100 Urine Test Strips 10 PARAMETER Ketone Infection Liver pH Blood UTI

Depending on the test and specific reagent panel, abnormal levels of specific chemical compounds contained in urine can be easily and readily identified as potential risks factors to overall health and/or indicators of underlying health problems.

DIRUI Diagnostics Reagent Strips for Urinalysis are firm plastic strips to which are affixed several separate reagent areas.

The reagent test areas on DIRUI Diagnostics Reagent Strips are ready to use upon removal from the bottle and the entire reagent strip is disposable. The strips may be read visually, requiring no additional laboratory equipment for testing.

The directions must be followed exactly. Accurate timing is essential to provide optimal results. The reagent strips must be kept in the bottle with the cap tightly closed to maintain reagent reactivity. To obtain optimal results, it is necessary to use fresh, well-mixed, uncentrifuged urine.

Reagents: (Based on dry weight at the time of impregnation)

Glucose: 1.7% w/w/ glucose oxidase (microbial, 123U); 0.2% w/w peroxidase (horseradish 203U); 0.1% w/w potassium iodide
Bilirubin: 0.6% w/w 2, 4-dichloroaniline diazonium salt;
Ketone: 5.7% w/w sodium nitroprusside;
Specific Gravity: 4.8% w/w bromthymol blue; 90.2% w/w poly (methyl vinyl ether/maleic anhydride);
Blood: 26% w/w diisopropylbenzene dihydroperoxide; 1.5% w/w tetramethylbenzidine;
pH: 3.3% w/w methyl red; 55% w/w bromthymol blue;
Protein: 0.1% w/w tetrabromphenol blue;
Urobilinogen: 0.2% w/w p-diethylamino-benzaldehyde;
Nitrite: 1.3% w/w p=arsanilicacid-N-(1-Naphthol)-ethylenediamine; 0.9% w/w tetrahydroquinoline
Leukocytes: 4.3% w/w pyrrole amino acid ester; 0.4% w/w phenyl diazonium salt;

INDICATIONS:

For In Vitro Diagnostic Use.
As with all laboratory tests, definitive diagnostic or therapeutic decisions should not be based on any single result or method.

WARNINGS

- Store at temperatures between 15-30C (59-86F) and out of direct sunlight.

- Replace cap immediately and tightly.

- Do not remove desiccant form bottle.

- Read enclosed directions carefully.

- Do not use after expiration date.

- Use only if tamper evident seals on this carton are intact.

These are the diagnostic reagent strips used by physicians, clinics and hospitals to initially screen for suspected and/or existing health conditions. Simple to use, urine diagnostic reagent strips can provide early indications of developing health problems and identify potential abnormal functions requiring more extensive testing. Additionally, routine use is frequently recommended by physicians for monitoring certain existing and chronic health conditions.

PROCEDURE & USE:

- Collect a fresh urine sample in a clean, dry container preferably glass. First morning samples contain the highest concentration of target markers.

- Remove one reagent strip from the bottle and immediately replace the container cap, minimizing the exposure of the remaining test strips to light and air.

- Completely immerse the reagent pads of the strip in the urine sample and then remove immediately to avoid dissolving out the reagent pads.

- While removing the reagent strip, run the edge of the strip against the rim of the specimen container to remove excess urine. Hold the strip in a horizontal position to prevent possible cross contamination of chemicals located in adjacent reagent pads.

- Compare the colour change of reagent pads to the corresponding colour chart on the bottle label. Read results according to the chart's time frame for each panel tested.

- Record the results of your readings for discussion and/or evaluation with your physician or healthcare provider and then discard the used reagent strip.

Each vial of urinalysis reagent strips includes a colour coded chart (shown in the images).

The reactive colour of each panel on the test strip is compared to the closest corresponding colour on the result chart. The concentration level range for each chemical marker is indicated below each colour block on the result chart. As with all tests dealing with colour intensity or colour matching, it is often recommended to obtain another person's interpretation of the test result. Shown to the left is the colour result chart for the URS-10, ten parameter test strip. Each of the ten reactive reagent pads on the test strip are compared to the corresponding line of colour blocks on the chart. The closest colour match indicates the test result. Use of reagent strips are intended as an initial indication only of elevated chemical markers and not conclusive of a specific diagnosis. Further testing and consultation with a healthcare professional is necessary to confirm the presence of specific disease or health conditions.

Glucose: Glucose should not be detected in normal urine. Small amounts of glucose may be excreted by the kidney. These amounts are usually below the sensitivity of this test but on occasion may produce a colour between the negative and the 1/10 g/dL colour blocks. Results of 1/10 g/dL (if consistent) or higher are considered to be significantly abnormal and professional advice should be obtained immediately.

Protein: Protein is usually not detectable in normal urine. A colour matching any block greater than "Trace" indicates significant proteinuria. For urine of high specific gravity, the test area may most closely match the "Trace" colour block even though only normal concentration of protein is present. Clinical judgment and advice along with further tests would be required to properly evaluate the significance of consistent "Trace" readings.

pH: Normal and abnormal urinary pH may range from 5 to 9. Readings are generally situation specific and should be discussed with your healthcare professional. Generally, certain conditions manifest in low or high consistent pH readings and should be professionally evaluated. First morning urine from healthy individuals will usually range from 5 to 6.

Expected results for Leucocytes, Nitrites, Ketone, Bilirubin, Blood, Urobilinogen and Specific Gravity (URS-Strip 10) including normal ranges are included in a complete instruction and use sheet. In most cases, for these additional test panels, you want to obtain a normal, or negative result meaning that the reagent panel does not change colour. A colour change in one or more of the reagent panels normally indicates an unexpected result. For example, a significant colour change in the leukocyte panel would indicate an elevated level of white blood cells indicating a possible infection.

A color change, or abnormal reading in the blood panel could indicate undiagnosed internal bleeding.