Title of Invention	A KIT FOR THE QUICK DETECTION OF PROTEIN IN URINE FOR ASSESSING KIDNEY'S HEALTH
Abstract	This invention discloses a One-Minute Home Test Kit for Albuminurea for the instant detection, prevention, and monitoring, through urine, of any minor, major, or total kidney damage (renal failure ). By the use of this kit—the Urine Albukit—the presence of micro quantities of albumin in the urine can be detected within just one minute"s time by sitting comfortably at home or office. Thus, this kit would help in preventing countless premature deaths owing to the otherwise undiagnosed kidney failures happening all Over the world every year. The invented kit may very logically also be described as "Dialysis Warning Kit" meant for saving a human life at negligible cost. The invented kit would be the first of its kind that could be used even by a non-medico common man to find out whether he/she or any other member of the family is suffering from some sort of kidney damage that would otherwise prove fatal later if it remains undiagnosed and immediate medical care is not taken. Thus the kit is a boon mostly for diabetics and hypertension patients who are most prone to kidney damage, etc. To perform the test, just 2 ml of the urine sample is taken in a test tube, and a few drops of Reagent No. 1 are added whereby a slight to strong white turbidity or precipitate, or a curdy or thick white precipitate, depending upon the quantity of albumin present, appears in the urine. Subsequently, upon the addition of a few drops of Reagent No.2 the white turbidity or precipitate gets completely dissolves and disappears. Now, upon the addition of just one or two drops of Reagent No. 3 a purple or violet colouration is formed instantly. The test for albumin would be negative if a blue colour appears instead of purple or violet. As an alternate way, 2 ml of urine is taken in the test tube and add 8 to 10 drops of the Reagent No. 2 are added and tube is shaken. Now as soon as 1 or 2 drops of Reagent No. 3 are added and the mixture is shaken again, a light to deep purple or violet colour would appear if kidney is in damaged state. The apparent visual depth of the purple-violet colour would be proportional to the quantity of albumin present or so to say the degree of damage caused to the kidney. If upon the addition of Reagent No. 3 only blue colour appears instead of clear purple or violet, then the test for albumin should be taken as negative ( ie, albumin is absent =kidney in good health ). To remain fit and free from kidney complications, occasional testing for the presence of albumin in the urine is essential with the newly invented kit even for normal and healthy persons.

Title of Invention

A KIT FOR THE QUICK DETECTION OF PROTEIN IN URINE FOR ASSESSING KIDNEY'S HEALTH

Abstract

This invention discloses a One-Minute Home Test Kit for Albuminurea for the instant detection, prevention, and monitoring, through urine, of any minor, major, or total kidney damage (renal failure ). By the use of this kit—the Urine Albukit—the presence of micro quantities of albumin in the urine can be detected within just one minute"s time by sitting comfortably at home or office. Thus, this kit would help in preventing countless premature deaths owing to the otherwise undiagnosed kidney failures happening all Over the world every year. The invented kit may very logically also be described as "Dialysis Warning Kit" meant for saving a human life at negligible cost. The invented kit would be the first of its kind that could be used even by a non-medico common man to find out whether he/she or any other member of the family is suffering from some sort of kidney damage that would otherwise prove fatal later if it remains undiagnosed and immediate medical care is not taken. Thus the kit is a boon mostly for diabetics and hypertension patients who are most prone to kidney damage, etc. To perform the test, just 2 ml of the urine sample is taken in a test tube, and a few drops of Reagent No. 1 are added whereby a slight to strong white turbidity or precipitate, or a curdy or thick white precipitate, depending upon the quantity of albumin present, appears in the urine. Subsequently, upon the addition of a few drops of Reagent No.2 the white turbidity or precipitate gets completely dissolves and disappears. Now, upon the addition of just one or two drops of Reagent No. 3 a purple or violet colouration is formed instantly. The test for albumin would be negative if a blue colour appears instead of purple or violet. As an alternate way, 2 ml of urine is taken in the test tube and add 8 to 10 drops of the Reagent No. 2 are added and tube is shaken. Now as soon as 1 or 2 drops of Reagent No. 3 are added and the mixture is shaken again, a light to deep purple or violet colour would appear if kidney is in damaged state. The apparent visual depth of the purple-violet colour would be proportional to the quantity of albumin present or so to say the degree of damage caused to the kidney. If upon the addition of Reagent No. 3 only blue colour appears instead of clear purple or violet, then the test for albumin should be taken as negative ( ie, albumin is absent =kidney in good health ). To remain fit and free from kidney complications, occasional testing for the presence of albumin in the urine is essential with the newly invented kit even for normal and healthy persons.

Full Text	COMPLETE SPECIFICATION TITLE OF THE INVENTION : One-Minute Home Test Kit For Albuminurea for the Instant Detection, Prevention, and Monitoring, Through Urine, of Any Minor, Major, or Total Kidney Damage (Renal Failure). FIELD OF INVENTION : Medical diagnostic (hy chemical analysis) APPLICANTS NATIONALITY ADDRESS (i) Johar, Sarabjeet Singh Indian KanpurTestHouse, 118/23 Nazirabad, Kanpur-208012 ( U. P.), India (ii) Johar, Manpreet Singh Canadian 183, Morning Dove Drive, Markham, Ontario L6B1L9, Canada The following specification particularly describes the invention and the manner in which it is to he performed: This invention involves the development of a simple, economical, and most reliable diagnostic kit—the URINE ALBUKIT-—to detect the presence of albumin in the urine ( Albuminurea ) within just one minute s time, by sitting in one s own home (or office), thus easily preventing countless premature deaths owing to otherwise undiagnosed kidney failures happening all over the world every year. India being one of the most affected countries of the world. BACKGROUND AND MOTTO OF THE INVENTION : Our invention is intended to give a product (for urine microalbumin test) to the world with the message : Save yourself and your near and dear ones from facing the state of fatal renal failure leading to the stage of painful dialysis in hospitals, or necessitating a kidney transplantation ! The message further says : Take care at home of your precious kidney, without visiting doctors in London or Sydney ! This means that taking care of one's own kidneys has no longer remained a tedious job. Since the routine monitoring of the kidney s health is highly desirable for every individual, and the latter step is now no longer a costly preposition; people at large can get full benefit of the new invention. But before one can start monitoring the functioning of the kidneys, he/she must have a clear concept of kidneys functioning mechanism, and for this, the undernoted paragraph titled Proteinurea has to he taken account into. Proteinurea Proteinurea (presence of protein in the urine) is a classic sign of kidney disease and its management carries powerful prognostic information about the health of the kidneys. The inventors stress that urinary albumin detection is the best approach for the management of chronic kidney diseases (CKD). Albumin is a protein which is normally found in the blood and it is regularly filtered by the kidneys and sent back to the blood stream. That is why when the kidneys are working properly, albumin should or rather must not be present in the urine in any significant amount. But somehow when the kidneys are damaged, small amounts of albumin (microalbumin) leak out into the urine a condition which is tantamount to a red alert indicating some serious threat to the kidneys. If prompt remedial measures are not taken then gradually elevated levels of albumin start showing up in the urine that may eventually drag the person up to the stage of total kidney failure and then requiring dialysis. The invented kit may therefore very logically also be described as Dialysis Warning Kit meant for saving a human life at negligible cost. Our new and easiest-to-operate one-minute home iesi kii to detect micro-(or macro-) albumin contents in urine which takes no more than one minutes time, can now be used individually or may be delivered to the health-care officials or agencies in any country of the world for community use in urban as well as rural areas. Worldwide, it has been estimated that as many as 400 to 600 million people suffer from chronic kidney diseases (CKD). Primarily the two major causes of CKD are diabetes and high blood pressure. Early detection of albumin can surely help prevent easily the progression of some early kidney damage that would otherwise lead to total kidney failure. Nearly kalf of tke people even reaching to an advanced stage of kidney failure do not even know tkat they kave keen lelt witk just a few montks or few weeks time before they are to ke put to dialysis. Tkis alarming warning kas keen stated in a recent researck published in tke American Journal of Kidney Diseases—the official American journal of tke National Kidney Foundation. Alkuminurea and Premature Deliveries by tke Pregnant Women According to a study published in July 2005 in tke American Journal of Kidneu Diseases, pregnant women witk albuminuria are several times more likely to give birth of a baby prematurely. The team leader of this piece of study had wished for having a simple and inexpensive test technique for urinary albumin so that doctors could easily target their efforts towards women at risk of undergoing a premature delivery. Research clearly suggests that albuminuria may be a sign that a woman has problems in the lining of her blood vessels. If so, some cases of prematurity may be caused by a dysfunction in the blood vessels supporting a fetus a finding that may point to new future treatments that could help babies stay longer in the mother's womb. This is because albuminuria serves as a sign of overall blood vessel problems. In pregnancy, blood vessel problems may disrupt fetal growth and trigger a premature delivery. These facts have been disclosed by Dr. David Warnock, President, of Americas National Kidney Foundation and Director of Nephrology at the University of Alabama at Birmingham. During the study, the investigators measured albumin levels in the urine of 111 women who gave birth to babies after less than 37 weeks' gestation, and 293 women who carried their babies to term. And the more albumin women had in their urine, the higher their chances of giving birth prematurely. Indeed, women with the most albumin in their urine were nearly five times more likely than women with the least amount of albumin to have premature babies. Dr. Warnock had also said If we know which mothers are most at risk of delivering early, we can target our efforts to those women who need it most; tracking urinary albumin looks like one way we can do that.' Our invented URINE ALBUKIT can successfully, economically, and most easily solve tke problem of monitoring tke urinary albumin levels of tkose would-be- motkers wko are at risk of delivering a premature baby. Albuminurea in HIV Patients Undergoing Antiretroviral Tkerapy Of late, it kas also been found tkat HIV-infected persons despite undergoing antiretroviral tkerapy continue to lose kidney function. Hence, monitoring of kidney damage in HIV-infected persons can also be done witk tke use of our URINE ALBUKIT. Tke State of General Carelessness and Rising Kidney Failure Cases Tke kealtky kuman kidneys constantly filter toxins (poisonous waste products ) from our blood. If our kidneys somehow turn damaged, some or many of tkese waste and toxic products may remain retained in our blood. At tke same time, a type of protein called albumin—which must stay back in our blood—leaks out into our urine in micro quantities. This is a dangerous situation wkick may prove fatal at tke later stage. Hence, Urine Microalbumin Test becomes necessary at least for tkose people wko kave kigk Hood pressure (kypertension) and diabetes of any type ( Type 1 or Type 2). It is mostly tke diabetes and kigk Hood pressure-related kidney damage wkick kills kundreds of tkousands of people every year all around tke world. In tke event of an affected person gets kis/ker urine tested tkrougk a patkologist at tke behest of a family pkysician, and if some minor or major renal damage is also detected, even tken, as per general tendency, neitker tke patkologist nor tke pkysician norm ally issues any stern warning or skows a clear red signal to tke patient about tke impending tkreat looming large over tke patient s life. Tkus, tke patient constantly remains ignorant about kis/ker kidneys deteriorating kealtk despite spending money on tke patkological testing. Having not warned, tke patient continues to lead tke normal life witkout taking precautions about tke diet regimen and drug-management, tkus resulting in further serious damage to tke kidney. This is a general trend of medical and kuman negligence not only in India but throughout tke world. As a consequence, tke pkysicians and patkologists go ricker and ricker, but tke patient's kidney kealtk turns poorer and poorer in tke coming years, and eventually landing kim/ker on tke bed of a dialysis chamber, and also creating necessity of a possible kidney transplant. Our product invention (URINE ALBUKIT) is tkerefore a Loon for tke entire kumanity for absolutely flawless and quick self-testing of one s own kidney s kealtk at tke tiny cost tkat too Ly sitting witkin tke boundary and comforts of one's own kome. Our product invention normally eliminates tke need for paying any immediate visit to a pkysician or patkologist, Lut once a positive test for albumin is observed Ly tke use of our kit, tken an immediate visit to tke doctor and/or patkologist becomes kigkly desirable so tkat any further damage to tke kidney is stopped, and if possible tke damaging process is reversed Ly proper medical treatment. To understand comprekensively tke importance of our invented kome test kit it is desirable to understand also, in brief, tke functions of tke kidney, and tke conditions tkat lead to tke kidney failure: Kidney failure and ike Use of URINE ALBUKIT Tke newly invented URINE ALBUKIT or tke Dialysis Warning Kit involves a simple one-minute test for alLumin wkick any individual can perform in tke privacy of kis/ker own kome or office. Tke test utilizes a fool proof Lut very simple technology tkat requires only a sample of urine and three special test reagents (provided in tke kit box). Tke kit box also contains two test tubes, a small funnel, and some filter papers (for filtering tke urine if it is dirty or cloudy, or not clearly transparent). Tkus, tke URINE ALBUKIT is designed to detect or monitor Kidney-damaging diseases before tkey Lecome catastropkically life-threatening, or incurable, or pocket -wise turn too costly to be treated. Various conditions can damage ones kidneys, suck as diabetes, kidney infections, kidney stone (renal calculi) formation or lithiasis, and otker conditions like high blood pressure tkat affect tke kidneys. If kidney damage Lecomes too severe, kidneys lose tkeir ability to function normally. As stated above, tke main function of kidney is to filter out toxins and excess salts, water, etc, from tke blood. If kidneys fail to perform tkis important function then, in simple terms, this condition is called renal insufficiency at first, and if this state of affairs continues unabated and unchecked, then the sad state of total kidney failure comes around. Kidney failure can happen rapidly (acute kidney failure ), usually in response to a severe acute (sudden or short-term) illness in another system of the body, or in the kidney itself. Now-a-days It is a very common complication in patients hospitalized for other reasons. If detected early, it can be maae completely reversible by resolving the underlying condition. Kidney failure can also happen very slowly and gradually {chronic kidney failure or CKD), usually in response to a chronic (long-term) disease such as diabetes or high blood pressure. Both types of kidney failure can also occur in response to a primary kidney disease as well. In some cases the kidney disease is hereditary; in that case constant monitoring of any kidney damage must be done with our URINE ALBUKIT. Infections and substances such as drugs, pain-relieving medicines, excessive alcohol consumption, and toxins can permanently scar the kidneys and lead to their failure. Here, the URINE ALBUKIT can help and send alarm signal to the patient to act and react for the prevention and progression of the malady. Thus, the URINE ALBUKIT for kidney care can very rapidly determine if a person has a fully functional normal kidney, or if he/she is suffering from a serious kidney disease that can necessitate emergency medical care including dialysis, etc. Tke URINE ALBUKIT can be used easily at one s own home or office without visiting a pathologist in the first place. Within one minute s time this kit can determine if a person (diabetic or non-diabetic) is running with a progressive kidney damage or kidney failure. If a person is found to have diabetes only without any kidney damage, then that person can carry on his/her medical treatment as advised by the consultant physician. But periodical use of URINE ALBUKIT is essential to identify any later-stage kidney damage. However, if URINE ALBUKIT gives an indication of kidney damage to a person who is afflicted with diabetes also, then it is advisable to seek immediate medical attention. Any further delay in seeking medical treatment may lead to complications such as minor or major kidney damage, retinopathy with blindness, kidney infection pain, stroke, heart disease, swelling of limbs and others. These conditions may endanger the person's life. In tke event of URINE ALBUKIT snowing a damaged kidney witkout any sign of diabetes, tken it is possikle tkat tke person may ke suffering from any of tke following conditions : 1. Higk blood pressure 2. Severe injury or kurns 3. Major surgery 4. Heart disease or keart attack 5. Liver disease or liver failure Any alkumin arising out of vein clot risk can also ke detected ky URINE ALBUKIT. Tke states of venous tkromkoemkolisms (VTEs) include deep vein tkromkosis (DVT) a clotting in tke lower extremities wkick gained recent notoriety when it occurred in passengers on long-kaul fligkts. Tkese clots can become dangerous if tkey travel to tke lungs to produce a pulmonary embolism. PRIOR ART Normally for testing alkumin in tke urine, tke latter is sent to tke clinical kiockemist (patkologist) for examination. Tke patkologist performs eitker of tke following metkods for tke detection of alkumin.: 1. Roberts Test. 2. Heat and Acetic Acid Test 3. Heller s Ring Test. 4. Sulfosalicylic Acid Test 5. Osgood-Haskins Test. 6. Pyrogallol Red-Molykdate Test 7. Strip Test ky using Tetrakromopkenol Blue or 5',5,"~Dinitro-3,3 -Diiodo-3,4,3,6-Tetrakromopkenolsulf onepktkalein, in tke presence of tartaric acid as kuffer Because of total lack of knowledge and facilities it is normally not possikle for a general patient or any otker common individual to perform any one of tke above noted tests at kome to learn about or evaluate tke dangerous presence of albumin in his/ker own or any body else urine. Tkus, for albumin testing in urine tke patient is wholly dependent on tke patkologist. But sadly, even if tke patient does get kis/ker urine tested from a patkologist, tke latter never issues any red alert even in tke case of strong positivity for albumin. Similarly tke personal pkysician of tke patient, even after going tkrougk tke alarming test results for albumin in tke urine test report, kardly performs kis/ker duty to sternly warn tke patient about tke dangerous consequences of tke reported results. This sort of unabated medical negligence eventually drags tke patient to dialysis room of an kospital or a nursing kome. Tke gullible unwarned patient goes on consuming tke prescription drugs, eta, and takes no precautions about tke diet regimen and otker prokibitions. Eventually a man wko was otkerwise kealtky a few years or a few montks ago suddenly turns critical, or expires. Tkis skocking state of medical negligence and personal ignorance is prevailing not in India alone, ratker it is a universal pkenomenon A U. S. Patent (No. 6447989) titled Kidney disease detection and treatment [ kttp://www.patentstorm.us/patents/6447989/fulltext.ktml J tkat was issued in September 2002, discloses a metkod for diagnosing early stage of a kidney disease in wkick an intact protein found in urine is described to be an indicator of tke disease. Tke metkod includes assaying urine sample to detect tke presence of modified protein using eitker immunological or non-immunological tecknique. But tke disclosed teckniques are too cumbersome to be applied by a common individual. Moreover tke metkod involves tke use of extremely costly instrument, tkus, out of bound for tke common man. Of late, in April 2009, M/s Biomerica received CE Mark Approval for a 5-Minute Home Test For Kidney Disease Screening For Diabetic And Hypertensive Individuals . [ http://www.medicaInewstoday.com/articIes/146926.php As a solution to tke above noted universal problem of ckecking kidney failure we have invented just a simple, economical, and most easy-to-perform kome test kit for tke rapid and foolproof detection of albumin in tke urine in tke privacy of one s own kome (or office) and tkat too witkin a skort period of just one minute's time. Tkus, our "One Minute Home Test Kit (tke "URINE ALBUKIT') gives virtually instant results wketker albumin in tke urine is present in micro- or macro-levels (in a highly diseased person), or if it is altogether absent (in a healthy person). It is recommended that any health-conscious citizen must possess our kidney care test kit if he/she is suffering from fluid retention, high blood pressure,, blood in the urine, frequent urination, difficulty in urinating or feeling a reduced volume of urine during urination, fatigue, lack of appetite, nausea, or pain in the waist or lower back area. These are all symptoms of a probable kidney disease. But above all, the use of our kit in the case of diabetic and hypertensive persons is indispensable because persons fall ing under this category are most prone to renal damage and total kidney failure. Limitations: Our test kit is intended as a most reliable health alert chemical marker. But for conclusive and in-depth specific diagnosis, an early consultation with a physician becomes desirable to confirm and/or pin point the presence of a specific disease or a hidden bad health condition including renal failure (kidney failure). Why URINE ALBUKIT Has Become Essential for All Diabetics? This is because India has achieved the notoriety for becoming the diabetic capital of the world with 40.9 million diabetics ; China comes next, with 59.8 million diabetics ; U.S., comes fourth with 19.2 millions ; Russia, Germany, and Pakistan have 9.U, 7.4, and 0.9 million diabetics respectively. If kidney care kit like URINE ALBUKIT to detect kidney damage (excluding sugar testing) is not used regularly, many millions of the world s diabetics would end up in the dialysis chamber, and might die prematurely. Tke URINE ALBUKIT is the most reliable and utmost economical means of testing any impending kidney damage in the case of diabetics alone. Detailed description of tke invention: Our invention is based on the joint application of certain simple natural reactions of the protein—albumin—with the additional involvement of tetraamminocopper(II) sulphate hydrate [Cu(NH3)4SO4H2O], in such a unique and new set of qualitative colour reactions that the detection of kazardous albumin in urine kas become an easy, quick, and absolutely mistake-free task even wken tke test is performed by a non-medico common man. Hence, tke inventors kave succeeded to produce a simple, kandy, and fully portable life-saving kit for common man s use. Hitkerto tke above described set of colour reactions of tke protein albumin kas remained unexplored, and inaccessible to tke common man for anu direct medical diagnostic use. Using tke undernoted set of simple colour reactions on kuman urine, extremely useful and life saving results can be obtained almost witkin as little as one minute s time, and tkat too in suck a foolproof manner tkat millions of lives can be saved per year wkick otkerwise migkt certainly be lost in tke absence of our newly-developed albumin detection kit and tke tecknique involved tkerein. To perform tke test, tke individual urine sample is first collected in any suitable clean glass or plastic bottle, or in a beaker. From tke vessel just 2 ml of tke urine sample is to be taken into a test tube (provided in tke kit box). Upon tke addition of a few to several drops of diluted nitric acid (3 parts concd. HNO3 +1 part of DM water) a white turbidity or precipitate, or sometimes a curdy wkite precipitate, would appear if albumin is present in tke urine. Subsequently, upon tke addition of a few drops of 20 % sodium kydroxide solution tke wkite turbidity or precipitate completely dissolves and disappears. Now, upon tke addition of just one or two drops of ~ 5 % tetraamminocopper(H) sulpkate kydrate [Cu(NH3)4SO4.H2O] solution a purple or violet colouration appears. Formation of light blue colour or precipitate instead of a clear purple or violet colour would show a negative test lor albumin or albuminurea. Tke appearance of distinct ligkt blue colour (tkat only skows tke absence of albumin) is tke diluted form of intense blue colouration of tke reagent tetraamminocopper(II) sulpkate kydrate itself. Tke intense blue-coloured amminocopper complex kas keen used in place of very ligkt blue plain copper sulpkate (of classic biuret test) because tke latter (CuSO4) fails to generate any visible blue colouration to indicate categorically or to any extent tkat albumin is absent in tke tested sample of urine Hence, tetraamminocopper(II) sulpkate kydrate [Cu(NH3)4SO4.H2O] has come up as a new marker for the detection of albumin in protein chemistry. The precipitation of albumin with diluted HNO3, the dissolution of the precipitated albumin with NaOH solution and subsequently generation of purple or violet colouration with tetraamminocopper(II) sulphate hydrate collectively provide one hundred percent surety that the kidney of the individual whose urine sample has been tested in this particular style is certainly afflicted with some medical problem that requires urgent medical attention. If no turbidity or precipitate is obtained upon addition of Reagent No. 1 to the urine, then it should be taken that kidney is in good health and it has not suffered any sort of damage. To categorically reconfirm the healthy state of the kidney, the urine sample is to be treated first with NaOH solution and subsequently with 1 or 2 drops of tetraamminocopper(II) sulphate hydrate solution. If kidney has not excreted any albumin in to the urine, then only light blue colour will appear. Precautions to be taken against false positive results: Sometimes small amounts of albumin might find their way into the urine under the following non-pathological conditions, thus giving false positive results. These results, due to the so-called physiological albuminurea , are purely temporary, and would disappear as soon as the effective conditions are removed. ( i ) Excessive muscular exertion or workout by persons who are unaccustomed to it. (ii) Excessive ingestion of proteinous diet. (iii) Prolonged cold baths. (iv) Prolonged standing ('Orthostatic albuminurea') (v) Consumtion of tolbutamide derivatives or taking high doses of penicillin. (vi) In persons having undergone X-ray examinations under contrast media. Urine Samples : Normal kealthy-looking volunteers as well as known patients witk damaged kidney were used to provide urine samples for analyzing and detecting tke presence or absence of albumin in tkeir urine. Reagents Used in tke Kit Process: (a) Reagent Na1. Partially diluted nitric acid (3 parts of concentrated nitric acid + 1 part of DM water ), packed in compressible plastic drop bottle. (b) Reagent Na 2. 20 % Sodium kydroxide solution in DM water, packed in compressible plastic drop bottle. (c) Reagent Na 3. ~5% Tetraamminocopper(II) sulpkate kydrate [Cu(NH3)4SO4.H2O] solution in DM water {prepared by adding or passing sufficient ammonia to 5 % copper sulphate solution until a clear and transparent deep blue colouration, without any trace of a precipitate, is formed/. This reagent is also packed in a compressible plastic drop bottle. Procedure: Collect tke urine sample in a clean plastic or glass bottle or beaker. If tke collected urine is cloudy, dirty, or opaque, or if it skows suspended epitkelial cells, casts, crystals, etc., tken filter it before testing, witk tke use of a filter paper and a small funnel (provided in tke kit). However, if tke urine sample is very clear and transparent [FIGURE 1 A], tken tkere is no need of filtering and test may be performed directly. Example 1 Take just about 2 ml of tke urine sample in tke test tube (provided in tke kit box), and add 8 to 10 drops of tke Reagent Na 1 on to tke urine. Sligktly skake and observe if any wkite turbidity or precipitate appears in tke test tube. Any visible wkite turbidity or a precipitate indicates tke certain presence of albumin. Greater tke density of tke wkite precipitate tke greater is tke quantity of albumin present [ FIGURE 1B and 1C ]. If urine sample remains unaffected, Le., it stows no change upon the addition of Reagent No. 1, then no further testing (as detailed in Example Nos. 2 to 4) may required, and the state of kidney health mau be taken as sound (i.e., the kidney is not damaged to any extent). However, for being double sure about the sound (or undamaged) state of kidneu, just perform a second test as given in Example 5. Note (i) : The formation of white turbidity or precipitate [FIGURE 1 B and \C]in the urine sample upon the addition of Reagent No. 1 is itself a certain indicative of some sort of kidney damage. Note (ii): The degree of kidney damage is directly linked to the density oi the white precipitate formed upon the addition ol Reagent No. /[FIGURE 1B and 1C]. Note (iii) : B only slight but clear white turbidity has been observed then it should be taken as Just a beginning of the kidney damage. This sort ol kidney damage can be easily reversed by consulting with your family doctor. If, however, a thick curdy white precipitate is observed then it should be taken as a state ol emergency with high degree ol kidney damage or total kidney failure, and the patient must be rushed to the hospital for intensive care and treatment. Example 2 To the white turbidity or the precipitate as obtained in Example 1 add 8-10 drops of Reagent No. 2, and slightly shake. The turbidity or the precipitate fully dissolves and disappears. If need be a few more drops of the reagent may be added. The dissolution or disappearance of the white turbidity or precipitate in the urine sample upon the addition of Reagent No. 2 is further strong indicative of some sort of kidney damage. Example 3 Add one or two drops of Reagent No. 3 to the clear solution as obtained in Example 2, and shake. The solution immediately turns purple or violet [FIGURE 1D]. Note (i) : The test method described in Example 3 gives very strong violet colour if the formation of a very strong or heavy white precipitate is observed in Example 2. With weak white precipitate or turbidity the violet colouration would be proportionately of lighter shade, hence it should be very carefully observed. Note (ii) : The formation of purple or violet coloured solution upon the addition of Reagent No. 3 is absolutely certain indicative of a kidney damage. Such a colouration can not develop if kidney is in perfect and sound state of health. Example 4 Add a few drops of Reagent No.1 to tke purple-violet coloured product (as obtained in Example 3), and skake; tke entire purple colouration disappears and a wkite turbidity or tke white precipitate (as obtained in Example No. 1) reappears. Example 5 Take just about 2 ml of tke urine in tke test tube (provided in tke kit box), and add 8 to 10 drops of tke Reagent No. 2 and skake. Now add just 1 or 2 drops of Reagent No. 3, and again skake. A ligkt or deep purple or violet colour would appear depending upon tke quantity of albumin present in tke urine [FIGURE 1D]. Note : If upon the addition of Reagent No. 3 just a light blue colour with or without any precipitate appears instead of clear purple or violet colouration , then the test for albumin should be taken as negative ( i.e., ALBUMIN ABSENT) [FIG. IE] Greater the density of the purple or violet colouration the greater is the quantity of albumin present, thus greater is the degree of damage to the kidney. Visual colour density (of purple or violet) α degree of kidney damage If now a few drops of Reagent No. 1 are added to the purple or violet-coloured solution, the entire colour is destroyed and a white precipitate is formed. Greater the density of the white precipitate the greater is the quantity of albumin present, thus greater is the degree of damage to the kidney. Degree of thickness of the white precipitate α degree of kidney damage Conclusion Finally, it is reiterated that URINE ALBUKIT for albumin test in urine—is a simplest home diagnostic kit for easily, speedily, and economically identifying the underlying risk of complications from hidden kidney and/or kidney-linked heart diseases. The presence of this kit for home testing of urine albumin is desirable in every house of the world. Depending on the alhumin concentration, the detection of urinary protein is made ty precipitating it with diluted nitric acid (3 :1 HNO3: Water). The latter is dissolved in an alkali, and the resultant clear solution is treated with tetraamminooopper(II) sulphate hydrate [Cu(NH3)4SO4.H2O] solution to produce a distinct violet coloration. The formation of a blue colour (instead of purple or violet) is negative test for albumin [FIG. 1E]. The above described test series of qualitative arrangement for detecting albumin in urine is a simplest and most economical alternative to traditional and comparatively much costlier testing methods done at the clinical or pathological laboratories around the world. The kit-observed results (if found positive ) immediately make an unaware patient of proteinuria absolutely sure of suffering from some simple to most serious medical problem that necessitates him/her to make an urgent visit to the family doctor for taking remedial course of action. Physicians, patients, and kidney-care organizations can all he benefited by making use of URINE ALBUKIT that instantly gives positive or negative results, about the presence or absence respectively of microalbumin (or macro albumin) in the urine. Thus, the invented kit provides the fastest, easiest, and instant test technique to detect subclinical nephropathy, if any. There is also proven accuracy in our kit s technique compared to costly commercial and traditional pathological examinations. Hence, the specificity and sensitivity of the involved method is 100 % accurate with full patient and physician satisfaction. The kit is not only suitable for in-home or in-office testing, there is long- and short-term huge cost savings as well. CLAIMS 1. A One-Minute Home diagnostic Test Kit For Albuminurea for the Instant Detection, Prevention, and Monitoring, Through Urine, of Any Minor, Major, or Total Kidney Damage (Renal Failure). 2. A One-Minute Home diagnostic Test Kit For Albuminurea that also acts a dialysis warning kit. 3. A diagnostic kit for detecting albumin in urine in which one of the reagents is diluted nitric acid ( three parts concentrated nitric acid and one part of pure DM water). 4. A diagnostic kit for detecting albumin in urine in which one of the reagents is 20 % sodium hydroxide in DM water. 5. A diagnostic kit for detecting albumin in urine in which one of the reagents is ~ 5 % tetraamminocopper(II) sulphate hydrate [Cu(NH3)4SO4 H2O] solution in water ( prepared by adding or passing sufficient ammonia to 5 % copper sulphate solution until a clear and transparent deep blue coloured solution is obtained ).

Full Text

COMPLETE SPECIFICATION
TITLE OF THE INVENTION : One-Minute Home Test Kit For Albuminurea for the Instant Detection, Prevention, and Monitoring, Through Urine, of Any Minor, Major, or Total Kidney Damage (Renal Failure).
FIELD OF INVENTION : Medical diagnostic (hy chemical analysis)
APPLICANTS NATIONALITY ADDRESS
(i) Johar, Sarabjeet Singh Indian KanpurTestHouse, 118/23
Nazirabad, Kanpur-208012 ( U. P.), India
(ii) Johar, Manpreet Singh Canadian 183, Morning Dove Drive,
Markham, Ontario L6B1L9, Canada
The following specification particularly describes the invention and the manner in which it is to he performed:
This invention involves the development of a simple, economical, and most reliable diagnostic kit—the URINE ALBUKIT-—to detect the presence of albumin in the urine ( Albuminurea ) within just one minute s time, by sitting in one s own home (or office), thus easily preventing countless premature deaths owing to otherwise undiagnosed kidney failures happening all over the world every year. India being one of the most affected countries of the world.
BACKGROUND AND MOTTO OF THE INVENTION : Our invention is intended to give a product (for urine microalbumin test) to the world with the message : Save yourself and your near and dear ones from facing the state of fatal renal failure leading to the stage of painful dialysis in hospitals, or necessitating a kidney transplantation ! The message further says : Take care at home of your precious kidney, without visiting doctors in London or Sydney ! This means that taking care of one's own kidneys has no longer remained a tedious job. Since the routine monitoring of the kidney s health is highly desirable for every individual, and the latter step is now no longer a costly preposition; people at large can get full benefit of the new invention. But before one can start monitoring the functioning of the kidneys, he/she must
have a clear concept of kidneys functioning mechanism, and for this, the undernoted paragraph titled Proteinurea has to he taken account into.
Proteinurea
Proteinurea (presence of protein in the urine) is a classic sign of kidney disease and its management carries powerful prognostic information about the health of the kidneys. The inventors stress that urinary albumin detection is the best approach for the management of chronic kidney diseases (CKD). Albumin is a protein which is normally found in the blood and it is regularly filtered by the kidneys and sent back to the blood stream. That is why when the kidneys are working properly, albumin should or rather must not be present in the urine in any significant amount. But somehow when the kidneys are damaged, small
amounts of albumin (microalbumin) leak out into the urine a condition
which is tantamount to a red alert indicating some serious threat to the kidneys. If prompt remedial measures are not taken then gradually elevated levels of albumin start showing up in the urine that may eventually drag the person up to the stage of total kidney failure and then requiring dialysis. The invented kit may therefore very logically also be described as Dialysis Warning Kit meant for saving a human life at negligible cost.
Our new and easiest-to-operate one-minute home iesi kii to detect micro-(or macro-) albumin contents in urine which takes no more than one minutes time, can now be used individually or may be delivered to the health-care officials or agencies in any country of the world for community use in urban as well as rural areas.
Worldwide, it has been estimated that as many as 400 to 600 million people suffer from chronic kidney diseases (CKD). Primarily the two major causes of CKD are diabetes and high blood pressure. Early detection of albumin can surely help prevent easily the progression of some early kidney damage that would otherwise lead to total kidney failure.
Nearly kalf of tke people even reaching to an advanced stage of kidney failure do not even know tkat they kave keen lelt witk just a few montks or few weeks time before they are to ke put to dialysis. Tkis alarming warning kas keen stated in a recent researck published in tke American Journal of Kidney Diseases—the official American journal of tke National Kidney Foundation.
Alkuminurea and Premature Deliveries by tke Pregnant Women
According to a study published in July 2005 in tke American Journal of Kidneu Diseases, pregnant women witk albuminuria are several times more likely to give birth of a baby prematurely. The team leader of this piece of study had wished for having a simple and inexpensive test technique for urinary albumin so that doctors could easily target their efforts towards women at risk of undergoing a premature delivery. Research clearly suggests that albuminuria may be a sign that a woman has problems in the lining of her blood vessels. If so, some cases of prematurity may be caused by a dysfunction
in the blood vessels supporting a fetus a finding that may point to new future
treatments that could help babies stay longer in the mother's womb. This is because albuminuria serves as a sign of overall blood vessel problems. In pregnancy, blood vessel problems may disrupt fetal growth and trigger a premature delivery. These facts have been disclosed by Dr. David Warnock, President, of Americas National Kidney Foundation and Director of Nephrology at the University of Alabama at Birmingham. During the study, the investigators measured albumin levels in the urine of 111 women who gave birth to babies after less than 37 weeks' gestation, and 293 women who carried their babies to term. And the more albumin women had in their urine, the higher their chances of giving birth prematurely. Indeed, women with the most albumin in their urine were nearly five times more likely than women with the least amount of albumin to have premature babies. Dr. Warnock had also said If we know which mothers are most at risk of delivering early, we can target our efforts to those women who need it most; tracking urinary albumin looks like one way we can do that.'
Our invented URINE ALBUKIT can successfully, economically, and most easily
solve tke problem of monitoring tke urinary albumin levels of tkose would-be-
motkers wko are at risk of delivering a premature baby.
Albuminurea in HIV Patients Undergoing Antiretroviral Tkerapy
Of late, it kas also been found tkat HIV-infected persons despite undergoing antiretroviral tkerapy continue to lose kidney function. Hence, monitoring of kidney damage in HIV-infected persons can also be done witk tke use of our
URINE ALBUKIT.
Tke State of General Carelessness and Rising Kidney Failure Cases
Tke kealtky kuman kidneys constantly filter toxins (poisonous waste products ) from our blood. If our kidneys somehow turn damaged, some or many of tkese waste and toxic products may remain retained in our blood. At tke same time, a type of protein called albumin—which must stay back in our blood—leaks out into our urine in micro quantities. This is a dangerous situation wkick may prove fatal at tke later stage. Hence, Urine Microalbumin Test becomes necessary at least for tkose people wko kave kigk Hood pressure (kypertension) and diabetes of any type ( Type 1 or Type 2). It is mostly tke diabetes and kigk Hood pressure-related kidney damage wkick kills kundreds of tkousands of people every year all around tke world.
In tke event of an affected person gets kis/ker urine tested tkrougk a patkologist at tke behest of a family pkysician, and if some minor or major renal damage is also detected, even tken, as per general tendency, neitker tke patkologist nor tke pkysician norm ally issues any stern warning or skows a clear red signal to tke patient about tke impending tkreat looming large over tke patient s life. Tkus, tke patient constantly remains ignorant about kis/ker kidneys deteriorating kealtk despite spending money on tke patkological testing. Having not warned, tke patient continues to lead tke normal life witkout taking precautions about tke diet regimen and drug-management, tkus resulting in further serious damage to tke kidney. This is a general trend of medical and kuman negligence not only in India but throughout tke world. As a consequence, tke pkysicians and patkologists go ricker and ricker, but tke patient's kidney kealtk turns poorer and poorer in tke coming years, and
eventually landing kim/ker on tke bed of a dialysis chamber, and also creating necessity of a possible kidney transplant.
Our product invention (URINE ALBUKIT) is tkerefore a Loon for tke entire kumanity for absolutely flawless and quick self-testing of one s own kidney s kealtk at tke tiny cost tkat too Ly sitting witkin tke boundary and comforts of one's own kome. Our product invention normally eliminates tke need for paying any immediate visit to a pkysician or patkologist, Lut once a positive test for albumin is observed Ly tke use of our kit, tken an immediate visit to tke doctor and/or patkologist becomes kigkly desirable so tkat any further damage to tke kidney is stopped, and if possible tke damaging process is reversed Ly proper medical treatment.
To understand comprekensively tke importance of our invented kome test kit it is desirable to understand also, in brief, tke functions of tke kidney, and tke conditions tkat lead to tke kidney failure:
Kidney failure and ike Use of URINE ALBUKIT
Tke newly invented URINE ALBUKIT or tke Dialysis Warning Kit involves a simple one-minute test for alLumin wkick any individual can perform in tke privacy of kis/ker own kome or office. Tke test utilizes a fool proof Lut very simple technology tkat requires only a sample of urine and three special test reagents (provided in tke kit box). Tke kit box also contains two test tubes, a small funnel, and some filter papers (for filtering tke urine if it is dirty or cloudy, or not clearly transparent). Tkus, tke URINE ALBUKIT is designed to detect or monitor Kidney-damaging diseases before tkey Lecome catastropkically life-threatening, or incurable, or pocket -wise turn too costly to be treated.
Various conditions can damage ones kidneys, suck as diabetes, kidney infections, kidney stone (renal calculi) formation or lithiasis, and otker conditions like high blood pressure tkat affect tke kidneys. If kidney damage Lecomes too severe, kidneys lose tkeir ability to function normally.
As stated above, tke main function of kidney is to filter out toxins and excess salts, water, etc, from tke blood. If kidneys fail to perform tkis important
function then, in simple terms, this condition is called renal insufficiency at first, and if this state of affairs continues unabated and unchecked, then the sad state of total kidney failure comes around.
Kidney failure can happen rapidly (acute kidney failure ), usually in response to a severe acute (sudden or short-term) illness in another system of the body, or in the kidney itself. Now-a-days It is a very common complication in patients hospitalized for other reasons. If detected early, it can be maae completely reversible by resolving the underlying condition. Kidney failure can also happen very slowly and gradually {chronic kidney failure or CKD), usually in response to a chronic (long-term) disease such as diabetes or high blood pressure. Both types of kidney failure can also occur in response to a primary kidney disease as well.
In some cases the kidney disease is hereditary; in that case constant monitoring of any kidney damage must be done with our URINE ALBUKIT. Infections and substances such as drugs, pain-relieving medicines, excessive alcohol consumption, and toxins can permanently scar the kidneys and lead to their failure. Here, the URINE ALBUKIT can help and send alarm signal to the patient to act and react for the prevention and progression of the malady. Thus, the URINE ALBUKIT for kidney care can very rapidly determine if a person has a fully functional normal kidney, or if he/she is suffering from a serious kidney disease that can necessitate emergency medical care including dialysis, etc.
Tke URINE ALBUKIT can be used easily at one s own home or office without visiting a pathologist in the first place. Within one minute s time this kit can determine if a person (diabetic or non-diabetic) is running with a progressive kidney damage or kidney failure. If a person is found to have diabetes only without any kidney damage, then that person can carry on his/her medical treatment as advised by the consultant physician. But periodical use of URINE ALBUKIT is essential to identify any later-stage kidney damage. However, if URINE ALBUKIT gives an indication of kidney damage to a person who is afflicted with diabetes also, then it is advisable to seek immediate medical attention. Any further delay in seeking medical treatment may lead to complications such as minor or major kidney damage, retinopathy with blindness, kidney infection pain, stroke, heart disease, swelling of limbs and others. These conditions may endanger the person's life.
In tke event of URINE ALBUKIT snowing a damaged kidney witkout any sign of diabetes, tken it is possikle tkat tke person may ke suffering from any of tke following conditions :
1. Higk blood pressure
2. Severe injury or kurns
3. Major surgery
4. Heart disease or keart attack
5. Liver disease or liver failure
Any alkumin arising out of vein clot risk can also ke detected ky URINE ALBUKIT. Tke states of venous tkromkoemkolisms (VTEs) include deep vein
tkromkosis (DVT) a clotting in tke lower extremities wkick gained recent
notoriety when it occurred in passengers on long-kaul fligkts. Tkese clots can become dangerous if tkey travel to tke lungs to produce a pulmonary embolism.
PRIOR ART
Normally for testing alkumin in tke urine, tke latter is sent to tke clinical kiockemist (patkologist) for examination. Tke patkologist performs eitker of tke following metkods for tke detection of alkumin.:
1. Roberts Test.
2. Heat and Acetic Acid Test
3. Heller s Ring Test.
4. Sulfosalicylic Acid Test 5. Osgood-Haskins Test.

6. Pyrogallol Red-Molykdate Test
7. Strip Test ky using Tetrakromopkenol Blue or 5',5,"~Dinitro-3,3 -Diiodo-3,4,3,6-Tetrakromopkenolsulf onepktkalein, in tke presence of tartaric acid as kuffer
Because of total lack of knowledge and facilities it is normally not possikle for a general patient or any otker common individual to perform any one of tke above noted tests at kome to learn about or evaluate tke dangerous presence
of albumin in his/ker own or any body else urine. Tkus, for albumin testing in urine tke patient is wholly dependent on tke patkologist. But sadly, even if tke patient does get kis/ker urine tested from a patkologist, tke latter never issues any red alert even in tke case of strong positivity for albumin. Similarly tke personal pkysician of tke patient, even after going tkrougk tke alarming test results for albumin in tke urine test report, kardly performs kis/ker duty to sternly warn tke patient about tke dangerous consequences of tke reported results. This sort of unabated medical negligence eventually drags tke patient to dialysis room of an kospital or a nursing kome. Tke gullible unwarned patient goes on consuming tke prescription drugs, eta, and takes no precautions about tke diet regimen and otker prokibitions. Eventually a man wko was otkerwise kealtky a few years or a few montks ago suddenly turns critical, or expires. Tkis skocking state of medical negligence and personal ignorance is prevailing not in India alone, ratker it is a universal pkenomenon
A U. S. Patent (No. 6447989) titled Kidney disease detection and treatment [ kttp://www.patentstorm.us/patents/6447989/fulltext.ktml J tkat was issued in September 2002, discloses a metkod for diagnosing early stage of a kidney disease in wkick an intact protein found in urine is described to be an indicator of tke disease. Tke metkod includes assaying urine sample to detect tke presence of modified protein using eitker immunological or non-immunological tecknique. But tke disclosed teckniques are too cumbersome to be applied by a common individual. Moreover tke metkod involves tke use of extremely costly instrument, tkus, out of bound for tke common man.
Of late, in April 2009, M/s Biomerica received CE Mark Approval for a
5-Minute Home Test For Kidney Disease Screening For Diabetic And
Hypertensive Individuals . [
http://www.medicaInewstoday.com/articIes/146926.php
As a solution to tke above noted universal problem of ckecking kidney failure we have invented just a simple, economical, and most easy-to-perform kome test kit for tke rapid and foolproof detection of albumin in tke urine in tke privacy of one s own kome (or office) and tkat too witkin a skort period of just one minute's time. Tkus, our "One Minute Home Test Kit (tke "URINE ALBUKIT') gives virtually instant results wketker albumin in tke urine is present in micro-
or macro-levels (in a highly diseased person), or if it is altogether absent (in a healthy person).
It is recommended that any health-conscious citizen must possess our kidney care test kit if he/she is suffering from fluid retention, high blood pressure,, blood in the urine, frequent urination, difficulty in urinating or feeling a reduced volume of urine during urination, fatigue, lack of appetite, nausea, or pain in the waist or lower back area. These are all symptoms of a probable kidney disease. But above all, the use of our kit in the case of diabetic and hypertensive persons is indispensable because persons fall ing under this category are most prone to renal damage and total kidney failure.
Limitations: Our test kit is intended as a most reliable health alert chemical marker. But for conclusive and in-depth specific diagnosis, an early consultation with a physician becomes desirable to confirm and/or pin point the presence of a specific disease or a hidden bad health condition including renal failure (kidney failure).
Why URINE ALBUKIT Has Become Essential for All Diabetics?
This is because India has achieved the notoriety for becoming the diabetic capital of the world with 40.9 million diabetics ; China comes next, with 59.8 million diabetics ; U.S., comes fourth with 19.2 millions ; Russia, Germany, and Pakistan have 9.U, 7.4, and 0.9 million diabetics respectively.
If kidney care kit like URINE ALBUKIT to detect kidney damage (excluding sugar testing) is not used regularly, many millions of the world s diabetics would end up in the dialysis chamber, and might die prematurely.
Tke URINE ALBUKIT is the most reliable and utmost economical means of testing any impending kidney damage in the case of diabetics alone.
Detailed description of tke invention:
Our invention is based on the joint application of certain simple natural reactions of the protein—albumin—with the additional involvement of tetraamminocopper(II) sulphate hydrate [Cu(NH3)4SO4H2O], in such a unique and new set of qualitative colour reactions that the detection of
kazardous albumin in urine kas become an easy, quick, and absolutely mistake-free task even wken tke test is performed by a non-medico common man. Hence, tke inventors kave succeeded to produce a simple, kandy, and fully portable life-saving kit for common man s use. Hitkerto tke above described set of colour reactions of tke protein albumin kas remained unexplored, and inaccessible to tke common man for anu direct medical diagnostic use.
Using tke undernoted set of simple colour reactions on kuman urine, extremely useful and life saving results can be obtained almost witkin as little as one minute s time, and tkat too in suck a foolproof manner tkat millions of lives can be saved per year wkick otkerwise migkt certainly be lost in tke absence of our newly-developed albumin detection kit and tke tecknique involved tkerein.
To perform tke test, tke individual urine sample is first collected in any suitable clean glass or plastic bottle, or in a beaker. From tke vessel just 2 ml of tke urine sample is to be taken into a test tube (provided in tke kit box). Upon tke addition of a few to several drops of diluted nitric acid (3 parts concd. HNO3 +1 part of DM water) a white turbidity or precipitate, or sometimes a curdy wkite precipitate, would appear if albumin is present in tke urine. Subsequently, upon tke addition of a few drops of 20 % sodium kydroxide solution tke wkite turbidity or precipitate completely dissolves and disappears. Now, upon tke addition of just one or two drops of ~ 5 % tetraamminocopper(H) sulpkate kydrate [Cu(NH3)4SO4.H2O] solution a purple or violet colouration appears. Formation of light blue colour or precipitate instead of a clear purple or violet colour would show a negative test lor albumin or albuminurea. Tke appearance of distinct ligkt blue colour (tkat only skows tke absence of albumin) is tke diluted form of intense blue colouration of tke reagent tetraamminocopper(II) sulpkate kydrate itself. Tke intense blue-coloured amminocopper complex kas keen used in place of very ligkt blue plain copper sulpkate (of classic biuret test) because tke latter (CuSO4) fails to generate any visible blue colouration to indicate categorically or to any extent tkat albumin is absent in tke tested
sample of urine Hence, tetraamminocopper(II) sulpkate kydrate
[Cu(NH3)4SO4.H2O] has come up as a new marker for the detection of albumin in protein chemistry. The precipitation of albumin with diluted HNO3, the dissolution of the precipitated albumin with NaOH solution and subsequently generation of purple or violet colouration with tetraamminocopper(II) sulphate hydrate collectively provide one hundred percent surety that the kidney of the individual whose urine sample has been tested in this particular style is certainly afflicted with some medical problem that requires urgent medical attention. If no turbidity or precipitate is obtained upon addition of Reagent No. 1 to the urine, then it should be taken that kidney is in good health and it has not suffered any sort of damage. To categorically reconfirm the healthy state of the kidney, the urine sample is to be treated first with NaOH solution and subsequently with 1 or 2 drops of tetraamminocopper(II) sulphate hydrate solution. If kidney has not excreted any albumin in to the urine, then only light blue colour will appear.
Precautions to be taken against false positive results:
Sometimes small amounts of albumin might find their way into the urine under the following non-pathological conditions, thus giving false positive results. These results, due to the so-called physiological albuminurea , are purely temporary, and would disappear as soon as the effective conditions are removed.
( i ) Excessive muscular exertion or workout by persons who are
unaccustomed to it. (ii) Excessive ingestion of proteinous diet.
(iii) Prolonged cold baths.
(iv) Prolonged standing ('Orthostatic albuminurea')
(v) Consumtion of tolbutamide derivatives or taking high doses of
penicillin. (vi) In persons having undergone X-ray examinations under contrast
media.
Urine Samples : Normal kealthy-looking volunteers as well as known patients witk damaged kidney were used to provide urine samples for analyzing and detecting tke presence or absence of albumin in tkeir urine.
Reagents Used in tke Kit Process:
(a) Reagent Na1. Partially diluted nitric acid (3 parts of concentrated nitric acid + 1 part of DM water ), packed in compressible plastic drop bottle.
(b) Reagent Na 2. 20 % Sodium kydroxide solution in DM water, packed in compressible plastic drop bottle.
(c) Reagent Na 3. ~5% Tetraamminocopper(II) sulpkate kydrate
[Cu(NH3)4SO4.H2O] solution in DM water {prepared by adding or
passing sufficient ammonia to 5 % copper sulphate solution until a clear and transparent deep blue colouration, without any trace of a precipitate, is formed/. This reagent is also packed in a compressible plastic drop bottle.
Procedure: Collect tke urine sample in a clean plastic or glass bottle or beaker. If tke collected urine is cloudy, dirty, or opaque, or if it skows suspended epitkelial cells, casts, crystals, etc., tken filter it before testing, witk tke use of a filter paper and a small funnel (provided in tke kit). However, if tke urine sample is very clear and transparent [FIGURE 1 A], tken tkere is no need of filtering and test may be performed directly.
Example 1
Take just about 2 ml of tke urine sample in tke test tube (provided in tke kit box), and add 8 to 10 drops of tke Reagent Na 1 on to tke urine. Sligktly skake and observe if any wkite turbidity or precipitate appears in tke test tube. Any visible wkite turbidity or a precipitate indicates tke certain presence of albumin. Greater tke density of tke wkite precipitate tke greater is tke quantity of albumin present [ FIGURE 1B and 1C ].
If urine sample remains unaffected, Le., it stows no change upon the addition of Reagent No. 1, then no further testing (as detailed in Example Nos. 2 to 4) may required, and the state of kidney health mau be taken as sound (i.e., the kidney is not damaged to any extent). However, for being double sure about the sound (or undamaged) state of kidneu, just perform a second test as given in Example 5.
Note (i) : The formation of white turbidity or precipitate [FIGURE 1 B and \C]in the urine sample upon the addition of Reagent No. 1 is itself a certain indicative of some sort of kidney damage.
Note (ii): The degree of kidney damage is directly linked to the density oi the white precipitate formed upon the addition ol Reagent No. /[FIGURE 1B and 1C].
Note (iii) : B only slight but clear white turbidity has been observed then it should be taken as Just a beginning of the kidney damage. This sort ol kidney damage can be easily reversed by consulting with your family doctor. If, however, a thick curdy white precipitate is observed then it should be taken as a state ol emergency with high degree ol kidney damage or total kidney failure, and the patient must be rushed to the hospital for intensive care and treatment.
Example 2
To the white turbidity or the precipitate as obtained in Example 1 add 8-10 drops of Reagent No. 2, and slightly shake. The turbidity or the precipitate fully dissolves and disappears. If need be a few more drops of the reagent may be added. The dissolution or disappearance of the white turbidity or precipitate in the urine sample upon the addition of Reagent No. 2 is further strong indicative of some sort of kidney damage.
Example 3
Add one or two drops of Reagent No. 3 to the clear solution as obtained in Example 2, and shake. The solution immediately turns purple or violet
[FIGURE 1D].

Note (i) : The test method described in Example 3 gives very strong violet colour if the formation of a very strong or heavy white precipitate is observed in Example 2. With weak white precipitate or turbidity the violet colouration would be proportionately of lighter shade, hence it should be very carefully observed.
Note (ii) : The formation of purple or violet coloured solution upon the addition of Reagent No. 3 is absolutely certain indicative of a kidney damage. Such a colouration can not develop if kidney is in perfect and sound state of health.
Example 4
Add a few drops of Reagent No.1 to tke purple-violet coloured product (as obtained in Example 3), and skake; tke entire purple colouration disappears and a wkite turbidity or tke white precipitate (as obtained in Example No. 1) reappears.
Example 5
Take just about 2 ml of tke urine in tke test tube (provided in tke kit box), and
add 8 to 10 drops of tke Reagent No. 2 and skake. Now add just 1 or 2 drops of
Reagent No. 3, and again skake. A ligkt or deep purple or violet colour would
appear depending upon tke quantity of albumin present in tke urine [FIGURE 1D].
Note : If upon the addition of Reagent No. 3 just a light blue colour with or without any precipitate appears instead of clear purple or violet colouration , then the test for albumin should be taken as negative ( i.e., ALBUMIN ABSENT) [FIG. IE]
Greater the density of the purple or violet colouration the greater is the quantity of albumin present, thus greater is the degree of damage to the kidney.
Visual colour density (of purple or violet) α degree of kidney damage
If now a few drops of Reagent No. 1 are added to the purple or violet-coloured solution, the entire colour is destroyed and a white precipitate is formed. Greater
the density of the white precipitate the greater is the quantity of albumin
present, thus greater is the degree of damage to the kidney.
Degree of thickness of the white precipitate α degree of kidney damage
Conclusion
Finally, it is reiterated that URINE ALBUKIT for albumin test in urine—is a
simplest home diagnostic kit for easily, speedily, and economically identifying the underlying risk of complications from hidden kidney and/or kidney-linked heart diseases. The presence of this kit for home testing of urine albumin is desirable in every house of the world.
Depending on the alhumin concentration, the detection of urinary protein is made ty precipitating it with diluted nitric acid (3 :1 HNO3: Water). The latter is dissolved in an alkali, and the resultant clear solution is treated with tetraamminooopper(II) sulphate hydrate [Cu(NH3)4SO4.H2O] solution to produce a distinct violet coloration. The formation of a blue colour (instead of purple or violet) is negative test for albumin [FIG. 1E].
The above described test series of qualitative arrangement for detecting albumin in urine is a simplest and most economical alternative to traditional and comparatively much costlier testing methods done at the clinical or pathological laboratories around the world. The kit-observed results (if found positive ) immediately make an unaware patient of proteinuria absolutely sure of suffering from some simple to most serious medical problem that necessitates him/her to make an urgent visit to the family doctor for taking remedial course of action. Physicians, patients, and kidney-care organizations can all he benefited by making use of URINE ALBUKIT that instantly gives positive or negative results, about the presence or absence respectively of microalbumin (or macro albumin) in the urine. Thus, the invented kit provides the fastest, easiest, and instant test technique to detect subclinical nephropathy, if any. There is also proven accuracy in our kit s technique compared to costly commercial and traditional pathological examinations. Hence, the specificity and sensitivity of the involved method is 100 % accurate with full patient and physician satisfaction. The kit is not only suitable for in-home or in-office testing, there is long- and short-term huge cost savings as well.

CLAIMS
1. A One-Minute Home diagnostic Test Kit For Albuminurea for the Instant Detection, Prevention, and Monitoring, Through Urine, of Any Minor, Major, or Total Kidney Damage (Renal Failure).
2. A One-Minute Home diagnostic Test Kit For Albuminurea that also acts a dialysis warning kit.
3. A diagnostic kit for detecting albumin in urine in which one of the reagents is diluted nitric acid ( three parts concentrated nitric acid and one part of pure DM water).
4. A diagnostic kit for detecting albumin in urine in which one of the reagents is 20 % sodium hydroxide in DM water.
5. A diagnostic kit for detecting albumin in urine in which one of the reagents is ~ 5 % tetraamminocopper(II) sulphate hydrate [Cu(NH3)4SO4 H2O] solution in water ( prepared by adding or passing sufficient ammonia to 5 % copper sulphate solution until a clear and transparent deep blue coloured solution is obtained ).

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http://ipindiaonline.gov.in/patentsearch/GrantedSearch/viewdoc.aspx?id=WR6qUozhqei6no2im0ftWQ==&loc=+mN2fYxnTC4l0fUd8W4CAA==

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Patent Number

268937

Indian Patent Application Number

2589/DEL/2009

PG Journal Number

40/2015

Publication Date

02-Oct-2015

Grant Date

23-Sep-2015

Date of Filing

14-Dec-2009

Name of Patentee

JOHAR, SARABJEET SINGH

Applicant Address

KANPUR TEST HOUSE 118/23, NAZIRABAD, KANPUR-208012 (U.P.), INDIA

Inventors:

#	Inventor's Name	Inventor's Address
1	JOHAR, SARABJEET SINGH	KANPUR TEST HOUSE 118/23, NAZIRABAD, KANPUR-208012 (U.P.), INDIA
2	JOHAR, MANPREET SINGH	183, MORNING DOVE DRIVE, MARKHAM, ONTARIO L6B1L9, CANADA.
3	JOHAR GURDEEP SINGH	KANPUR TEST HOUSE, 118/23 NAZIRABAD, KANPUR-208012 (U.P.), INDIA

PCT International Classification Number

A61K35/00

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA