular diagnostics such as PCR
testing.
Negative test result
If only colored lines are visible in the area of the control line
(C), but not at the test line (T), the test result is negative.
This suggests that the nasal samples were either absent or too
little of the SARS-CoV-2 antigen and probably not infected with the
SARS-CoV-2 virus.
Continue to follow applicable rules regarding contact with others and applicable protective measures. In case of suspicion, repeat the test using new test kit, as SARS-CoV-2 virus cannot be accurately detected at all stages of infection. A negative result does not rule out infection with SARS CoV-2 and should be confirmed by PCR testing if suspected.
INVALID TEST RESULT
If no line is visible in the control line (C) or only one line is
visible in the test line area (T), indicating the test is not
performed correctly and the result is invalid. It is important to
follow the instructions for the test carefully. Please repeat the
test with new sample and new test set.
If test results remain invalid, please contact a physician or COVID-19 testing center.
Interpretation Of The Test Result
Check whether a line is visible at the control line (C). The color
thickness of the control line (C) is irrelevant. If it is not
visible, the test was not performed correctly and a new test with a
new test set must be performed.
Storage and disposal
Store at room temperature (2-30°C or 35.6-86 T).
Shelf life 12 months (from production date to expiration date).
Test cassettes must be stored in airtight foil pouches until use.
Do not use after expiration date.
Waste from used tests should be disposed of according to local
regulations.
Q1: When will it be shipped?
A1: We will ship the goods for you as soon as possible within 7
working days after receiving the payment. (In the event of the
epidemic and other external factors, there may be delays in
shipping)
Q2: Does it support OEM/ODM?
A2: It can be supported, but the specific quantity needs to be more
than 100,000 pieces to facilitate customized products.
Q3: How is your factory doing in terms of quality control?
A3: We have ISO9001 and ISO13485 certified by the state. Our
production process is in accordance with the standard process,
which can ensure that the quality of the products is optimal.
Q4: How is after-sales service provided?
A4: We provide professional online technical after-sales service.
We can provide you with one-on-one guidance in the form of video,
phone calls, etc.
Q5: What is the payment method?
A5: We receive payment by T/T.
Q6: How to ship?
A6: By obtaining quotations from our many cooperative carriers,
choose the best way to ship for you, or you can ship according to
your requirements.
