Description
Contents: 25 Divided Pouches, Each containing: Test Device (1) Absorbent Packet (1) Developer and Solution Vial (1), Test Stands(5) Package Insert (1) Quick Reference Instructions (QRI) (1)
Regulatory Status: FDA EUA Authorized, CLIA Waived
Determinations:Detection of the SARS-CoV-2 nucleocapsid protein antigen
Processing Time: 30 Minutes
The Wondfo Clarity WELLlife™ COVID-19 / Influenza A&B Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals aged two (2) years or older. This test is only authorized for individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests.
Features:
The InteliSwab™ COVID-19 Rapid Test Pro is a manually performed, visually read immunoassay for the qualitative detection of SARSCoV-2 nucleocapsid protein antigen using a proprietary integrated collection swab to directly collect samples from the anterior nasal cavity. The InteliSwab™ COVID-19 Rapid Test Pro is comprised of both a single-use test device and a vial containing a pre-measured amount of a buffered developer solution. The test consists of a sealed pouch with two separate compartments for each component. The InteliSwab™ COVID-19 Rapid Test Pro utilizes a proprietary lateral flow immunoassay procedure.
Product Documents:
