Flowflex™ rapid antigen test is the market-leading rapid antigen lateral flow, using nasal and nasopharyngeal swab samples. It is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings.
|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)|
|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.
|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|
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.
|Sample Type:||Nasal/Nasopharyngeal Swabs|
|Relative Sensitivity - Nasal:||97.1%|
|Relative Specificity- Nasal:||99.5%|
|Accuracy - Nasal:||98.8%|
|Relative Sensitivity- Nasopharyngeal:||97.6%|
|Relative Specificity- Nasopharyngeal:||99.4%|
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.
|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.