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InBios SCoV-2 Ag Detect™ Rapid Self-Test - 2 pack

Sample: Shallow Nasal
Format: Cassette
Time to result: 20 minutes
Package: 2 test per box
Min Qty: 2 tests
Volume Pricing: contact us for a quote

$9.99/box

In stock

SKU: INBIOS2PK Categories: , Tags: ,

Description

Key Features

  • Test in the privacy of your own home – currently available in a two test per kit configuration.
  • Patent pending ease-of-use design.
  • Uses minimally invasive shallow nasal swab.
  • Easy visual read – no instrument required.
  • Fast results in ~ 20 minutes.
  • Versatile – for people with or without symptoms.
  • Can be used by individuals 14 years and older or with adult-collected nasal swabs from children as young as 2 years old.
  • PPA (Sensitivity): 85.71%; NPA (Specificity): 100%
  • Room temperature storage.

The SCoV-2 Ag Detect™ Rapid Self-Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 Nucleoprotein antigen. The test can be performed using anterior nasal (nares) swab samples collected without transport media, requires no training and takes ~20 minutes to obtain results, making it a suitable diagnostic tool for use at home use.

The nasal swab test, designed to be extremely simple to use for consumers who are not familiar with self-testing, may be used by individuals 14 years and older, or with adult-collected nasal swabs from children as young as 2 years old.

The SCoV-2 Ag Detect™ Rapid Self-Test kit features the same SARS-CoV-2 rapid antigen test that received an EUA from the FDA for use in professional settings in May 2021. The test, which is currently available in a two test per kit configuration, features a unique ease-of-use patent-pending design and uses shallow nasal swabs with no instrumentation required to read results. It is designed for use with symptomatic and asymptomatic serial testing.

Disclaimer
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS[1]CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Additional information

Weight 0.05 lbs
Dimensions 12 × 12 × 6 in
Test TechnologyAntigen
Diagnostic Sensitivity85.71%
Diagnostic Specificity100.0%
Shelf Life (expiration)10 months
Storage Temperature15-30°C/59-86°F
Time to Result20 minutes
Sample CollectionShallow nasal

Instructions

Dyu14o-LBL-0142-02-900317-EUA-SCoV-2-Ag-Detect-Rapid-Self-Test-QRI

eForm-0150-01-SCoV-2-Ag-Detect-Rapid-Self-Test-Fact-Sheet-for-Healthcare-Providers

EUA210619.S001.InBiosOTC-EUA-LOA-reissue-01-25-2022-FINAL

EUA210619.S002.InBios-Letter-Granting-EUA-Revision-03-03-2022-shelf-life

owM9am-LBL-0141-02-900318-EUA-SCoV-2-Ag-Detect-Rapid-Self-Test-HCP-IFU

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