SARS-CoV-2 Antigen Rapid Test At Home 10 Tests/Kit CE For Nasal Specificity 100%

SARS-CoV-2 Antigen Home Test Kit 10 Tests/Kit CE for Nasal Specificity 100%

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.

Antigen Swab 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.

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.

Disease severity classification

Mild: The clinical symptoms are mild, or even no obvious clinical symptoms, and no pneumonia is seen on imaging.

Ordinary type: with symptoms such as fever and respiratory tract, and pneumonia can be seen on imaging.

Heavy:

Adults meet any of the following:

· Respiratory distress, respiratory rate ≥ 30 breaths/min;

· In resting state, oxygen saturation ≤93%;

Arterial blood oxygen partial pressure (PaO₂)/inhaled oxygen concentration (FiO₂)≤300mmHg (1mmHg=0.133kPa), high altitude (over 1000 meters above sea level) area should be based on the following formula PaO₂/FiO₂ x [760/atmospheric pressure (mmHg) ].

In addition, if lung imaging shows that the lesions have progressed more than 50% within 24 to 48 hours, they are managed as severe.

Children meet any of the following:

· Persistent high fever for more than 3 days;

Shortness of breath (<2 months old, RR≥60 times/min; 2~12 months old, RR≥50 times/min; 1~5 years old, RR≥40 times/min; >5 years old, RR≥30 times/min /min), excluding the effects of fever and crying;

·Oxygen saturation ≤93% in resting state;

· Assisted breathing (groaning, alar flaring, three concave signs), cyanosis, intermittent apnea; drowsiness, convulsions;

· Rejection or feeding difficulties, with dehydration.

Critical:

One of the following conditions:

Respiratory failure occurs and requires mechanically assisted exhalation;

· Shock occurs;

· Combined with other organ failure requiring ICU monitoring and treatment.

Severe/critical high-risk groups

Older people over 60 years old; patients with underlying diseases; immunodeficiency; obesity (body mass index ≥ 30); women in late pregnancy and perinatal period; heavy smokers.

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.