SARS-CoV-2 Antigen Self Test Kit 1 5 10 25 Tests/Kit CE For Nasal Swab

SARS-CoV-2 Antigen Self Test Kit 1 5 10 25 Tests/Kit CE for Nasal Swab

Issued Date: 2022-04-08

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.

Summary

COVID-19 is an acute respiratory infectious disease caused by the novel coronavirus SARS-CoV-2. Humans are generally susceptible to it. Currently, patients infected with the novel coronavirus are the main source of infection; asymptomatically infected people may also be a 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 may occur.

Materials Provided

To perform the test correctly everytime should require the Clock or timer, however we don’t provide the clock or timer originally.

Performance data

For the anterior nasal swab method, 645 specimens were collected.

Detection Limit

The limit of detection (LOD) for the SARS-CoV-2 Antigen Rapid Test is 4 x 102 TCID50/mL.

Cross Reactivity and Microbial Interference

The cross-reactivity with the following microorganisms was examined. Samples that tested positive for the following microorganisms were negative when tested with the SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). The microbial interference study evaluated whether microorganisms possibly contained in clinical samples interfere with the detection capability of the kit which may lead to false negative results. Each microorganism was tested in the presence of a fabricated SARS-CoV-2 positive sample. No cross-reactivity or interference with the microorganisms listed in the table below was found.

Interference

The following interfering substances have no impact on SARS-CoV-2 Antigen Rapid Test (Colloidal Gold).

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%).

Preparation

Read the instructions for use carefully before performing the test. Blow your nose and then wash your hands thoroughly with soap or disinfect them with disinfectant. Keep the test cassette and components at room temperature (15°C to 30°C) before performing the test. Place all the materials supplied on a clean, dry and flat surface.

Sampling In The Nose

Please follow the instructions on the next page step by step for sampling test.

Antigen Self Test Kit 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.

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 physician or local health department. Follow local guidelines for self isolation and have a PCR confirmatory test performed.
*Note: The thickness of the line is irrelevant; any reddish line in the test line (T) should be interpreted as a positive test result. A positive test result must be confirmed by molecular diagnostics (e.g. PCR test).

Negative Test Result

If only a colored line is visible in the area of the control line (C), but not at the test line (T), the test result is negative. This indicates that no or too few SARS-CoV-2 antigens are present in the nasal sample and that there is probably no infection 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.

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.

Shenzhen Wensidun Technology Co., Ltd. was established in 2018 and is located in Longgang District, Shenzhen, Guangdong Province, China. We have in-depth cooperation with Green Spring, which has 20 years of production and R&D experience.

We have more than 2000 square meters of GMP clean production workshop and more than 1000 square meters of R&D center in Shenzhen. Products cover over 100 varieties of food safety test kits, animal diseases diagnostic kits, in vitro diagnostic reagents, genetic antibody antigen preparation and form a complete set of testing instrument.Currently,our food safety test kit and animal disease diagnostic kit are widely used in many governments,enterprises and research institutes.Our products are sold to more than 40 countries and areas.

We have ISO9001, ISO13485 quality management system certification, GMP certificate. SARS-CoV-2 Antigen Rapid Test Kit has been awarded CE certification, German BfArM approved self-test and professional test, PEI certification, EU general and mutual recognition list, and multinational white list. Ranked No. 1 in German authoritative medical magazine Daz and No. 1 in Hong Kong sales.

Enterprise mission: Caring for health and benefiting the society. Focus on products and lead the industry.

Core values: Inheriting innovation, improving quality, honesty and law-abiding, and win-win cooperation.

Our vision is to become a leading company in the biodiagnostic reagent industry, providing high-quality, convenient and reliable services to the world.