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Policies,Clinical,UWHC Clinical,Department Specific,Point of Care,Urinalysis Testing with Reagent Strips

Urinalysis Testing with Labstix Reagent Strips, Hemacombistix Reagent Strips or Multistix Reagent Strips (1595.P039)

Urinalysis Testing with Labstix Reagent Strips, Hemacombistix Reagent Strips or Multistix Reagent Strips (1595.P039) - Policies, Clinical, UWHC Clinical, Department Specific, Point of Care, Urinalysis Testing with Reagent Strips

1595.P039

UWHC Clinical Laboratories Original Date: 5/1/2013
Point of Care Current Version Date: 3/1/2017
Document Title: Urinalysis Testing with Labstix Reagent
Strips, Hemacombistix Reagent Strips or
Multistix Reagent Strips

Document ID: 1595.P039 Page 1 of 6


Medical Director and Date: Diane Norback 5/6/2013
Diane Norback 3-16-2017



Effective Date: 5/1/2013
Faculty Director Date Manager Date Technical Reviewer Date
Teresa Darcy, MD 5/3/13 Christine Reuter 5/22/13 Beth Urban 4/29/13
Teresa Darcy, MD 3/26/15 Cheryl Jordan 4/1/15 Sarah Emond 3/23/15
David Yang, MD 3/16/17 Cheryl Jordan 3/16/17 Lori Trader 3/16/17





I. Principle
Urinalysis Dipstick (UAD) includes reagent strip tests for blood, glucose, ketones, leukocyte
esterase, nitrites, pH, protein, and specific gravity. Test results may provide information
regarding the status of carbohydrate metabolism, kidney and liver function, acid-base
balance and urinary tract infections. The reagent strips used are firm plastic to which are
affixed several separate reagent areas. The reagent test areas are ready to use upon
removal from the bottle and the entire reagent strip is disposable. Accurate timing is
essential to provide optimal results. The reagent strips must be kept in the bottle with the
desiccant and the cap tightly closed to maintain reagent reactivity. To obtain optimal
results, it is necessary to use FRESH, well mixed, uncentrifuged urine. See the product
insert for chemical principles of the procedure for each test of the reagent strip. The reagent
strips are read visually using the color chart at times specified on the bottle label.

II. Policy
In order to ensure quality, accurate patient results, the clinics will adhere to the following:
A. This test may only be performed on units/clinics that have been approved to perform this
test and which perform the necessary quality control checks and maintain the necessary
competencies.
B. If a unit/clinic is not approved to perform this test, the unit/clinic should collect and label
the specimen and send to the Clinical Lab to perform testing.
C. The list of units/clinic approved to perform this point of care test will be maintained by the
Point of Care Testing Coordinators in the Clinical Laboratory.

III. Specimen
A. Patient Identification and Preparation: Patient should be instructed to collect a clean-
catch, mid-stream specimen. See UConnect policies Patient Identification 3.2.1, and
Collecting a Urine Specimen 2.5.2.
B. Specimen: Random or first morning void, mid-stream, clean catch urine in a sterile
container is preferred. Others are acceptable.
C. Handling Conditions: If testing cannot be done within an hour after voiding, the specimen
should be refrigerated and brought back to room temperature before testing. Specimens
are good for two hours at room temperature and 24 hours in the refrigerator. Specimens

UWHC Clinical Laboratories Original Date: 5/1/2013
Point of Care Current Version Date: 3/1/2017
Document Title: Urinalysis Testing with Labstix Reagent
Strips, Hemacombistix Reagent Strips or
Multistix Reagent Strips

Document ID: 1595.P039 Page 2 of 6


may not be frozen. Any urine more than 2 hours old that has not been refrigerated or
greater than 24 hours regardless of storage conditions is unacceptable.

IV. Reagents (or Media), Standards, Supplies and Equipment
A. Reagents: Use of one of the following reagent strips for urinalysis
1. Hemacombistix® - pH, Protein, Glucose, Blood
2. Labstix®- pH, Protein, Glucose, Ketone, Blood
3. Multistix®- pH, Protein, Glucose, Ketone, Blood, Nitrite, Leukocytes, Specific Gravity.
i. Storage Requirements: All unused reagent strips must remain in the original
bottle with the cap tightly in place. Transfer to any other container may cause
reagent strips to deteriorate and become nonreactive. Store at temperatures
between 15-30C (59-86F). 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.
ii. Acceptability Testing – Both levels of external control are run with acceptable
results before the bottle of strips is put into use. See section XIII on Quality
Assurance.
B. Standards: Alta Diagnostics® Urine Dipstick Control Solutions – Positive and Negative
1. Store refrigerated at 2-8 degrees C. Controls are good until expiration date on the
bottle when refrigerated.
2. If stored at room temperature, controls are stable up to 8 weeks. New 8 week
expiration date must be noted on bottle when removed from refrigerator.
3. Acceptable ranges for the controls are lot specific and may change with each new lot
opened. Be sure to keep the package insert in the control binder.
C. Supplies
1. 15mL plastic conical centrifuge tubes
2. Specimen container, 4 oz, sterile, 50/box
3. Gloves and other personal protective equipment

V. Calibration and Calibration Verification (Not Applicable)

VI. Procedure - Health Link Ordering
Providers order the POC urine in Health Link

VII. Procedure - Urine Macroscopic Visual Read
A. Confirm QC was run according to policy and recorded on QC forms 1595.P039.F.2. See
details in Section XIII Quality Assurance.
1. Pour 10-12 mL of fresh, well-mixed, uncentrifuged urine into a 15 mL plastic conical
centrifuge tube labeled with two patient identifiers. Do not immerse reagent test
strip into original urine container – this will contaminate the specimen if
needed for culture.
2. Remove one reagent strip from the bottle and replace cap. Completely immerse all
but the top white area of the strip in the urine and remove immediately to avoid
dissolving out reagents. While removing, run the strip across the top edge of the
urine centrifuge tube to remove excess urine.
3. With the reagent areas to one side, touch the edge of the strip on a paper towel or
gauze. Do not draw the strip across the towel or gauze; touch the edge only.
4. Set a timer for 2 minutes.
5. Compare the reagent pads on the strip to the color chart of the bottle label at the
indicated time intervals.

UWHC Clinical Laboratories Original Date: 5/1/2013
Point of Care Current Version Date: 3/1/2017
Document Title: Urinalysis Testing with Labstix Reagent
Strips, Hemacombistix Reagent Strips or
Multistix Reagent Strips

Document ID: 1595.P039 Page 3 of 6


Analyte timing Points
Analyte Timing
Glucose 30 Seconds
Ketone 40 Seconds
Specific Gravity 45 Seconds
Blood 60 Seconds
PH 60 Seconds
Protein 60 Seconds
Nitrite 60 Seconds
Leukocytes 120 Seconds

6. Record specific results ordered in the patient’s clinical record, either on an approved
form with Reference Ranges or by using the electronic POC enter edit program.
7. Colorimetric reagent test strips measure specific gravity from 1.000 to 1.030. If
specific gravity result is ≥1.030, and measurement greater than 1.030 is needed,
order “Specific Gravity, urine” and send to the specimen to the Core Lab or measure
by refractometer if applicable.
8. If specific gravity result is 1.030 and results are being entered in Enter/Edit in Health
Link, add the smart phrase .SGCOM in the narrative tab which expands to read:
“Colorimetric reagent test strips measure the specific gravity from 1.000 to 1.030. If
measurement greater than 1.030 is needed, order “Specific Gravity, urine”.

VIII. Method Specification
A. Interferences/Limitations
1. Protein: A urine that is visibly bloody may cause falsely elevated results.
2. Blood: Capoten (captopril) may reduce the sensitivity. Certain oxidizing
contaminants, such as hypochlorite, may produce false positive results. Microbial
peroxidase associated with urinary tract infection may cause a false positive
reaction.
3. Leukocytes: Elevated glucose concentrations (≤3 g/dL) may cause decreased test
results. The presence of cephalexin (Keflex) or high concentrations of oxalic acid
may also cause decreased test results. Tetracycline may cause decreased
reactivity, and high levels of the drug may cause a false negative reaction. Positive
results may occasionally be due to contamination of the specimen by vaginal
discharge.
4. Nitrite: Pink spots or pink edges should not be interpreted as a positive result. A
negative result does not rule out significant bacteriuria. False negative results may
occur with shortened bladder incubation of urine, absence of dietary nitrite, or the
presence of non-reductive pathological microbes.
5. Glucose: Ketone bodies reduce the sensitivity of the test; moderately high ketone
levels (40 mg/dL) may cause false negatives for specimens containing small
amounts of glucose (75-125 mg/dL) but the combination of such ketone levels and
low glucose levels is metabolically improbable in screening.
6. Ketone: False trace results occur with highly pigmented urine specimens or those
containing large amounts of levodopa metabolites. Compounds such as mesna (2-
mercaptoethane sulfonic acid) that contain sulfhydryl groups may cause false
positive results or an atypical color reaction.
7. Specific Gravity: The Siemens SG test is dependent on ions in urine and results
may differ from those obtained with other specific gravity methods when certain
nonionic urine constituents, such as glucose, are present. Highly buffered alkaline

UWHC Clinical Laboratories Original Date: 5/1/2013
Point of Care Current Version Date: 3/1/2017
Document Title: Urinalysis Testing with Labstix Reagent
Strips, Hemacombistix Reagent Strips or
Multistix Reagent Strips

Document ID: 1595.P039 Page 4 of 6


urines may cause low readings, while the presence of moderate quantities of protein
(100-750 mg/dL) may cause elevated readings.
8. pH: Bacterial growth by certain organisms in a specimen may cause a marked
alkaline shift (pH>8.0), usually because of urea conversion to ammonia.
B. AMR (Analytical Measurement Range) – See chart below.
Note: AMR = CMR (Clinical Measurement Range) for this method.
Reagent Area Sensitivity/Measuring Range
Glucose 75-125 mg/dL glucose
Ketone 5-10 mg/dL acetoacetic acid
Blood 0.015-0.062 mg/dL hemoglobin
Protein 15-30 mg/dL albumin
Nitrite 0.06-0.1 mg/dL nitrite ion
Leukocytes 5-15 cells/hpf
pH within 1 unit in the 5-9 range
Specific Gravity 1.000-1.030

C. Limitations and/or Exceptions:
Highly colored urines or grossly bloody urines may affect the readability of the reagent
areas on the urinalysis reagent strips. The color development may be masked, or the
color reaction may be produced on the pad that could be interpreted as a false positive.
Unreadable or questionable results for a specific analyte should be reported as “invalid,
interfering color” when resulting in enter/edit. If no results are reported, credit the POC
urine. Highly colored urines can be sent to Core Lab for analysis.

IX. Procedure Notes (Not Applicable)

X. Calculations (As Applicable)

XI. Result Reporting and Interpretation
A. Result Review and Data Entry
1. Record specific results ordered in the patient’s clinical record on an approved form
with Reference Ranges or by using the electronic POC enter edit program.












B. Reference Ranges
1. Leukocytes – Negative
2. Nitrite- Negative
3. Protein- Negative
4. pH- 5.0 – 8.0
5. Blood – Negative
Test Name Allowable Reportable Results in Enter/Edit
SPECIFIC GRAVITY, URINE (POC) ≤1.005,1.010,1.015,1.020,1.025,≥1.030
PH, URINE (POC) 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5
PROTEIN, URINE (POC) NEG, TRACE, 1+, 2+, 3+
GLUCOSE, URINE (POC) NEG, TRACE,1+, 2+, 3+
KETONE, URINE (POC) NEG, TRACE, 1+, 2+, 3+
BLOOD, URINE (POC) NEG, TRACE, 1+(SM), 2+( MOD), 3+(LRG)
LEUKOCYTES, URINE (POC) NEG, TRACE, 1+(SM), 2+(MOD), 3+(LRG)
NITRITE, URINE (POC) NEG, POS

UWHC Clinical Laboratories Original Date: 5/1/2013
Point of Care Current Version Date: 3/1/2017
Document Title: Urinalysis Testing with Labstix Reagent
Strips, Hemacombistix Reagent Strips or
Multistix Reagent Strips

Document ID: 1595.P039 Page 5 of 6


6. Specific Gravity – 1.005-1.035
7. Ketone – Negative
8. Glucose – Negative

XII. Safety
All reagents have been reviewed for risk including reproductive toxicity, acute toxicity, and
carcinogenic potential. None were found.

XIII. Quality Assurance
A. Urine Dipstick (Labstix, Hemacombistix, Multistix)
1. Each time a new bottle of reagent strips is opened, document on the bottle label with
the date it was opened and the staff initials of the person who opened it.
2. Once QC has been run and is acceptable, write on the bottle label that QC was
acceptable or ok.
3. Check expiration date of bottle. Do not use after expiration date.
B. Quality Control
1. Control Materials. Control products used are Alta Diagnostics Urine Dipstick Control
Solutions- Negative and Positive. Known ranges for each analyte are included in
package insert.
2. Control Product Storage. Store in the refrigerator at 2°-8°C. Unopened vials are
stable until the expiration date printed on the vial. Once opened vials are stable for 8
weeks at room temperature. Record date opened and expiration date on bottle. Do
not use any control product past its expiration date.
3. Frequency of Control Runs. Both Negative and Positive controls are run weekly and
whenever a new bottle of reagent strips is opened. They may be run at any other
time for troubleshooting or maintenance.
4. Procedure and Interpretation
i. Remove one reagent strip from the bottle and replace cap. Hold the reagent
strip at a 45 degree angle and apply the control solution first to the uppermost
reagent pad. Allow the control material to flow downward over the reagent
stick until all pads have been saturated.
ii. With the reagent areas to one side, touch the edge of the strip on a paper
towel or gauze to remove excess. Do not draw the strip across the towel or
gauze; touch the edge only.
iii. Set a timer for 2 minutes.
iv. Compare the reagent pads on the strip to the color chart of the bottle label at
the indicated time intervals.
v. Review results and record on QC log: 1595.P039.F2
vi. If QC is within the acceptable ranges, patient specimens may be run.
5. Control Ranges - Acceptable ranges are received with each new lot of Negative and
Positive controls or available online at ultadiagnostics.com
6. Quality Control Acceptability. If any control is not acceptable:
i. Repeat the control.
ii. If still not acceptable, repeat with new vial of control and/or new bottle of
reagent strips. If repeating with new control material, make sure that the new
control material is allowed to warm to room temperature before testing
iii. After documenting the controls, circle the parameter that was not acceptable,
record what action you are taking to attempt to get controls to be acceptable
in the comment section of the QC sheet. Example: Repeat on new vial.

UWHC Clinical Laboratories Original Date: 5/1/2013
Point of Care Current Version Date: 3/1/2017
Document Title: Urinalysis Testing with Labstix Reagent
Strips, Hemacombistix Reagent Strips or
Multistix Reagent Strips

Document ID: 1595.P039 Page 6 of 6


iv. If a problem still exists, contact the Point of Care office at 608-263-8039 or
608-263-5589 or 263-890-9360 for assistance.
C. Training and Competency Assessment
1. All staff that perform urinalysis testing are trained and competency before performing
any patient testing. Initial training is documented and records are retained.
2. After their first year of testing, all staff is required to complete an annual competency
assessment.
3. Copies of the competency records will be kept with nursing education or the testing
unit or clinic.

XIV. Maintenance (Not Applicable)

XV. Alternate Testing and/or Down Time Procedures
A. Send the specimen to the main lab.

XVI. References
A. Alta Diagnostics® Urine Dipstick Control product insert, 8/1/2016
B. U-Connect: Laboratory Test Directory – Urinalysis without Microscopy (UAD)
C. Package insert, Siemens Multistix 10 SG-Revised
D. U-Connect: Collecting a urine specimen 2.5.2
E. U-Connect: Patient Identification 3.2.1

XVII. Related Documents (Not Applicable)

XVIII. Appendices and Forms
A. 1595.P.039.F.1 Urinalysis Dipstick Training and Competency Form (pdf), February, 2013
B. 1595.P.039.F.2 Urinalysis Testing – Quality Control Record Hemacombistix®, Labstix®, ,
Multisitx® (pdf), February 2013

XIX. Author and/or Revised By
Elizabeth Urban, MT (ASCP) Point of Care Testing Coordinator
Lori Trader, M (ASCP) Point of Care Testing Coordinator

XX. Coordination and/or Review
Point of Care Testing Faculty Director
CLIA Laboratory Director UWHC Point of Care Testing
Nursing Patient Care Policy and Procedures Committee