4.

Open the foil pouch, and check a test device, a silica gel,
Quality approved by SD BIOSENSOR / For In vitro use only
and a Spoit™ containing a HbA1c latex tablet. HbA1c

Test Device
(36°F)
2°C
STANDARD F

(86°F)
1. Result window

30°C
Yellow

HbA1c
Green
2. Sample well
Yellow : Valid
F-A1C Green : Invalid
<Foil pouch> <SpoitTM (Blue)> <Test Device> <Silica gel>

STANDARD TM
F HbA1c
PLEASE READ THE INSTRUCTIONS CAREFULLY BEFORE YOU PERFORM THE TEST
• Do not write on the bar code or damage the bar code of the test device.
• If the color of moisture indicators are changed from yellow to green, please do not use the test device.
CAUTION

[Test Procedure]
EXPLANATION AND SUMMARY • Using a STANDARD F100 Analyzer
1. Prepare a STANDARD F100 Analyzer and set the 'Standard
[Introduction] Test' mode according to the analyzer's manual.
High levels of blood glucose result in over-glycation of proteins throughout the body including hemoglobin.1 Glycation of
2. Take the test device and the SpoitTM out of the foil pouch.
hemoglobin can occur at the amino termini of the alpha and beta chains, as well as other sites with free amino groups.1
Hemoglobin A undergoes a slow glycation with glucose that is dependent on the time-average concentration of glucose
over the 3 months life span of red blood cells. The correlation of glycated hemoglobin (HbA1c) and blood glucose levels
makes it a useful method of monitoring long-term blood glucose levels in people with diabetes.2 Previous studies, such as
the Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS), used
glycated hemoglobin as a way to measure overall glycemic control during the studies. These studies and others have shown
that tight glycemic control is associated with fewer diabetes-related complications (e.g., vision problems, cardiovascular
problems, and kidney problems).3 Studies show a direct relationship between %HbA1c and average blood glucose (MBG)
levels. For every 1% change in HbA1c, there is a change of about 30 mg/dL in MBG.4-8

[Intended use] 3. Insert the test device into the Test Slot of the analyzer. The
STANDARD F HbA1c is an in vitro diagnostic system for quantitative measurement of HbA1c in human capillary or venous analyzer automatically reads the information of the bar
whole blood. This test is for professional use to monitor glycemic control in people with diabetes. STANDARD F HbA1c should code on the test device and releases the test device for
be used with the appropriate analyzer, STANDARD F Analyzers, manufactured by SD BIOSENSOR. adding sample.

[Test principle]
STANDARD F HbA1c is based on a reflectometry and immunoassay technology. STANDARD F HbA1c uses an anti-HbA1c(%)
antibody which is specific for the first few amino acid residues of the glycated N-terminus of the β-chain of hemoglobin
A0. STANDARD F HbA1c contains a test device, latex-tablet and extraction buffer. The extraction buffer is instantly lysed
to release the glycated hemoglobin (hereafter, HbA1c) and the latex-tablet included the blue dyed latex-microparticles
conjugated to specific antibodies. When whole blood is added to the buffer solution and is mixed with the latex-tablet,
the erythrocytes are instantly lysed to release the HbA1c. When the sample mixture is loaded onto the sample port of
the test panel, the mixture fluid migrates along the membrane of test panel by capillary action and then HbA1c has been
immobilized onto the anti-HbA1c antibody coated line. The amount of the blue conjugates on the anti-HbA1c line reflects 4. Collect the 5μl of blood sample with the SpoitTM. The
the amount of HbA1c in the sample. For measuring of total hemoglobin in the sample, STANDARD F Analyzer measured the sample will be collected automatically by the capillary
intensity of the total Hb assay zone color at the test panel. Chemical and immuno reaction that occurs on the test panel are action when the end of SpoitTM is put on the sample.
measured by optical system in STANDARD F Analyzer. This analyzer measures both fractions and an algorithm converts the
result into the percentage HbA1c in the sample.

[Kit contents]
① Test Device ② Extraction buffer ③ Instructions for use

[Materials required but not provided]

• STANDARD F Analyzer

KIT STORAGE AND STABILITY

Store the kit at 2-30°C / 36-86°F, out of direct sunlight. Kit materials are stable until expiration date printed on the outer box.
Do not freeze the kit.

WARNINGS AND PRECAUTIONS

1. STANDARD F HbA1c is only use for in vitro diagnostic. • If you use the venous whole blood, check the collection date and the anticoagulant.
2. Carefully follow instructions and procedures described in this instruction before testing.
3. STANDARD F HbA1c should be used with STANDARD F Analyzers. CAUTION
4. STANDARD F HbA1c should remain in its original sealed pouch until ready to use. Do not use the test kit if the pouch is 5. Insert the edge of the SpoitTM into an extraction buffer
damaged or the seal is broken. tube.
5. STANDARD F HbA1c is only single use. Do not re-use it. 6. Mix the sample, latex tablet, and extraction buffer by
6. A blood sample of person with hemolytic anemia or microorganism infection can produce the inaccurate results. carefully pressing and releasing the rubber at the top of
7. Extreme Hematocrit (below 25% or over 65%) may affect the test result. the SpoitTM for 6-8 times. Mix well to avoid bubble forming.
8. Do not use frozen blood or any artificial materials.
9. If the total hemoglobin result is out of 7-23g/dL, the test result the test result could be inaccurate.
10. Do not use other anticoagulant (sodium or lithium heparin, K2 EDTA or sodium citrate is available).
11. Before testing, check the latex tablet if it is not contaminated or broken.
12. Place the analyzer on a flat surface when in use.
13. Wash your hands in warm, soapy water. Rinse well and dry completely before testing.
14. Discard the used test kit according to the proper method.
15. Mix the blood sample and extraction buffer well. And then, collect all of the mixed solution.
16. Check the expiration date printed at the pouch or package. Put in 6-8 times mix
17. Blood sample, HbA1c latex tablet and extraction buffer should be well mixed by using the rubber at the top of the
SpoitTM. And then, immediately apply the sample at the test device within 1 minute at least. 7. Collect all the reaction mixture with the SpoitTM from the
18. Use the STANDARD F HbA1c at 15-32°C / 59-90°F. tube.
19. Mix well to avoid bubble forming and do not put bubbles in the sample well of the test device.
20. All kit components are must be at room temperature (15-30°C / 59-86°F) 30 minutes before running the assay.
21. Do not write on the bar code or damage the bar code of the test device.

SPECIMEN COLLECTION AND PREPARATION

[Whole blood]
• Capillary whole blood
1. Capillary whole blood should be collected aseptically by fingertip.
2. Clean the area to be lanced with an alcohol swab.
3. Squeeze the end of the fingertip and pierce with a sterile lancet. 8. Apply the sample mixture at the sample well of the test
4. Collect the accurate volume of capillary whole blood using the SpoitTM in kit for the testing.
5. The capillary whole blood must be tested immediately after collection. device.

• Venous whole blood

1. Collect the venous whole blood into the commercially available anti-coagulant tube such as K2 EDTA, sodium heparin,
lithium heparin, sodium fluoride by venipuncture.
2. The venous blood treated by anticoagulant is able to test within 8 hours at room temperature.
3. If venous whole blood in an anti-coagulant tube is stored in a refrigerator at 2-8°C / 36-46°F, the specimen can be used for
testing within 3 days after collection.
4. Do not use hemolyzed blood samples.

• Anticoagulants such as K2 EDTA, sodium heparin, lithium heparin, sodium fluoride do not affect the
test result. 9. After applying the sample, immediately press the
• As known relevant interference, haemolytic samples, rheumatoid factors-contained samples and
center button to start the test.
CAUTION lipaemic, icteric samples can lead to impair the test results.
• Do not use the frozen blood or the artificial materials.

TEST PROCEDURE
[Preparation]
1. Allow kit components and collected sample to room
temperature (15-30°C/ 59-86°F) at least 30 minutes before
starting the test.
2. Carefully read instructions for the STANDARD F HbA1c.
3. Check the expiry date at the back of the foil pouch. Use / Item HbA1c

another lot, if expiry date has passed. 10. The analyzer will automatically display the test result after
/ REF No. xxxxxxxxxxxx

/ LOT No. xxxxxxxxxxxx

xxxx.xx.xx

3 minutes.
/ MFG DATE
/ EXP DATE xxxx.xx.xx

3
ML25RT7MLR1
Issue date : 2017.10

Read
After 3 mins
STANDARD™ F HbA1c

• Using a STANDARD F200 Analyzer [Expected values]

1. Prepare a STANDARD F200 Analyzer and select the %HbA1c Interpretation of results
`Standard Test’ on the analyzer’s screen.
4-6 Non Diabetic Range
7 ADA Target *
8-12 Above Target
*ADA: American Diabetes Association

QUALITY CONTROL
2. Input operator ID, patient ID, and order #. If patient ID is [STANDARD F Analyzers Calibration Check]
not input into the analyzer by touching the ‘Direct’ item, The calibration set test of STANDARD F Analyzers should be conducted according to the analyzers’ manual.
the analyzer will regard the test as that of the guest. When to use calibration set
3. Take the test device out of the foil pouch. 1. Before using the analyzer for the first time
2. When you drop the analyzer
3. Whenever you do not agree with your result
4. When you want to check the performance of an analyzer and test device
How to use calibration set
Calibration set test is a required function that ensures optimal performance by checking the internal analyzer optics and
functions.
4. Once the ‘Insert Device’ is displayed in the screen, insert 1. Select the ‘Calibration’ menu.
the test device to the Test Slot of the analyzer. 2. The specific calibration set is included with the analyzer.
3. Insert the CAL-1 first, and then insert the CAL-2 for UV-LED testing and the CAL-3 for RGB-LED testing in order.

[External quality control]

Quality control testing should be run to check the performance of STANDARD F HbA1c and STANDARD F Analyzers. SDB
HbA1c Control manufactured by SD BIOSENSOR should be used for quality control testing. Control test should be conducted
in accordance with the instruction of SDB HbA1c Control.
Control test should be run:
-- once for each new lot.
5. When inserting the test device to the analyzer, the -- once for each untrained operator.
analyzer automatically reads the information of the bar -- as required by test procedures in the instructions for use of SDB HbA1c Control and in accordance with local, state and
code on the test device and releases the test device for federal regulations or accreditation requirements.
adding sample.

PERFORMANCE CHARACTERISTICS
[Accuracy (Method comparison)]
The accuracy of STANDARD F HbA1c Test system(y) was assessed by comparing results obtained by using an NGSP-certified
method (x=reference), a high performance liquid chromatography (HPLC). The following results were obtained by 80
6. Collect the 5μl of blood sample with the SpoitTM. The patients.
sample will be collected automatically by the capillary Slope Y-intercept R
action when the end of SpoitTM is put on the sample.
0.9765 0.1254 0.9986
*NGSP certification Bias criteria: 37 of 40 results within ± 6%

Criteria Below -6% Between -6% and 6% Over 6%

Sample # 2 76 2
% 2.5%(2/80) 95%(76/80) 2.5%(2/80)
*This represents the 95% results within ±6%

[Precision]
7. Insert the edge of the SpoitTM into an extraction buffer Precision studies were performed according to the CLSI (Clinical and Laboratory Standards Institute) guideline EP5-A.
tube. Within-run, between-day and total precision were determined with three levels of EDTA blood sample assayed for 5 days.
8. Mix the sample, latex tablet, and extraction buffer by The samples were analyzed in duplicate twice a day.
carefully pressing and releasing the rubber at the top of Average Within-run Between-day Total
the SpoitTM for 6-8 times. Mix well to avoid bubble forming. Sample N
%HbA1c CV (%) CV (%) CV (%)
Sample 1 20 4.8 1.46% 1.18% 2.33%
Sample 2 20 7 1.64% 1.52% 2.58%
Sample 3 20 13.7 1.61% 1.38% 2.38%

[Abnormal Hemoglobins]
STANDARD F HbA1c uses immunoassay to determine the level of A1C in a blood sample. STANDARD F HbA1c do not interfere
Put in 6-8 times mix with Hb S, Hb F, Carbamylated Hemolgobin.

9. Collect all the reaction mixture with the SpoitTM from the [Interfering Substances]
tube. The following materials with up to the indicated concentration do not interfere with the test result.
Acetaminophen 30mg/dL Acetylsalicylic acid 30mg/dL
Ibuprofen 50mg/dL Ascorbic acid 10mg/dL
Rheumatoid Factor 600IU/mL Bilirubin 20mg/dL
Metformim 5.1mg/dL Caffeine 30mg/dL
Glibenclamide 0.2mg/dL Hydroxyzine dihydrocholoride 30mg/dL
Labile A1c 2,000mg/mL Triglyceride 900mg/dL
Carbamylated hemoglobin 20 mg/mL Glyburide 20mg/dL
Acetylated hemoglobin 200mg/mL Dopamine 2mg/dL
10. Apply the sample mixture at the sample well of the test
device.
11. After applying the sample, immediately press the
BIBLIOGRAPHY
1. Goldstein DE, Little RR, Lorenz RA, Malone JI, Nathan D, Peterson CM. Tests of glycemia in diabetes. Diabetes Care 1995;
start button. 18:896-909.
2. Bunn HF. Nonenzymatic glycosylation of protein: relevance to diabetes. Am J Med 1981; 70:325-30.
3. Jovanovic L, Peterson CM. The clinical utility of glycosylated hemoglobin. Am J Med 1981; 70:331-8.
4. Nathan DM, Singer DE, Hurxthal K, Goodson JD. The clinical information value of the glycosylated hemoglobin assay.
N EnglJ Med 1984; 310:341-6.
5. Brooks DE, Devine DV, Harris PC, et al. RAMP(TM): A rapid, quantitative whole blood immunochromatographic platform
for point-of-care testing. Clin Chem 1999;45:1676-1678.
12. The analyzer will automatically display the test result after 6. Little RR et al., Relationship of glycosylated hemoglobin to oral glucose tolerance. Implications for diabetes screening.
3 minutes. Diabetes 1988; 37(1):60-64.
7. Little RR et al., Glycated haemoglobin predicts progression to diabetes mellitus in Pima Indians with impaired glucose
tolerance. Diabetologia 1994; 37:252-256.
8. Rohlfing CL et al., Use of GHb (HbA1c) in Screening for Undiagnosed Diabetes in the U.S. Population. Diabetes Care
2000; 23(2):187-191.

Product Disclaimer
Whilst every precaution has been taken to ensure the diagnostic ability and accuracy of this product, the product is used outside
• Do not put bubbles in the sample well of the test device. of the control of the SD BIOSENSOR and distributor and the result may accordingly be affected by environmental factors and/or
• Discard the used test kit in proper container, according to your healthcare professional’s user error. A person who is the subject of the diagnosis should consult a doctor for further confirmation of the result.
recommendation.
• If you feel the test result is inaccurate or do not agree your test result, do not change the treatment and Warning
CAUTION The SD BIOSENSOR and distributors of this product shall not be liable for any losses, liability, claims, costs or damages whether
contact your healthcare professional.
direct or indirect of consequential arising out of or related to an incorrect diagnosis, whether positive or negative, in the use of
this product.
• The mark on the label between sample well and result window is scanned by the STANDARD F200
Analyzer and displayed on the screen.
NOTE

Manufactured by
INTERPRETATION OF TEST RESULTS Head office : C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690,
The STANDARD F HbA1c test range is reported 4.0% to 15.0%. If the result is below 4%, it will be reported as “↓4.0%”. If the REPUBLIC OF KOREA
result is above 15%, it will be reported as “↑15%”. Manufacturing site : 74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-
do, 28161, REPUBLIC OF KOREA
• Results should be considered in conjunction with the clinical history and other data available to the
physician. Authorized Representative
• If an error message appears on the analyzer's screen, refer to the analyzer's manual.
CAUTION Altenhofstrasse 80 D-66386 St. Ingbert Germany
Phone : +49 6894 581020, Fax : +49 6894 581021
[Calibration]
STANDARD F HbA1c is calibrated to %HbA1c result of the Diabetes Control and Complication Trial (DCCT) through the
National Glycohemoglobin Standardization Program (NGSP). All values in this insert manual are in NGSP calibration. Any inquiries regarding instructions provided should be addressed to: [email protected]
or you can also contact us through www.sdbiosensor.com
L28A1C1ENR5
Issue date : 2018.01

To indicate the temperature limita�ons in Fulfill the requirements of

which the transport package has to be Direc�ve 98/79/EC on in vitro diagnos�c
kept and handled. medical devices
Reference number In vitro Diagnos�cs Consult Instruc�ons for Use Contains Sufficient Cau�on Note Do not re-use. Use by Batch code Manufacturer Date of manufacture
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