Tests for Protein, Blood, Leukocytes, Nitrite, Clucose, Ketone (Acetoacetic
Acid), pH, Specific Gravity, Bilirubin and Urobilinogen in Urine.
SUMMARY AND EXPLANATION /
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
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
CAUTION: Ensure that work
areas and specimen containers are always free of detergents and other
contaminating substances. Some substances can interfere with patient
1. • Collect a fresh urine
specimen in a clean, dry container.
• Mix well
just before testing.
• Remove one
strip from the bottle.
• Replace the
2. Dip all the test pads
of the strip into the urine.
Immediately remove the strip.
If reading the strip visually,
3. Drag the edge of the
strip against the container rim to remove excess urine.
4. a) If reading visually :
each test pad to the corresponding row of color blocks on the bottle label.
each pad at the time shown on the label, starting with the shortest time.
the strip close to the color blocks and match carefully.
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.
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
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.
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.
PROTECTION AGAINST EXPOSURE TO
LIGHT, HEAT AND AMBIENT MOISTURE IS MANDATORY TO GUARD AGAINST ALTERED
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.