A1CNow+ Controls
A1CNow+ Controls
A1CNow+ Controls
Transcripts
We recommend running controls in accordance with A1CNow Plus test system requirements, which include the following.
– With each new shipment,
– with each new lot,
– whenever storage, operator, instrument, or other problems are identified,
– in accordance with state, local, and federal regulations and your facility’s requirements.
If the A1CNow+ test kit has been stored for more than a month and it has been at least a month since the last control testing, run quality control before running a patient sample to ensure that storage conditions have not affected the product.
A1CNow+ Controls contain ready to use blood based level one and level two controls in 0.9 milliliter dropper style vials and instructions for use.
Once the controls are thawed, they can be placed in refrigerated storage for up to 8 months.
Be sure to mark on the box when the controls were placed in refrigerated storage.
Thawed control materials can also be stored at room temperature for up to 7 days.
Again, be sure to mark on the box when the controls were placed in room temperature storage.
To run controls, first wash, thoroughly rinse, and dry your hands. Then put on your gloves.
Then gather the following materials: the A1CNow+ test kit components, the A1CNow+ controls materials, the quality control instructions which can be found in the box, and a clean, flat surface.
Approved collection surfaces include sample cups, parafilm, weigh boats, and glass slides.
Surfaces must meet the following criteria: Disposable, non-porous, and non-biologically contaminated.
Check the expiration dates on the A1CNow+ Controls and the A1CNow+ test kit to make sure they have not expired.
If the control solution is frozen or refrigerated, allow it to warm to room temperature for at least 30 minutes with the cap on.
To begin, pick up the vial of level one control solution.
Gently invert the vial at least t10 times to mix. Do not vigorously shake the vial.
Remove the cap and turn the bottle upside down.
Carefully squeeze the vial to deliver one drop of control solution onto the clean, flat surface.
Immediately replace the lid on the vial.
Once opened and thawed, A1CNow+ control solution cannot be placed back in frozen storage.
Open the shaker pouch from your A1CNow+ test kit.
Hold the blood collector at a 45 degree angle.
Collect the A1CNow+ control solution from your clean, flat surface.
Verify that you’ve collected the appropriate amount of control solution with the blood collector.
Insert the blood collector into the shaker body using a twisting motion.
Shake vigorously six to eight times, then stand the shaker body on the table.
Open the cartridge pouch.
Remove the cartridge from the pouch and insert it into the analyzer.
Next, ensure that the A1CNow+ analyzer is on a level surface. The analyzer will run through an internal self test and display WAIT.
Then remove the shaker base and once the screen reads SMPL, dispense the control solution by pushing it down completely into the test cartridge.
The analyzer will display results in five minutes.
Once the results appear, check the ranges in the A1CNow+ Controls instructions for use to see if your results are within the specified range.
Record your results and remove the test cartridge from the analyzer.
Discard the test cartridge in a biohazard container.
Using new shaker and cartridge pouches, repeat the procedure using the level two vial of control solution.When complete, return A1CNow+ Controls kit to the refrigerator or room temperature storage.
If the control results fall outside of the acceptable limits, review the procedure and retest the control material with new A1CNow+ test kit components.
A new shaker pouch and test cartridge pouch must be used each time a control test is run.
If control testing fails a second time, contact PTS Diagnostics customer service.
Do not test additional patient samples until the A1CNow+ test kit has successfully passed quality control testing.
