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Catalog No.           Product Name                 

ABT-UM-A34           Urine Analysis Test Strips


Intended Use

ACCU-TELL® One Step Urine Analysis Test Strips (Uric 11V) are intended use in the home to provide tests for the semi-quantitative determination of Ascorbic acid, Glucose, Bilirubin, Ketone (acetoacetic acid), Specific Gravity, Blood, PH, Protein, Urobilinogen, Nitrite and Leukocytes in Urine. Screening test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and urinary tract infection. It is measured by comparison of test paper attached to a plastic strip with the color chart blocks printed on the vial label. The strips may be read visually.


 

Performance Characteristics 

The performance characteristics of the strips are determined by clinical analysis and study. The results from visual readings and instrumental readings represent an actual range of analyte concentrations. Because of the variety of the specimens and reading methods, the values obtained from the results of tests may have errors compared to the actual values of the specimens. 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.

The following table shows the +/-1 color block % Agreement using 967 samples in laboratory comparison studies between ACCU-TELL® One Step Urine Analysis Test Strips (Uric 11V) and Bayer Multistix 11 Reagent Strips.

Analyte

% Agreement

Analyte

% Agreement

Urobilinogen

Ketone

Blood

Protein

Nitrite

Bilirubin

94.2%(910/967 )

95.6 %(924/967 )

96.3 %(931/967 )

97.9 %(947/967 )

95.2 %(920/967 )

97.6%(944/967 )

Leukocytes

Glucose

PH

Specific Gravity

Ascorbic acid

96.6 %(934/967 )

96.9 %(937/967 )

86 %(831/967)

95.2 %(920/967)

96.9 %(937/967 )


  
  
  
  
  
  








Urobilinogen: This test can detect urobilinogen in concentrations as low as 0.2mg/dL (approximately 0.2 EU/dL); therefore, most normal urines

will give a slightly pink reaction. The absence of urobilinogen in the specimen cannot be determined.

Bilirubin: The test has a sensitivity of 0.5mg/dL bilirubin. Bilirubin in urine indicates liver disease before any clinical signs are usually evident.

Ketone: In 90% of urines tested, acetoacetate acid at5.0 mg/dL will produce a positive reaction. The strip does not react with hydroxybutyric acid.

Blood: The test is specific for hemoglobin and myoglobin. In 90% of urines tested, hemoglobin or erythrocytes concentrations of 5 Ery/μL will produce a positive result.

Protein: In 90% of urines tested, albumin concentrations of 0.1 g/L or greater will produce a color change. The test pad is more sensitive to albumin than globulin, Bence-Jones proteins, and mucoproteins.

Nitrite: The test has a sensitivity of 0.08-0.1 mg/dL nitrite ion in urine of normal excreted in urine. Comparison of the reacted area against a white background may aid in the detection of low levels of nitrite. A negative result doesn't mean the existence of bacteria in a large amount. A negative result may occur (1) when urine doesn't contain organisms that cause the conversion from nitrate to nitrite; (2) when urine has not remained in the bladder long enough (four hours or more) to let the nitrate covert into nitrite; or (3) the nitrate in foods is absent.

Leukocytes: Urinary tract infection in up to 90% of all patients can be detected by analysis of random urine specimens. A positive reaction (small or greater) at less than the 2 minutes reading time may be regarded as a positive indication of leukocytes in urine.   

Glucose: In 90% of urines tested, glucose concentrations of 80 mg/dL or greater will produce a positive result. Sugars other than glucose will not react with the reagent. If the color appears somewhat mottled at the higher glucose concentrations, match the darkest color to the blocks.

Specific Gravity: The reagent strips test urine specimens for specific gravity between 1.000 and 1.030. In general, the mean error between the results of the strip test and results from the refractive index method is only 0.005. For increased accuracy 0.005 may be added to readings from urine samples with pH equal to or greater than 6.5. Strips read instrumentally are automatically adjusted for pH by the instrument.

PH: Strip tests for pH measure pH values from 5.0-8.5 visually and 5.0-8.5 instrumentally generally to within one level of the expected result.

The sensitivity of the strips on clinical urine specimens may vary depending upon several factors, such as the variability of color perception, specific gravity, pH value, and the lighting conditions when the strips are read visually. Test sensitivities and are given in the following table.

Sensitivity of ACCU-TELL® One Step Urine Analysis Test Strips (Uric 11V)

Test Pad

Sensitivity

Test range

Urobilinogen(mg/dL)

1

1-12

Blirubin (mg/dL)

1

1-10

Ketone (mg/dL)

15

15-80

Blood (Ery/μL)

10

10-200

Protein (mg/dL)

15

15-300

Nitrite (mg/dL)

0.5

0.5-1.5

Leukocytes(Leu/μL)

15

15-500

Glucose (mg/dL)

100

100-2000

Specific Gravity

1.005

1.005-1.030

PH

-

5.9-9.0

Ascorbic acidg/L)

0.1

0.1-1.0

 

LIMITATION

l   Urobilinogen: The reagent area may react with interfering substances, such as sulfonamides. Atypical color reactions may be obtained in the presence of high concentrations of p-aminosalicylic acid. False negative results may be obtained if formalin is present and the specimen has been in direct sunlight. The test is not a reliable method for the detection of porphobilinogen.

l   Bilirubin: Medicines that dye urine red and anything that shows red in an acid medium (e.g., phenzaopyridine) may affect the test result. A high concentration of ascorbic acid (49mg/dL) may cause a false negative result. Ketone: False positive results may occur in highly pigmented urine or those specimens containing a large amount of levodopa metabolites.

l   Protein: False positive results may be obtained with highly buffered or alkaline urines. Contamination of the urine specimen with quaternary ammonium compounds (e.g., from some antiseptics and detergents) or with cleansers containing chlorhexidine may also produce false positive results.

l   Nitrite: A negative result does not rule out significant bacteriuria.  False negative results may occur (1) when urine does not contain the organism that caused the conversion from nitrate to nitrite, (2) when urine has not remained in the bladder long enough (up to four hours) for the nitrate to covert into nitrite, or (3) when nitrate in foods is absent. A high specific gravity of urine may reduce the sensitivity of the test. A 17mg/dL concentration of ascorbic acid or less will not affect the test result.

l   Leukocytes: A high glucose concentration (2000mg/dL) or a high specific gravity in urine may reduce the sensitivity of the test. High concentration of oxalic acid may cause decreased test results. Tetracycline may cause decreased reactivity, and high levels of tetracycline may cause a false negative reaction.

l   Glucose: Ascorbic acid concentrations of 4.9 mg/dL and/or acetoacetic acid concentrations of 19.4mg/dL or lower will not influence the test.

l   Specific Gravity: Urine nonionic constituents such as glucose or highly buffered alkaline urine may produce low readings compared to other methods. Elevated specific gravity readings may occur in the presence of moderate quantities of protein (100mg/dL). The reagent strip is not suitable for testing newborn because of their low specific gravity (1.002-1.004).

l   PH: Bacterial growth in a specimen may cause a marked alkaline shift (>8.0), usually because of urea conversion to ammonia.

l   Ascorbic acid: No interferences are known.

l   Expected Values/Reference Ranges

l   Expected values for a “normal” healthy population and abnormal populations are listed below for each test.

l   Urobilinogen: Urobilinogen is normally present in urine at concentrations up to 1.0 mg/dL (1 Ehrlich unit/dL). A level of 2mg/dL in urine is the critical value, representing the transition from normal to abnormal, which requires a further check on patients and specimens. Evaluation of both the bilirubin and urobilinogen results helps in the differential diagnosis of jaundice, as well as other liver and biliary disorders.

l   Bilirubin: Normally, even the most sensitive method cannot detect bilirubin in healthy urine. It is abnormal to have even a little bilirubin in urine, which requires further inspection.

l   Ketone: Normal urine specimens usually produce negative results in the test. In ketoacidosis, starvation, fasting, pregnancy and frequent strenuous exercise, ketones may appear in urine and may produce positive results. 

l   Blood: The 'trace' reaction may vary among patients. Clinical judgments are required for individual cases. The presence of green spots (intact erythrocytes) or green color (hemoglobin/myoglobin) on the reagent area within 60 seconds after dipping indicates the need for a further diagnostic check. Erythrocytes are often, but not always, found in the urine of menstruating females.

l  Protein: The reagent area is more sensitive to albumin than to globulins, hemoglobin, Bence-Jones protein, and muco-protein. Therefore a Negative Result' is not sufficient to indicate that these proteins do not exist in urine. Normally protein is not detectable in urine with conventional methods, although a minute amount of protein is excreted through normal kidney function. Protein in urine is indicated when the color is darker than the plus/minus mark on the chart.

l   Nitrite: Gram-negative bacteria in urine converts nitrate (derived from foods) into nitrite. The reagent strip is specific to nitrite and will not react with other substances in urine. Any degree of uniform pink color development should be taken as a positive result. The degree of color development and the number of bacteria are not in direct proportion.

l   Leukocytes: The reagent area of the strip reacts with esterase in leukocytes (granulocyte leukocytes).  Normal urine specimens generally yield negative results.  Positive results (+ or greater) are clinically significant. Individual 'trace' results are clinically questionable, and it is very important that 'trace' results be confirmed in a repeated test.

l   Glucose: Normally, a small amount of glucose may be excreted through the kidneys. The amount is usually below the sensitivity of the reagent test. Results at the first positive level may be significantly abnormal if found consistently.

l   Specific Gravity: The normal specific gravity of urine ranges from 1.003-1.035.  If the specific gravity of random urine is 1.023 or greater, the concentrating ability of the kidneys can be considered normal.

l   PH: The normal PH of urine can range from 4.6 to 8.0. Certain dietary conditions can produce acid or alkaline urines, which can be useful in the treatment, or some calculi.

l   Ascorbic acid: The average daily intake ranges from 30-80mg, with an output of 20-30mg/dL.