URIT 11G英文说明书20101208
Contents
1. may be reduced in urine with high specific gravity The test is equally sensitive to myoglobin as to hemoglobin Captopril and Lodine may also cause decreased reactivity Blood is often found in the urine of menstruating females Certain oxidizing contaminants such as hypochlorite may produce false positive results Microbial peroxidase associated with urinary tract infection may cause a false positive reaction Ascorbic acid concentrations greater than 1 4mmol L may cause false negatives at the trace levels pH This test contains a mixed indicator which assures a marked change in colour between pH4 5 and pH9 Ascorbic Acid The test involves the decolorization of Tillman s reagent False positive reactions may be caused by other reducing agent SENSITIVITY Sensitivity is dependent upon the presence or absence of interfering specimens Leukocytes 15 40 cells uL granulocyte Protein 0 1 0 3g L albumin Ketone 0 5 1 0mmol L acetoacetic acid Glucose 2 2 2 8 mmol L Nitrite 18 33umol L Blood 0 15 0 45mg L hemoglobin about 5 15Ery uL Urobilinogen 17 33umol L Ascorbic Acid 0 6 0 85mmol L Bilirubin 8 6 17umol L REAGENTS COMPOSITION Based on the dry weight content of each areas of 100 strips Leukocytes indoxyl ester 1 4mg diazonium salt 0 7mg Ketones sodium nitroprusside 30 0mg Nitrite sulfanilamide 0 65mg N naphthyl ethylenediammonium dihydrochloride 0 45mg Urobilinogen fast blue B salt 1 2mg Bilirubin 2 4 dichlorobenzene diazon2. 01 PR China URIT Medical Electronic Co Ltd Tel 86 773 2288586 Fax 86 773 2288560 Email service uritest com C http www urit com Rev 10 2010
3. URIT 11G Urine Reagent Strips PLEASE CAREFULLY READ THIS PACKAGE INSERT BEFORE USE For In Vitro Diagnostic Use Only INTENDED USE URIT 11G urine reagent strips provide tests for the semi quantitative measurement of leukocytes ketone nitrite urobilinogen bilirubin protein glucose specific gravity blood pH and ascorbic acid in urine For use with the urine analyzers of Uritest 50 500 500B URIT 30 50 180 330 500B 500C The test is intended for use by health care professionals SUMMARY URIT 11G urine reagent strips consist of a plastic strip affixed with reagent papers and a calibration pad This feature facilitates measurement of multiple urine constituents and use for everyday diagnosis and group examinations The calibration pad which is not impregnated with reagents allows instrumental correction interference from natural color of urine automatically and obtains accurate result TEST PRINCIPLES AND LIMITATION Leukocytes The test reveals the presence of granulocyte esterases These esterases cleave an indoxy ester and the indoxyl so liberated reacts with a diazonium salt to produce a violet dye Leukocyte esterase results may be positive in the absence of observable cells if the leukocytes have lysed Positive results may occasionally be found with random specimens from females due to contamination of the specimen by vaginal discharge Elevated glucose concentrations 55 110 mmol L or high specific gravity may cause decreased test
4. ium 14 3mg Protein tetrabromphenol blue 0 36mg Glucose glucose oxidase 800 LU peroxidase 200 P U 4 aminoantipyrine 2 0mg Specific Gravity bromthymol blue 0 4mg Blood cumene hydroperoxide 35 2mg 3 3 5 5 Tetramethylbenzidine 15 0mg pH bromxylenol blue 3 3mg bromocresol green 0 2mg Ascorbic Acid 2 6 dichloro phenol indophenol 0 5mg TESTING PROCEDURE Please refer to the User s manual of the Uritest URIT urine analyzer PRECAUTIONS 1 HANDLING Use only clean vessels to collect urine False positive readings for blood and glucose can result from residues of strongly oxidizing disinfectants in the specimen collection vessel Do not add preservatives to the urine Do not expose urine specimens to sunlight as this induces oxidation of bilirubin and urobilinogen and hence leads to artificially low results for these two paraments 2 OPERATION Incorrect results may be obtained when you shake the strip in specimen container The dipping time is too short or too long may result in a negative error HANDLING CARE Improper storage may cause insufficient performance of test strips Return to room temperature before use Do not use deteriorated discolored or blackened test strips Avoid contamination by volatile chemicals Do not touch test papers of reagent strips PLEASE NOTE On principle diagnosis or therapy should not be based on one test result alone but should be established in the contest of all other medical findings Know
5. ledge of the effects of drugs or their metabolites upon the individual tests is not yet complete In doubtful cases it is therefore advisable to repeat the test after discontinuing a particular drug Large amounts of ascorbic acid in the urine can produce artificially low to false negative results for glucose blood nitrite and bilirubin STORAGE AND STABILITY Store at temperatures between 2 C to 30 C avoiding humidity direct sunlight or heat Store only in original bottle Do not remove desiccants Do not remove strip from the bottle until immediately before it is to be used for testing Replace cap immediately and tightly after removing reagent strip Unused strips that remain in the original capped container are stable within 3 month Do not use reagent strips after expiry date printed on the label of the vial AVAILABILITY 100 strips per container EXPLANATIONS FOR SYMBOLS ON THE LABEL ivo In vitro diagnostic medical device Temperature limitation Cli Consult instructions for use Do not reuse Batch Code ea Use by J Keep dry Keep away from sunlight EC REP ual Manufacturer Authorized Representative in the European Community C This product fulfils the requirements of Directive 98 79 EC on in vitro diagnostic medical devices Wellkang Ltd t a Wellkang Tech Consulting Suite B 29 Harley Street LONDON W1G 9QR UK URIT Medical Electronic Co Ltd Supplied by No 4 East Alley Jiuhua Road Guilin Guangxi 5410
6. ns of 1 4mmol L or greater may cause false negative results with specimens containing nitrite ion concentrations of 58umol L or less Urobilinogen This test is based on the Ehrlich reaction The reagent area may react with interfering substances known to react with Ehrlich s reagent Excreted pigments and medicaments that have a red intrinsic coloration in acidic medium may produce false positive results This test is inhibited by elevated concentrations of formaldehyde Strip reactivity increases with temperature the optimum temperature is 22 C to 26 C The absence of urobilinogen cannot be determined with this test Bilirubin This test is based on the coupling of bilirubin with diazonium salt in an acid medium Normally no bilirubin is detectable in urine by even the most sensitive methods Even trace amounts of bilirubin are sufficiently abnormal to require further investigation Some urine constituents medicines urinary indicants may produce a yellowish or reddish discoloration of the test paper that may interfere with interpreting the result Ascorbic acid concentrations of 1 4mmol L or greater may cause false negatives Protein The test is based on the principle of the protein error of a pH indicator The reagent area is more sensitive to albumin An elevated pH up to 9 may affect the test The residues of disinfectants containing quaternary ammonium groups or chlorohexidine are present in the urine vessel maybe lead to a false positive res
7. results The presence of cephalexin cephalothin tetracycline may cause decreased reactivity and high levels of the drug may cause a false negative reaction The test area does not react with lymphocyte Ketone This test is based on the principle of Legal s test and is more sensitive to acetoacetic acid than to acetone The reagent area does not react with B hydroxybutyric acid Some high specific gravity low pH urines may give reactions up to and including Trace Normal urine specimens usually yield negative results with this reagent False positive results Trace may occur with highly pigmented urine specimens or those containing large amounts or levodopa metabolites Nitrite The test is based on the principle of Griess s test and is specific to nitrite Any degree of uniform pink colour development should be interpreted as a positive Nitrite test suggesting the presence of 10 or more organisms per mL but colour development is not proportional to the number of bacteria present A negative result does not in itself prove that there is no significant bacteriuria Negative results may occur when urinary tract infections are cause by organisms which do not contain reductase to convert nitrate to nitrite when urine has not been retained in the bladder long enough 4 8hrs for reduction of nitrate to occur or when dietary nitrate is absent even if organisms containing reductase are present and bladder incubation is ample Ascorbic acid concentratio
8. ult Glucose The test is based on the specific glucose oxidase peroxidase reaction The test is specific for glucose no substance excreted in urine other than glucose is known to give a positive result Ascorbic acid of more than 1 4mmol L and or high Ketone concentrations 8mmol L may cause false negatives for specimens containing small amounts of glucose 5 5mmol L The reactivity of the glucose test decreases as the SG of the urine increases False positive reactions may be caused by hypochlorite or peroxide cleaning agents Reactivity may also vary with temperature Specific Gravity This test contains a detergent and Bromthymol blue that indicates the presence of ionic constituents in the urine by changing color from green to yellow The specific gravity test permits determination of urine specific gravity between 1 005 and 1 030 In general it correlates within 0 005 with values obtained with the refractive index method Strips are automatically adjusted for pH by the instrument when pH 7 0 or pHS lt S 0 Highly buffered alkaline urine may cause low readings relative to other methods Elevated specific gravity readings may be obtained in the presence of moderate quantities 5g L of protein Blood Hemoglobin and myoglobin catalyze the oxidation of the indicator by means of organic hydroperoxide contained in the test paper This test is highly sensitive to hemoglobin and thus complements the microscopic examination The sensitivity of this test
Download Pdf Manuals
Related Search