ACCU-TELL URINE REAGENT STRIPS 1-11 PARA (CE)

Declaration: As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.

 

INTENDED USE

MAIN PERFORMANCE CHARACTERISTICS

REAGENT COMPOSITION

STORAGE AND STABILITY

Glucose: The glucose oxidized by enzyme catalyzes the formation of glucuronic acid and peroxide hydrogen. Peroxide hydrogen releases neo-ecotypes oxide(O) under the function of peroxidase. (O) oxidizes iodide potassium , which makes the colour changes.
Bilirubin: The direct bilirubin and dichlorobenzene diazonium produce azo dyes in a strongly acid medium.
Ketone: The acetoacetate in the urine and sodium nitroprusside cause reaction in alkaline medium, which produces violet colour.

Specific Gravity: Electrolyte(M+X−) in the form of salt in urine reacts with poly methyl vinyl etherand maleic acid(-COOH),which are weak acid ionic exchanger. The reaction produces hydrogenous ionogen, which reacts with pH indicator ,that causes the colour change.
Blood: Hemoglobin acts as peroxidase. It can cause peroxidase release neo-ecotypes oxide(O). (O) oxidizes the indicator and make the colour change subsequently.
pH:  The method of pH indicator is applied.
Protein: This is based on the protein-error-of-indicator principle. Anion in the specific pH indicator attracted by cation on protein molecule makes the indicator further ionized, which changes its colour.
Urobilinogen: Urobilinogen and diazonium produce pink azo dyes under the function of strong acid medium.
Nitrite: Nitrite in the urine and aromatic amino sulphanilamide are diazotized to form a diazonium compound. The diazonium compound reacting with tetrahydro benzo(h)quinolin 3-phenol causes the colour change.
Leukocytes: Granulocyte leukocytes in urine contains esterases that catalyze the hydrolysis of the pyrrole amino acid ester to liberate 3-hydroxy –5-pheny pyrrole. This pyrrole reacting with diazonium forms a purple colour.
Ascorbic Acid: Ascorbic acid ,with 1,2-dihydroxy alkenes,under the alkaline condition, deoxidizes the blue 2,6 dichloroindophenolate into colourless N-(p-pheno)-2,6-dichloro-P-amine phenol.

1.  Do not remove desiccant from the bottle.
2.  Do not touch test area of Urine Reagent Strips.
3.  Do not open container until ready to use.
4.  The use of urine preservatives can prevent the decomposition of ketone, bilirubin and urobilinogen in the urine.
5.  Do not store the sample long time (one hour or longer) before testing.

Collect fresh urine in a clean container and test as soon as possible. Do not centrifuge. If testing can not be performed within one hour after voiding, refrigerate the specimen immediately. Allow refrigerated specimen to return to room temperature before testing.

VISUAL TEST PROCEDURE
1.  Remove from the bottle only enough strips for immediate use and replace cap tightly.
2.  Completely immerse reagent areas of the strip in fresh, well-mixed urine specimen. Remove the strip immediately to avoid dissolving out the reagent areas.
3.  While removing, touch the side of the strip against the rim of the urine container to remove excess urine.
4.  Compare each reagent area to its corresponding color blocks on the color chart and read at the times specified. Proper read time is critical for optimal results.
5.  Obtain results by direct color chart comparison.
Note: Changes in color after 2 minutes are of no diagnostic value. Please read the result of analysis according to the given time which is noted on the color chart of the bottle.

INSTRUMENTAL TEST PROCEDURE

Please follow the manual of the instrument.

 

MAIN PERFORMANCE CHARACTERISTICS

Glucose: The test is specific for gluccose. No substance in urine other than glucose is known to show a positive result. 2.2 mmol/L glucose in dilute urine containing 0.28mmol/L ascorbic may produce a color change that might be interpreted as positive.Ascorbic acid concentrations of 0.28mmol/L and/or acetoacetic acid concentrations(1.1mmol/L) or lower may not influence the test. Normally,small amount of glucose may be excreted through kidney. The amount is usually below the sensitivity of the reagent test.
Bilirubin: Normally , even the most sensitive method can’t detect bilirubin in urine.It is abnormal to have little bilirubin in urine ,which requires further inspection.Medicines that dyes urine red and anything that shows red itself in an acid medium e.g. phenazopyridine may affect the test result.High concentration of the ascorbic acid may cause false negative result.
Ketones: The reagent strip reacts with acetoacetic acid in urine.It doesn’t do with acetone or a-hydro butyric acid. Normal urine specimens usually conduct negative results in the test.False positive results may occur in highly pigmented urine or those containing a large amount of levodopa metabolites.
Specific Gravity: The reagent strip for Specific Gravity allows the urine specimens specific gravity between 1.000 and 1.030.In general, the mean error between the results of the strip test and those from the refractive index method is only 0.005.To make it more accurate,0.005 may be added to readings from urines with pH equal or greater than 6.5. Urine reading instrument can automatically make these adjustments in strip-readings. The urine nonionic constituents such as glucose or radiopaque dye won’t make any changes in the test.Highly buffered alkaline urines may cause the low readings comparing with the other methods.Elevated specific gravity readings may occur in the presence of moderate quantities of protein(1.75g/L).
Blood: ‘Trace’ reaction may vary among the patients. Clinical judgments are required for individual cases. The presence of green spots (intact erythrocytes) or green color( haemoglobin/myoglobin) on the reagent area within 60 seconds indicates for further diagnostic check. Blood is is often found in the urine of the menstruating females. Haemoglobin 150-620ug/L is approximately equivalent to 5-15/ug/L intact erythrocytes.
The reagent strip is highly sensitive to haemolobin and thus can be used as a supplementary to the microscopic examination .the sensitivity of the strip might be reduced in urine with a large amount of specific gravity.The strips are equally sensitive to myglobin as to haemoglobin.Certain oxidizing contaminants,such as hypochlorite, may lead to false positive results.Microbial peroxidase associated with urinary tract infection may also produce a false positive result.Ascorbic acid less than 5.0mmol/L in urine may not influence the result of the test.
pH:  The strip tests for pH values are generally in the range of 5.0-8.5 visually and 5.0-9.0 instrumentally.
Protein:  The reagent area is more sensitive to albumin than to globulins,haemoglobin,Bence-Jones protein and mucoprotein. So a ‘Negative Result’ is not good enough to indicate that these proteins don’t exist in urine.Normally no protein is detectable in urine with conventional methods,although a minute amount of protein is excreted through a normal kidney. It shows the protein in urine when the color is darker than ± mark on the chart.False positive results may be obtained in highly buffered alkalino urines.Urine specimens contaminated with quaternary ammonium compounds and cleansers containing chlorhexidine may also produce false positive results.
Urobilinogen:  The reagent strips can detect urobilinogen in low amount as 3ηmol/L (approximately 0.2 Ehrlich unit/dL)in urine. A result of 3ηmol/L in urine indicate the critical value, representing the transition from normal to abnormal, which reqires further check on patients and specimens.The negative results are not final to determine the absence of urobilinogen.
Nitrite: Gram-negative bacteria in urine converts nitrate( derived from foods)into nitrite.The reagent strip is essential to nitrite and won’t react with the other substances in urine. Pink spots or edges on the strip should not be interpreted as positive result, but any degrees of uniform pink color development should be taken as positive result. The degrees of colour development the numbers of bacteria are not in direct proportion. The negative result doesn’t mean the existence of bacteria in a large amount. Negative result may occur (1) when urine doesn’t contain organism that caused the conversion from nitrate to nitrite.(2)when urine has not remained in the bladder long enough(four hours up)to let the nitrate covert into nitrite.(3) the nitrate in the foods is absent.Large High volume of specific gravity in urine may reduce the sensitivity of the test. 2.8mmol/L ascorbic acid or less won’t interfere the test result.
Leukocytes: The reagent area of the strip react with esterase in leukocytes (granulocyte leukocytes).Normal urine specimens generally yield negative result in the test. Positive results (+ or greater) are clinically significant; however, certain individual ‘trace’ results are clinically questionable; however it is very important if the ‘trace’ results are repeated.Positive results may occasionally be found in the random urine specimens from females due to contamination by vaginal discharge.High glucose concentration (160mmol/L) or high specific gravity in urine may reduce the sensitivity of the reagent strip.
Ascorbic acid:  The reagent strip is for testing ascorbic acid, through which we will know the levels of ascorbic acid in human body and the influence that ascorbic acid makes on glucose, bilirubin ,blood, and nitrite.The oxidants (e.g. potassium permanganate and hypochlorite)in urine may reduce the sensitivity of the test.
The performance of the strips are based on clinical analysis and study.The sensitivity of the strips on clinical urine specimen may vary upon several factors, such as the variability of colour perception ,specific gravity,pH values and the lighting conditions when it is read visually. The results from visual readings and instrumental readings represent aa actual range of the test.Because of the variety of the specimens and reading methods, the values obtained from the results of the test may have errors with the actual values of the specimens. The error of the of the second positive values on the test of protein, glucose, ketone,and urobilinogen is normally within one ‘+’ unit. Visual reading results may not exactly match the instrumental reading results because of the inherent difference between the perception of human eyes and the optical instruments.

Item	Sensitivity	Instrumental Visual Test	Range Test Range
Glucose (mmol/L)	2.8 – 5.5	Neg. –55	Neg. – 55
Protein (g/L)	0.15 – 0.3	Neg. –3.0	Neg. – 20.0
Ketone (mmol/L)	0.5 – 1.0	Neg. – 7.8	Neg. – 16
Blood (Ery/ul)	5 – 15	Neg. – 200	Neg. – 200
Bilirubin (μmol/L)	3.3 – 8.6	Neg. – 100	Neg.– 100
Nitrite (μmol/L)	13 – 22	Neg. or pos.	Neg. or pos.
Leukocytes (cells/μl)	5 – 15	Neg. – 500	Neg. – 500
Urobilinogen (μmol/L)	3.3 – 16	3.3 – 131	3.3 – 131
Ascorbic acid (mmol/L)	0.3-0.6	0 – 5.0	0 – 5.0
PH	—	5.0 – 9.0	5.0 – 8.5
Specific Gravity	—	1.005 – 1.030	1.000– 1.030

REAGENT COMPOSITION
Leukocyte: 4.3% w/w pyrrole amino acid ester; 0.4% w/w diazonium salt; 92.6% w/w buffer; 2.7% w/w non-reactive ingredients.
Nitrite: 1.3% w/w p-arsanilicacid; 0.9% N-(1-Naphthol)-ethylenediamine; 89.6% w/w buffer; 8.2% w/w non-reactive ingredients.
Urobilinogen: 0.2% w/w p-diethylaminobenzaldehyde; 98.0% w/w buffer; 1.8% w/w mon-reactive ingredients.
Protein: 0.1% m/m tetrabromphenol blue; 97.4% w/w buffer; 2.5% w/w non-reactive ingredients.
PH: 3.3% w/w bromcresol green;55.0% w/w bromthymol blue;41.7% w/w non-reactive ingredients.
Blood: 26% w/w disopropylbenzene dihydro peroxide; 1.5% w/w tetramethylbenzidine; 35.3% w/w buffer; 37.2 % non-reactive ingredients.
Specific Gravity: 4.8% w/w bromthymol blue; 90.2% w/w poly(methyl vinyl ether co maleic anhydride); 5.0% w/w sodium hydroxide
Ketone: 5.7% w/w sodium nitroprusside; 29.9% w/w non-reactive ingredients; 64.4% w/w buffer
Bilirubin: 0.6% w/w 2.4-dichlorbenzene amine diazonium salt; 57.3% w/w buffer; 42.1% w/w non-reactive ingredients
Glucose: 1.7% w/w glucose oxidase (microbial.123U); 0.2 % w/w peroxidase(horseradish. 203 IU); 0.1% w/w potassium iodide; 71.8% w/w buffer; 26.2% w/w non-reactive ingredients.
Ascorbic Acid: 0.8% w/w 2.6-dichloroindophenolate hydrate; 40.7% w/w buffer; 58.5% w/w non-reactive ingredients.

LIMITATIONS

Comparison to the color chart is dependent on the interpretation of the individual. It is therefore, recommended that all laboratory personnel interpreting the results of these strips be tested for color blindness. As with all laboratory tests, definitive diagnostic or therapeutic decisions should not be based on any single test or method.

The above information is just for reference. The actual technical specifications are subject to the insert provided with the product.