SARS-CoV-2 Antigen Self Test Kit Colloidal Gold 5 Tests/Kit CE for Nasal Swab
Summary
COVID-19 is an acute respiratory infectious disease caused by the novel coronavirus SARS-CoV-2. Humans are generally susceptible to it. At present, patients infected with the new coronavirus are the main source of infection; asymptomatic infections may also be the source of infection. Symptoms include fever, fatigue, loss of smell and/or taste, and dry cough. In some cases, symptoms may include a stuffy or runny nose, sore throat, muscle aches, and diarrhea.
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 |
Performance data
For the anterior nasal swab method, 645 specimens were collected.
Vitassay qPCR SARS-CoV-2 | Total | |||
Positive | Negative | |||
SARS-CoV-2 Antigen Rapid Test kit | Positive | 238 | 0 | 238 |
Negative | 7 | 400 | 407 | |
Total | 245 | 400 | 645 |
Statistic | Value | 95% CI |
Sensitivity | 97.14% | 94.20% to 98.84% |
Specificity | 99.99% | 99.08% to 100% |
Total coincidence rate | 98.91% | 97.78% to 99.56% |
Antigen Self Test Kit Test Procedure
1. Blow your nose. Wash or sanitize hands. Tear open the foil bag, remove the test box and place it in front of you.
2. Remove the cap of the extraction buffer tube and press into the perforated hole at the top of the package to use as a tube holder.
3. Remove the cotton swab. Do not touch the sterile tip of the swab. Instead, hold the handle of the cotton swab. Insert the swab approximately 2.5 cm deep into the nostril until resistance is felt.
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. Put 3 drops into the sample hole (S) on the test card.
9. 15-20 minutes to interpret the test results. Results after 20 minutes are invalid.
Interpretation of test results
Check that the wire is visible at the control wire (C). The color thickness of the control line (C) does not matter. If it is not visible, the test was not executed correctly and a new test must be executed with the new test set.
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.