The CareStart™ COVID-19 Antigen Home Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2, not for any other viruses or pathogens.
Fast and easy to self-test at anywhere
Easy to interpret the results using mobile application
Qualitatively detect the SARS-CoV-2 nucleocapsid protein
Use for nasal swab specimen
Fast results only in 10 minutes
Identify individual’s current infection status to COVID-19
Disclaimer: As of November 22, 2021, CareStart™ 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 (Quick Reference Instructions (QRI) and Fact Sheet for Individuals, Instructions for Use (IFU) for Healthcare Providers (HCP), Fact Sheet for HCP, and kit package); however, CareStart™ 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 CareStart™ 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 CareStart™ COVID-19 Antigen Home Test kit with the new indication for use (described above).
