4. Open the foil pouch, and check the test device and Spoit 9.

9. After applying the sample, immediately press the 10. Apply the sample mixture at the sample well of the test
Quality approved by SD BIOSENSOR / For In vitro use only
(Blue) with HbA1c latex tablet in the foil pouch. center button to start the test. device.
11. After applying the sample, immediately press the
HbA1c

Test Device
start button.
STANDARD F

(36°F)
2°C
(86°F)
1. Result window

30°C
HbA1c F-A1C

<Foil pouch> <Spoit (Blue)> <Test Device>

2. Sample well

STANDARDTM F HbA1c 12. The analyzer will automatically display the test result after
PLEASE READ THE INSTRUCTIONS CAREFULLY BEFORE YOU PERFORM THE TEST 3 minutes.

• Do not write on the bar code or damage the bar code of the test device.
CAUTION 10. The analyzer will automatically display the test result after
3 minutes.
[Test Procedure]
• Using a STANDARD F100 Analyzer 3 Read
1. Prepare a STANDARD F100 Analyzer and set the 'Standard After 3 mins
Test' mode according to the analyzer's manual. • Do not put bubbles in the sample well of the test device.
EXPLANATION AND SUMMARY 2. Take the test device and the spoit out of the foil pouch. • Discard the used test kit in proper container, according to your healthcare professional’s
[Introduction] recommendation.
High levels of blood glucose result in over-glycation of proteins throughout the body including hemoglobin.1 Glycation of CAUTION • If you feel the test result is inaccurate or do not agree your test result, do not change the treatment and
hemoglobin can occur at the amino termini of the alpha and beta chains, as well as other sites with free amino groups.1 • Using a STANDARD F200 Analyzer contact your healthcare professional.
Hemoglobin A undergoes a slow glycation with glucose that is dependent on the time-average concentration of glucose over 1. Prepare a STANDARD F200 Analyzer and select the
the 3 months life span of red blood cells. The correlation of glycated hemoglobin (HbA1c) and blood glucose levels makes `Standard Test’ on the analyzer’s screen. • The mark on the label between sample well and result window is scanned by the STANDARD F200
it a useful method of monitoring long-term blood glucose levels in people with diabetes.2 Previous studies, such as the
Analyzer and displayed on the screen.
Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS), used glycated
NOTE
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 3. Insert the test device into the Test Slot of the analyzer. The INTERPRETATION OF TEST RESULTS
analyzer automatically reads the information of the bar 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 result
[Intended use] code on the test device and releases the test device for is above 15%, it will be reported as “↑15%”.
STANDARD F HbA1c is an in vitro diagnostic system for quantitative measurement of HbA1c in human capillary or venous adding sample.
whole blood. This test is for professional use to monitor glycemic control in people with diabetes. STANDARD F HbA1c should 2. Input operator ID, patient ID, and order #. If patient ID is • Results should be considered in conjunction with the clinical history and other data available to the
be used with the appropriate analyzer, STANDARD F Analyzers, manufactured by SD BIOSENSOR. not input into the analyzer by touching the ‘Direct’ item, physician.
the analyzer will regard the test as that of the guest. • If an error message appears on the analyzer's screen, refer to the analyzer's manual.
CAUTION
[Test principle] 3. Take the test device out of the foil pouch.
STANDARD F HbA1c is based on a reflectometry and immunoassay technology. STANDARD F HbA1c uses an anti-HbA1c(%) [Calibration]
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 is calibrated to %HbA1c result of the Diabetes Control and Complication Trial (DCCT) through the National
STANDARD F HbA1c contains a test device, latex-tablet and extraction buffer. The extraction buffer is instantly lysed to release Glycohemoglobin Standardization Program (NGSP). All values in this insert manual are in NGSP calibration.
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
[Expected values]
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- 4. Collect the 5μl of blood sample with the spoit. The sample %HbA1c Interpretation of results
HbA1c antibody coated line. The amount of the blue conjugates on the anti-HbA1c line reflects the amount of HbA1c in the will be collected automatically by the capillary action when 4. Once the ‘Insert Device’ is displayed in the screen, insert 4-6 Non Diabetic Range
sample. For measuring of total hemoglobin in the sample, STANDARD F Analyzer measured the intensity of the total Hb assay the end of spoit is put on the sample. the test device to the Test Slot of the analyzer. 7 ADA Target *
zone color at the test panel. Chemical and immuno reaction that occurs on the test panel are measured by optical system in 8-12 Above Target
STANDARD F Analyzer. This analyzer measures both fractions and an algorithm converts the result into the percentage HbA1c
in the sample. *ADA: American Diabetes Association

[Kit contents]
① Test Device ② Spoit (Blue) ③ Extraction buffer ④ Instructions for use QUALITY CONTROL
[STANDARD F Analyzers Calibration Check]
[Materials required but not provided] The calibration set test of STANDARD F Analyzers should be conducted according to the analyzers’ manual.
• STANDARD F Analyzer When to use calibration set
5. When inserting the test device to the analyzer, the
1. Before using the analyzer for the first time
analyzer automatically reads the information of the bar
2. When you drop the analyzer
KIT STORAGE AND STABILITY code on the test device and releases the test device for
adding sample.
3. Whenever you do not agree with your result
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. 4. When you want to check the performance of an analyzer and test device
Do not freeze the kit. How to use calibration set
Calibration set test is a required function that ensures optimal performance by checking the internal analyzer optics and
functions.
WARNINGS AND PRECAUTIONS • If you use the venous whole blood, check the collection date and the anticoagulant. 1. Select the ‘Calibration’ menu.
1. STANDARD F HbA1c is only use for in vitro diagnostic. 2. The specific calibration set is included with the analyzer.
CAUTION
2. Carefully follow instructions and procedures described in this instruction before testing. 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.
3. STANDARD F HbA1c should be used with STANDARD F Analyzers.
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 6. Collect the 5μl of blood sample with the Spoit (Blue). The [External quality control]
damaged or the seal is broken. sample will be collected automatically by the capillary Quality control testing should be run to check the performance of STANDARD F HbA1c and STANDARD F Analyzers. STANDARD
5. STANDARD F HbA1c is only single use. Do not re-use it. 5. Insert the edge of the spoit into an extraction buffer tube. action when the end of spoit is put on the sample. F HbA1c Control manufactured by SD BIOSENSOR should be used for quality control testing. Control test should be conducted
6. A blood sample of person with hemolytic anemia or microorganism infection can produce the inaccurate results. 6. Mix the sample, latex tablet, and extraction buffer by in accordance with the instruction of STANDARD F HbA1c Control.
7. Extreme Hematocrit (below 25% or over 65%) may affect the test result. carefully pressing and releasing the rubber at the top of Control test should be run:
8. Do not use frozen blood or any artificial materials. the spoit for 6-8 times. Mix well to avoid bubble forming. -- once for each new lot.
9. If the total hemoglobin result is out of 7-23g/dL, the test result the test result could be inaccurate. -- once for each untrained operator.
10. Do not use other anticoagulant (sodium or lithium heparin, K2 EDTA or sodium citrate is available). -- as required by test procedures in the instructions for use of STANDARD F HbA1c Control and in accordance with local, state
11. Before testing, check the latex tablet if it is not contaminated or broken. and federal regulations or accreditation requirements.
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. PERFORMANCE CHARACTERISTICS
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.
[Accuracy (Method comparison)]
The accuracy of STANDARD F HbA1c Test system(y) was assessed by comparing results obtained by using an NGSP-certified
17. Blood sample, HbA1c latex tablet and extraction buffer should be well mixed by using the rubber at the top of the Spoit
Put in 6-8 times mix method (x=reference), a high performance liquid chromatography (HPLC). The following results were obtained by 80 patients.
(Blue). And then, immediately apply the sample at the test device within 1 minute at least.
18. Use the STANDARD F HbA1c at 15-32°C / 59-90°F. Slope Y-intercept R
19. Mix well to avoid bubble forming and do not put bubbles in the sample well of the test device. 0.9765 0.1254 0.9986
20. All kit components are must be at room temperature (15-30°C / 59-86°F) 30 minutes before running the assay. 7. Insert the edge of the spoit into an extraction buffer tube.
21. Do not write on the bar code or damage the bar code of the test device. *NGSP certification Bias criteria: 37 of 40 results within ± 6%
8. Mix the sample, latex tablet, and extraction buffer by
7. Collect all the reaction mixture with the spoit from the
carefully pressing and releasing the rubber at the top of
tube.
SPECIMEN COLLECTION AND PREPARATION the spoit for 6-8 times. Mix well to avoid bubble forming. Criteria Below -6% Between -6% and 6% Over 6%
Sample # 2 76 2
[Whole blood]
• Capillary whole blood % 2.5%(2/80) 95%(76/80) 2.5%(2/80)
1. Capillary whole blood should be collected aseptically by fingertip. *This represents the 95% results within ±6%
2. Clean the area to be lanced with an alcohol swab.
3. Squeeze the end of the fingertip and pierce with a sterile lancet.
4. Collect the accurate volume of capillary whole blood using the Spoit (Blue) in kit for the testing. [Precision]
5. The capillary whole blood must be tested immediately after collection. Put in 6-8 times mix
Precision studies were performed according to the CLSI (Clinical and Laboratory Standards Institute) guideline EP5-A.
Within-run, between-day and total precision were determined with three levels of EDTA blood sample assayed for 5 days. The
• Venous whole blood samples were analyzed in duplicate twice a day.
1. Collect the venous whole blood into the commercially available anti-coagulant tube such as K2 EDTA, sodium heparin, lithium Average Within-run Between-day Total
Sample N
heparin, sodium fluoride by venipuncture. %HbA1c CV (%) CV (%) CV (%)
2. The venous blood treated by anticoagulant is able to test within 8 hours at room temperature. 8. Apply the sample mixture at the sample well of the test 9. Collect all the reaction mixture with the spoit from the Sample 1 20 4.8 1.46% 1.18% 2.33%
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 device. tube. Sample 2 20 7 1.64% 1.52% 2.58%
testing within 3 days after collection.
Sample 3 20 13.7 1.61% 1.38% 2.38%
4. Do not use hemolyzed blood samples.

• Anticoagulants such as K2 EDTA, sodium heparin, lithium heparin, sodium fluoride do not affect the test
result. [Abnormal Hemoglobins]
• As known relevant interference, haemolytic samples, rheumatoid factors-contained samples and STANDARD F HbA1c uses immunoassay to determine the level of A1C in a blood sample. STANDARD F HbA1c do not interfere
CAUTION lipaemic, icteric samples can lead to impair the test results. with Hb S, Hb F, Carbamylated Hemolgobin.
• Do not use the frozen blood or the artificial materials.
[Interfering Substances]
The following materials with up to the indicated concentration do not interfere with the test result.
TEST PROCEDURE Acetaminophen 30mg/dL Acetylsalicylic acid 30mg/dL
[Preparation] Ibuprofen 50mg/dL Ascorbic acid 10mg/dL
1. Allow kit components and collected sample to room Rheumatoid Factor 600IU/mL Bilirubin 20mg/dL
temperature (15-30°C/ 59-86°F) at least 30 minutes before Metformim 5.1mg/dL Caffeine 30mg/dL
starting the test. Glibenclamide 0.2mg/dL Hydroxyzine dihydrocholoride 30mg/dL
2. Carefully read instructions for the STANDARD F HbA1c. / Item HbA1c

/ REF No. xxxxxxxxxxxx

Labile A1c 2,000mg/mL Triglyceride 900mg/dL
3. Check the expiry date at the back of the foil pouch. Use / LOT No. xxxxxxxxxxxx
xxxx.xx.xx

Carbamylated hemoglobin 20 mg/mL Glyburide 20mg/dL

/ MFG DATE
xxxx.xx.xx

another lot, if expiry date has passed.

/ EXP DATE

ML25RT7MLR1
Acetylated hemoglobin 200mg/mL Dopamine 2mg/dL
Issue date : 2017.10
STANDARDTM F HbA1c

BIBLIOGRAPHY
1. Goldstein DE, Little RR, Lorenz RA, Malone JI, Nathan D, Peterson CM. Tests of glycemia in diabetes. Diabetes Care 1995;
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.
6. Little RR et al., Relationship of glycosylated hemoglobin to oral glucose tolerance. Implications for diabetes screening.
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 of
the control of the SD BIOSENSOR and distributor and the result may accordingly be affected by environmental factors and/or user
error. A person who is the subject of the diagnosis should consult a doctor for further confirmation of the result.

Warning
The SD BIOSENSOR and distributors of this product shall not be liable for any losses, liability, claims, costs or damages whether direct
or indirect of consequential arising out of or related to an incorrect diagnosis, whether positive or negative, in the use of this product.

Manufactured by
Head office : C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690,
REPUBLIC OF KOREA
Manufacturing site : 74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-
do, 28161, REPUBLIC OF KOREA
Authorized Representative

Altenhofstrasse 80 D-66386 St. Ingbert Germany

Phone : +49 6894 581020, Fax : +94 6894 581021

Any inquiries regarding the instructions provided should be addressed to: [email protected]
or you can also contact us through www.sdbiosensor.com

L28A1C1ENR5
Issue date: 2017.11

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

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