Document No. : INS-AA_F-EN (Rev.

05)
Revision date : December 21, 2016

result(s). - C-tip (Zipper bag, 10 μL) 24

The cartridge should remain sealed in its aluminum pouch until use. Do not use the
cartridge if that is damaged or already opened. - ID Chip 1
For shipping, samples must be packed in accordance with the regulations. Sample - Instruction For Use 1
with severe hemolytic and hyperlipidemia cannot be used and should be
recollected. MATERIALS REQUIRED BUT SUPPLIED ON DEMAND
Just before use, allow the cartridge and sample to be at room temperature for
approximately 30 minutes. Following items can be purchased separately from AFIAS HbA1c.
AFIAS HbA1c as well as the instrument for AFIAS tests should be used away from Please contact our sales division for more information.

HbA1c vibration and/or magnetic field. During normal usage, it can be noted that the
instrument for AFIAS tests may produce minor vibration.
Used C-tips, and cartridges should be handled carefully and disposed by an
appropriate method in accordance with relevant local regulations.
AFIAS-1 REF FPRR019
AFIAS-6 REF FPRR020
Boditech HbA1c Control REF CFPO-96
Boditech HbA1c Calibrator REF CFPO-108
INTENDED USE An exposure to larger quantities of sodium azide may cause certain health issues
like convulsions, low blood pressure and heart rate, loss of consciousness, lung
AFIAS HbA1c is a fluorescence Immunoassay (FIA) for the quantitative determination injury and respiratory failure. SAMPLE COLLECTION AND PROCESSING
of HbA1c (Hemoglobin A1c) in human whole blood. It is useful as an aid in management AFIAS HbA1c will provide accurate and reliable results subject to the following
and monitoring of the long-term glycemic status in patients with diabetes mellitus. conditions. The sample type for AFIAS HbA1c is human whole blood.
For in vitro diagnostic use only. - Use AFIAS HbA1c should be used only in conjunction with the instrument for It is recommended to test the sample within 12 hours after collection.
AFIAS tests. Samples may be stored for up to a week at 2-8 °C prior to being tested.
INTRODUCTION - Any anticoagulants other than EDTA, sodium heparin, sodium citrate should be If testing will be delayed more than a week, samples should be frozen at -70 °C or
avoided. below. Samples stored frozen at -70 °C or below for 3 months showed no
Glycated protein is formed post-translationally through the slow, nonenzymatic reaction C-tip should be used when the following conditions are met. performance difference.
between glucose and amino groups on proteins. HbA1c is a clinically useful index of mean Once the sample was frozen, it should be used one time only for test, because
glycemia during the preceding 120 days, the average life span of erythrocytes. Carefully - C-tip provided with the kit is recommended to obtain correct test result.
repeated freezing and thawing can result in the change of test values.
controlled studies have documented a close relationship between the concentrations of - Capillary blood should be immediately tested after collection. Collection of capillary blood sample using C-tip (Fingertip blood)
HbA1c and mean glycemia. HbA1c is considered as a more reliable parameter in monitoring - Do not leave C-tip after collection of blood, test immediately. (1) Clean the area with a pre-injection swab.
glycemia over the glycemic reading with the conventional glucometer. (2) Pierce with a sterile lancet.
- Do not perform a test with C-tip on General Mode. It might cause an erroneous
(3) Wipe away first drop of blood.
result.
(4) Gently massage the surrounding area towards a C-tip for a second drop.
PRINCIPLE - Excess capillary blood around the C-tip should be wiped off. (5) Hold a C-tip horizontally and touch the tip of C-tip to the blood drop.
The test uses a sandwich immunodetection method; the detector antibody in buffer - In order to avoid cross-contamination, please do not re-use C-tip for multiple (6) Capillary action will automatically draw the blood sample to C-tip and stop
binds to antigen in sample, forming antigen-antibody complexes, and migrates onto samples. (7) Wipe off any excess blood around the tip.
nitrocellulose matrix to be captured by the other immobilized-antibody on test strip. - AFIAS cartridge should be inserted and positioned in the cartridge holder prior (8) Double-check if capillary blood is fully filled in the C-tip and AFIAS reader is
The more antigen in sample forms the more antigen-antibody complex and leads to to the blood sample collection. ready for a test on the ‘C-tip mode’.
stronger intensity of fluorescence signal on detector antibody, which is Instrument for the
instrument for AFIAS tests displays the content of glycated hemoglobin in terms of percent TEST SETUP
of the total hemoglobin in blood. LIMITATIONS OF THE TEST SYSTEM
The test may yield false positive result(s) due to the cross-reactions and/or non- Check the components of the AFIAS HbA1c as described below. : Cartridge, C-tip,
ID chip and instruction for use
COMPONENTS specific adhesion of certain sample components to the capture/detector antibodies.
Keep the sealed cartridge (if stored in refrigerator) at room temperature for at least
The test may yield false negative result. The non-responsiveness of the antigen to
AFIAS HbA1c consists of ‘Cartridge’, ‘C- tip’, ‘ID chip’ and ‘Instruction for use’. the antibodies is most common where the epitope is masked by some unknown 30 minutes just prior to the test. Place the cartridge on a clean, dust-free and flat
components, so as not to be detected or captured by the antibodies. The instability surface.
Each cartridge packaged in an aluminum pouch has three components, detection or degradation of the antigen with time and/or temperature may cause the false Turn on the instrument for AFIAS tests.
buffer part, hemolysis buffer part and cartridge part. negative as it makes antigen unrecognizable by the antibodies. Empty the tip box.
Cartridge part contains a test strip, the membrane which has anti human HbA1c at Other factors may interfere with the test and cause erroneous results, such as Insert the ID chip into the “ID chip port”.
the test line, while rabbit IgG at the control line. technical/procedural errors, degradation of the test components/reagents or Please refer to the instrument for AFIAS tests ‘Operation Manual’ for complete
Detection buffer part contains anti human HbA1c-fluorescence conjugate, anti presence of interfering substances in the test samples. information and operating instructions.
rabbit IgG-fluorescence conjugate, bovine serum albumin (BSA) as a stabilizer and Any clinical diagnosis based on the test result must be supported by a TEST PROCEDURE
sodium azide in phosphate buffered saline (PBS) as a preservative. comprehensive judgment of the concerned physician including clinical symptoms
Hemolysis buffer part contains non-ionic detergent and sodium azide in phosphate and other relevant test results. 1) Select “Test Mode” in the instrument for AFIAS tests.
buffered saline (PBS) as a preservative.
C-tip (Capillary tip) is a useful tool for point of care testing which requires a small - General Mode : Tube blood (with anticoagulant)
volume of capillary blood from fingertip, heel site (in infants) or ear-lobe. STORAGE AND STABILITY - C-tip Mode : Fingertips blood (non-anticoagulant blood)
The cartridge is stable for 20 months (while sealed in an aluminum pouch) if stored - You must use C-tip only to collect test samples in both test mode (General / C-
WARNINGS AND PRECAUTIONS at 2-8 °C. tip mode). Do not use a general pipette tip to collect test samples.
2) Insert the cartridge into the cartridge holder.
For in vitro diagnostic use only.
Carefully follow the instructions and procedures described in this ‘Instruction for MATERIALS SUPPLIED 3) Take 10 μL of whole blood (tube blood or fingertip blood) with a C-tip. (Please
use’. refer to “SAMPLE COLLECTION AND PROCESSING”)
REF SMFP-28 4) Insert the whole blood-filled C-tip into the tip hole of the cartridge.
Use only fresh samples and avoid direct sunlight.
Lot numbers of all the test components (cartridge and ID chip) must match each 5) Tap the ‘START’ icon on the screen.
Components of AFIAS HbA1c
other. 6) The test result will be displayed on the screen after 10 minutes.
Cartridge Box Contains
Do not interchange the test components between different lots or use the test
components after the expiration date, either of which might yield misleading of test - Cartridge 24 ※ Note: Refer to the instrument for AFIAS tests Operation Manual to select sample type.
Document No. : INS-AA_F-EN (Rev. 05)
Revision date : December 21, 2016

establishing a diagnosis and in treatment. Ann Intern Med 1989; 110:125-37.

INTERPRETATION OF TEST RESULT - Between day 11. Molnar GD. Clinical evaluation of metabolic control in diabetes. Diabetes 1978; 27:216-25.
One person tested AFIAS HbA1c during five days; five times at each concentration 12. UK Prospective Diabetes Study. Reduction in HbA1c with basal insulin supplement, sulfonylurea
The instrument for AFIAS tests calculate the test result automatically and displays of the control standard. or biguanide therapy in maturity-onset diabetes. Diabetes 1985; 34:793-8.
HbA1c concentration of the test sample in terms of percentage (%). 13. Baker JR, Johnson RN, Scott DJ. Serum fructosamine concentrations in patients with type II (non-
The reference value - Between site insulin-dependent) diabetes mellitus during changes in management. BMJ (Clin Res Ed) 1984;
One person tested AFIAS HbA1c at three different sites; five times at each 288:1484-6.
- NGSP (%): 4.5-6.5 % 14. Tahara Y, Shima K. Kinetics of HbA1c, glycated albumin, and fructosamine and analysis of their
The working range concentration of the control standard. weight functions against preceding plasma glucose level. Diabetes Care 1995; 18:440-7.
- NGSP (%): 4-15 % HbA1c Between lot Between reader Between day Between site 15. Brooks DE, Devine DV, Harris PC, et al. RAMP(TM): A rapid, quantitative whole blood
(%) Avg. CV(%) Avg. CV(%) Avg. CV(%) Avg. CV(%) immunochromatographic platform for point of care testing. Clin Chem 1999; 45:1676-1678.
QUALITY CONTROL 5.3
8.1
5.21
8.15
2.7
3.1
5.25
8.12
3.6
2.7
5.31
8.20
2.5
2.9
5.27
8.23
2.3
3.0
Note: Please refer to the table below to identify various symbols.
Quality control tests are a part of the good testing practice to confirm the expected 13.5 13.48 2.8 13.38 3.3 13.60 2.8 13.57 2.8
results and validity of the assay and should be performed at regular intervals. Accuracy
The control tests should be performed immediately after opening a new test lot to The accuracy was confirmed each different concentrations.
ensure the test performance is not altered.
HbA1c Between lot Between reader Between day Between site
Quality control tests should also be performed whenever there is any question (%) Avg. Bias(%) Avg. Bias(%) Avg. Bias(%) Avg. Bias(%)
concerning the validity of the test results. 5.3 5.21 -0.02 5.25 -0.01 5.31 0.00 5.27 -0.01
Control materials are not provided with AFIAS HbA1c. For more information 8.1 8.15 0.01 8.12 0.00 8.20 0.01 8.23 0.02
regarding obtaining the control materials, contact Boditech Med Inc.’s Sales Division 13.5 13.48 0.00 13.38 -0.01 13.60 0.01 13.57 0.01
for assistance. Comparability
(Please refer to the instruction for use of control material.) HbA1c concentrations of 165 clinical samples were quantified independently with
AFIAS HbA1c and Tosoh G7 HPLC (Tosoh Bioscience Inc. Japan) as per prescribed
PERFORMANCE CHARACTERISTICS test procedures. Test results were compared and their comparability was
investigated with linear regression and coefficient of correlation (R). Linear
Analytical sensitivity regression and coefficient of correlation between the two tests were Y= 0.997X +
- Limit of Blank (LoB) 2.26% 0.0309 and R = 0.9982 respectively.
- Limit of Detection (LoD) 2.39%
- Limit of Quantification (LoQ) 3.0 % 16.0
Analytical Specificity
14.0
- Cross-reactivity y = 0.997x + 0.0309
There was no significant cross-reactivity from these materials with the AFIAS HbA1c 12.0 R = 0.9982

AFIAS HbA1c [%]

test measurements. N = 165
10.0
Standard material conc. (%) 8.0
cross-reactivity material 5.3 8.1 13.5
Recovery (%) 6.0
HbA0 (2 mg/mL) 98.9 102.0 101.0
HbA1a&A1b mixture (5 mg/mL) 100.9 101.9 100.1 4.0
Acetylated hemoglobin (100 mg/mL) 100.7 100.2 100.5 For technical assistance; please contact:
Carbamylated hemoglobin (100 mg/mL) 100.2 101.2 100.6 2.0 Boditech Med Inc.’s Technical Services
Glycated h-Albumin (2.2 mg/mL) 100.1 100.6 102.0 0.0
Tel: +82 33 243-1400
HbA1d (100 mg/mL) 101.6 101.3 100.5 E-mail: [email protected]
0.0 2.0 4.0 6.0 8.0 10.0 12.0 14.0 16.0
Acetylaldehyde hemoglobin (100 mg/mL) 99.8 101.4 100.7
Tosoh G7 HPLC analyzer HbA1c [%]
- Cross-reactivity
There was no significant interference from these materials with the AFIAS HbA1c Boditech Med Incorporated
REFERENCES 43, Geodudanji 1-gil, Dongnae-myeon,
test measurements.
1. Goldstein DE,Little RR, Lorenz RA, Malone JI, Nathan D, Peterson CM. Tests of glycemia in diabetes. Chuncheon-si, Gang-won-do, 24398
Standard material conc. (%) Diabetes Care 1995; 18:896-909. Republic of Korea
Interference material 5.3 8.1 13.5 2. Bunn HF. Nonenzymatic glycosylation of protein: relevance to diabetes. Am J Med 1981; 70:325- Tel: +(82) -33-243-1400
Recovery (%) 30. Fax: +(82) -33-243-9373
Non-interference 100.0 99.8 99.5 3. Jovanovic L, Peterson CM. The clinical utility of glycosylated hemoglobin. Am J Med 1981; 70:331-
Acetaminophen (1.5 mmol/L) 100.3 100.6 99.6
www.boditech.co.kr
8.
L-Ascorbic acid (5 mg/dL) 100.1 100.6 100.8 4. Nathan DM, Singer DE, Hurxthal K, Goodson JD. The clinical information value of the glycosylated
Bilirubin (20 mg/mL) 100.3 100.3 100.0 hemoglobin assay. N Engl J Med 1984; 310:341-6. Obelis s.a
D-Glucose (500 mg/dL) 99.8 100.6 102.0 5. Goldstein DE, Little RR, Wiedmeyer HM, England JD, McKenzie EM. Glycated hemoglobin: Bd. Général Wahis 53,
Intralipid (1 mg/mL) 101.0 99.7 100.5 methodologies and clinical applications. Clin Chem 1986; 32:B64-70. 1030 Brussels, BELGIUM
Triglyceride (3000 mg/mL) 100.4 99.6 99.9 6. Goldstein DE, Little RR, England JD, Wiedemeyer H-M, McKenzie E. Methods of glycosylated Tel: +(32) -2-732-59-54
Urea (100 mmol/L) 100.3 100.0 100.8 hemoglobins: high performance liquid chromatography and thiobarbituric acid colorimetric Fax: +(32) -2-732-60-03
Precision methods. In: Clarke WL, Larner J, Pohl SL, eds. Methods in diabetes research, Vol. 2. New York:
E-Mail: [email protected]
John Wiley, 1986:475-504.
- Between lot 7. Tahara Y, Shima K. The response of GHb to stepwise plasma glucose change over time in diabetic
One person tested three different lots of AFIAS HbA1c, five times at each patients. Diabetes Care 1993; 16:1313-4.
concentration of the control standard. 8. Svendsen PA, Lauritzen T, Soegaard U, Nerup J. Glycosylated haemoglobin and steady-state mean
blood glucose concentration in type 1 (insulin-dependent) diabetes. Diabetologia 1982; 23:403-
- Between reader 5.
Three different persons tested AFIAS HbA1c at three different reader; five times at 9. Cefalu WT, Wang ZQ, Bell-Farrow A, Kiger FD, Izlar C. Glycohemoglobin measured by automated
affinity HPLC correlates with both short-term and long-term antecedent glycemia. Clin Chem 1994;
each concentration of the control standard. 40:1317-21.
10. Singer DE, Coley CM, Samet JH, Nathan DM. Tests of glycemia in diabetes mellitus. Their use in