InteliSwab™ COVID-19 Rapid Home Test
Buy Over-the-Counter, Use at Home.
The InteliSwab™ Covid-19 rapid home test is authorized for home use by the FDA (EUA). With visual results in 30 minutes and lower nasal swab collection, InteliSwab™ is fast and comfortable to use.
General Details
Test type: Antigen
Run time: 30 minutes
Collection type: Lower nasal swab
Authorization: FDA EUA for home and over-the-counter use. No CLIA certfication required.
Intended Use: Lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein.
Manufacturer: OraSure Technologies (USA)
CPT Codes: Covid-19 87811QW
Clinical Details
SARS-CoV-2: 84% Sensitivity, 98% Specificity (Self-Collected)
Specificity: No cross-reaction with species tested
Interference: No interfering factors tested
*See Instructions For Use for detailed clinical data.
Box Components
Test devices (2)
Test Stand (1)
Solution vial (2)
Instructions for use (1)
Quick reference guide (1)
Storage & Handling
Test kits should be stored at 2-30°C (35-86°F). Reagents and materials are stable until the expiration date printed on the outer packaging. Do not use beyond the expiration date. The test device must remain in the sealed pouch until use. Do not freeze any contents of the kit.
Manuals and Instructions
Product Images
Disclaimer
The InteliSwab™ COVID-19 Rapid Test is a single-use lateral flow immunoassay with an integrated swab, intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours but not more than 36 hours between tests. This test is authorized for non-prescription home use with self-collectedanteriornasalsamplesfromindividuals18yearsorolderoradultcollectedanteriornasalsamplesfrom individuals age 15 years or older.