Description:Title of the Invention
“A Diagnostic Test Kit for Glucose”
Field of the Invention
The present disclosure relates generally to field of medical devices. More specifically the present invention relates to diagnostic test kit works on photometric method to determine Glucose from blood serum / plasma in vitro for laboratories and medical professionals.
Background of Invention
A blood glucose test is a blood test that mainly screens for diabetes by measuring the level of glucose (sugar) in your blood. There are two main types of blood glucose tests: Capillary blood glucose test: A healthcare professional collects a drop of blood — usually from a fingertip prick. These tests involve a test strip and glucose meter (glucometer), which shows your blood sugar level within seconds. Venous (plasma) blood glucose test: A phlebotomist collects a sample of blood from a vein (venipuncture). These glucose tests are usually part of a blood panel, such as a basic metabolic panel. The provider will send the samples to a lab. There, a medical laboratory scientist will prepare your samples and perform the test on machines known as analyzers. Venous blood glucose tests are generally more accurate than capillary blood glucose tests. Healthcare providers often order fasting blood glucose tests to screen for diabetes. Since eating food affects blood sugar, fasting blood glucose tests show a more accurate picture of your baseline blood sugar.
Blood glucose determination is one of the most common clinical diagnostic tests. Often, blood is collected in a field station and analysis is carried out in a remote laboratory. Because blood cells can continue to metabolize glucose, the time of determination of blood glucose after drawing the blood is important. In order to test the relative suitability of plasma and serum for blood glucose determination, fluoride plasma and Ethylene Diamine Tetra Acetic acid (EDTA) plasma were compared with the serum of the same patient. The analyses were carried out within 10 min of drawing the blood and, thereafter, with a gap of 4 hr and 8 hr.

Therefore, there is a need for a device that overcomes at least the above mentioned problems. There is a need for a rapid, precise, and cost-effective diagnostic kit and method for the measurement of Glucose.
The present disclosure relates generally to field of medical devices. More specifically the present invention relates to diagnostic test kit works on photometric method to estimate Glucose from serum / plasma, in vitro for laboratories and medical professionals.
Object of the Invention
The primary object of the invention is to develop a diagnostic test kit to estimate Glucose from blood serum / plasma useful effectively.
The secondary objective of the invention is that the diagnostic test kit for Glucose utilizes photometric method herein the kit configured with suitable reagents like Phosphate Buffer, Glucose Oxidase, Peroxidase and Glucose as standard, taken in effective concentration of blood serum /plasma.
Another objective of the invention is that the prepared blood serum/plasma samples with reagents estimated for absorbance in photometer at desired wavelength and room temperature.
Further objective of the invention is that Glucose is determined through calculation by the absorbance of sample and standard.
Summary of the Invention

The present disclosure relates a diagnostic kit specifically to determine Glucose concentration in the blood serum/plasma wherein the desired size kit is developed, essentially consist of reagents for reaction with blood serum/plasma samples, detected on photometer at desired wavelength to measure the absorbance and finally calculated to determine Glucose concentration.
A diagnostic test kit for Glucose comprising a test kit characterized in that 500 ml size kit of one compartment cell reagents preferably consist of Phosphate Buffer, Glucose Oxidase, Peroxidase with Glucose as standard estimate Glucose in vitro from blood serum / plasma sample effectively, wherein reagent cell composed of 100 mmol/l of Phosphate Buffer, 8 u/ml of Glucose Oxidase and 0.6 u/l of Peroxidase, taken with blood serum/ plasma sample from 0.010 ml to 0.015 ml into two clean test tube for test sample and blank sample and Glucose 100 mg/dl sample as standard in third test tube; pipette out the reagent from the kit separately; transferring said reagent into the test tubes respectively at room temperature (37oC) and , uniformly mixed with test sample, blank sample and standard; incubating the reaction mixture for 10 minutes; determining the absorbance of said test sample blank sample and standard Glucose sample on photometer at a wavelength of 510 nm for 30-90 seconds; and finally calculating the absorbance to estimate Glucose from the test serum / plasma sample effectively.

One of the preferred embodiments of the present invention is the unique design of the kit prefilled with the preferred reagent like Phosphate Buffer, Glucose Oxidase and Peroxidase reacts with serum/ plasma Glucose evaluated through the absorbance on photometer.

One of the preferred embodiments of the present invention is that to determine Glucose from the varied concentration more preferably making the test sample, blank sample and standard Glucose sample to infer the clinical findings effectively.

One of the preferred embodiments of Glucose is estimated in vitro through all in one reagent kit.

Brief Description of Drawings

The following thorough explanation of the various aspects of the invention, taken in conjunction with the corresponding drawing that represents various aspects and other features of the disclosure invention.

Figure 1: Flow chart of method of estimation of Glucose

Detailed Description of the Invention

The following description is of exemplary embodiments only and is not intended to limit the scope, applicability or configuration of the invention in any way. Rather, the following description provides a convenient illustration through explanation and figures for implementing exemplary embodiments of the invention. Various changes to the described embodiments may be made in the function and arrangement of the ingredients described without departing from the scope of the invention.
The use of “including”, “comprising” or “having” variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced items. Further, the use of terms “first”, “second”, and “third”, and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another.
The terms used in the invention
mmol: milimole
mmol/l: millimole per liter
A blood glucose test is a blood test that mainly screens for diabetes by measuring the level of glucose (sugar) in your blood. There are two main types of blood glucose tests: Capillary blood glucose test: A healthcare professional collects a drop of blood — usually from a fingertip prick. These tests involve a test strip and glucose meter (glucometer), which shows your blood sugar level within seconds. Venous (plasma) blood glucose test: A phlebotomist collects a sample of blood from a vein (venipuncture).
A diagnostic test kit for Glucose comprising a test kit characterized in that 500 ml size kit of one compartment cell reagents preferably consist of Phosphate Buffer, Glucose Oxidase, Peroxidase with Glucose as standard estimate Glucose in vitro from blood serum / plasma sample effectively, wherein reagent cell composed of 100 mmol/l of Phosphate Buffer, 8 u/ml of Glucose Oxidase and 0.6 u/l of Peroxidase, taken with blood serum/ plasma sample from 0.010 ml to 0.015 ml into two clean test tube for test sample and blank sample and Glucose 100 mg/dl sample as standard in third test tube; pipette out the reagent from the kit separately; transferring said reagent into the test tubes respectively at room temperature (37oC) and , uniformly mixed with test sample, blank sample and standard; incubating the reaction mixture for 10 minutes; determining the absorbance of said test sample blank sample and standard Glucose sample on photometer at a wavelength of 510 nm for 30-90 seconds; and finally calculating the absorbance to estimate Glucose from the test serum / plasma sample effectively.
The present disclosure relates a diagnostic kit specifically to determine Glucose concentration in the blood serum/plasma wherein the desired size kit is developed, essentially consists of reagents for reaction with blood serum/plasma samples, detected on photometer at desired wavelength to measure the absorbance and finally calculated the Glucose concentration.
Preferred embodiments of diagnostic kit for Glucose
i) Diagnostic Kit: The Glucose kit comprises of 500 ml size wherein reagent cell prefilled for the determination of Glucose, herein the key reagent like Phosphate Buffer, Glucose Oxidase and Peroxidase reacts with serum/ plasma Glucose used in different concentration, estimates serum / plasma Glucose through the absorbance using photometer of desired wavelength.
ii) Reagents: Blood serum /plasma, Phosphate Buffer, Glucose Oxidase and Peroxidase.
iii) Apparatus / Instrument: Test tubes, Photometer, Incubator etc.
Table no. 01: Preferred embodiments and parameters of the kit with concentrations

Particulars Name of ingredient with concentration
Serum/ plasma sample 0.010 ml to 0.015 ml
Reagent 100 mmol/l of Phosphate Buffer, 8 u/ml of Glucose Oxidase and 0.6 u/l of Peroxidase
Shelf Life 24 months
Kit Size 500 ml
Wavelength 510 nm
Temperature 37oC
Time of Estimation 30 to 90 seconds

Table no. 02: Method to operate Glucose

Particulars Blank Standard Sample
Reagent 1.0 ml 1.0 ml 1.0 ml
Standard -- 0.010 ml --
Serum/plasma test sample -- -- 0.010 to 0.015 ml

General Method to operate the device

Taking the 0.010 to 0.015 ml blood serum/ plasma sample as test sample, reagent as blank sample and Glucose as standard separately in clean test tubes;
pipette out the reagent 100 mmol/l of Phosphate Buffer, 8 u/ml of Glucose Oxidase and 0.6 u/l of Peroxidase from the kit separately; transferring said reagent into the test tubes respectively at room temperature (37oC); incubating the reaction mixture for 10 minutes; determining the absorbance of said test sample, blank sample and 100 mg/dl Glucose sample as standard, on photometer at a wavelength of 510 nm for 30-90 seconds; and finally calculating the absorbance to estimate Glucose from the test serum / plasma sample effectively.

The absorbance is calculated using below formula:
Concentration = Absorption of sample / Absorption of standard x 100 mg/dl
(Table No. 1, 2 and Figure No. 1)
Example 1
Taking the 0.010 ml blood serum/ plasma sample as test sample, reagent as blank sample and Glucose as standard separately in clean test tubes;
pipette out the reagent 100 mmol/l of Phosphate Buffer, 8 u/ml of Glucose Oxidase and 0.6 u/l of Peroxidase from the kit separately; transferring said reagent into the test tubes respectively at room temperature (37oC); incubating the reaction mixture for 10 minutes; determining the absorbance of said test sample, blank sample and 100 mg/dl Glucose sample as standard, on photometer at a wavelength of 510 nm for 30-90 seconds; and finally calculating the absorbance to estimate Glucose from the test serum / plasma sample effectively.
The absorbance is calculated using below formula:
Concentration = Absorption of sample / Absorption of standard x 100 mg/dl
Example 2
Taking the 0.015 ml blood serum/ plasma sample as test sample, reagent as blank sample and Glucose as standard separately in clean test tubes;
pipette out the reagent 100 mmol/l of Phosphate Buffer, 8 u/ml of Glucose Oxidase and 0.6 u/l of Peroxidase from the kit separately; transferring said reagent into the test tubes respectively at room temperature (37oC); incubating the reaction mixture for 10 minutes; determining the absorbance of said test sample, blank sample and 100 mg/dl Glucose sample as standard, on photometer at a wavelength of 510 nm for 30-90 seconds; and finally calculating the absorbance to estimate Glucose from the test serum / plasma sample effectively.

The absorbance is calculated using below formula:
Concentration = Absorption of sample / Absorption of standard x 100 mg/dl
Scope of the Invention

A diagnostic test kit for Glucose principally design to develop a simple method to analyse the Glucose level using photometric method having size of 500 ml size kit of reagent preferably consist of effective concentration of 100 mmol/l of Phosphate Buffer, 8 u/ml of Glucose Oxidase and 0.6 u/l of Peroxidase, taken with blood serum/ plasma sample from 0.010 ml to 0.015 ml as test sample and blank sample and Glucose 100 mg/dl sample as standard respectively determines Glucose in vitro from blood serum / plasma sample effectively, could be potential diagnostic and economical method, compare to expensive conventional methods in future.

It is to be understood that the present invention is not limited to the embodiments described above, it should be clear that various modifications and alterations can be made along with various features of one embodiment included in other embodiments, within the scope of the present invention.
, Claims:We claim,
1- A diagnostic test kit for Glucose comprising a test kit characterized in that 500 ml size kit of reagent preferably consist of effective concentration of 100 mmol/l of Phosphate Buffer, 8 u/ml of Glucose Oxidase and 0.6 u/l of Peroxidase estimates Glucose in vitro from blood serum / plasma sample taken from 0.010 to 0.015 ml as test sample and 100 mg/dl of Glucose as standard, using photometer effectively.

2- The diagnostic test kit for Glucose as claimed in claim 1, operates through in vitro diagnostic method to determine Glucose comprises the following steps:
taking the 0.010 to 0.015 ml blood serum/ plasma sample as test sample, reagent as blank sample and Glucose as standard separately in clean test tubes;
pipette out the reagent Phosphate Buffer, Glucose Oxidase and Peroxidase from the kit separately;
transferring said reagent into the test tubes respectively at room temperature (37oC);
incubating the reaction mixture for 10 minutes;
determining the absorbance of said test sample, blank sample and standard Glucose sample on photometer at a wavelength of 510 nm for 30-90 seconds; and
calculating the absorbance to estimate Glucose from the test serum / plasma sample effectively.