What is afinion2?

What is afinion2?

The Afinion™ 2 Analyzer is a compact, rapid, multi-assay analyzer that provides valuable near patient testing at the point-of-care. With the Afinion™ System there’s no need to send patients to the lab or spend time tracking down their results. That way you can keep your focus where it belongs ‑ on the patient.

What is the Alere afinion HbA1c’s measuring range?

6-20 g/dL
The Afinion™ HbA1c reportable range is 4.0-15.0% HbA1c. The HbA1c results are displayed in 0.1% intervals. The hemoglobin measuring range is 6-20 g/dL.

How long are Alere afinion HbA1c controls stable for once the vials are opened?

60 days
Reagents and Storage 1. Afinion™ HbA1c Test Cartridges can be stored unopened at room temperature (15°-25°C or 59°-77°F) for 90 days. 2. Once opened, control vials are stable for 60 days when stored refrigerated, 2°- 8°C (36°- 46°F).

Does a1c need to be refrigerated?

1. Afinion™ HbA1c Test Cartridges can be stored unopened at room temperature (15°-25°C or 59°-77°F) for 90 days. 2. Once opened, control vials are stable for 60 days when stored refrigerated, 2°- 8°C (36°- 46°F).

Can I check my own A1C?

You can also find home A1C kits in most pharmacies such as CVS and at Walmart. A1C kits that require you to collect a blood sample at home and send it to a lab is also available. One FDA-cleared kit that I’ve tried is the Home Access Health home A1C test which was $40 (as of September 2020).

What is Afinion 2 analyzer used for?

Afinion™ 2 Analyzer — Simply More Efficient Improve the way you diagnose, monitor, and manage your patients. The Afinion™ 2 Analyzer is a compact, rapid, multi-assay analyzer that provides valuable near patient testing at the point-of-care.

What is the Alere Afinion HbA1c test?

The Alere Afinion HbA1c test offers lab quality, point-of-care, in-office results from 1.5 µL of fingerstick whole blood or

Is Alere Afinion 510(k) a valid test for the diagnosis of diabetes?

510(k) cleared in the US as a moderate complexity test for monitoring glycemic control in people with diabetes in 2005 and CLIA waived in 2006 In other parts of the world, Alere Afinion HbA1c is legally marketed and widely used for both monitoring and diagnosis of diabetes (ex. in Norway, Sweden, Germany etc.)

Can CLIA waived laboratories use the Afinion system?

Extensive and comprehensive error mitigations have been incorporated into the design and use of the Afinion system to ensure accurate results in any setting (including CLIA waived) Alere’s proposed approach ensures that CLIA waived laboratories cannot use the new moderate complexity test 4