Flowflex COVID-19 Antigen Home Test

$7.95

Flowflex COVID-19 Antigen Home Test – a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection.

description

Product Description

Flowflex COVID-19 Antigen Home Test is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. For self-testing use. For use under an Emergency Use Authorization (EUA) only.

OMICRON UPDATE:

An independent evaluation conducted by the National Institutes of Health’s (NIH) RADx program has indicated that the Flowflex™ COVID-19 Antigen Home Test does detect the Omicron subvariant BA.1 and BA.2 in live clinical samples.

Clinical Performance:

The performance of Flowflex COVID-19 Antigen Home Test was established in an all-comers clinical study conducted between March 2021 and May 2021 with 172 nasal swabs self-collected or pair-collected by another study participant from 108 individual symptomatic patients (within 7 days of onset) suspected of COVID-19 and 64 asymptomatic patients. The Flowflex COVID-19 Antigen Home Test results were compared to an FDA EUA RT-PCR COVID-19 assay to determine test performance in the table below:

Flowflex COVID-19 Antigen Home Test	RT-PCR method
	Positive	Negative	Total
Positive	39	0	39
Negative	3	130	133
Total	42	130	172
Positive Percent Agreement (PPA)	93% (95% CI: 81% -99%)
Negative Percent Agreement (NPA)	100% (95% CI: 97% - 100%)

Analytical Sensitivity: Limit of Detection (LoD): LoD was determined as the lowest virus concentration that was detected ≥ 95% of the time. Based on this testing, the LoD in nasal matrix was confirmed to be 2.5 x 10³ TCID₅₀/mL

IMPORTANT: This test procedure overview does not replace the package insert. Before you begin the test, it is important to carefully read and follow the detailed instructions in the package insert. Failure to follow the instructions may result in inaccurate test results.

CPT Code for COVID-19: 87811QW

FEATURES & BENEFITS

Cassette Format
Detects the nucleocapsid protein antigen from SARS-CoV-2
Nasal Specimen sample
Results in 15 minutes
FDA Emergency Use Authorization (EUA)
Positive Percent Agreement (PPA): 93% (95% Cl: 81%-99%)
Negative Percent Agreement (NPA): 100% (95% Cl: 97%-100%)
Analytical Sensitivity: Limit of Detection (LoD): 2.5 x 10³ TCID₅₀/mL

DOCUMENTATION AND VIDEOS

Flowflex COVID-19 Antigen Home Test brochure, package inserts, authorized FDA letter and additional literature provided below:

Product Brochure

Technical Product Brochure

fact sheet

Package insert (english)

Package Insert for Healthcare Providers

safety data sheet

statement on omicron variant

Package Insert (Spanish)

Frequently Asked Questions

EUA Letter from FDA

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-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 IVDs 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.For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorizationFor the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19

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Acon Labs

Flowflex COVID-19 Antigen Home Test

$7.95