Description

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The EcoTest and FaStep COVID-19 antibody tests are the same test marketed under two brands.  Both are manufactured by Assure Tech.  Depending on current availability, you may receive either the EcoTest or FaStep branded test.

 

Features:

• First ever FDA EUA authorized CLIA waived finger stick whole blood IGM/IGG combination antibody test.
• Results in 15 minutes.
• For the detection of IgG and IgM antibodies to aid in the diagnosis of COVID-19. The Assure EcoTest / FaStep COVID-19 IgG and IgM Rapid Test Kit is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2 in human venous whole blood, serum, and plasma.

 

• Identify and differentiate IgG and IgM antibodies to confirm past or current exposure to SARS-CoV-2 and provide qualitative information to complement molecular studies.
• Identify SARS-CoV-2 IgG – IgG is produced in later stages of the infection and can indicate recent or prior infection
• Identify SARS-CoV-2 IgM – IgM is an acute phase marker and is the first antibody produced by the immune system in response to an infection
• Differentiate – Monitor seroconversion and immunological status of patients by providing IgG and IgM specific results

Must provide a CLIA # to order.

Kit Contents:

• 20 Test Droppers
• 20 Alcohol Wipes
• 20 Lancets
• 1 Buffer
• 1 Procedure card

Key Disclaimer
This test has not been FDA cleared or approved; the test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. A valid CLIA number is required upon checkout.

Refund Policy
The standard refund policy does not apply for COVID-19 rapid tests. All sales are final once goods are shipped and in transit with courier. NO EXCHANGES OR REFUNDS WILL BE MADE.

 

Product Attachments:
Product Insert
Quick Reference Instructions
Fact Sheet for Patients
Fact Sheet for Healthcare Providers
Letter of Authorization

CPT Code: 86328