URICHA - 10 - Robonik India.in
Contents
1. 2030Nil URICHA Urine Test strips for Urine Analysis URICHA 10 Strips for quantitative determination of Blood Urobilinogen Bilirubin Protein Nitrite Ketones Glucose pH Density Leukocytes In vitro diagnostic test kit for professional use only INTENDED USE Screening test for detection of diabetes metabolic abnormalities liver diseases biliary and hepatic obstructions hemolytic diseases and diseases of kidney and urinary tract URICHA 10 Test strips are compatible with URICHA Urine Chemistry Analyser ORDERING INFORMATION Pack Size Cat No 1 X 100 Test Strips UR1001 100 6 X 100 Test Strips UR1006 100 INSTRUCTIONS FOR USE Dip the test strip for approximately one second into the urine Draw it across the rim of the container to remove excess urine Place the test strips onto the instrument URICHA according to instructions for use in the user s manual The Test pads are evaluated on Uricha reflectance meter the results are displayed amp printed out The results obtained with the Urichal 0 and Uricha 10 V correspond to the concentration ranges indicated on the colour chart for visual evaluation For visual evaluation please compare colour changes with the colour chart between 30 amp 60 seconds leukocyte test field between 60 amp 120 seconds Colour changes that take place after more than 2 minutes are of no significance When tested the urine should not be older than 2 hours Due to the fact th2. fruit juices can lead to lower or falsely negative results In addition an inhibitory effect is produced by gentisic acid Falsely positive reactions can also be produced by a residue of peroxide containing cleansing agents pH The pH value of fresh urine of healthy individuals varies between pH 5 and pH 6 The colour scale gives a clear distinction of pH value between pH 5 and pH9 Density The test permits the determination of urine density between 1 000 and 1 030 Urines from adults with normal diets and normal fluid intake will have a density of 1 015 1 025 The chemical nature of the test strip may cause slightly different results from those obtained with other methods when elevated amounts of certain urine constituents are present e g the increase of urine density in dependence on glucose concentrations of gt 1000 mg dl gt 56 mmol l cannot be demonstrated by the strips Elevated density readings may be obtained in the presence of moderate quantities of protein Highly buffered alkaline urines may cause low readings Leukocytes The test records values starting from approx 10 25 leukocytes Ul urine Changes in colour that can not be assigned to the negative reference field and faint violet colours of 120 seconds must be evaluated as positive The colour reference fields correspond to the following leukocyte concentrations negative normal 25 75 500 leukocytes Ul A weakened reaction can be expected in the case of prote
3. at the human eye evaluates colour changes somewhat differently than a Uricha Reflectance Meter there can also be differences between these two evaluations REAGENTS K ee 2 minimum quantity resp activity cm at time of expiry Blood Nitrite pH Tetramethylbenzidine 59 ug Sulfanilic Acid 80 Ug Methyl Red 2 8 Ug Cumene Hydroperoxide 253 Ug Quinoline Derivative 25 Ug Bromothymol Blue 10 ug Urobilinogen Ketones Density Diazonium Salt 28 Ug Sodium Nitroprusside 116g Bromothymol Blue 12 ug Bilirubin Glucose Copolymer 295 ug Diazonium Salt 26 Ug Glucose Oxidase 3 2U Leukocytes Protein Peroxidase 0 2U Carboxylic Acid Ester 10 6ug Tetrabromophenol Blue 7 5 ug tolidine 65 Ug Diazonium Salt 4 4 Ug STORAGE INSTRUCTIONS AND REAGENT STABILITY Store the container between 15 to 30 C ina dry place The test strips are stable when stored properly up to the date of expiry indicated WASTE MANAGEMENT Please dispose all used Test Strips in accordance with your local laws and regulations WARNINGS amp PRECAUTIONS In any case in order to establish a final diagnosis and prescribe an appropriate therapy the results obtained with test strips should be correlated with other medical results The effect of medicaments or their metabolic products on the test is not known in all cases In case of doubt it is recommended not to take the medicaments and repeat the test Use well washed and c
4. d azo compound is formed by diazotisation and subsequent coupling Ketones The test is based on the principle of Legal s test Acetoacetic acid and acetone form a violet coloured complex with sodium nitroprusside in alkaline medium Glucose The detection is based on the glucose oxidase peroxidase chromogen reaction Apart from glucose no other compound in urine is known to give a positive reaction pH The test paper contains indicators which clearly change colour between pH 5 and pH 9 from orange to green to turquoise Density The test determines the concentration of ions in urine and shows a good correlation to the refractometric method The colour of the test strip changes from deep blue in urine with low ionic concentration through green to yellow in urines with high ionic concentrations Leukocytes The test is based on the esterase activity of granulocytes This enzyme splits carboxylic acid esters The alcohol constituent released reacts with a diazo salt producing a violet colour PERFORMANCE CHARACTERISTICS Measuring Range Specificity Sensitivity Interpretation Compensation Area The compensation test pad is free of any chemicals and is solely used as reference for the reflectance meter evaluation of the other test pads Blood The minimum sensitivity of the test strip is 5 to 10 erythrocytes Ul of urine corresponding to approx 0 015 mg hemoglobin dl of urine Intact erythrocytes are indicated by flecky discolo
5. inuria of over 500 mg dl and a glucose concentration of over 2 g dl as well as in the case of patients taking preparations containing cephalexin and gentamycin Bacteria Trichomonas and erythrocytes do not interfere with this test Formaldehyde as a preservative can result in a false positive reaction Excretion of bilirubin nitrofruantoin or other strongly coloured compounds may disguise the colour of the reaction Tests with female patients have shown that vaginal discharge can cause a false positive reaction QUALITY CONTROL To ensure adequate quality use of commercially available urine control is recommended ROBONIK offers URICHA N amp P Control in 2 X 15 ml pack size BIBLIOGRAPHY 1 Goldner AP Mayron R amp Ruiz E Are urine dipsticks reliable indicators of hematuria in blunt trauma patients Ann Emerg Med 1985 14 6 580 582 2 Chandhoke PS amp McAninch JW Detection and significance of microscopic hematuria in patients with blunt renal trauma J Urol 1988 140 16 18 3 McPherson RA Ben Ezra J Zhao S Basic examination of urine In McPherson RA Pinchu MR eds Henry s Clinical Diagnosis and Management by Laboratory Methods 21st ed Philadelphia Pa Saunders Elsevier 2006 chap 27 4 Naumann HN Studies on bile pigments A study of Ehrlich s test for urobilinogen and Schlesinger s reaction for urobilin Biochem J 1936 Mar 30 3 347 351 5 Yoder J Adams E C and Free H M Simultaneous Sc
6. lean containers only for urine collection The presence of usual urine preservatives will not affect the test results Remove only as many test strips as required and reseal the container immediately after use Do not touch the test pads Avoid exposing the strips to sunlight and moisture The cap contains a non poisonous and harmless desiccant In case this desiccant is swallowed accidently then drink plenty of water seek medical aid SPECIMEN Use fresh and uncentrifuged urine Shake urine sample well before use PRINCIPLE Blood The detection is based on the pseudoperoxidative activity of hemoglobin and myoglobin which catalyze the oxidation of an indicator by an organic hydroperoxide producing a green colour Urobilinogen The test paper contains a stable diazonium salt forming a reddish azo compound with urobilinogen when present Bilirubin A red azo compound is obtained in presence of acid by coupling of Bilirubin with a diazonium salt Protein The test is based on the protein error principle of indicators The test zone is buffered to a constant pH value and colour changes from yellow to greenish blue in the presence of albumin Other proteins are indicated with less sensitivity Nitrite Microorganisms which are able to reduce nitrate to nitrite are indicated indirectly by this test The principle of Griess reagent is the basis of this test The test paper contains an amine and a coupling component A red coloure
7. reening for Urinary Occult Blood Protein Glucose and pH Amer J Med Tech 31 285 1956 6 Shchersten B and Friz H Subnormal Levels of Glucose in Urine JAMA 201 129 132 1967 7 Tietz NW Taxtbook of Clinical Chemistry W B Saunders Company 1986 1734 8 Tsai S C et al J Anal Toxicol 1998 22 6 474 URICHA 10 is the Trade Mark of ROBONIK INDIA PVT LTD for Test Strips Urine Analysis URICHA is the Trade Mark of ROBONIK INDIA PVT LTD for Urine Chemistry Analyser Manufactured and Marketed by ROBONIK INDIA PVT LTD A 374 TTC Industrial Area Mahape Navi Mumbai 400710 INDIA Tel No 91 22 67829700 Fax No 91 22 67829701 Orders sales reagents robonikindia com Queries feedback robonikindia com Website www robonik in 2030NiI _ An ISO 9001 2008 Certified Company An ISO 13485 2003 Certified Company SYMBOLS USED ON THE LABELS For in vitro diagnostic use Store at Ci Consult Instructions for use REF Catalogue Number x Exp Date OT Lot No Do Not Reuse wal Manufacturer s Address mil Date of Manufacture Ver UR10 0811 00
8. sitivity of the test strip is 0 5 to 1 mg bilirubin dl urine The colour fields correspond to the following values O negative 1 2 4 mg dl or O negative 17 35 70 Umol L Some urine contents can produce a yellow colouration of the test strip Ascorbic acid and nitrite in higher concentrations inhibit the test Exposure of the urine to light for a longer period of time may lead to lowered or falsely negative results Too high or falsely positive results can be caused by the presence of diagnostic or therapeutic dyes in the urine Protein The minimum sensitivity of the test strip is 10 mg protein dl urine The colour fields correspond to the following ranges of albumin concentrations Negative 30 100 and 500 mg dl or negative 0 3 1 0 and 5 0 g l Falsely positive results are possible in alkaline urine samples pH gt 9 after infusions with polyvinylpyrrolidone blood substitute after intake of medicaments containing quinine and also by disinfectant residues in the urine sampling vessel The protein colouration may be masked by the presence of medical dyes e g methylene blue or beetroot pigments Nitrite The test detects concentrations from 0 05 to 0 1 mg nitrite dl urine Every pink colour indicates a bacterial infection of the urinary tract The colour intensity depends only on the nitrite concentration but does not provide information about the extent of the infection A negative result does not precl
9. ude an infection of the urinary tract if bacteria which cannot produce nitrite are present Falsely negative results can be produced by high doses of ascorbic acid by antibiotics therapy and by very low nitrate concentrations in urine as the result of low nitrate diet or strong dilution diuresis Falsely positive results can be caused by the presence of diagnostic or therapeutic dyes in the urine Ketones The test is more sensitive to acetoacetic acid than to acetone Values of 10 mg dl acetoacetic acid or 50 mg dl acetone are indicated The colour fields correspond to the following acetoacetic acid values O negative 25 100 and 300 mg dl or O negative 2 5 10 and 30 mmol l Phenylketones in higher concentrations interfere with the test and will produce variable colours B Hydroxybutyric acid is not detected Phthalein compounds interfere by producing a red colouration Glucose Pathological glucose concentrations are indicated by a colour change from green to bluish green Yellow or greenish test fields should be considered negative or normal The colour fields correspond to the following ranges of glucose concentrations neg yellow neg or normal greenish 50 150 500 and gt 1000 mg dl or neg yellow neg or normal greenish 2 8 8 3 27 8 and gt 55 5 mmol l Larger amounts of ascorbic acid which may be present in urine after a high intake of vitamin C e g vitamin tablets antibiotics or
10. urations of the test field A slight green colouration of the test field is normal and not an indication of the presence of blood in urine When the green colouration matches the first positive colour block on the colour scale then the results are to be determined as positive The colour fields correspond to the following values O negative ca 5 10 ca 50 ca 250 Ery Ul resp hemoglobin concentration out of ca 10 ca 50 ca 250 Ery Ul Normal concentrations of Ascorbic Acid lt 40 mg dl do not influence the test results Falsely positive reactions can be produced by residue of peroxide containing cleansing agents Urobilinogen In dependence upon the urine colour 0 5 to 1 mg urobilinogen dl urine are indicated 1 mg dl is considered to be the normal excretion rate Higher values are pathological A complete absence of urobilinogen in the urine which is likewise pathological cannot be indicated by the strips The colour fields correspond to the following urobilinogen concentrations norm normal 2 4 8 12 mg dl or norm normal 35 70 140 200 pmol l The test will be inhibited by higher concentrations of formaldehyde Exposure of the urine to light for a longer period of time may lead to lowered or falsely negative results Too high or falsely positive results can be caused by the presence of diagnostic or therapeutic dyes in the urine Larger amounts of bilirubin produce a yellow colouration Bilirubin The minimum sen
Download Pdf Manuals
Related Search