CareStart™

COVID-19

Antigen Home Test

Rapid test for the detection of antigen of SARS-CoV-2

The CareStart™ COVID-19 Antigen Home Test is a rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal swab samples from individuals aged 2 years or older.

We are the sales agent for CareStart COVID-19 Antigen Home Test.

 

  • For use under Emergency Use Authorization Only
  • For In Vitro Diagnostic Use Only

Compatible OS Systems:

  • iOS13 or newer for Apple iPhone
  • Android10 or newer for Android Phone

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).

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 individual’s current infection status to COVID-19
PROCEDURE

RESULTS INTERPRETATION

ORDER INFORMATION
CATALOG NO.
RCPM-00171, RCPM-00271, RCPM-00471, and RCPM-02071
PACKAGE UNIT
1,2,4, or 20 TESTS / KIT
KIT COMPONENT
  • Test Devices
  • Extraction Vials and Caps
  • Nasal Swab
  • User Instructions with Fact Sheet for Individuals
PRODUCT DOCUMENTATION