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Siemens Reagent Strips

Tests for Protein, Blood, Leukocytes, Nitrite, Clucose, Ketone (Acetoacetic Acid), pH, Specific Gravity, Bilirubin and Urobilinogen in Urine.

SUMMARY AND EXPLANATION / INTENDED USE
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid), pH, specific gravity, bilirubin and urobilinogen. Please refer to the carton or bottle label to see which tests are included on the product you are using.

Siemens Reagent Strips are for professional use in near-patient (point-of-care) and centralized laboratory locations. The strips are intended for use in at-risk patient groups to assist diagnosis in the following areas:
• kidney function
• urinary tract infections
• carbohydrate metabolism (e.g., diabetes mellitus)

• liver function

The strips also measure physical characteristics, including acid-base balance and urine concentration. Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.

Siemens 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 strips can also be read instrumentally, using the CLINITEK family of Urine Chemistry Analyzers and the appropriate software; contact your product representative for further information.

Siemens Reagent Strips are for in vitro diagnostic use. They have been determined to be nonhazardous under the guidelines issued by NOHSC:2011 (2003).

SPECIMEN COLLECTION AND PREPARATION

Collect freshly-voided urine in a clean container and test it as soon as possible. The container should allow for complete dipping of all reagent strip areas. A first-morning specimen is preferred but random collections are acceptable. Test the urine within two hours after voiding, sooner if testing for bilirubin or urobilinogen. If unable to test within the recommended time, refrigerate the specimen immediately and let it return to room temperature before testing. Work areas and specimen containers should always be free of detergents and other contaminating substances.

Procedure

1. • Collect a fresh urine specimen in a clean, dry container.

    • Mix well just before testing.

    • Remove one strip from the bottle.

    • Replace the cap.

2. Dip all the test pads of the strip into the urine.

Immediately remove the strip.

If reading the strip visually, start timing.

3. Drag the edge of the strip against the container rim to remove excess urine.

4. a) If reading visually :

    • Compare each test pad to the corresponding row of color blocks on the bottle label.

    • Read each pad at the time shown on the label, starting with the shortest time.

    • Hold the strip close to the color blocks and match carefully.

    • Read the pads in good light.

b) If using a CLINITEK instrument, carefully follow the directions given in the appropriate instrument operating manual. The instrument will automatically read each test pad at a specified time.

5. Report the results to the lab supervisor or physician.

RESULTS

With visual use, results are obtained in clinically meaningful units directly from the Color Chart comparison. With CLINITEK instruments, the test pads are "read" by the instrument and the results are displayed or printed as soon as they are available.

QUALITY CONTROL

Test known negative and positive specimens or controls whenever a new bottle is first opened. Water should NOT be used as a negative control. Each laboratory should establish its own goals for adequate standards of performance. CHEK-STIX Positive and Negative Control Strips provide a convenient basis for a quality control program.

STORAGE

All unused strips must remain in the original bottle. Transfer to any other container may cause reagent strips to deteriorate and become unreactive. Store at temperatures between 15°-30°C (59°-86°F). Do not use the strips after their expiration date. Do not store the bottle in direct sunlight and do not remove the desiccant from the bottle.

IMPORTANT NOTE

PROTECTION AGAINST EXPOSURE TO LIGHT, HEAT AND AMBIENT MOISTURE IS MANDATORY TO GUARD AGAINST ALTERED REAGENT REACTIVITY.

REAGENT PERFORMANCE
Expected values for the "normal" healthy population and the abnormal population are listed below for each reagent.

Sensitivities listed for each reagent are the generally detectable levels of the analytes in contrived urines; however, because of the inherent variability of clinical urines, lesser concentrations may be detected under certain conditions. The percentage of clinical specimens correctly detected as positive increases with analyte concentration.

Performance characteristics are based on clinical and analytical studies and depend upon several factors: the variability of color perception; the presence or absence of inhibitory and matrix factors typically found in urine; and the laboratory conditions in which the product is used (e.g., lighting, temperature, and humidity). The strips should be read in good light, such as fluorescent; do not read in direct sunlight.

Each color block or instrumental result represents a range of values. Because of specimen and reading variability, specimens with analyte concentrations that fall between nominal levels may give results at either level. Results will usually be within one level of the true concentration. Exact agreement between visual results and instrumental results might not be found because of the inherent differences between the perception of the human eye and the optical systems of the instruments.

Limitations: given for the reagents include specific substances and conditions that may affect the test results. As with all laboratory tests, definitive diagnostic or therapeutic decisions should not be based on any single result or method.

Substances that cause abnormal urine color may affect the readability of test pads on urinalysis reagent strips. These substances include visible levels of blood or bilirubin and drugs containing dyes (e.g., Pyridium, Azo Gantrisin, Azo Gantanol), nitrofurantoin (Macrodantin, Furadantin), or riboflavin. Levels of ascorbic acid normally found in urine do not interfere with these tests.

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