On/Go Product Updates

ON/GO EXPIRATION UPDATE FOR ALL CUSTOMERS 

Please click here for updated expiration dates by LOT number

May 12, 2022

EXPIRATION DATE EXTENSION (click here)

Attention: On May 12, 2022, the FDA granted a twelve-month shelf-life extension for On/Go COVID-19 Antigen Self-Tests (also known under CareStart COVID-19 Antigen Self-Test EUA letter).  For many boxes, for example, if the expiration date printed on your box states April 2022, the expiration date for the test is now October 31, 2022. Please note, the expiration date for the tests is the last day of the labeled expiration month.  The attached document lists the new expiration dates for On/Go Self-Tests by lot number.  We will continue to apply to FDA for shelf-life extensions every three months based on our stability studies, and the new shelf-lives for our tests will apply to tests already produced as well as future production.

View all new expiration dates by lot number

View the FDA letter

April 18, 2022

Updated in-house performance evaluation demonstrated that all major known variants, including Omicron and BA.2 do not affect the performance of the On/Go COVID-19 Antigen Self test.

Please read the full letter of notification here

December 2, 2021

Based on the internal studies, the mutated Omicron variant of SARS-CoV-2 should not affect the performance of the On/GoTM COVID-19 AntigenSelf-Test. Our tests detect the nucleocapsid protein antigen (“N-Protein”) of the virus, which are not affected by variant strain that mainly mutate in the virus' spike proteins (“S-Protein”). We will continue to monitor and analyze variants of SARS-CoV-2 and, based on the design of our test, it is highly likely that our test will continue to detect all variants of SARS-CoV-2.

Read our brief here

November 22, 2021

As of November 22, 2021, On/Go TM COVID-19 Antigen Home Test is authorized to use with individual anterior nasal swab specimens from individuals age 14 years and older (self-collected), or 2 years and older (collected with adult assistance) for non-prescription home use by FDA under the EUA (EUA210314/S002). The authorized labeling has been changed with the new indication; however, On/Go COVID-19 Antigen Home Test will continue to be distributed with the labeling previously authorized per EUA210314/S001 on the FDA’s enforcement discretion in efforts to increase the testing accessibility for COVID-19. Since the differences between the On/Go COVID-19 Antigen Home Test kit previously authorized (EUA210314/S001) and currently authorized (EUA210314/S002) are limited to the authorized labeling, you may use the On/Go COVID-19 Antigen Home Test kit with the new indication for use.

On/Go COVID-19 Antigen Home Test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 7 days of symptom onset.

This test is also authorized for non-prescription home use with adult-collected nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.

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