Description
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.
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.