Description:Title of the Invention
“A Diagnostic Test Kit for Creatinine”
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 Creatinine from blood serum / plasma in vitro for laboratories and medical professionals.
Background of Invention
In general, however, normal creatinine levels range from 0.9 to 1.3 mg/dL in men and 0.6 to 1.1 mg/dL in women who are 18 to 60 years old. Normal levels are roughly the same for people over 60. Each kidney has millions of small blood-filtering units called nephrons. The nephrons constantly filter blood through a very tiny cluster of blood vessels known as glomeruli. These structures filter waste products, excess water, and other impurities out of the blood. The toxins are stored in the bladder and then removed during urination. Creatinine is one of the substances that your kidneys normally eliminate from the body. Doctors measure the level of creatinine in the blood to check kidney function. High levels of creatinine may indicate that your kidney is damaged and not working properly.
Creatinine blood tests are usually performed along with several other laboratory tests, including blood urea nitrogen (BUN) test and a basic metabolic panel (BMP) or comprehensive metabolic panel (CMP). These tests are done during routine physical exams to help diagnose certain diseases and to check for any problems with your kidney function. These symptoms include: fatigue and trouble sleeping, a loss of appetite, swelling in the face, wrists, ankles, or abdomen, lower back pain near the kidneys, changes in urine output and frequency, high blood pressure, nausea, vomiting. Kidney problems can be related to different diseases or conditions, including: glomerulonephritis, which is an inflammation of the glomeruli due to damage, pyelonephritis, which is a bacterial infection of the kidneys, prostate disease, such as an enlarged prostate, blockage of the urinary tract, which may be due to kidney stones, decreased blood flow to the kidneys, which may be caused by congestive heart failure, diabetes, or dehydration, the death of kidney cells as a result of drug abuse, streptococcal infections, such as poststreptococcal glomerulonephritis. Aminoglycoside medications, such as gentamicin (Garamycin, Gentasol), can also cause kidney damage in some people. If you’re taking this type of medication, your doctor may order regular creatinine blood tests to make sure your kidneys remain healthy.
For a creatinine blood test: A health care professional will take a blood sample from a vein in your arm, using a small needle. After the needle is inserted, a small amount of blood will be collected into a test tube or vial. You may feel a little sting when the needle goes in or out. This usually takes less than five minutes.
For a creatinine urine test: You may need to provide all the urine you pass over 24 hours. That's because creatinine levels vary through the day. But your provider may use a urine sample from a shorter period of time.
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 Creatinine 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 Creatinine from blood serum / plasma useful effectively.
The secondary objective of the invention is that the diagnostic test kit for Creatinine utilizes photometric method herein the kit configured with suitable reagents like Sodium hydroxide, Picric acid and Creatinine 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 Creatinine 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 Creatinine 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 Creatinine concentration.
A diagnostic test kit for Creatinine comprising a test kit characterized in that 100 ml and 200 ml size kit of two compartment cell reagents preferably consist of Sodium hydroxide and Picric acid with Creatinine as standard estimate Creatinine in vitro from blood serum / plasma sample effectively, wherein the two cell reagent composed of reagent I cell of 0.4 mol/l of Sodium hydroxide and reagent II cell of 9 mmol/l of Picric acid in effective ratio of 1:1 to form working reagent, taken with blood serum/ plasma sample from 0.080 ml to 0.100 ml into two clean test tube for test sample and blank sample and Creatinine 2 mg/dl sample as standard in third test tube; pipette out the reagent I and II from the kit separately in effective ratio of 1:1 respectively, uniformly mixed to form working reagent; transferring said working reagent into the test tubes respectively at room temperature (37oC); incubating the reaction mixture for 5 minutes; determining the absorbance of said test sample blank sample and standard Creatinine sample on photometer at a wavelength of 505 nm for 30-90 seconds; and finally calculating the absorbance to estimate Creatinine from the test serum / plasma sample effectively.

One of the preferred embodiments of the present invention is the unique design of the kit consist of two reagent cell (I & II ), which prefilled with the preferred reagent like Sodium hydroxide and Picric acid reacts with serum/ plasma Creatinine evaluated through the absorbance on photometer.

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

One of the preferred embodiments of Creatinine 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 Creatinine

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
In general, however, normal creatinine levels range from 0.9 to 1.3 mg/dL in men and 0.6 to 1.1 mg/dL in women who are 18 to 60 years old. Normal levels are roughly the same for people over 60. Each kidney has millions of small blood-filtering units called nephrons. The nephrons constantly filter blood through a very tiny cluster of blood vessels known as glomeruli. These structures filter waste products, excess water, and other impurities out of the blood. The toxins are stored in the bladder and then removed during urination. Creatinine is one of the substances that your kidneys normally eliminate from the body. Doctors measure the level of creatinine in the blood to check kidney function. High levels of creatinine may indicate that your kidney is damaged and not working properly.
A diagnostic test kit for Creatinine comprising a test kit characterized in that 100 ml and 200 ml size kit of two compartment cell reagents preferably consist of Sodium hydroxide and Picric acid with Creatinine as standard estimate Creatinine in vitro from blood serum / plasma sample effectively, wherein the two cell reagent composed of reagent I cell of 0.4 mol/l of Sodium hydroxide and reagent II cell of 9 mmol/l of Picric acid in effective ratio of 1:1 to form working reagent, taken with blood serum/ plasma sample from 0.080 ml to 0.100 ml into two clean test tube for test sample and blank sample and Creatinine 2 mg/dl sample as standard in third test tube; pipette out the reagent I and II from the kit separately in effective ratio of 1:1 respectively, uniformly mixed to form working reagent; transferring said working reagent into the test tubes respectively at room temperature (37oC); incubating the reaction mixture for 5 minutes; determining the absorbance of said test sample blank sample and standard Creatinine sample on photometer at a wavelength of 505 nm for 30-90 seconds; and finally calculating the absorbance to estimate Creatinine from the test serum / plasma sample effectively.

The present disclosure relates a diagnostic kit specifically to determine Creatinine 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 Creatinine concentration.
Preferred embodiments of diagnostic test kit for Creatinine
i) Diagnostic Kit : The Creatinine kit comprises of 100 ml and 200 ml size wherein two compartment cell consist prefilled reagent for the determination of Creatinine, herein the key reagent Sodium hydroxide and Picric acid used in different concentration, effectively reacts with serum / plasma Creatinine measures the absorbance using photometer of desired wavelength.
ii) Reagents: Blood serum /plasma, Sodium hydroxide and Picric acid.
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 0.080 ml to 0.100 ml
Reagent I 0.4 mol/l of Sodium hydroxide
Reagent II 9 mmol/l of Picric acid
Effective Ratio of reagent I : reagent II 1:1
Shelf Life 24 months
Kit Size 100 ml and 200 ml
Wavelength 505 nm
Temperature 37oC
Time of Estimation 30 to 90 seconds

Table no. 02: Method to operate Creatinine

Particulars Blank Standard Sample
Working Reagent ( I& II) 1.0 ml 1.0 ml 1.0 ml
Standard -- 0.100 ml --
Serum/plasma test sample -- -- 0.080 to 0.100 ml

General Method to operate the device

Taking the 0.080 to 0.100 ml blood serum/ plasma sample into two clean test tubes for test and blank sample separately;
pipette out the reagent I (0.4 mol/l of Sodium hydroxide ) and II (9 mmol/l of Picric acid ) in 1:1 ratio from the kit separately and mixed uniformly to prepare working reagent and 1.0 ml each of working reagent separately used to prepare test and blank sample; transferring said working reagent into the test tubes respectively at room temperature (37oC); incubating the reaction mixture for 5 minutes; determining the absorbance of said test sample blank sample and standard Creatinine sample on photometer at a wavelength of 505 nm for 30-90 seconds; and finally calculating the absorbance to estimate Creatinine from the test serum / plasma sample effectively.

The absorbance is calculated using below formula:
Concentration = Absorption of sample / Absorption of standard x 2 mg/dl
(Table No. 1, 2 and Figure No. 1)
Example 1
Taking the 0.080 ml blood serum/ plasma sample into two clean test tubes for test and blank sample separately;
pipette out the reagent I (0.4 mol/l of Sodium hydroxide ) and II (9 mmol/l of Picric acid ) in 1:1 ratio from the kit separately and mixed uniformly to prepare working reagent and 1.0 ml of working reagent used to prepare blank sample; transferring said working reagent into the test tubes respectively at room temperature (37oC); incubating the reaction mixture for 5 minutes; determining the absorbance of said test sample blank sample and standard Creatinine sample on photometer at a wavelength of 505 nm for 30-90 seconds; and finally calculating the absorbance to estimate Creatinine from the test serum / plasma sample effectively.

The absorbance is calculated using below formula:
Concentration = Absorption of sample / Absorption of standard x 2 mg/dl
Example 2
Taking the 0.100 ml blood serum/ plasma sample into two clean test tubes for test and blank sample separately;
pipette out the reagent I (0.4 mol/l of Sodium hydroxide ) and II (9 mmol/l of Picric acid ) in 1:1 ratio from the kit separately and mixed uniformly to prepare working reagent and 1.0 ml of working reagent used to prepare blank sample; transferring said working reagent into the test tubes respectively at room temperature (37oC); incubating the reaction mixture for 5 minutes; determining the absorbance of said test sample blank sample and standard Creatinine sample on photometer at a wavelength of 505 nm for 30-90 seconds; and finally calculating the absorbance to estimate Creatinine from the test serum / plasma sample effectively.

The absorbance is calculated using below formula:
Concentration = Absorption of sample / Absorption of standard x 2 mg/dl

Scope of the Invention

A diagnostic test kit for Creatinine principally design to develop a simple method to analyse the Creatinine level using photometric method having size of 100 ml and 200 ml size kit of two compartment cell reagent preferably consist of effective concentration of 0.4 mol/l of Sodium hydroxide ( reagent I ) and 9 mmol/l of Picric acid ( reagent II) in effective ratio of 1:1 to form working reagent, taken with blood serum/ plasma sample from 0.080 ml to 0.100 ml as test sample and blank sample and Creatinine 2 mg/dl sample as standard in effective ratio of 1:1 respectively determines Creatinine 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 Creatinine comprising a test kit characterized in that 100 ml and 200 ml size kit of two compartment cell reagent preferably consist of effective concentration of 0.4 mol/l of Sodium hydroxide (reagent I) and 9 mmol/l of Picric acid (reagent II) in effective ratio of 1:1 respectively estimates Creatinine in vitro from blood serum / plasma sample taken from 0.080 to 0.100 ml as test sample and Creatinine ( 2 mg/dl) as standard using photometer effectively.
2- The diagnostic test kit for Creatinine as claimed in claim 1, operates through in vitro diagnostic method to determine Creatinine comprises the following steps:
taking the 0.080 to 0.100 ml blood serum/ plasma sample into two clean test tubes for test and blank sample separately;
pipette out the reagent I (0.4 mol/l of Sodium hydroxide ) and II (9 mmol/l of Picric acid ) in 1:1 ratio from the kit separately and mixed uniformly to prepare working reagent and 1.0 ml each of working reagent separately used to prepare test and blank sample;
transferring said working reagent into the test tubes respectively at room temperature (37oC);
incubating the reaction mixture for 5 minutes;
determining the absorbance of said test sample blank sample and standard Creatinine sample on photometer at a wavelength of 505 nm for 30-90 seconds; and calculating the absorbance to estimate Creatinine from the test serum / plasma sample effectively.