Read i-CHROMATM text version

BODITECH MED INC.

i-CHROMA HbA1c 25

REFERENCES

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 Engl J Med 1984; 310:341-6. 5. Goldstein DE, Little RR, Wiedmeyer HM, England JD, McKenzie EM. Glycated hemoglobin: methodologies and clinical applications. Clin. Chem. 1986; 32:B64-70. 6. Goldstein DE, Little RR, England JD, Wiedemeyer H-M, McKenzie E. Methods of glycosylated hemoglobins: high performance liquid chromatography and thiobarbituric acid colorimetric methods. In: Clarke WL, Larner J, Pohl SL, eds. Methods in diabetes research, Vol. 2. New York: John Wiley, 1986:475-504. 7. Tahara Y, Shima K. The response of GHb to stepwise plasma glucose change over time in diabetic patients. Diabetes Care 1993; 16:1313-4. 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; 23:403-5. 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; 40:1317-21. 10. Singer DE, Coley CM, Samet JH, Nathan DM. Tests of glycemia in diabetes mellitus. Their use in establishing a diagnosis and in treatment. Ann Intern Med 1989; 110:125-37. 11. Molnar GD. Clinical evaluation of metabolic control in diabetes. Diabetes 1978; 27:216-25. 12. UK Prospective Diabetes Study. Reduction in HbA1c with basal insulin supplement, sulfonylurea or biguanide therapy in maturity-onset diabetes. Diabetes 1985; 34:793-8. 13. Baker JR, Johnson RN, Scott DJ. Serum fructosamine concentrations in patients with type II (non-insulin-dependent) diabetes mellitus during changes in management. BMJ (Clin Res Ed) 1984; 288:1484-6. 14. Tahara Y, Shima K. Kinetics of HbA1c, glycated albumin, and fructosamine and analysis of their weight functions against preceding plasma glucose level. Diabetes Care 1995; 18:440-7. 15. 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. 16. Oh SW, Moon JD, Park SY, et al. Evaluation of fluorescence hs-CRP immunoassay for point-of-care testing. Clin Chim Acta 2005; 356:172-177.

i-CHROMATM HbA1c (Pipetting Method)

ImmunoAssay for Quantitative Measurement of Hemoglobin A1c in Human blood with i-CHROMATM Reader System

INTENDED USE

The i-CHROMATM HbA1c Test along with i-CHROMATM Reader is a fluorescence immunoassay that measures a ratio of hemoglobin A1c to total hemoglobin in whole blood. The test is used for routine monitoring of long-term glycemic status in patients with diabetes mellitus.

INTRODUCTION

Glycated proteins are formed post-translationally from the slow, nonenzymatic reaction between glucose and amino groups on proteins1. For hemoglobin, the rate of synthesis of Hemoglobin A1c (HbA1c) is principally a function of the concentration of glucose to which the erythrocytes are exposed. HbA1c is a clinically useful index of mean glycemia during the preceding 120 days, the average life span of erythrocytes1, 2-9. Although carefully controlled studies have documented a close relationship between the concentrations of HbA1c and mean glycemia, routine determinations of blood glucose by patients or by their healthcare providers are not considered as reliable as HbA1c to quantify mean glycemia 1, 3, 4, 10-12. Concentrations of other blood-based glycated proteins (e.g., glycated serum/plasma proteins, "fructosamine") also reflect mean glycemia, but over a much shorter time than HbA1c: 15-30 days and 60-120 days, respectively1, 2-10, 13, 14.

PRINCIPLE

The i-CHROMATM HbA1c Test is based on fluorescence immunoassay technology15. The i-CHROMATM HbA1c Test uses a competitive immunodetection method, such that by mixing detector buffer with hemolysed whole blood in test vial, the fluorescence-labeled detector anti-HbA1c antibody in buffer binds to HbA1c in blood specimen. As the sample mixture is loaded onto the sample well of the test device and migrates the nitrocellulose matrix of test strip by capillary action, the detector antibody competitively binds to HbA1c in the sample and glycated hemoglobin that has been immobilized on test strip. Thus as the more HbA1c antigen is in blood specimen, signal intensity of fluorescence of detector antibody decreases proportionally. The default result unit of i-CHROMATM HbA1c Test is displayed as a percentage(%) from i-CHROMATM Reader. The working range of i-CHROMATM HbA1c Test system is 4­15%.

* Reference Value : < 6.5 %

COMPOSITION OF REAGENTS

Rev. 11_100125_Multi

BODITECH MED INC.

The i-CHROMATM HbA1c Test Kit consists of Test Device, Blood Collecting Capillary, and Detector Buffer tube. Test Device is individually sealed with a desiccant in aluminum pouch. Detector Buffer/Hemolysis buffer is pre-dispensed individually in a tube, packed in a box, and delivered separately from Test Device in a styrofoam box filled with ice pack. · Test Device contains a test strip in which glycated hemoglobin and avidin have been immobilized on the test and on the control line of strip, respectively. · Hemolysis buffer is pre-dispensed individually in a small tubes and composed of cationic detergent · Detector Buffer is dispensed in a vial. It contains fluorescencelabeled goat anti-HbA1c (mouse monoclonal, 4.5µg/mL), fluorescence-labeled BSA-biotin (200 ng/mL), 1% gelatin as a stabilizer, and 0.1% Sodium Azide as a preservative in PBS.

i-CHROMA HbA1c 25

STROAGE AND STABILITY

· Store the Hemolysis and Detector buffer in a refrigerator at 2° 8°C. The Hemolysis and Detector Buffer are stable up to 20 months. · Once removed from refrigerator, allow the Hemolysis and Detector Buffer for 30 minutes to return to room temperature before testing. · Store i-CHROMATM HbA1c Test Device at 4-30°C in its sealed box. The i-CHROMATM HbA1c Test Device is stable for 20 months (while in the sealed pouch) if stored at 4-30°C. · If stored in a refrigerator, allow a minimum of 30 minutes for the Test Device to reach room temperature while it is in the sealed pouch. · Do not remove the device from the pouch until ready to use. The Test Device should be used immediately once opened.

WARNINGS AND PRECAUTIONS

· IVD For In Vitro Diagnostic Use. · Carefully follow the instructions and procedures described in this insert. REF Catalog No. HbA1c -25T · Don't use Test Device if its lot number does not match with ID Chip that is inserted onto the instrument. · The i-CHROMA HbA1c Test Kit is only operational in the iCHROMATM Reader. And tests should be applied by trained staff working in the laboratories where the sample(s) is taken by qualified medical personnel. · LOT Neither inter-change materials from different product lots nor use beyond the expiration date. The use of medical device beyond expiration date may affect on test result.

TM TM

· The storage and shipping of Test Kit should be complied as indicated in manual. However, it is remotely possible that only part of test Kit is affected by stability problems.

SAMPLE COLLECTION AND PREPARATION

The test can be performed with human blood samples. · The whole blood specimen must be at room temperature and be homogeneous before testing. Fresh blood samples must be used a immediately as possible, within 24 hours after collection. .

MATERIALS PROVIDED

BodiTech Med Incorporated i-CHROMATM HbA1c Test Catalog REF Catalog No. HbA1c-25T

· The i-CHROMA HbA1c Test Device should remain in its original sealed pouch until ready to use. Do not use the Test Device if the pouch is damaged or the seal is broken. Discard after single use. · The i-CHROMATM HbA1c Test Device and Reader should be used away from vibration and magnetic field. During normal usage, i-CHROMATM HbA1c Test may introduce minute vibration, which should be regarded normal. · Use separate clean pipette tips and sample vials for different specimens. The pipette tips and sample vials should be used for one specimen only. Discard after single use. · Blood specimens, used test devices, pipette tips and sample vials are potentially infectious. Proper laboratory safety techniques, handling and disposal methods should be followed in accordance with standard procedures and relevant regulations observed by microbiological hazard materials.. · The test will be applied on a routine basis and not in emergency situations. · Do not smoke, eat, or drink in areas in which specimens or kit reagents are handled.

Kit contains:

Test Devices Hemolysis Buffer Detection buffer 25T/box 25 tubes/box 1 vial

MATERIALS REQUIRED BUT NOT PROVIDED

i-CHROMATM Reader Thermal Printer Transfer pipette Glass capillary (5 ul) REF Catalog No. FR-203

Rev. 11_100125_Multi

BODITECH MED INC.

i-CHROMA HbA1c 25

PROCEDURE

· Image of the test kit

Quality Control

A quality control test using commercially available controls should be performed as a part of good testing practice, to confirm the expected QC results, to confirm the validity of the assay, and to assure the accuracy of patient results. If you want to perform QC of Test Kit, we recommend using Boditech Med's i-CHROMA HbA1c control.

1. 2. 3.

Set a Test Device on a dust-free clean place. Check/insert ID chip onto an instrument. Make sure that the Test Device lot # matches with ID chip #.

Take out a Detector Buffer vial and Hemolysis buffer tubes from a refrigerator and leave it at room temperature.

4. Take 100 ul of Detection Buffer from the vial, put into the pre-dispensed Hemolysis buffer tube, and mix well.

A quality control test should be performed at regular intervals, and before using a new kit with patient specimens, controls should be tested to confirm the test procedure, and to verify the tests produce the expected QC results. QC specimens should also be run whenever there is any question concerning the validity of results obtained. Upon confirmation of the expected results, the test device is ready to use with patient specimens. Control standards are not provided with this test kit. For information about obtaining the controls, contact BodiTech Med Inc. Technical Services for assistance.

5. 6. 7. 8. 9.

Make a prick on a fingertip or prepare a tube blood. Draw 5 µL of whole blood with a glass capillary. Put the glass capillary into the Hemolysis buffer tube and shake the tube 10 times by inversion to take the blood out of the capillary. Apply 50 ul of the mixture onto the sample well and 100 ul onto the Hb sample well of the test device cartridge (refer the picture above) Leave the Test Device at room temperature for 12 min before inserting the device into the holder. To start scanning, insert test device onto the holder of i-CHROMATM Reader and press "SELECT" button.. Make sure direction of Test Device and push the device back all the way.

Procedure Control Each i-CHROMATM HbA1c Test Device contains internal control that satisfies routine quality control requirements. This internal control is performed each time a patient sample is tested. This control indicates that the test device was inserted and read properly by i-CHROMATM Reader. An invalid result from the internal control causes an error message on i-CHROMATM Reader indicating that the test should be repeated.

LIMITATIONS OF THE PROCEDURE

· The results of i-CHROMATM HbA1c Test should be evaluated with all clinical and laboratory data available. If HbA1c Test results do not agree with the clinical evaluation, additional tests should be performed. · The false positive results include cross-reactions with some components of blood from individual to antibodies; and nonspecific adhesion of some components in human blood that have similar epitopes to capture and detector antibodies. In the case of false negative results, the most common factors are: nonresponsiveness of antigen to the antibodies by that certain unknown components are masking its epitope, such that antigen cannot be seen by the antibodies; instability of A1c antigen, resulting in degradation with time and, or temperature, such that they become no longer recognizable by antibodies; and degraded other test components. The effectiveness of the test is highly dependent on storage of kits and sample specimens at optimal conditions. · Other factors may interfere with i-CHROMA TM HbA1c Test and may cause erroneous results. These include technical or procedural errors, as well as additional substances in blood specimens.

10.

11. The instrument will automatically start to scan the Test Device immediately.

12.

Read the results on the display screen of iCHROMATM Reader or tear out the print for record.

Refer to i-CHROMATM Reader Operation Manual for the complete instructions on use of the Test. REF Catalog No. FR- 203

RESULT

The i-CHROMATM Reader calculates HbA1c test results automatically and displays percentage (%) of Hemoglobin A1c in blood on the LCD. For further information, refer to the Operation Manual for the iCHROMATM Reader.

PERFORMANCE CHARACTERISTICS

1. Analytical Sensitivity: Analytical sensitivity means the lowest concentration of HbA1c that the test system can detect with CV<10%. Analytical sensitivity of i-CHROMATM HbA1c was determined by testing 10 times with three lots of reagents. Analytical sensitivity of i-CHROMATM HbA1c system was 4%.

Rev. 11_100125_Multi

BODITECH MED INC.

2. Specificity: Other bio-molecules, such as Bilirubin, Triglyceride, Ascorbic acid and glucose were added to test specimen with much higher level than their physiological level in normal blood. There was no significant interference with the HbA1c measurement, nor was there any significant assay cross-reactivity with other disease-related biomarkers in blood. 3. Imprecision: For the intra-assay imprecision, 20 replicates were tested at each control sample. For the imprecision evaluation, tests were conducted on 10 sequential days with 5 replicates and for 3 persons at each HbA1c concentration.

i-CHROMA HbA1c 25

Imprecision of i-CHROMATM HbA1c

Intra-assay HbA1c (%) Mean S.D CV% 5.6 10.1 5.4 9.7 0.3 0.41 5.6 4.3 Mean 5.5 10.2 S.D CV% 0.26 0.42 5.0 4.1 Inter-assay

4. Linearity: The coefficient of linear regression was R=0.997. Linearity of i-CHROMATM HbA1c Test was 4~15%.

5. Comparability: The HbA1c concentrations of 152 clinical specimens were quantified independently with i-CHROMATM HbA1c and Bio Rad Variant II(HPLC) automatic analyzer. The test results were compared and their compatibilities were investigated with linear regression and correlation of coefficient (R). i-CHROMATM HbA1c was comparable well to other method (R=0.97).

Rev. 11_100125_Multi

Information

i-CHROMATM

4 pages

Find more like this

Report File (DMCA)

Our content is added by our users. We aim to remove reported files within 1 working day. Please use this link to notify us:

Report this file as copyright or inappropriate

415054