A1cNow - HbA1c and Diabetes Monitoring - (10 Test Kit)

The A1cNow (A1cNow+) system tests for glycosylated haemoglobin (HbA1c), offers incredibly fast quantitative results utilising micro-optical technology integrated into a proprietary reusable monitor with single-use-cartridges.

The A1cNow (A1cNow+) test requires 5 µL of whole blood (1 large drop) obtained with a fingerprick procedure.

A1cNow+ benefits:

• A1cNow+ has launched the NEW IMPROVED BLOOD SAMPLER
• EASIER - New Integrated Sampler takes the place of the original "pipettes"
• FASTER - No Technique Required - Blood collector, dilution and transferring sample are now All-In-One step!! (3 second hands-on time - used to be 30 seconds)
• LESS BLOOD - HALF the blood sample is required with the new sampler - only 5 micro liters (original was 10 micro liters)

A1cNow+ features:

• Results in only 5 minutes
• Requires only 5 µL of blood
• Simple 3 step procedure
• Pager-sized all-in-one sampling device
• Stable at room temperature for 3 months
• No daily controls, calibration or maintenance required
• Lab accurate at 99%

A1cNow+ technology:

• The A1cNow+ monitor utilizes both immunocassay and chemistry technology to measure A1C and total haemoglobin, respectively.
• Upon the addition of a diluted blood sample, the micro particles conjugated to anti-A1C antibodies migrate along the reagent strip. The amount of blue micro particles captured on the strips reflects the amount of A1C in the sample.

Technical Details

• Sample Medium: Blood (fingerstick or venous)
• Sample Volume: 10 µL
• Result Type: Quantitative (DCCT aligned and NGSP certified)
• Result Time: 5 minutes
• Shelf Life: 12 months from the date of manufacture
• Storage Temperature: 2–8°C - can be stored at room tempertaure (18–28°C) for up to 3 months
• Regulatory Approval: CE marked for professional use

Contents

• 1 x ATC Meter
• 10 x Single Use Cartridges
• 10 x Sample Dilution Kits
• 10 x Patient Result Labels
• 1 x Procedure Card

Step 1. Gently touch blood drop to fill. (Only 5μl of blood required)

Step 2. Insert Blood Collector into Sampler Body. (Fewer parts involved thanks to the improved sampler)

Step 3. Push down gently, remove in 1 second. Results will appear automatically in 5 minutes. (Easier disposal)

What is Hemoglobin A1c ?

To explain what an A1c is, think in simple terms. Sugar sticks, and when it's around for a long time, it's hard to get it off

In the body, sugar sticks too, particularly to proteins. The red blood cells that circulate in the body live for about three months before they die off. When sugar sticks to these cells, it gives us an idea of how much sugar is around for the preceding three months

In most labs, the normal range is 4-5.9 %. In poorly controlled diabetes, its 8.0% above, and in well controlled patients it's less than 7.0 %

The benefits of measuring A1c is that it gives a more reasonable view of what's happening over the course of time (three months), and the value does not bounce as much as finger stick blood sugar measurements

The A1cNow meter will display accurate results for Hba1c in around 5 minutes using only 5ul of blood sample

How difficult is the procedure?

The single-use test provides quantitative results from a single drop of blood. Simply prick the finger, apply pressure to the finger to obtain a large drop of blood, touch the tip of a capillary pipette to the drop of blood, mix the blood with the liquid supplied, shake the mixture, add the sample to the A1CNow+ monitor and wait five minutes for the result. Actual hands on time for the test is less than one minute!

How much blood is required to perform the test?

A1cNow+ requires a 5μl blood sample to perform the test. Samples may be taken from either a finger stick or venous draw.

How long does it take the system to produce results?

Once the sample is prepared and added to the test cartridge, A1cNow+ provides results in five minutes. Can I run multiple tests at the same time? A1cNow+ is a fully self contained, portable testing system which requires no expensive capital equipment. This allows physicians offices the ability to operate multiple devices in as many exam rooms as necessary.

Is A1cNow+ CLIA waived?

Yes, A1cNow+ is CLIA waived.

How accurate is A1cNow+?

A1cNow+ is lab accurate at 99% and meets all NGSP performance standards. EuroMedix has additional data on file supporting the high accuracy levels of A1cNow+.

What is the technology behind A1cNow+?

A1cNow+ uses dry chemistry and micro-optics. The monitor simultaneously analyzes two independent A1C tests and has several built in controls to ensure accuracy.

Does A1cNow+ have to warm up before use?

If refrigerated, the test will need to come to room temperature for one hour before testing, otherwise the system is ready to use out of the box.

What is the shelf life of A1cNow+?

The A1cNow+ system is stable at room temperature for up to three months. When refrigerated, the system is stable for up to twelve months but must be brought to room temperature for one hour before use.

Are external controls needed?

A1cNow+ is designed to require no maintenance and no daily controls. In addition, no calibration is necessary.

What do the error codes mean? If I get one error code and have more tests left on the monitor will I lose the rest of the tests?

All error messages should be called into EuroMedix HelpDesk and they will be able to assist you. Getting an error message usually will not mean that you cannot use the monitor. It typically means that the procedure was not done correctly and you can use a new cartridge to perform the test again. Receiving an error message means that the system did not pass the internal controls. If you receive an error message, please call EuroMedix for technical support.

How long will the result be displayed on the monitor?

There is adequate time to both record the result and to show the result on the monitor to the patient. The result will stay for 60 minutes or until you insert a new test cartridge.