Description

The A1CNow®+ test provides quantitative measurement of glycated haemoglobin levels in capillary (fingerprick) or venous whole blood.

This test can be used to monitor glycemic control in people with diabetes and as an aid to diagnose diabetes and identify patients at risk of developing diabetes.

This PTS Diagnostics test utilizes enabling technology that incorporates microelectronics, optics, and dry-reagent chemistry strips within a reusable, self-contained, integrated handheld analyzer and a single-use test cartridge.

An unmeasured whole blood mixture (diluted) is directly applied to the sample port, and results are displayed in numeric form on the analyzer’s liquid crystal display after 5 minutes.

Having no switches or buttons, the analyzer self-activates upon insertion of the test cartridge.
The A1CNow+ analyzer utilizes both immunoassay and chemistry technology to measure A1C and total haemoglobin, respectively.

Upon the addition of a diluted blood sample, blue microparticles conjugated to anti-A1C antibodies migrate along the reagent strips.
The amount of blue microparticles captured on the strips reflects the amount of A1C in the sample.

For the total haemoglobin (Hb) portion of the test, the sample diluent converts Hb to met-Hb.
The intensity of met-Hb color measured on the reagent strips is proportional to the concentration of haemoglobin in the sample. Test results are expressed as % A1C (A1C÷ total Hb × 100).

Specifications

Materials provided

• A1CNow+ analyzer (1).
• A1CNow+ test cartridges (see box label for quantity).
  Each test cartridge contains:
  1. two dry-reagent strips containing: Anti-HbA1c antibody: latex conjugate, minimum 3 µg HbA1c minimum hapten, covalently attached to carrier protein, minimum 0.02 µg.
  2. Shaker kit (see box label for quantity), each containing: Shaker (1) containing: 0.2% w/v potassium ferricyanide, 2% w/v surfactant, 0.7% w/v non-reactive ingredients, 5 mM buffer in water. Blood collector (1).
• Instructions for use.
• Patient result labels (matches quantity of tests in box).

Materials needed but not provided

• Fingerprick sample: Lancet, or other blood fingerprick collection device or,
• Venous sample: Heparin (sodium or lithium [“green top”]) preferred, venous collection supplies.
• Gauze pad or cotton ball.
• Bandage.
• Liquid control solution.

Video

https://ptsdiagnostics.wistia.com/medias/tt8mo39npw