Reagents and Materials:

Materials provided:

All following required components for single-use are packed and sealed in a tray.

• a test device: foil pouched test device containing one test strip which is encased in 

plastic device cassette with a desiccant. 

• an extraction vial and cap: the extraction vial contains 500 µL of extraction buffer 

solution.

• a nasal swab: swab for anterior nasal specimen collection.

Quick Reference Instructions and Individual Fact Sheet are also included in each box.

CareStart™ COVID-19 Antigen Home Test is available in the following packaging 

configuration: 2 tests (REF: RCPM-00271), 4 tests(REF: RCPM-00471), or 20 tests (REF: 

RCPM-02071)

Materials required but not provided:

• Smartphone (supplied by the user): iOS13 or newer for Apple iPhone

Android10 or newer for Android Phone

• Mobile application: Prior to testing, the user should download the free mobile 

application, on/go™ App, for iOS or Android smartphones.

• Timer

Storage and Stability:

• Store the test kit as packaged between 1 ~ 30°C. 

• The test device must remain in the sealed pouch until use.

• Do not freeze any contents of the kit.

Disposal:

Dispose of all used test kit components and patient samples in household trash.

Specimen Collection and Handling:

Acceptable specimen type for testing with the CareStart™ COVID-19 Antigen is a direct anterior nasal (nares) swab specimen. It is essential that correct specimen collection and preparation 

methods be followed. Inadequate specimen collection, improper specimen handling and/or transport may yield false results. Process the test swab sample immediately after collection 

(specimens are stable up to 4 hours in extraction buffer). Refer to the CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 

2019 (COVID-19)

https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html

Instructions for Running the Test:

IMPORTANT: Do not open kit components until instructions to do so. Follow the in-app selfpaced, step-by-step instructions or paper instructions printed on the QRI as below.