Colloidal Gold SARS-CoV-2 Self Ag Antigen Rapid Test Home Use Tests / Kit CE Nasal Swabs

Colloidal Gold SARS-CoV-2 Ag Home Test Kit 5 Tests / Kit CE Nasal Swabs

Detection Limit

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

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

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.

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 the left and right nostril with the same swab: rub the swab against the inner wall of your nose and turn it at least 5 times to make sure you collect a sufficient amount of sample. Repeat the procedures in the other nostril.
Note: Children (at least 2 years old) younger than 15 years old, and people who are unable to perform the test themselves including the elderly and the sick should be tested by another adult. To sample a child, insert the swab into of one of their nostris until you feel some resisteance (about 2 cm). Rotate the swab 5 times against the nasal wall. Remove the swab and insert the same swab into the other nostril, repeat the sampling process. Do not continue the test if the child feels any pain.
5. Dip the swab into the tube and ensure that it is thoroughly mixed with the extraction liquid by agitating it and dipping it up and down at least 5 times. Allow the swab to soak for one minute.
6. Slowly pull the swab out of the tube while gently squeezing the sides of the tube to keep 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.

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.