INTENDED USE
The A1CNow® Self Check test system provides quantitative measurement
of glycated haemoglobin levels in capillary (fingerprick) blood samples.
The test is for home use to monitor glycemic control in people with
diabetes.
Before using this test, please read all instructions carefully.
If you need further help, call +1-317-870-5610.
We invite you to call and we will guide you through the test.
Do not take any decision of medical relevance without first
consulting your medical practitioner.
INTRODUCTION
The concentration (mmol/mol HbA1c) of A1C in your blood today tells
you how well you have been controlling your blood sugar (glucose) levels
over the past 2-3 months. About 50% of the A1C result is from the past
30 days of blood sugar levels, about 25% is from the past 30-60 days, and
about 25% is from the past 60-90 days.
1
The American Diabetes Association (ADA) recommends that your A1C
levels should be tested at least 2 times per year if you are meeting
your diabetes treatment goals and your blood sugar is stable. If your
treatment changes or you are not meeting your treatment goals, the ADA
recommends that you test at least every 3 months.
2
The A1CNow Self Check test system is an easy-to-use at home test to
measure your A1C levels, with results in 5 minutes. In addition to blood
sugar testing, you can further participate in your diabetes care using
this test. You can have the results ready before you have your checkups
to share with your healthcare professional. Contact your healthcare
professional if you have any concerns about your A1C result. The A1CNow
Self Check test system is not a substitute for regular assessment in a
doctor’s office or laboratory setting where a quality control program is
in effect.
MATERIALS PROVIDED
The box contains materials for multiple A1C tests. See outside box for
quantity as it may vary. Make sure all of the following parts are in the
box. DO NOT open the pouches until ready to use.
• A1CNow Self Check analyzer (see box label for quantity)
• Cartridge pouch (see box label for quantity)
• Shaker pouch (see box label for quantity), each containing:
- Shaker (1)
- Blood collector (1)
- Lancet, disposable (1)
• Product insert(s)
MATERIALS NEEDED BUT NOT PROVIDED
• Gauze pad or cotton ball
• Bandage
Contact Customer Service for a list of liquid controls.
PREPARING TO TAKE THE TEST
You may run your A1C test any time of the day. Remember to wash your
hands prior to performing the test.
No special diet is necessary (you do not have to be fasting when taking
this test). You may want to run this test at the same time as you do a
blood sugar test.
In order to help ensure an accurate result, please complete the test from
beginning to end within 15 minutes. Avoid running the test in direct
sunlight, on hot or cold surfaces or near sources of heat or cold. If the test
has recently been at high temperatures (greater than 25°C/ 77°F) or at
low temperatures (lower than 18°C/ 64°F), allow the kit parts to come to
room temperature (18-25°C/ 64-77°F) for at least one hour before you
run your test. Leave the parts in their sealed pouches while waiting.
Do not move the analyzer while test is in progress.
WHAT TO DO WITH THE RESULT
The analyzer will not store your results for more than 60
minutes, so write down the result and the test date on the result
log on the front of this insert to prevent loss of information.
WHAT THE TEST RESULT MEANS
For most people with diabetes, the American Diabetes Association (ADA)
recommends that your A1C should be under 53 mmol/mol (7%).
2
Your
healthcare professional will tell you what target level is right for you.
HOW DOES THIS TEST COMPARE WITH THE A1C TEST FROM
THE DOCTOR’S OFFICE OR THE LABORATORY?
Test results will rarely match exactly. This is true even for repeated tests
done in the same lab.
A1C results may be different due to: slight differences between labs,
normal variation within each test method, and the time between
tests.
STORAGE AND HANDLING
• Store and use at room temperature at 18-25°C (64-77°F) and out of
direct sunlight.
• If you cannot confidently store the kit under these recommended
conditions, you have the option of refrigerating the kit at 2-8°C
(36-46°F). DO NOT freeze. However, you must bring the kit to room
temperature for at least one hour prior to use.
• If the temperature label, placed on the outside of every kit, is exposed
to a temperature in excess of 50°C (122°F), the dot on the label will
turn red and the product should not be used.
• DO NOT use the test after the expiration date shown on the box.
• If disinfection of the analyzer is desired, Super Sani-Cloth® wipes
are recommended (EPA Reg. No. 9480-4, Professional Disposables
International (PDI), Orangeburg, New York), concentration of active
ingredients (0.25%) and with a contact time of 2 minutes. The active
ingredients in this disinfectant are n-Alkyl dimethyl ethylbenzyl
ammonium chlorides.
• Store analyzer in protective package when not in use.
WARNINGS AND PRECAUTIONS
• When this analyzer is used for the monitoring of an existing
disease, you should only adapt the treatment if you have
received the appropriate training to do so.
• For self-testing use outside of the body only (
in vitro
diagnostic use).
• To ensure proper test performance, carefully read and follow the
steps located on the front side of this product insert.
• DO NOT adjust your medication unless instructed to do so by
your doctor or healthcare professional.
• DO NOT substitute this test for blood sugar monitoring.
• The following conditions may affect the accuracy of your A1C result:
haemoglobin variants (HbS, HbC), elevated HbF, anemia, recent
significant blood loss, a recent blood transfusion, or high amounts of
rheumatoid factor.
• People with hemophilia (bleeding disorder) or on anti-coagulant
therapy (blood thinning medicine) should consult their doctor or
healthcare professional before using this kit.
• DO NOT use the test kit if any parts are cracked or broken.
• DO NOT eat or drink any parts of this kit.
• Keep out of reach of children under the age of 7 years. When children
are performing the test, be sure that testing is done under adult
supervision.
• DO NOT use any other body fluids or food to perform this test. Use
ONLY your fingerprick blood sample.
• DO NOT reuse the shaker or the cartridge. Throw these parts away
after using them once. Refer to Step 11 on the front side of this insert.
• If the solution from inside the shaker touches your skin or your eyes,
flush with water.
• Leave the cartridge pouch sealed until ready for use.
• DO NOT add your blood directly to the cartridge. Your blood must first
be added to the shaker.
• DO NOT touch the white circle area of the cartridge.
• This test is to be used at room temperature between 18° and 25°C
(64° and 77°F). Using the test outside this temperature range will
give you an error code.
• The test cartridges should not be used if the foil pouch or any other
protective packaging is damaged.
• Caution: The analyzer contains material of animal origin and
should be handled as a potential carrier and transmitter of
disease.
LIMITATIONS
• This test is NOT for the screening or diagnosis of diabetes.
• If the user has high levels of Haemoglobin F, Haemoglobin S,
Haemoglobin C, or other haemoglobin variants, the A1CNow system
may report incorrect results.
• Any cause of shortened red cell survival (e.g., haemolytic anemia or
other haemolytic diseases, pregnancy, recent significant blood loss,
etc.) will reduce exposure of red cells to glucose. This results in a
decrease in A1C concentrations (mmol/mol). Glycated haemoglobin
results are not reliable in users with chronic blood loss and
consequent variable erythrocyte life span.
• Rheumatoid Factor in high amounts will cause low results, or an
error code. It is recommended that A1C be re-checked by alternate
methodology, such as boronate affinity, by a healthcare professional.
• This test is NOT a substitute for regular healthcare provider visits and
blood glucose monitoring.
• As with any laboratory procedure, a large discrepancy between
clinical impression and test results usually warrants investigation.
QUALITY
CONTROLS
Each PTS Diagnostics A1CNow Self Check analyzer performs over 50
internal chemical and electronic quality control checks, including
potential hardware and software errors (e.g. cartridge alignment,
programming), and potential test strip errors (e.g. insufficient sample
volume, invalid calculations). The analyzer has been programmed to
report an error code if these quality checks are not passed. Contact
Customer Service at +1-317-870-5610, if you receive any errors.
TROUBLESHOOTING
See the table below for a description of A1CNow Self Check test system
operating and error codes (“OR”= Out of Range, “QC”= Quality Control,
“E”= Analyzer Error).
MESSAGE DESCRIPTION AND RESOLUTION
OR 1
The blood sample may have too little haemoglobin for
the test to work properly, or you added too little blood.
Call Customer Service.
OR 2
The blood sample may have too much haemoglobin for
the test to work properly, or you added to much blood.
Call Customer Service.
OR 3
The blood sample may have too little haemoglobin
A1C for the test to work properly, or you added too
little blood. Call Customer Service.
OR 4
The blood sample may have too much haemoglobin
A1C for the test to work properly, or you added too
much blood. Call Customer Service.
OR 5
The analyzer temperature is below 18°C (64°F). The
test must be repeated with a new cartridge at room
temperature (18-25°C).
OR 6
The analyzer temperature is above 25°C (77°F). The
test must be repeated with a new cartridge at room
temperature (18-25°C).
<20
The A1C is less than 20 mmol/mol. Call Customer
Service.
>120
The A1C is greater than 120 mmol/mol. Call your
healthcare professional.
QC 2
Occurs when you insert a cartridge that already has
sample added to it. Do not remove and reinsert a
cartridge after adding sample.
QC 6
Sample was added to cartridge before “SMPL” display.
This counts down one test on the analyzer. Remove
and discard cartridge. To avoid this error, do not add
sample until the “WAIT” prompt clears and “SMPL”
appears.
QC 7
The cartridge remained in the analyzer without sample
addition for 2 minutes after “SMPL” prompt. This
counts down one test on the analyzer. Discard the test
cartridge and insert a fresh one when you are ready to
dispense the shaker.
QC 30
to 33
The analyzer was unable to obtain a valid initial
reading. Be sure to remove the shaker within one
second after dispensing it into the sample port, and
do not disturb the analyzer while the test is running.
QC 50
to 51
QC 55
to 56
Insufficient sample was delivered to the test cartridge.
To avoid this error be sure to fully insert the blood
collector into the shaker and shake immediately.
All other
QC Codes
The quality control checks inside the analyzer did not
pass. The test will need to be repeated with another
kit. Call Customer Service.
E Codes
The analyzer is not working. Call Customer Service.
Customer Service:
+1-317-870-5610
DISPOSAL OF MATERIALS
Keep the analyzer to run the other test(s) and dispose of it after the last
test has been performed. Dispose of the other used components (except
the lancet) in household waste. Each lancet, shaker, blood collector and
cartridge can be used only once.
Since the lancet has a sharp point, it should be disposed of in an
appropriate sharps container in the same way you dispose of your blood
sugar testing lancets.
The analyzer could have residual biological material and in this case it
should be regarded as contaminated waste and be disposed of in an
appropriate biohazardous waste container.
PERFORMANCE
CHARACTERISTICS
Expected Values (non-diabetic population)
The expected normal range for mmol HbA1c/mol Hb (or % A1C) using
the system was determined by testing blood samples from
118 presumptively non-diabetic individuals (fasting glucose levels <127
mg/dL or <7 mmol/L) across three US sites. The population included 33
males and 85 females, and an age range from 19 to 76 with a mean age
of 43. The mean HbA1c result was 33± 7.8 mmol/mol (or 5.2% ±0.71%)
(1 SD). The 95% confidence limits were 19-48 mmol/mol (or 3.9% to
6.5%). These values are similar to those reported in the literature.
Linearity
Studies were performed to evaluate the linearity of the
system across its dynamic range. Clinical samples representing low and
high HbA1c levels were identified, and were mixed in various proportions
into nine preparations. These samples were tested in replicates of at
least five (n = 5). The observed results were compared to the expected
results and analyzed in terms of percent recovery. The test is linear for
A1C levels between 20 and 120 mmol/mol (4% and 13%), and produces
reliable results with hematocrits between 20% and 60% packed cell
volume (PCV).
Precision
The precision analysis was performed with 110 diabetic (n=93) and non-
diabetic (n=17) subjects across two US sites. Each subject performed 2
self-tests using the A1CNow Self Check test system, with blood samples
taken from two separate fingersticks. The analysis was performed on all
subjects who received a numeric result for both self-tests. The data are
provided below.
N
AVERAGE WITHIN
SUBJECT SD
AVERAGE WITHIN
SUBJECT CV
74
4.5 (0.41)
6.0% (4.57%)
Accuracy
Accuracy studies were conducted with 110 diabetic (n=93) and
non-diabetic (n=17) subjects across two US sites. Each subject
performed 2 self-tests using the A1CNow Self Check test system, with
blood samples taken from two separate fingersticks. Venous blood
was also collected from each subject for comparative testing using an
NGSP-certified laboratory method. All subject self-tests which resulted
in evaluable numeric readings were included in the analysis. Accuracy
was based on the regression of the two subject self-tests compared to the
laboratory method result, and bias calculations were conducted. The data
are provided below.
A1CNow Self Check Fingerstick Comparative Testing
(NGSP-certified method is the TOSOH A1C 2.2 Plus)
N
R
2
ADJ.
SLOPE
Y-INTERCEPT
178
0.924
1.010
0.135
(Analytical Bias at 42, 64 and 86 (6, 8 and 10%))
A1C VALUE
BIAS
STANDARD ERROR
42 (6%)
2 (0.20)
0.5 (0.05)
64 (8%)
2 (0.22)
0.4 (0.04)
86 (10%)
3 (0.24)
0.7 (0.07)
Interference Testing/Specificity
Studies were performed to assess the effect of common test interferents,
various common over-the-counter therapeutic agents, and oral
antihyperglycemic agents commonly used to treat Type Il diabetes.
Two levels of A1C (low and high, approximately 20 and 86 mmol/mol,
respectively) were tested. See table below.
INTERFERENT
TEST CONCENTRATION
Bilirubin (unconjugated)
20 mg/dL
0.34 mmol/L
Triglycerides
3000 mg/dL
49 mmol/L
Haemoglobin
500 mg/dL
78E-3 mmol/L
Acetaminophen/Paracetamol
8 mg/dL
0.53 mmol/L
Ascorbic acid
5 mg/dL
0.28 mmol/L
Ibuprofen
12 mg/dL
0.53 mmol/L
Acetylsalicylic acid
1 mg/dL
56E-3 mmol/L
Glyburide (glibenclamide)
24E-3 mg/dL 490E-6 mmol/L
Metformin
(1.1-dimenthylbiguanide HCI)
2.5 mg/dL
0.15 mmol/L
The studies showed no effect from any of these potential interferents
at concentrations up to approximately 5-times their normal levels
or therapeutic doses. Studies showed no interference from modified
hemoglobins, including labile glycated hemoglobin when tested at two
levels of % A1C (low and high, approximately 31 and 97 mmol/mol
respectively). The modified hemoglobins, and the levels evaluated, were:
labile hemoglobin with 78 mmol/L glucose, carbamylated hemoglobin
at a final concentration of 5 mmol/L potassium cyanate, and acetylated
hemoglobin at a final concentration of 14 mmol/L acetylsalicylic acid.
There were mixed results from the testing of high levels of Hemoglobin
F, Hemoglobin S, and Hemoglobin C. Unreliable results may be obtained
from patients with elevated levels of variant hemoglobins.
FREQUENTLY ASKED QUESTIONS
When should I do the A1CNow Self Check system test?
The A1CNow Self Check system test can be performed at any time of day.
No fasting is required. You may wish to run the test at the same time you
do your blood sugar test.
Sometimes I have trouble getting a blood drop that is large
enough. What can I do?
Try washing your hands in warm water. Warm water will help increase
blood flow for a better fingerprick. You may also massage the finger
before the fingerprick.
What is the best way to fill the blood collector?
Hold the blood collector horizontally or at a 45° angle relative to the
blood drop. Touch the tip gently to the drop of blood and allow the tube
to fill. It will stop automatically when it is filled completely.
My blood collector is not filled completely. What should I do?
Apply pressure to your finger to get more blood. Again, touch the tip
gently to the drop of blood and allow the tube to fill. You may have to
re-prick your finger to get the necessary blood. If the blood collector does
not fill, call Customer Service: +1-317-870-5610.
There is extra blood on the tip of the blood collector. What
should I do?
Carefully wipe the tip of the blood collector with a piece of gauze or
tissue. If some of the blood comes out while doing this, touch the tip
gently to the blood drop to re-fill the blood collector.
The shaker seemed to leak when I pushed the blood collector
into it. What should I do?
Call Customer Service.
The cartridge will not insert into the analyzer.
What should I do?
Make sure you are inserting the cartridge facing correctly. The code
should be on top as you insert the cartridge into the analyzer.
I accidentally opened the cartridge pouch too early. What should
I do?
Throw away the cartridge that has been opened for more than 2 minutes.
Inaccurate results can be obtained. Use another cartridge in the kit
instead.
The codes on the cartridge and the analyzer are not the same.
Do not use the cartridge. Save the packaging materials and call Customer
Service.
The analyzer did not turn on after I inserted the cartridge. What
should I do?
Take the cartridge out. Re-insert in until it ‘clicks’. If the analyzer still does
not turn on, this means that it may have a problem and can’t be used. Call
Customer Service.
I did not see ‘RUN’ and a countdown after I added the sample
using the shaker. What should I do?
Call Customer Service.
My result says ‘QCOK’ and a number. What should I do?
‘QCOK’ means the analyzer is working correctly. The number you see is
your A1C result. Write your result down in the result log on the front of
this insert. The analyzer will show the result for 60 minutes and will turn
off automatically.
Review your result with your healthcare professional.
My result is not ‘QCOK’ and a number. What should I do?
If “QCOK” is not displayed, refer to troubleshooting section or contact
Customer Service.
What should I do with the test after I am done with it?
After you write down your result, you can throw away the used blood
collector, shaker, and cartridge appropriately. These items can be used
only once. Note that the lancet is also a single-use item.
Save the analyzer for additional tests (see outside box for quantity as it
may vary). The analyzer will display, for example, “01TL” showing that
there is one test left. When analyzer is displaying “00TL”, it indicates that
you have used all tests. Once you have used all tests, you can discard the
analyzer appropriately.
Self Check
A1CNow
®
A1CNow
+
®
Sistema professionale
di autodiagnosi
A1CNow
®
A1CNow
+
®
Sistema professionale
A1CNow
®
Self Check
Sistema di analisi
QUESTIONS OR COMMENTS
Call Customer Service: +1-317-870-5610.
REFERENCES
1. Burtis, C.A., Ashwood, E.R., Tietz Textbook of Clinical Chemistry, 3rd Edition, W.B.
Saunders Co., 1999.
2. American Diabetes Association. Standards of medical care in diabetes-2011. Diabetes
Care, 34 (S1) 2011, pp. S11-S61.
CUSTOMER SERVICE
For assistance with PTS Diagnostics products, please contact
PTS Diagnostics Customer Service (M-F, 6 a.m. - 9 p.m. US EST) or your
local authorized dealer.
Toll-free inside the USA and Canada:
1-877-870-5610
Direct:
+1-317-870-5610
Fax:
+1-317-870-5608
E-mail:
The A1CNow system is manu fac tured in the United States by Polymer
Technology Systems, Inc., Indianapolis, IN 46268 USA.
© 2018 Polymer Technology Systems, Inc.
A1CNow is a trademark of Polymer Technology Systems, Inc.
All other trademarks and product names are the property of their
respective owners.
EXPLANATION OF SYMBOLS
Use by
Catalog number
Lot number
Consult instructions for use
Caution
Contains sufficient for <n> tests
Authorized representative in the European Community
Keep away from sunlight
Keep dry
In vitro
diagnostic medical device
Manufacturer
This product fulfills the requirements of European Directive
98/79/EC on
in vitro
diagnostic medical devices
Temperature limitation
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
Polymer Technology Systems, Inc.
7736 Zionsville Road,
Indianapolis, IN 46268 USA
+1-317-870-5610
Product requires separate collection for electrical and electronic equipment
per the WEEE Directive
