CareStart™

COVID-19

Antigen Home Test

Self Test for SARS-CoV-2 Antigen Detection

The CareStart™ COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein 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 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.

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).
  • For use under Emergency Use Authorization Only
  • For In Vitro 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 individual’s current infection status to COVID-19
  • In Vitro Diagnostic Use Only

Compatible OS Systems:

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

Access Bio Carestart Antigen Home Test Kit - Instructional Video

Play Video
PROCEDURE
RESULTS INTERPRETAION
ORDER INFORMATION

Catalog No :

RCPM-00171, RCPM-00271, RCPM-00471, and RCPM-02071

Package Unit :

1,2,4, or 20 TESTS / KIT

Package Unit :

  • Test Devices
  • Extraction Vials and Caps
  • Nasal Swab
  • User Instructions with Fact Sheet for Individuals

Other Antigen Test Kits Products We Have

Flowflex™

COVID-19 Antigen Home Test

A rapid test for the detection of COVID-19 antigens in nasal specimens. 1 for $15.00 and 5 for $70.00.

Critical Information When & Where You Need It

The Flowflex™ COVID-19 Antigen Home Test is all you need to determine your family’s Covid-19 status, whether symptoms are present or not. Can be used on children as young as 2 years old. Get the convenience of Flowflex! Easy and Affordable Highly Accurate Nasal Swab Test Quick Results in 15 minutes Safe for children as young as 2 years old For use with and without symptoms

iHealth™

COVID-19 Antigen Rapid Test

Results in 15 minutes. Only $18.00 2 packs test. $85.00 5 2 packs test.

4 Steps. 15 Minutes. Zero Discomfort.

iHealth COVID-19 Antigen Rapid Test is the simplest way to detect SARS-CoV-2 nucleocapsid protein antigen. It only takes 4 steps and 15 minutes to complete the test. The test is also non-invasive. You won't need to collect a sample from deep in your nasal cavity to get accurate results. Sample collection by yourself or by guardians.