About
The Urinalysis Reagent Strips (Urine) are firm plastic strips onto which several separate reagent areas are affixed. The test is for the qualitative and semi-quantitative detection of one or more of the following analytes in urine: Blood, pH, Nitrite and Leukocytes. The Urinalysis Reagent Strips (Line) are for single use in professional near-patient (point-of-care) and centralized laboratory locations.
Refer to the box label for the specific analyte(s) listed, and compare to the appropriate analyte(s) and color blocks on the color chart for results.
Urine undergoes many changes during states of disease or body dysfunction before blood composition is altered to a significant extent. Urinalysis is a useful procedure as an indicator of health or disease, and as such, is a part of routine health screening. The Urinalysis Reagent Strips (Urine) can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract.
Principle
Blood: This test is based on the peroxidase-like activity of hemoglobin which catalyzes the reaction of diisopropylbenzene dihydroperoxide and 3.3 ,5.5 -tetramethylbenzidine
The resulting color ranges from orange to green to dark blue. Any green spots or green color development on the reagent area within 60 seconds is significant and the urine specimen should be examined further. Blood is often, but not invariably, found in the urine of menstruating females. The significance of a race reading varies among patients and clinical judgment is required in these specimens.
pH: This test is based on a double indicator system which gives a broad range of colors covering the entire urinary pH range. Colors range from orange to yellow and green to blue. The expected range of larger normal urine specimens from newborns is ph 5-7. The expected range of other normal urine specimens is pH 4.5-8, with an average result of pH6
Nitrite: This test depends upon the conversion of nitrate to nitrile by the action of Gram negative bacteria in the urine. In an acidic medium, nitrite in the urine reacts with p-arsanilic acid to farm a diazonium compound. The diazonium compound in turn couples with 1 N-(1-naphthyl) ethylenediamine to produce a pink color. Nitrite is not detectable in normal urine.9 The nitrite area will be positive in some cases of infection, depending on how long the urine specimens were retained in the bladder prior to collection. Retrieval of positive cases with the nitrite test ranges from as low as 40% in cases where little bladder incubation occurred, Io as high as approximately 80% in cases where bladder incubation took place for at least 4 hours
Leukocytes: This lest reveals the presence of granulocyte esterases. The esterases cleave a derivatized pyrazole amino acid ester to liberate denvatized hydroxyl prazole.
This pyrazole then reacts with a diazonium salt to produce a beige-pin‹ lo purple color.
Normal urine specimens generally yield negative results. Trace results may be of questionable clinical significance. When trace results occur, it is recommended 1o retest using a fresh specimen from the same patient. Reheated traces and positive results are of clinical significance.
Warnings & Precautions
Warnings & Precautions:
1)For in vitro diagnostic use only. Do not use it after the expiration date.
The strip should remain in the closed container until use.
2)Do not touch the reagent areas of the strip.
3)Discard any discolored strips that may have deteriorated.
4)All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
4)The used strip should be discarded according to local regulations after testing.
Procedure
Procedure:
Allow the strip, urine specimen, and/or controls to reach room temperature
(15-30°C) prior to testing.
1. Remove the strip from the closed canister and use it as soon as possible. immediately close the Container tightly after removing the required number of strips).
Completely immerse the reagent areas of the strip in fresh, well-mixed urine and immediately remove the strip to avoid dissolving the reagents. See illustration 1 below.
2. While removing the strip from the urine in the edge of the strip against the sim of
The urine container to remove excess up Hoed the strip in a horizontal position and bring the edge of the strip into contact with an absorbent material (e.g, a paper towel] to avoid mixing chemicals from adjacent reagent areas and/or soiling hands with urine. See illustration 2 below.
3. Compare the reagent areas of the corresponding color blocks on the canister label at the expected times. Hold the strip close to the calor blocks and match carefully. See Illustration 3 below.
Note: Results may be read up to 2 minutes after the specified times. Results may also be read using the Urine Analyzers. Refer to the Instruction Manual for details.
Other Details
Storage and Stability:
Store as packaged in the closed canister either at room temperature or refrigerated
(2-30 C) Keep out of direct sunlight. The strip is stable through the expiration date printed on the canister label. Do not remove the desiccant. Remove only enough strips for immediate use. Replace cap immediately and lightly. DO NOT FREEZE. Do not use beyond the expiration date.
Note: Once the canister has been opened, the remaining strips are stable for up to 3 months. Stability may be reduced in high humidity conditions
MAU is for in vitro diagnostic use. Store at room temperature under 35C, Do not refrigerate. The product should not be used after expiration date.
Quality Control: For best results, performance of reagent strips should be confirmed by testing known positive and negative specimen controls whenever a new test is performed, or whenever a new container is first opened. Each laboratory should establish its own goals for adequate standards of performance.
Tushar –
Gives utmost accuracy and efficiency.
Mayur –
Provides consistent and reliable results in urinary analysis