Self Test for SARS-CoV-2 AntigenĀ Detection
TheĀ CareStartā¢Ā COVID-19 Antigen Home Test is aĀ lateral flow immunoassay intended for theĀ qualitative detection of nucleocapsid proteinĀ antigens from SARS-CoV-2.
Under FDA's EUA, CareStart⢠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 forĀ non-prescription home use with adult-collectedĀ nasal {nares) swab samples from individuals agedĀ 2 years or older with symptoms of COVID-19Ā within the first 7 days of symptom onset.
This testĀ is also authorized for non-prescription home useĀ with self-collected anterior nasal (nares) swabĀ samples from individuals aged 14 years or older, orĀ adult-collected anterior nasal {nares) swabĀ samples from individuals aged 2 years or older,Ā with or without symptoms or other epidemiological reasons to suspect COVID-19Ā when tested twice over three days with at least 24Ā hours {and no more than 48 hours) between tests.
- For use under Emergency Use Authorization Only
- ForĀ In VitroĀ Diagnostic Use Only
Features
- 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 individualās current infection status to COVID-19
Compatible OS Systems:
- iOS13 or newer for Apple iPhone
- Android10 or newer for Android Phone
Disclaimer:
- As of November 22, 2021,Ā CareStart⢠COVID-19 Antigen Home Test is authorized to use with individual anterior nasal swab specimens from individuals aged 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,Ā Instructions for Use (IFU) for Healthcare Providers (HCP),Ā Ā Fact Sheet for HCP, andĀ Ā kit package); however,Ā CareStart⢠COVID-19 Antigen Home Test will continue to be distributed with the labeling previously authorized per EUA210314/S001 on the FDAās enforcement discretion in efforts to increase the testing accessibility for COVID-19. Since the differences between theĀ 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 theĀ CareStart⢠COVID-19 Antigen Home Test kit with the new indication for use (described above).
Order Information
- Test Devices
- Extraction Vials and Caps
- Nasal Swab
- User Instructions with Fact Sheet for Individuals
Procedure
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Results InterpretationFACT SHEET FOR HEALTHCARE PROVIDERS
INSTRUCTIONS FOR USE HEALTHCARE