A1C TESTING USING
THE AFINION AS-100
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For Medical
Clinical Staff
WellOne Primary Medical and Dental Care
WARNING
Conducting this test exposes the operator to potentially
infectious material. Standard precautions, including
glove use are required for this procedure.
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A1C Basics
A1C (also known as Hemoglobin A1C,
HgbA1C, HbA1c) or Glycated Hemoglobin) is
a bood test that reflects average blood
glucose over the last 2-3 months.
 The goal for most people with diabetes is less
than 7%.
 An A1C of 7% corresponds to an average
blood glucose level of 170 mg/dL..
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A1C Basics
The A1C
represents
a measure
of glycemic
control
over the
preceding
The goal for most
patients is an A1C value
of 7 or less
2-3
months
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A1C Basics
The United Kingdom Prospective Diabetes Study
(UKPDS) is study that showed, among people with type 2
diabetes, improved glycemic control
(average A1C = 7% vs average A1C = 7.9% in the
conventionally treated group) led to a reduction in risk by:
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25% for small vessel disease
21% for retinopathy (eye)
33% for albuminuria (kidneys)
16% for myocardial infarction (heart attack)
24% for cataract extraction
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A1C Basics
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The A1C test will be considered a diagnostic test at WellOne facilities.
Patients with values >14% should be referred to a CLIA Laboratory for
quantification.
HbA1c assay optimal performance occurs on specimens with total
hemoglobin concentrations between 7 and 24 g/dl. Specimens from
patients with severe anemia or polycythemia whose hemoglobin
concentrations are less than 7 g/dl or greater than 24 g/dl should be
tested using a different assay method.
Specimens containing >10% Hemoglobin F may yield lower than expected
HbA1c results with this test. Do not compare results for such patients to
published normal or abnormal results.
Results will be reported in percent (%) Glycated Hemoglobin.
Results preceded by a < (less than) sign are below 2.5%. This is a rare
condition and should be reported as "less than 2.5%". Results preceded by
a > (greater than) sign are greater than 14.0% and should be reported as
"greater than 14.0%".
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A1C Testing USING THE Afinion
AS-100: Cleaning
Weekly, and as needed:
 Turn the analyzer off and unplug.
 Dampened with water or alcohol, wipe down the
exterior, then dry. If necessary, disinfect with 1 part
bleach plus 9 part water solution, allowing to sit on
the analyzer for 10 minutes.
 Wipe with water then dry.
 Plug in and turn on unless further maintenance is
required.
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A1C Testing USING THE Afinion AS-100:
STORAGE AND STABILITY
Reagent Cartridges
 Upon receipt, check the temperature indicator
located on the inside top lid of the carton. Do not
use if indicator has turned red. Follow instructions
located on the carton for receiving a replacement
kit.
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A1C Testing USING THE Afinion
AS-100: STORAGE AND STABILITY
Reagent Cartridges
 All unopened test cartridges may be used until the manufacturer's
expiration date when refrigerated at 2 - 8*C. Kits not in use will be
stored in the laboratory specimen refrigerator.
 Kits in use may be stored at room temperature (15-30*C) for up to
3 months. Upon opening, write the date the kit was placed at room
temperature and the date the kit will expire (3 months from this
date).
 Prior to use, allow the reagent cartridge to warm to room
temperature (64-86 * F) for at least 15 minutes in an unopened foil
pouch. Information code 210 will be displayed if the cartridge is too
cold when used.
 The reagent cartridge must be used within 10 minutes after opening
the foil pouch.
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True or false: A1C reagent kits not in
use must be stored in the laboratory
specimen refrigerator
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True
False
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THE CORRECT ANSWER IS ……
TRUE
….The temperature of the laboratory fridge must be
checked and documented daily by MA staff with
action taken for out of range temperatures
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True or false: A1C reagent kits in use stored
at room temperature in the laboratory are
stable for 2 months after placing at room
temperature
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True
False
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THE CORRECT ANSWER IS ……
FALSE
Kits in use may be stored at room temperature (1530*C) for up to 3 months (not 2 months).
Upon opening, write the date the kit was placed at
room temperature and the date the kit will expire
(3 months from this date).
….The temperature of the laboratory room must be
checked and documented daily by MA staff with
action taken for out of range temperatures
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True or false: After opening the A1c reagent
foil pack, the test kit must be used within 1
hour
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True
False
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THE CORRECT ANSWER IS ……
False
…. The reagent cartridge must be used within 10
minutes after opening the foil pouch. Do not
refrigerate after the foil pouch has been opened.
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When taking a test kit from the refrigerator, the test
kit must be allowed to sit at room temperature for ________
minutes in the foil packet and ___________ minutes when
removed from the foil packet before using or erroneous
results will occur
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15, 20
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10, 5
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15, 10
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The correct answer is
15, 10………………….
When taking a test kit from
the refrigerator, the test
kit must be allowed to sit
at
room temperature for ________
minutes in the foil packet
and ______ minutes when
removed from the foil packet
before using or erroneous
results will occur
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A1C Testing USING THE Afinion AS100: STORAGE AND STABILITY
Controls
 Un-reconstituted control material is stable until the expiration
date marked on the package when stored refrigerated at
2 - 8*C.
 Once prepared, the material may be used for up to 60 days
after reconstitution if stored at 2 – 8 C. Be certain to note the
date prepared on each bottle. Material stored otherwise must
be discarded after one day of use
A1C controls are stored in the refrigerator
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A1C Testing USING THE Afinion
AS-100: control testing
Run a normal and abnormal control under the
following conditions:
 With each new shipment or lot number
 Monthly, if not previously done within this time
period
 Anytime an unexpected test result is obtained
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A1C Testing USING THE Afinion
AS-100: control testing
The measured value should be within the acceptable limits
stated for the control material. Consult the Afinion HbA1c
Control package insert.
If the result obtained for the Afinion HbA1c Control is outside the
acceptable limits, make sure that:
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Patient samples are not analyzed until control results are within acceptable
limits.
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The control vial has not passed its expiration date.
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The control vial has not been in use for more than 30 days.
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The control vial and test Cartridges have been stored according to
recommendations.
Correct any procedural error and re-test the control material.
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A1C Testing USING THE Afinion
AS-100: control testing
If no procedural errors are detected:
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Examine the laboratory’s quality control record to investigate
the frequency of control failures.
Ensure that there is no trend in out-of-range quality control
results.
Re-test the control material using a new control vial.
Patient results must be declared invalid when controls do not
perform as expected. Contact your customer service
representative for advice before analyzing patient samples.
Record incident in quality control manual and report to
supervisor.
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A1C Testing USING THE Afinion AS100: Standing order for ma staff
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Collect and test specimen on all diabetic patients
without a HgbA1C in the last 2- 3 months.
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A1C Testing USING THE Afinion
AS-100: testing Steps
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Switch on the Afinion AS100 Analyzer.
Allow the Test Cartridge to reach operating
temperature (64-86ºF). Open the foil pouch just
before use.
Be sure to properly label the Test Cartridge with
sample ID. The Test Cartridge has a dedicated ID
area.
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A1C Testing USING THE Afinion
AS-100: testing Steps
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Follow procedure for finger stick
Holding the glass capillary holder at an angle, touch only the tip of the
capillary to the drop of blood on the finger until the capillary is filled. It is
not possible to overfill. Avoid air bubbles.
Do not wipe capillary tube.
Once the capillary is filled, analysis of the Test Cartridge must start within 1
minute.
Do not process any specimen that has remained in the glass
capillary for longer than one minute prior to analysis.
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A1C Testing USING THE Afinion
AS-100: testing Steps
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Identify patient using two patient identifiers (name and DOB)
Explain procedure to patient in culturally appropriate, age appropriate
terms.
Gather all necessary equipment and supplies prior to start of the
procedure.
Inspect all equipment and supplies for damage, general integrity and
expiration date- do not use any damaged or expired materials
Perform hand hygiene before and after patient contact; before and
after donning gloves.
Don all appropriate personal protective equipment prior to conducting
procedure. Gloves are required.
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A specimen should be processed as soon as possible
and under no circumstances should a specimen be
processed that has been in the glass capillary
holder for more than ________________
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1 minute
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10 minutes
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5 minutes
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The correct answer is………………………….
No longer
than………….
1 MINUTE
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A1C Testing USING THE Afinion
AS-100: testing Steps
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Insert the capillary tube into the Test Cartridge and then insert
the Test Cartridge in the Analyzer. The analysis time is 3
minutes and 20 seconds.
Record the test results in the EMR according to the laboratory
guidelines. The results will also be stored in the Analyzer
electronic result records.
Remove the Test Cartridge from the Analyzer and dispose in
biohazard trash.
Remove gloves, dispose of in regular trash and perform hand
hygiene.
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You have reached the end of this
program…..
Once you are confident that you are comfortable with all the
materials presented, proceed to the A1C Testing Using the Afinion
AS-100 post test at http://www.classmarker.com/
Your username is the first initial of your first name followed by
your full last name. Your password is= nwhealth
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