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.
- 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
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 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, 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).
Order Information
CATALOG NO. RCPM-00171, RCPM-00271, RCPM-00471, and RCPM-02071
PACKAGE UNIT: 2 Test /Kit
KIT COMPONENT:
- Test Devices
- Extraction Vials and Caps
- Nasal Swab
- User Instructions with Fact Sheet for Individuals
Procedure
Results Interpretation
FACT SHEET FOR HEALTHCARE PROVIDERS
INSTRUCTIONS FOR USE HEALTHCARE
Vizocare's Test Kits
Vizocare has emerged as a significant player in providing COVID test kits, offering innovative and reliable test kits to aid in the ongoing global battle against COVID. With a focus on accuracy, accessibility, and user-friendly design, Vizocare's test kits, including the iHealth and Flowflex variants, have become instrumental in detecting and managing COVID cases.
Vizocare’s iHealth test kit stands out for its advanced technology and precision. Leveraging cutting-edge innovations, iHealth test kits provide users with a highly accurate and rapid means of determining their COVID status. These test kits are designed to be user-friendly, enabling individuals to conduct tests at home or in healthcare settings with ease. The speed and accuracy of iHealth test kits are particularly crucial for timely decision-making, allowing individuals to isolate and seek treatment promptly.
In addition to the iHealth test kit, Vizocare's lineup includes the Flowflex test kit, which employs lateral flow technology for quick and efficient detection of COVID antigens. The simplicity of the Flowflex test kit makes it accessible to a wide range of users, including those without medical expertise. The user-friendly design, combined with the rapid results, encourages more people to get tested, contributing to a more comprehensive understanding of the virus's prevalence.
Vizocare's commitment to technological innovation is evident in both the iHealth and Flowflex test kits. These test kits not only aid in the identification of symptomatic cases but also play a crucial role in detecting asymptomatic carriers, helping to curb the spread of the virus within communities. The accessibility and reliability of Vizocare's test kits make them valuable tools in the arsenal against COVID. By empowering individuals to take charge of their health through at-home testing options, Vizocare contributes to broader public health strategies. As the world continues to grapple with the challenges posed by the pandemic, Vizocare's COVID test kits play a vital role in shaping effective testing, tracking, and containment measures.