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Urine test strip

A urine test strip or dipstick is a basic diagnostic tool used to determine pathological changes in a patient's urine in standard urinalysis.

Test method
The test method consists of immersing the test strip completely in a well mixed sample of urine for a short period of time, then extracting it from the container and supporting the edge of the strip over the mouth of the container to remove excess urine. The strip is then left to stand for the time necessary for the reactions to occur (usually 1 to 2 minutes), and finally the colours that appear are compared against the chromatic scale provided by the manufacturer. An improper technique can produce false results, for example, leukocytes and erythrocytes precipitate at the bottom of the container and may not be detected if the sample is not properly mixed, and in the same way, if an excess of urine remains on the strip after it has been removed from the test sample, may cause the reagents to leak from the pads onto adjacent pads resulting in mixing and distortion of the colours. To ensure that this does not occur it is recommended the edges of the strip are dried on absorbent paper. ==Reactions for generalised tests==
Reactions for generalised tests
), and an unreacted strip. From top to bottom the pathological strip shows: Leukocytes (-), nitrites (-), urobilinogen (-), proteins (+), pH (5), hemoglobin (+), specific gravity (1.025), ketones (++++), bilirubin (+), glucose (+++). pH The lungs and kidneys are the main regulators of an organism's acid / alkali balance. The balance is maintained through the controlled excretion of acidic hydrogens in the form of ammonia ions, monohydrogenated phosphate, weak organic acids and through the reabsorption of bicarbonate through glomerular filtration in the convoluted tubules of the nephron. The pH of urine normally vary between 4.5 and 8 with the first urine produced in the morning generally being more acidic and the urine produced after meals generally more alkaline. Normal reference values are not provided for urine pH as the variation is too wide and results have to be considered in the context of the other quantifiable parameters. Methyl red produces a colour change from red to yellow in the range of pH 4 to 6 and the bromothymol blue changes from yellow to blue between pH 6 and 9. In the range 5 to 9 the strips show colours that change from orange at pH 5, passing through yellow and green to dark blue at pH 9. Specific gravity One of the kidneys' important functions is to reabsorb water after glomerular filtration. The complex process of reabsorption is usually one of the first renal functions to be affected by disease. The specific gravity of urine is a measure of its density compared to H2O and depends on the quantity and density of solutes (molecules with more mass per volume increase measure of specific gravity). The measurement of specific gravity should not be confused with the measurement of osmotic concentration, which is more related to the number of particles than with their mass. The urine test strip test for specific gravity is based on the change in dissociation constant (pKa) of an anionic polyelectrolyte (poly-(methyl vinyl ether/maleic anhydride)) in an alkali medium that is ionised and releases hydrogen ions in proportion to the number of cations present in the solution. It should be remembered that the test strip only measures cation concentration, it is therefore possible that urine with a high concentration of non-ionic solutes (such as glucose or urea) or with high molecular weight compounds (such as the media used to provide radiographic contrast) will yield a result that will be erroneously lower than that measured by densitometry. The colours vary from dark blue with a reading of 1.000 to yellow for a reading of 1.030. • In an alkaline medium Polyelectrolyte-Hn + Cationsn+ → Polyelectrolyte-Cations + nH+ • In an alkaline mediumH+ + Bromothymol blue(Blue) → Bromothymol blue-H+(Yellow) Elevated protein concentrations produce slightly elevated specific density results as a consequence of the indicator's protein error; in addition, samples with a pH above 6.5 give lower readings as a result of the indicator's bias. For this reason the manufacturers recommend that 5 units are added to the specific gravity reading when the pH is greater than 6.5. == Diseases identified ==
Diseases identified
With the aid of routine examinations early symptoms of the following four groups can be identified: • Diseases of the kidneys and the urinary tract • Carbohydrate metabolism disorders (diabetes mellitus) • Liver diseases and haemolytic disorders • Urinary infections Urinary tract Screening parameters: Many renal and urinary tract diseases may be asymptomatic for a long period of time. Routine urinalysis is recommended as a basic yet fundamental step in identifying renal damage and/or urinary tract disease at an early stage, especially in high-risk populations such as diabetics, the hypertensive, African Americans, Polynesians, and those with a family history. Specific kidney and urinary tract diseases that can be identified include: chronic kidney disease, glomerulonephritis, proteinuria and haematuria. Protein testing Of the routine chemical tests performed on urine, the most indicative of renal disease is the protein determination. Proteinuria is often associated with early renal disease, making the urinary protein test an important part of any physical examination. Normal urine contains very little protein, usually less than 100–300 mg/L or 100 mg per 24 hours is excreted. This protein consists primarily of low-molecular-weight serum proteins that have been filtered by the glomerulus and proteins produced in the genitourinary tract. Due to its low molecular weight, albumin is the major serum protein found in the plasma, the normal urinary albumin content is low because the majority of albumin presented in the glomerulus is not filtered, and much of the filtered albumin is reabsorbed by the tubules. Other proteins include small amounts of serum and tubular microglobulins. Uromodulin produced by the renal tubular epithelial cells and proteins from prostatic, seminal, and vaginal secretions. Uromodulin is routinely produced in the distal convoluted tube, and forms the matrix of casts. Traditional reagent strip testing for protein uses the principle of the protein error of indicators to produce a visible colorimetric reaction. Contrary to the general belief that indicators produce specific colours in response to particular pH levels, certain indicators change colour in the presence of protein even though the pH of the medium remains constant. This is so because protein accepts hydrogen ions from the indicator. The test is more sensitive to albumin because albumin contains more amino groups to accept the hydrogen ions than other proteins. Depending on the manufacturer, the protein area of the strip contains different chemicals. Multistix contains tetrabromophenol blue and Chemstrip contains 3’,3”,5’,5”-tetrachlorophenol, 3,4,5,6-tetrabromosulfonphthalein. Both contain an acid buffer to maintain the pH at a constant level. At a pH level of 3, both indicators appear yellow in the absence of protein. However, as the protein concentration increases, the colour progresses through various shades of green and finally to blue. Readings are reported in terms of negative, trace, 1+, 2+, 3+ and 4+ or the semi-quantitative values of 30, 100, 300 or 2000 mg/dL corresponding to each colour change. Trace values are considered to be less than 30 mg/dL. Interpretation of trace readings can be difficult. Indicator-H+(Yellow) + Protein → Indicator(Blue-green) + Protein-H+ The major source of error with reagent strips occurs with highly buffered alkaline urine that overrides the acid buffer system, producing a rise in pH and a colour change unrelated to protein concentration. Likewise, a technical error of allowing the reagent pad to remain in contact with the urine for a prolonged period may remove the buffer. False-positive readings are obtained when the reaction does not take place under acidic conditions. Highly pigmented urine and contamination of the container with quaternary ammonium compounds, detergents and antiseptics also cause false-positive readings. A false-positive trace reading may occur in specimens with a high specific gravity. Hemoglobin and myoglobin testing is clearly visible, it is rare to find examples in such a well conserved condition. The presence of blood in the urine is, of all the parameters normally tested, the one that is most closely related with traumatic damage to the kidneys or the genitourinary tract. The most common causes of hematuria are: nephrolithiasis, glomerular disease, tumours, pyelonephritis, exposure to nephrotoxins, and treatment with anticoagulants. Non-pathological hematuria can be observed after strenuous exercise and during menstruation. The normal number of red blood cells in urine should not usually exceed 3 per high power field. A urine test strip showing positive for blood can also indicate hemoglobinuria, which is not detectable using a microscope due to the lysis of red blood cells in the urinary tract (particularly in alkaline or dilute urine), or intravascular hemolysis. Under normal conditions the formation of haptoglobin-hemoglobin complexes prevents glomerular filtration, but if the hemolysis is extensive haptoglobin's uptake capacity is exceeded and hemoglobin can appear in urine. Hemoglobinuria can be caused by hemolytic anaemia, blood transfusions, extensive burns, the bite of the recluse spider (Loxosceles), infections and strenuous exercise. The urine test strip test for blood is based on hemoglobin's pseudo peroxidase activity in catalysing a reaction between hydrogen peroxide and the chromogen tetramethylbenzidine in order to produce a dark blue oxidation product. • Na2[Fe(CN)5NO] + CH3COCH2COOH + 2Na(OH) → Na4[Fe(CN)5-N=CHCOCH2COOH](magenta) + H2OSodium nitroprusside + Acetoacetic acid + Alkali medium → Pink-magenta complex + Water The test does not measure beta-hydroxybutyric acid and it is only weakly sensitive to acetone when glycine is added to the reaction. However, as these compounds are derived from the acetoacetic acid their existence can be assumed and a separate test is not therefore necessary. Those medicines that contain sulfhydryl groups, such as mercaptoethane sulphonate Na (Mesna) and captopril and L-DOPA can give atypical colouring. A false negative can occur in samples that have not been adequately stored due to volatilization and bacterial degradation. Liver and blood disorders In many liver diseases the patients often show signs of pathology only at a late stage. Early diagnosis allows appropriate therapeutic measures to be instituted in good time, avoiding consequential damage and further infections. Specific liver diseases and haemolytic disorders able to be identified include liver disease, (accompanied by jaundice), cirrhosis, urobilinogenuria and bilirubinuria. Bilirubin test Bilirubin is a highly pigmented compound that is a by-product of haemoglobin degradation. The haemoglobin that is released after the mononuclear phagocyte system (located in the liver and spleen) withdraws old red blood cells from circulation is degraded into its components; iron, protoporphyrin and protein. The system's cells convert the protoporphyrin into unconjugated bilirubin that passes through the circulatory system bound to protein, particularly albumin. The kidney is unable to filter out this bilirubin as it is bound to protein, however, it is conjugated with glucuronic acid in the liver to form water-soluble conjugated bilirubin. This conjugated bilirubin does not normally appear in the urine as it is excreted directly from the intestine in bile. Intestinal bacteria reduce the bilirubin to urobilinogen, which is later oxidised and either excreted with the faeces as stercobilin or in the urine as urobilin. Conjugated bilirubin appears in urine when the normal degradation cycle is altered due to the obstruction of the biliary ducts or when the kidney's functional integrity is damaged. This allows the escape of conjugated bilirubin into the circulation as occurs in hepatitis and hepatic cirrhosis). The detection of urinary bilirubin is an early indication of liver disease and its presence or absence can be used to determine the causes of clinical jaundice. The jaundice produced by the accelerated destruction of red blood cells does not produce bilirubinuria, as the high serum bilirubin is found in the unconjugated form and the kidneys are unable to excrete it. The test strips use a diazotization reaction in order to detect bilirubin. The bilirubin combines with a diazonium salt (2,4-dichloroaniline or 2,6-dichlorobenzene-diazonium-tetrafluoroborate) in an acid medium to produce an azo dye with colouration that varies from pink to violet: Any deterioration in liver function reduces its ability to process the recirculated urobilinogen. :* (1) Reaction on Multistix (in acid medium) Urobilinogen + p-dimethylaminobenzaldehide → Red dye :* (2) Reaction on Chemstrip (in acid medium) Urobilinogen + 4-methoxibenzene-diazonium-tetrafluoroborate → Red azo dye A number of substances interfere with the Ehrlich reaction on the Multistix strip: porphobilinogen, indican, p-amino salicylic acid, sulphonamide, methyldopa, procaine and chlorpromazine. The test should be carried out at room temperature as the reaction's sensitivity increases with temperature. Poorly stored samples can yield false negative results as the urobilinogen suffers photo oxidation to urobilin that does not react. The formaldehyde used as a preservative produces false negatives in both reactions. The test is a rapid screen for possible infections by enteric bacteria, but it does not replace the urinalysis tests nor microscopic examination as diagnostic tools, nor subsequent monitoring as many other microorganisms that do not reduce nitrate (gram positive bacteria and yeasts) can also cause urinary infections. The reactive strips detect nitrite by using the Griess reaction in which the nitrite reacts in an acid medium with an aromatic amine (para-arsanilic acid or sulphanilamide) in order to form a diazonium salt that in turn reacts with tetrahydrobenzoquinoline to produce a pink azo dye. Neutrophil granulocytes are the leukocytes most commonly associated with urinary infections. A positive test for leukocyte esterase normally indicates the presence of bacteria and a positive nitrite test (although it is not always the case). Infections caused by Trichomonas, Chlamydia and yeasts produce leukocyturia without bacteriuria. The inflammation of the renal tissues (interstitial nephritis) can produce leukocyturia, in particular toxic interstitial nephritis with predominant eosinophils. == Detection limit ==
Detection limit
The detection limit of a test is the concentration at which the test starts to turn from negative to positive. Although the detection limit may vary between urine samples, the detection limit is defined as the concentration of the analyte that results in a positive reaction in 90% of the examined urines. == Medical uses ==
Medical uses
Urine test strips can be used in many areas of the healthcare chain including screening for routine examinations, treatment monitoring, self-monitoring by patients and/or general preventive medicine. Screening Urine test strips are used for screening both in hospitals and in general practice. The aim of screening is early identification of likely patients by examination of large groups of the population. The importance of screening for diabetes and kidney disease amongst high-risk populations is becoming very high. Treatment monitoring Treatment monitoring with the aid of urine test strips allows a health professional to check on the results of the prescribed therapy, and if necessary to introduce any changes into the course of therapy. Self-monitoring Self-monitoring with urine test strips under the guidance of a health professional is an effective method for monitoring the disease state. This applies particularly to diabetics, where the idea of self-monitoring of the metabolic status (determinations of glucose and ketones) is self-evident. Veterinary In veterinary medicine, especially in cats and dogs, the test strip can be used for urinalysis. == History ==
History
In many cultures urine was once regarded as a mystical fluid, and in some cultures it is still regarded as such to this day. Its uses have included wound healing, stimulation of the body's defences, and examinations for diagnosing the presence of diseases. It was only towards the end of the 18th century that doctors interested in chemistry turned their attention to the scientific basis of urinalysis and to its use in practical medicine. • 1797 - Carl Friedrich Gärtner (1772–1850) expressed a wish for an easy way of testing urine for disease at the patient's bedside. • 1797 - William Cumberland Cruikshank (1745–1800) described for the first time the property of coagulation on heating, exhibited by many urines. • 1827 - English physician Richard Bright describes the clinical symptom of nephritis in “Reports of Medical Cases.” • 1840 - The arrival of chemical urine diagnostics aimed at the detection of pathological urine constituents • 1850 - Parisian chemist Jules Maumené (1818–1898) develops the first “test strips” when he impregnated a strip of merino wool with “tin protochloride” (stannous chloride). On application of a drop of urine and heating over a candle the strip immediately turned black if the urine contained sugar. • 1883 - English physiologist George Oliver (1841–1915) markets his “Urinary Test Papers” • approx. 1900 - Reagent papers become commercially obtainable from the chemical company of Helfenberg AG. • 1904 - A test for the presence of blood by a wet-chemical method using benzidine became known. • approx. 1920 - Viennese chemist Fritz Feigl (1891–1971) publishes his technique of “spot analysis". • 1930s - Urine diagnostics makes major progress as reliability improves and test performance becomes progressively easier. • 1950s - Urine test strips in the sense used today were first made on industrial scale and offered commercially. • 1964 - The company Boehringer Mannheim, today Roche, launched its first Combur test strips. Even though the test strips have changed little in appearance since the 1960s, they now contain a number of innovations. New impregnation techniques, more stable colour indicators, and the steady improvement in colour gradation have all contributed to the fact that the use of urine test strips has now become established in clinical and general practice as a reliable diagnostic instrument. The parameter menu offered has steadily grown longer in the intervening decades. == Ascorbic acid interference ==
Ascorbic acid interference
Ascorbic acid (vitamin C) is known to interfere with the oxidation reaction of the blood and glucose pad on common urine test strips. Some urine test strips are protected against the interference with iodate, which eliminates ascorbic acid by oxidation. Some test strips include a test for urinary ascorbate. == Urinary sediment ==
Urinary sediment
During routine screening, if a positive test for leukocytes, blood, protein, nitrite, and a pH greater than 7 is identified, the urine sediment may be microscopically analysed to further pinpoint a diagnosis. == Automated analysers ==
Automated analysers
Automatic analysis of urine test strips using automated urine test strip analysers is a well-established practice in modern-day urinalysis. They can measure calcium, blood, glucose, bilirubin, urobilinogen, ketones, leukocytes, creatinine, microalbumin, pH, ascorbic acid and protein. == References ==
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