Description

CareStart COVID-19 Antigen Rapid Test

The CareStart COVID-19 Antigen Rapid Test detects proteins from SARS-CoV-2 and provides results in just 10 minutes. To help ensure accurate reading of test results, the test also includes built-in quality control. The test is a minimally invasive, point-of-care (POC) test meant for in-vitro diagnostic use only.

This product can only be sold to a facility that has a CLIA certificate or waiver. The CLIA certificate or waiver ensures that your facility complies with legal requirements under the Clinical Laboratory Improvements Amendments to administer this testing.

This product has been authorized by the FDA under its Emergency Use Authorization. This test is authorized for use at the Point of Care (POC) by qualified healthcare professionals, i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. It is the provider’s responsibility to conduct and report covid-19 test findings.

Manufacturer’s Description

Regulatory Status: FDA EUA Authorized – this test has not been FDA cleared or approved but has been authorized by the FDA under an EUA for use by authorized laboratories.

Contents: (20) Sealed Test Devices, (20) Assay Buffer, (20) Extraction Vials and Caps, (20) Anterior Nasal Specimen Collection Swabs, (1) Positive and (1) Negative Control Swabs , (1) Instructions for Use

Determinations: Detection of the SARS-CoV-2 nucleocapsid protein antigen

Storage Requirements: 34° – 86° F

Processing Time: Approximately 10-15 Minutes

Intended to be a point-of-care (POC) test, the CareStart COVID-19 Antigen Rapid Test has a 10-15 minute processing time and allows testing for SARS-CoV-2 nucleocapsid protein antigen on a large scale without the use of a separate analyzer.

• Minimally invasive specimen collection
• Lateral flow assay
• Rapid results within 10-15 minutes (do not read after 15 minutes)