HbA1c TURBILATEX

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Intended Use:

Test for estimation of Glycohemoglobin in human whole blood by using Latex turbidimetric method.

Summary:

Glycosylated Haemoglobin (GHb) is formed continuously by the addition of glucose by covalent bonding to the amino-terminal valine of the haemoglobin beta chain progressively & irreversibly over a period of time & is stable till the life of the RBC. This process is slow, non-enzymatic and is dependent on the average blood glucose concentration over a period of time. HbA1c is a glycated product of haemoglobin A0 (HbA1c), the predominant form of haemoglobin in adults. Measurement of the percentage of HbA1c reflects the mean blood glucose concentration over the preceding one to two months, and is therefore considered to be an important diagnostic marker for monitoring blood glucose levels.

Principle:

HbA1c-Turbilatex is a quantitative turbidimetric test for the measurement of Glycohemoglobin A1c percent in human whole blood. In first reaction HbA1c interacts with antihuman haemoglobin A1c mouse monoclonal antibody-sensitized latex and in the second reaction, it will further interact with anti-human haemoglobin A1c mouse monoclonal antibody labelled-anti-mouse. IgG goat polyclonal antibody. Then, measure absorbance of coagulated reaction solution and determine the ratio of Hba1c volume against total Hb amount from concentration of HbA1c and values of calibrator

Specification

Methodology Immunoturbidimetry
Reaction Type Rate Kinetic
Reaction Direction Increasing
Sample Type Human Whole Blood
R1:R2 Mixing Ratio 3:1
Primary Wavelength 630 nm
Secondary Wavelength NA
Blank Settings Distilled Water
Blank Absorbance Limit <0.300
Reagent Volume Required Per Test 400 µl
Sample Volume Required Per Test 10 µL
Delay Time 10 seconds
Calibrator Available in the Kit Yes
Factor NA
Linearity 16%
Automation Enabled
Pack Sizes 1×50 ml
Kit components Reagent bottles – R1 and R2.
1 Calibrator vial.
Instructions for Use.
Storage Temperature 2- 80C
Shelf life 24 months
Kit dimensions 1×50 ml – 85x105x45 mm
Approx. weight of kit 1×50 ml – 130 gms
Production Capacity 600 mn ml per annum