SARS-CoV-2 Ag Self Test Kit 25 Tests/Kit CE for Nasal Swab Accuracy 99.68%

Materials Provided

Performance data

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

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 doctor or local health department. Follow local self-isolation guidelines and take a PCR confirmation test.
* Note: Line thickness is irrelevant; any reddish lines in the test line (T) should be interpreted as a positive test result. Positive test results must be confirmed by molecular diagnostics such as PCR testing.

Negative test result

If only colored lines are visible in the area of the control line (C), but not at the test line (T), the test result is negative. This suggests that the nasal samples were either absent or too little of the SARS-CoV-2 antigen and probably not infected 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.

If test results remain invalid, please contact a physician or COVID-19 testing center.

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.

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.