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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Covid 19 Ag Nasal Swab Test Kit Colloidal Gold 5 Tests / Kit CE
Intended Use
The SARS-CoV-2 Antigen Rapid Test(Colloidal Gold) is an
immunochromatographic test for the rapid qualitative detection of
SARS-CoV-2 nucleocapsid protein antigens in human nasal swabs. It
is intended to be used as a self-test during the acute phase of
infection in cases of suspected COVID-19. The SARS-CoV-2 Antigen
Rapid Test cannot be used as a basis for diagnosis or exclusion of
SARS-CoV-2 infection. Children under 18 years of age must be
supervised by adults when performing the test.
Materials Provided
| Component | Description | Specification |
| 5 test/kit | ||
| Test cassette | Foil ouched test device containing one reactive strip. | 5 |
| Sterile swab | For sample collection and transfer. | 5 |
| Inside page | Instructions for use. | 1 |
| Extraction buffer | Dissolve the sample | 5 |
| The certificate of conformity | 1 | |
| Packages with holes | Be used as tube stand (optional). | 1 |
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 |
Test Procedure
1. Blow your nose. Wash or disinfect your hands. Remove the test
cassette by tearing open the foil pouch and place it in front of
you.
2. Tear off the seal of extraction buffer tube, Press in the
perforated hole on the top of the packaging and use the hole as a
tube stand.
3. Remove the swab. Do not touch the sterile tip of the swab.
Instead, grasp the swab by the handle. Insert the swab about 2.5 cm
deep into your nostril until you feel resistance.
4. Collect sample from left and right nostrils with the same swab:
Rub the swab against the inner wall of the nose and turn it at
least 5 times to ensure sufficient sample is collected. Repeat the
process in the other nostril.
Note: Children under 15 years of age (at least 2 years old), and
people including the elderly and sick who are unable to perform the
test themselves should be tested by another adult. To sample a
child, insert a cotton swab into one of their nostrils until you
feel some resistance (about 2 cm). Rotate the swab against the
nasal wall 5 times. Repeat the sampling process by removing the
swab and inserting the same swab into the other nostril. If the
child feels any pain, do not continue the test.
5. Dip a cotton swab into the tube and make sure it is well mixed
with the extract by stirring and dipping up and down at least 5
times. Let the cotton swab soak for a minute.
6. Slowly pull the swab out of the tube while gently squeezing the
sides of the tube to retain as much liquid in the tube as possible.
7. Place the dropper tip firmly on the extraction buffer tube and
mix the liquid thoroughly.
8. Drop 3 drops into the sample well (S) on the test card.
9. Interpret the test result between 15-20 minutes. The result
after 20 minutes is invalid.
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).
12 months of shelf life (production date to expiration date).
The test cassettes must be stored in the sealed foil pouch before
use. Do not use after the expiration date.
Waste from used tests should be disposed according to the 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.
