Flowflex SARS-CoV-2 Antigen Rapid Test (pack 25)


Quantity: 25 Pack - (Point Of Care)
Price:
Sale price$125.00

Description

Flowflex™ rapid antigen test is the market-leading rapid antigen lateral flow, using nasal and nasopharyngeal swab samplesIt is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings.

Key Points 

Key Points 

Authorized by Health Canada (IO #  327573)
Approved for POC and Lab use REF# L031-11815
25 Extraction tubes pre-filled with buffer solutions
Nasal and nasopharyngeal swab samples
Fast Results in 15 minutes
Can also test specimens from asymptomatic individuals
2 Years Shelf Life
The most accurate test for the Omicron variant (independent validation study)

Kit Content

25 Test Cassettes
25 Sterile Nasal/Nasopharyngeal Swabs
1 Positive Control Swab
1 Negative Control Swab
25 Pre-filled Extraction Tubes
1 Instruction for Use

 

Test Procedure and Interpretation

 

Results are for the identification of SARS-CoV-2 nucleocapsid antigen. This antigen is generally detectable in upper respiratory samples during the acute phase of infection.

Packaging

Carton Dimension 530 x 445 x 410mm
Carton Gross Weight 12.25kg
Packs / Carton 32 packs of 25 tests / 800 tests per carton
Pallet Specifications 16 Cartons = 12,800 tests


Specifications

The Flowflex SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms.

Product Specifications

    Sample Type: Nasal/Nasopharyngeal Swabs
    Detection Time:
    15 minutes
    Relative Sensitivity - Nasal: 97.1%
    Relative Specificity- Nasal: 99.5%
    Accuracy - Nasal: 98.8%
    Relative Sensitivity-  Nasopharyngeal: 97.6%
    Relative Specificity-  Nasopharyngeal: 99.4%
    Accuracy- Nasopharyngeal: 98.7%


    Intended use

    The tests are authorized for the following applications & settings:

    • Lab-based tests, conducted in a lab environment by a trained laboratory technician.
    • Point-of-care testing when used by an approved operator (often a health care professional) in a near-patient environment, such as a medical office or at the bedside. The patient waits for the results.

    Documentation

    PRODUCT BROCHURE
    INSTRUCTION FOR USE MANUAL (EN)

     

    ACON Laboratories, Inc. is one of the nation’s largest capacity manufacturers of cost-effective rapid point-of-care diagnostic solutions, Immunoassays, and Molecular Diagnostics. ACON Laboratories, Inc. is the only legal manufacturer of the FDA EUA Flowflex™ COVID-19 Antigen Rapid Point of Care Test.