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

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

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 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.

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

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.