Rapid SARS-CoV-2 Antigen Test Card

Test Procedure Overview

The test procedure overview does not replace the package insert. Please read and follow the detailed instructions in the Quick Reference Instructions.
 

1.Swab

Slowly rotate the swab in a circular motion 5 times by firmly pressing against the inside walls of the nostril for a total of 15 seconds. Do not just spin the swab. Gently remove the swab and repeat in the other nostril using the same swab.

2.Dip

Place swab in buffer tube. Rotate swab 5 times. Set a timer and leave swab in buffer tube for 1 minute. Pinch buffer tube with fingers and remove the solution from swab as much as possible.

3.Drop

Invert the buffer tube and add 3 drops of test sample into the sample well (S) by gently squeezing the extraction tube. Do not add test sample to the rectangular results window.

4. See Results

If a Control (C) line and the Test (T) line are visible, the test is positive. Any faint visible pink/purple test (T) line with the control line (C) should be read as positive. If a control line (C) is not visible, even if the test line is visible, the result must be considered invalid.

Instruction Video

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Contact Us

Tel:

+1-800-689-7794 (technical support)

Company Info:

Address: 90-94 Tianfeng Road, Jimei North Industrial Park Xiamen, Fujian 361021, China

Product Inquiry

Frequently Asked Questions

The test kits that you received have been approved by the FDA and are free of charge. If you no longer wish to receive this test kits, please contact the supplier that sent you the test cards to discontinue delivery. We investigated and found that Medicare patients will receive eight test cards per month in the period of Public Health Emergency. It is our understanding that Medicare patients will stop getting test cards at the end of Public Health Emergency (October 2022). Please note that the Public Health Emergency could be extended.

A negative test means that the virus that causes COVID-19 was not detected in your sample. It is unlikely that you have COVID- 19. However, even if your test is negative, continue to observe all hygiene and safety measures. If you suspect that you have an infection (i.e., if you have prolonged symptoms or if your symptoms are worsening), contact your doctor/primary care physician. You may have another infection, or your test result may be false. Negative results do not rule out COVID-19. This means that you could still have COVID-19 even if your test is negative. If you do not have symptoms of COVID-19 and your result is negative, you should test again with at least 24 hours and no more than 48 hours between tests.

A positive test result means that the virus that causes COVID-19 was detected in your sample, and it is very likely that you have COVID-19.Please contact your doctor/primary care physician or your local health authority immediately and adhere to the local guidelines regarding self-isolation. Your doctor may require you to undergo a molecular PCR test to confirm the result. There is a very small chance that this test can give a result that is incorrect (a false positive).

The test is invalid. The test is not working correctly and you should perform another test using a different test kit. You may have performed the test incorrectly. Carefully read the Quick Reference Instructions and repeat the test. If your test result is still invalid, please contact a doctor or visit a COVID-19 test center.

When infected with a COVID-19, the virus will amplify in the body. Because of individual differences, the rate of virus growth in the body varies and the COVID-19 antigen can only be detected when the virus level in the body is above the limit of detection of the product.
Currently, the S protein site mutation is the predominant mutation in the COVID-19 mutant strains identified, with the N protein site mutation accounting for a minority. The Rapid SARS-CoV-2 Antigen Test Card, which targets the N protein, may affect detection performance when the mutation site occurs in the N protein. Based on the performance evaluation of the Rapid SARS-CoV-2 Antigen Test Card, mutant strains such as Alpha, Bata, Gamma, Delta, Zeta and Omicron can be detected.
There is no evidence that vaccination affects test results. However, it is recommended that the test be carried out 48 hours after the vaccine has been administered.
The tests can be stored sealed at 2°C–30°C for long term storage. The tests can be stored in the refrigerator at 2-8°C

News

The validity of BosonTM SARS-CoV-2 Antigen Test Card has been extended to 11 months
Recently, Xiamen Boson Biotech passed the Medical Device Single Audit Program (MDSAP) certification and received the MDSAP certificate. The MDSAP quality system certificate will not only help Boson further expand the international market, but also promote the company’s medical device quality managem
COVID-19 pneumonia is still raging around the world, and waves of new mutant strains in epidemic proportions are challenging rapid antigen tests (RAT) based on the principles of immunochromatography. On 28 July 2022, the Statens Serum Institut (SSI) in Denmark published a study that tested the abili
Boson has participated in the AACC exhibition in the USA from 26-28 July 2022, which ended successfully yesterday.At the exhibition, Boson Biotech exhibited rapid test reagents including COVID-19 test, infectious disease test and FOB test, which were warmly welcomed by the attending customers. One o
The Boson Rapid SARS-CoV-2 Antigen Test Card for self-testing (FDA EUA Authorizations) is already available for purchase on Amazon.com. Customers who require them can purchase them directly by clicking on the link below: For 2 Tests/kit: https://www.amazon.com/dp/B0B29211CL?ref=myi_title_dpFor 8 Tes

Boson Introduction

Xiamen Boson Biotech Co., Ltd., as a specialist of in vitro diagnostic kits field was founded in 2001, develops and manufactures high-quality point of care and other immunoassay test kits for the world-wide market. Our factory is operated strictly under ISO 13485 and GMP guidelines. Our product lines provide immunoassays in various formats to detect infectious diseases, cardiac markers, drugs of abuse, fertility hormones and tumor markers. Many of our products have been approved by the China NMPA and are CE certified.

The Rapid SARS-CoV-2 Antigen Test Card for self-testing manufactured by Xiamen Boson Biotech was the first in the world to obtain the CE certificate issued by a notified body on April 1, 2021. Up to 2021, Boson has exported more than 700 million antigen tests to the EU and other countries, contributing to the combat against the ongoing global pandemic.
Xiamen Boson Biotech’s mission is to provide affordable high-quality products to help fight diseases.
 
  • This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA;
  • This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and,
  • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
  • For more information on EUAs visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatoryand-policy-framework/emergency-use-authorization
  • For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19