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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
Hemoglobin A1c
HbA1c
Cat. No.: KAI-196   or   KAI-197
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid (Lyophilized Calibrator)
Linearity: 2.0 - 16.0 %
Sample: Whole Blood


KIT COMPOSITION
Cat. No. KAI-196
R1:   1 X 30 mL buffer
R2:   1 X 10 mL antibody buffer
Hemolysis Reagent:   1 x 125 mL

Tests / Kit:   166 (Hitachi 717)
(Can Vary Based On Analyzer Model)
    
KAI-196
Click Image To Enlarge       

Click here for an example package insert.

Click here for the Safety Data Sheets (SDS):
Reagent-1 (R-1)
Reagent-2 (R-2)
Hemolysis Reagent

Click here for information about recommended calibrators and controls.




Cat. No. KAI-197
Note: Large size kit, available by special order.
R1:   1 X 90 mL buffer
R2:   1 X 30 mL antibody buffer
Hemolysis Reagent:   1 x 500 mL

Tests / Kit:   500 (Hitachi 717)
(Can Vary Based On Analyzer Model)

    
KAI-197
Click Image To Enlarge       

Click here for an example package insert.

Click here for the Safety Data Sheets (SDS):
Reagent-1 (R-1)
Reagent-2 (R-2)
Hemolysis Reagent

Click here for information about recommended calibrators and controls.




Cat. No. KAI-195
Hemoglobin A1c Hemolysis Reagent Only
Hemolysis Reagent:   1 x 125 mL

Note: Both kits above include hemolysis reagent.
But, it is also available seperately, if needed.


    
KAI-195
Click Image To Enlarge       

Click here for the Safety Data Sheets (SDS):
Hemolysis Reagent


INTENDED USE
For the quantitative determination of human Hemoglobin A1c (HbA1c) in blood.  The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus.  HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks.  A higher HbA1c value indiciated poorer glycemic control.
FOR IN VITRO DIAGNOSTIC USE.

REAGENT PREPARATION
R1 and Hemolysis reagents are supplied as ready to use liquids.  R2 is prepared by pouring the entire contents of the R2b vial into the R2a vial.   Mix gently.

STORAGE AND HANDLING
Unopened reagents are stable to the expiration date stated on the labels.  Do not use the reagents past their expiration date.  R1 and R2 are stable for at least one month after opening when stored at 2-8°C.

PERFORMANCE
Precision
Precision was establish by assaying two blood samples following NCCLS protocol EP5 on a Hitachi 917.

Precision - Within Run
Sample I Sample II
Mean = 5.48 Mean = 10.28
S.D. = 0.078 S.D. = 0.176
C.V. = 1.43% C.V. = 1.72%

Precision - Day to Day
Sample I Sample II
Mean = 5.48 Mean = 10.28
S.D. = 0.152 S.D. = 0.275
C.V. = 2.77% C.V. = 2.68%

Accuracy / Correlation
A study using 40 human specimens between this Hemoglobin A1c procedure and an automated HPLC procedure (Tosoh) yielded the following results:

y = 1.050x - 0.481
r = 0.988
n = 40
x = Tosoh Test Kit
y = K-ASSAY ®   Hemoglobin A1c assay

Assay Range
2.0 - 16.0 %

INTERFERENCE
Bilirubin :     No interference up to 50 mg/dL
Ascorbic Acid :     No interference up to 50 mg/dL
Triglycerides :     No interference up to 2,000 mg/dL
Carbamylated Hb :     No interference up to 7.5 mmol/L
Acetylated Hb :     No interference up to 5.0 mmol/L

It has been reported that results may be inconsistent in patients who have the following conditions: opiate addiction, lead poisoning, alcoholism, ingest large doses of aspirin.

It has been reported that elevated levels of HbF may lead to underestimation of HA1c.  Also, it has been reported that labile intermediated (Schiff base) are not detected and do not interfere with HbA1c determination by immunoassay.

It has been determined that Hemoglobin variants HbA2, HbC, and HbS do not interfere with this method.

Other very rare variants of hemoglobin (e.g. HbE) have not been assessed.