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Thank you for watching our A1CNow+ training video. The A1CNow+ is a portable, professional multi-test A1C system. The correlation of glycated hemoglobin A1C or HbA1c and blood glucose levels make it a useful method of monitoring long term blood glucose levels in people with diabetes. 

The A1CNow+ provides healthcare professionals with a fast and easy way of getting A1C results at the point of care. In five minutes, with a small drop of fingerstick blood, this portable disease management tool allows for informed conversations about how patients are managing their diabetes. 

The calibration of A1CNow+ system is traceable to the NGSP and to an NGSP-certified network reference method. The relationship between the NGSP A1C calibration, expressed as percentage A1C, and the IFCC network calibration, expressed as millimoles per mole, has been shown to be stable and is given by the master equation contained within our analyzers so that either type of result reporting is available for our customer base. 

In this video, we will walk you through how to store the test and test preparation, how to collect blood from a patient, how to run the test, and how to read the results. 

Prior to product use, please read the Professional Procedure Guide, which outlines this information in further detail. 

Now let's take a look at the contents of the A1CNow+ box. Each A1CNow+ package contains one analyzer, multiple pouches labeled as number 1 containing shakers and blood collectors, multiple test cartridge pouches labeled as number 2, and a Professional Procedure Guide. 

Before conducting testing, it is always good to understand the storage requirements of the system. The A1CNow+ box can be stored refrigerated until expiration or at room temperature for 4 months. 

Make sure to record on the box in the provided space the date the product was placed in room temperature storage. 

If refrigerated, the product must be placed in room temperature conditions for one hour prior to use. You can refer to your professional procedure guide for any additional storage requirements. Additionally, the product should be kept out of direct sunlight. While storing the device after use, keep all components together and make sure to only use the analyzer with the materials included in the original box. 

Let's discuss test preparation. 

Prior to testing, make sure the lot number on each pouch matches the lot number on the back of the analyzer and the box. You will find the lot number located at the bottom of the pouches. 

After you confirm the lot numbers, tear the plastic shaker pouch labeled number one open at the perforation line. 

Do not open the pouch labeled number 2 until you have collected the blood, prepared the shaker, and are ready to insert the test cartridge into the analyzer and initiate the test. 

When collecting blood from a patient, make sure to wear the appropriate personal protective equipment to protect yourself from bloodborne pathogens. 

The A1CNow+ can use either capillary or venous whole blood. In this video, we will discuss how to conduct a finger stick to obtain a blood sample. In order to do so, you will need the A1CNow+ blood collector from the pouch labeled number one, alcohol wipes, gauze, a lancet, and a bandage. 

  

The A1CNow+ requires 5 µL of blood. To collect this amount, you'll want to use an appropriately sized lancet. 

Note, if not using the fingerstick method, the venous draw method can also be used in this step. Venous blood should be collected in heparin tubes and mixed well prior to use. 

To collect the patient's blood, you'll want to practice good fingerstick technique. 

To do so, use either the patient's middle or ring finger as the fingerstick site. 

Clean the site thoroughly with an alcohol wipe and dry with gauze prior to sticking with a lancet. 

Once clean, apply gentle pressure to the patient's finger with a lancet and stick the finger left or right of center. 

Apply pressure to the finger using the thumbs up technique to create a large drop of blood for collection. 

Gently touch the tip of the blood collector to the blood drop to fill it. Tilt the the blood collector at a low angle nearly parallel to the ground for easy collection. 

Always make sure to verify the blood collector is completely filled. Refer to the overfill and underfill example on screen. 

Now, fully insert the blood collector into the shaker body. A twisting motion helps to fully seat the collector into the shaker. 

Before shaking, confirm the blood collector is fully inserted. 

Once confirmed, shake vigorously back and forth six to eight times. This will mix the blood and the solution within the shaker. 

You can then place the shaker body on the table standing upright while preparing the cartridge within pouch number 2. 

Now that you have collected the patient's blood, you are ready to run the test on the analyzer. 

To begin, tear the foil test cartridge pouch labeled with a number two open at the notches on the side. Do not open the foil pouch until this step. 

Once the cartridge pouch has been opened, it must be used within 2 minutes. If the foil pouch is damaged prior to use, do not use. 

  

Confirm the 2-digit analyzer code on the face of the analyzer matches the code on the cartridge, and then insert the test cartridge into the analyzer by clicking it into place. 

Set the analyzer down, making sure that it remains stationary and on a flat surface for the remainder of the test. The analyzer will automatically begin over 50 internal quality control checks once the cartridge is inserted. 

WAIT appears on the analyzer screen while these checks are being completed. 

Next, the analyzer screen will display SMPL. 

The previously prepared shaker should now be used to dispense the sample into the cartridge. 

Immediately remove the base from the shaker body. Keep the shaker in a vertical upright position and push down completely to dispense the sample. 

Remove the shaker quickly. The analyzer screen will display run once the contents are dispensed and a countdown from five minutes will commence. 

The test results will appear at the end of the countdown. 

It is important that you understand how to read the result screen. After a successful test, the analyzer will display three messages. 

First, the analyzer will confirm that all quality control checks have been completed successfully by displaying QCOK on the screen. 

Next, the analyzer will display the A1C result in %A1C or mmol/Mol depending on the appropriate unit of measure for your country. 

The results will range from 4 –13 %A1C or 20 to 120 mmol/Mol. 

Results that fall outside of this range will not display QCOK and will either display <4.0 or 20 or >13.0 or 120. 

Lastly, the analyzer will display the number of tests left. 

This result cycle remains displayed for fifteen minutes or until the next test cartridge is inserted. 

Note, the analyzer is reusable until all cartridges in the original box are depleted or the number of tests left on the device is zero, whichever comes first. 

00TL indicates that all program tests have been used. 

  

After the A1C result is recorded, remove the cartridge with gloved hands and dispose of the cartridge and shaker in accordance with your biohazard procedures. 

Thank you for watching our A1CNow+ training video. For additional information about your A1CNow+ system, refer to your professional procedure guide. If you have any questions, please contact your local representative or PTS representative. 

You can also find more information at the PTS Diagnostics website, www.ptsdiagnostics.com.