Your Lab Name
Manual Urinalysisby Bayer 10-SG MultiStix
Urine Dipstick
Document Number:
Pro 68-0.3
Effective (or Post) Date:
5 May 2008
Author: Penny Stevens
Document Origin
US Army Hospital Heidelberg, Germany
Company:
N/A
SMILE Approved by:
Heidi
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s
specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering
their use in other applications. If you have any questions contact SMILE.
Copy # _____
Effective Date: Date
U. URINALYSIS
U.1. MANUAL URINALYSIS by Bayer 10-SG MultiStix Urine Dipstick
U.1.1. PRINCIPLE:
1. Routine Urinalysis consists of both physical and chemical analyses to assist
physicians in the diagnosis and treatment of renal and urinary tract diseases and in the
detection of metabolic or systemic disease processes not directly related to the kidney.
2. The macroscopic examination of urine includes physical appearance, such as color,
character and clarity. The microscopic examination of the centrifuged urine sediment
includes the study of formed elements, such as WBC’s, RBC’s, casts and crystals.
3. A qualitative chemical analysis of the urine is performed by using a multi-parameter
test strip that measure pH, protein, glucose, ketones, bilirubin, urobilinogen, nitrite,
blood, leukocyte esterase, and specific gravity. The test strips are dipped in the urine
and read visually according to the color comparison chart printed on the side of the
container at prescribed time intervals.
U.1.2. PURPOSE - Visual and manual determination of semi-quantitative urine chemistries
using the Bayer 10-SG urine dipstick.
U1.3. SPECIMENS
1. Use only fresh well-mixed urine collected by clean-catch method into a sterile
container.
2. The specimen must be unpreserved and uncentrifuged.
3. All urine specimens must reach the laboratory within one (1) hour after collection
and be properly labeled.
Manual Urinalysis by Bayer 10-SG Dipstick U01 v.1
Page __ of 18
Effective: Date
4. Urine specimens must be tested within two (2) hours after collection. If urine
cannot be tested within two (2) hours, it may be stored for up to four (4) hours at 2
to 8C. (The specimen must be brought to room temperature before testing.)
5. The following urine samples are not satisfactory for testing:
5.1. Specimens received over two hours after collection (non-refrigerated).
5.2. Mislabeled samples.
5.3. Improperly collected samples. For example, urine samples with preservatives,
specimens collected in non-sterile containers, or specimens collected in
containers with soap or detergent residues will not be accepted.
5.4. QNS (Quantity Not Sufficient) - The recommended minimum volume is 2 mL’s.
The required minimum volume for all tests on the Bayer 10-SG Dipstick is 0.5
mL. In the event that less than <0.5 mL is received:
5.4.1. Contact the provider and advise him that there is insufficient specimen
to perform all of the requested tests.
5.4.2. Request the provider to indicate the order of priority for testing.
5.4.3. Perform testing in the order indicated.
5.4.4. See section U.1.7 for specific and/or additional steps.
5.5. In the event of an unacceptable sample, another sample must be requested.
Document all action taken in the LIS.
U.1.4. EQUIPMENT & REAGENTS
1. Equipment:
Lint-free tissues
Stopwatch or timer with seconds denoted
Log sheets
Laboratory markers and pens
Clean gauze (4 x 4)
Kova tubes
Plastic test tubes
Test tube racks
Disposable plastic transfer pipettes
2. Reagents:
Bayer 10-SG MultiStix Urine Dipsticks
Normal and Abnormal Kova Controls
U.1.5. CALIBRATION: Not applicable
Manual Urinalysis by Bayer 10-SG Dipstick U01 v.1
Page _ of 18
Effective: Date
U.1.6. QUALITY CONTROL:
1. Control Materials and Procedural Notes:
1.1. A Run in Urinalysis is defined as all patient testing performed in a 24-hour
period. Quality Control must be performed under the following conditions.
1.1.1. Every morning prior to testing patient specimens.
1.1.2. When using a new bottle or new lot of reagent strips.
1.1.3. Whenever test results appear questionable.
1.2. Normal and Abnormal Kova Controls will be performed on the multi-parameter
test strips every run.(see above)
1.3. Reconstitute new Kova controls with 60 mL Reagent Grade water according
to manufacturer’s instructions.
1.3.1. After reconstitution, separate controls into 2 mL aliquots using
disposable transfer pipettes and plastic test tubes. Cap tightly!
1.3.2. Label each plastic test tube with Normal or Abnormal Kova Control,
lot number, expiration date, reconstitution date, and initials of tech who
reconstitutes controls.
1.3.3. Sample aliquots will be stored frozen at -20C. The sample aliquots
may be stored at this temperature for up to four (4) months.
1.3.4. Only one freeze/thaw cycle should be done. Allow the aliquots to come
to room temperature on their own before use. Do not use a warming
block.
1.3.5. Sample aliquots are stable for one hour at 15-20°C or 24 hours at 2-8°C.
1.4. Perform the Kova controls in the same manner as patient samples. See section
U.1.7 for patient testing procedure. Record the results on the Urinalysis Quality
Control Worksheets. See appendix I & II.
1.5. All results must fall into the expected ranges, which are obtained from the
Manufacturer’s insert for each control and recorded on the top of the Urinalysis
Quality Control Worksheets.
1.6. If all results are within expected ranges, proceed with patient testing.
1.7. If QC results are outside of expected ranges for controls:
1.7.1.
1.7.2.
1.7.3.
1.7.4.
Review reagents and control expiration dates. Do not use expired
reagents or control material.
Check for signs of contamination in the reagent strips and controls.
Repeat the procedure with newly thawed or freshly reconstituted Kova
controls.
If results are still out of range, repeat the procedure with a new bottle of
Manual Urinalysis by Bayer 10-SG Dipstick U01 v.1
Page _ of 18
Effective: Date
1.7.5.
1.7.6.
multi-parameter reagent strips.
If the results are still out of range after performing the above steps,
notify the next higher supervisor immediately. Corrective action must
be taken and QC must be in range before patient testing can be
performed.
Record all out of range QC values and corrective actions on the Quality
Control Worksheets, appendix I & II.
1.8. Parallel Testing: All new reagent and quality control lots or separate shipments
of current lots will be tested against the current lots for performance verification
before performing patient testing. See the Parallel Testing form, Appendix III.
Results are considered acceptable if they are within the quality control limits and
no more than ± one step difference from the previous lot.
1.9. Bayer 10-SG MultiStix Expiration: This reagent is stable until the
manufacturer’s expiration date provided it has not been opened. The expiration
date must be revised to 7-days after opening.
1.10.Note: The multi-parameter reagent test strips must be stored under 24C
(preferably at room temperature) in their original container and tightly
capped. Do not use any controls or reagents after their expiration dates.
U.1.7. PROCEDURE
1. Remove the specimens/controls from the refrigerator or freezer, as applicable, and
allow them come to room temperature for at least 30 minutes before mixing.
2. Positively identify the specimens using the patient name and date of birth.
3. Log the sample on the testing worksheet using the LIS generated patient label,
appendix IV.
4. Add the LIS generated label to the sample cup (not the sample lid). Any discrepancy
must be investigated before processing the specimen.
5. Mix patient urine sample by swirling. Mix control aliquots by inverting several times
to ensure homogeneity of the contents.
6. Perform a macroscopic examination. Record the results on the worksheet (appendix
IV) and in the LIS:
6.1. Color and Clarity: Evaluate the specimen visually in the specimen cup and
report from the following available choices:
Manual Urinalysis by Bayer 10-SG Dipstick U01 v.1
Page _ of 18
Effective: Date
Color
Clarity
Yellow
Green
Clear
Dark Yellow
Orange
Slightly Cloudy
Straw
Red
Cloudy
Amber
Other
Turbid
Other
6.2. Reporting Other: If the color or clarity cannot be selected from the available
choices and “other” is selected, a comment must be included along with the
result on the manual report and in the LIS. The comments must include specific
details that provide an accurate color and/or clarity as applicable.
6.3. Bloody urine:
6.3.1. Do not centrifuge the specimen prior to testing.
6.3.2. If a specimen appears to be bloody, perform the urine dipstick test
on uncentrifuged urine.
6.3.3. Verify the blood on the dipstick. It should be positive.
6.3.4. If it is, enter the [BLOOD] canned comment in the color field:
“Some multi-parameter dipstick results may be inaccurate due to
color interference by the presence of blood. If contamination is
suspected, recollect and repeat testing with an uncontaminated
specimen if necessary.”
6.3.5. Perform all confirmatory testing as noted in section U.1.7.13.
6.3.6. If blood is not positive on the dipstick, do not use the [BLOOD]
comment.
6.4. Yellow-brown or green-brown urine is most often associated with bile
pigments, primarily bilirubin.
6.4.1. Shake the sample to distinguish bilirubin pigmentation from
normal dark (concentrated) urine. If the color is due to bile
pigments, the urine will form yellow foam when shaken. Normal
urine will form a white foam.
6.4.2. If bile pigments are confirmed, enter the [BILE] canned comment
in the color field: “Visual test for bile pigments confirmed. Some
multi-parameter dipstick results may be inaccurate due to color
interference. Recollect and repeat testing with a clean and clear
specimen if possible or necessary.”
6.4.3. Perform all confirmatory testing as noted in section U.1.7.13.
6.4.4. If the bile pigments cannot be confirmed, do not enter the [BILE]
comment.
6.5. Other abnormal urine colors: Many other substances can cause abnormal urine
color. The most common are those containing azo dyes which produce an
orange color. The orange color may affect the readability of the reagent areas on
Manual Urinalysis by Bayer 10-SG Dipstick U01 v.1
Page _ of 18
Effective: Date
the urine dipstick.
6.5.1. If the urine is orange or color interference is suspected, enter the
[COLOR] canned comment in the color field: “Abnormal urine
color. Some multi-parameter dipstick results may be inaccurate
due to color interference. Recollect and repeat testing with a
clean and clear specimen if possible or necessary.
6.5.2. Perform all confirmatory testing as noted in section U.1.7.13.
7. Pour 2-mL’s of specimen into a sterile Kova tube and label the tube with the LIS
specimen label. If the total specimen volume is 0.5 mL or less, do not pour the sample
into a Kova tube. Perform testing from the specimen cup as indicated in the
following steps.
8. Testing:
8.1. Volumes greater than 0.5 mL:
8.1.1. Dip a multi-parameter reagent strip into the sample in the Kova
tube for about one second, covering all reagent squares with urine.
8.1.2. Run the edge of the strip along the lip of the tube to remove excess
and prevent run-over between reagent squares.
8.1.3. Place the strip on a fresh, clean gauze pad or paper towel with the
reagent squares face up.
8.1.4. Start the timer and proceed with step 9.
8.2. Volumes less than 0.5 mL:
8.2.1. Contact the provider and advise him/her that there is insufficient
specimen to perform all of the requested tests and ask for the order
of priority for testing.
8.2.2. Aspirate sample into a disposable pipette.
8.2.3. Identify the correct time in step 9.2 for the first priority test as
indicated by the provider.
8.2.4. Obtain one multi-parameter reagent strip and lay it with the reagent
pads face up on a clean gauze pad.
8.2.5. Place one drop of sample to the reagent pad of the first priority test.
8.2.6. Start the timer
8.2.7. At the end of the specified time, grade the result as indicated in
step 9.3.
8.2.8. Record the result on the Manual Result Form, appendix IV.
8.2.9. Repeat steps 8.2.1 through 8.2.7 for remaining tests in the order
requested by the provider.
9. Determine test results by comparing the reagent pad to the Multistix color chart on the
bottle’s label. The reagent test times are as follows:
Manual Urinalysis by Bayer 10-SG Dipstick U01 v.1
Page _ of 18
Effective: Date
Analyte
Time Interval
Glucose & Bilirubin:
30 Seconds
Ketones:
40 Seconds
Specific Gravity:
45 Seconds
Blood, pH, Protein, Urobilinogen, & Nitrite:
60 Seconds
Leukocytes:
2 Minutes
10. INTERPRETATIONS & REPORTING RESULTS: Record the result in the LIS
and on the testing worksheet as follows:
Analyte
Reaction Grades
Glucose:
Bilirubin:
Ketone:
Negative, 100 mg/dL, 250 mg/dL, 500 mg/dL, or ≥1000 mg/dL
Negative, Small, Moderate, and Large.
Negative, Trace, 15 mg/dL, 40 mg/dL, or ≥80 mg/dL
Specific gravity:
≤1.005, 1.010, 1.015, 1.020, 1.025, ≥1.030.
Blood:
Negative, Trace, Small, Moderate, or Large.
pH:
Protein:
Urobilinogen:
Nitrite:
Leukocytes:
5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 or ≥9.0.
Negative, Trace, 30 mg/dL, 100 mg/dL, ≥300 mg/dL.
0.2 EU/dL, 1 EU/dL, 2 EU/dL, 4 EU/dL, or 8 EU/dL
Negative or Positive.
Negative, Trace, Small, Moderate, or Large.
NOTE: Bilirubin and Blood QC results will be resulted just like patient results,
Trace, 1+ = Small, 2+ = Moderate, 3+ = Large.
11. Record all results on the Patient Manual Result Report, appendix IV.
12. Enter all results and comments into CHCS and review. See U.1.10 for Expected
Results - Abnormal results will be flagged. File results that require backup testing
and/or microscopic examination. Certify results after confirming that the result is
entered correctly. Do not certify any dipstick results that require backup testing until
the backup testing is complete.
13. Backup tests and/or microscopic examination must be performed on urines that
test positive for the following:
Positive Result
Backup Test
Microscopic Exam
Blood
N/A
Yes
Nitrite
N/A
Yes
Ketones
Acetest
No
Manual Urinalysis by Bayer 10-SG Dipstick U01 v.1
Page _ of 18
Effective: Date
Glucose
Clinitest
No
Bilirubin
Ictotest
No
Protein
3% Sulfosalicylic Acid
Yes
Leukocyte Esterase
N/A
Yes
13.1. Perform the Clinitest confirmatory test on all pediatric urine samples with
patients age 2 years old or younger, regardless of whether it was requested or
not. See Clinitest SOP U06.1
13.2. Perform Ictotest, Acetest, and Clinitest on urine before centrifuging. Urine
requiring SSA testing or microscopic examination must be centrifuged prior to
testing. Refer to individual confirmatory test SOPs as listed in the reference
sections.
13.3. Confirmatory tests are not required for TRACE results on PROTEIN or
KETONES.
14. QNS (Quantity Not Sufficient) - If less than <0.5 mL is received and all tests cannot
be performed as requested by the provider or as indicated in this procedure, report the
result as QNS. Enter the canned comment [QNS] in the first field where QNS is
reported - “Insufficient volume submitted to perform all requested tests. Testing
performed for priority tests per physician’s request. Please reorder and resubmit if
additional testing is required”.
15. Urine samples are retained at 2-10°C for 24 hours in the Hematology refrigerator.
U.1.8. URINALYSIS CRITICAL VALUES:
1. The following results are critical:
Bayer Multistix 10-SG Dipstick
Critical Results
Ketones:
Adults
≥ 80 mg/dL or Large
< 2 years
≥ 15 mg/dL
Glucose:
Adults
≥ 1000 mg/dL
< 2 years
≥ 100 mg/dL
Protein
≥ 1000 mg/dL
All
2. If any of the above values are obtained, repeat the test to verify the result:
2.1
If the repeat value is not critical, report the repeated result.
Manual Urinalysis by Bayer 10-SG Dipstick U01 v.1
Page _ of 18
Effective: Date
2.2.
If the repeat value is critical, report the first result.
3. Repeated results should not be greater than 1-step different than the first result
obtained. If they are, investigate the cause for the difference.
4. Contact the provider and report the critical result. Request the provider to read-back
the result to verify.
5. Document the critical notification in the LIS using the canned comment [CRITICAL]:
“Critical result reported to and read back by:” After the comment include the name
of the person it was reported to, the date & time of notification and your initials. A
final critical comment example is as follows: “Critical result reported to and read
back by: Dr. Jones 29 Jan 2006 at 0910. PSS”
U.1.9. PROCEDURAL NOTES:
1. NORMAL CHARACTERISTICS OF URINE: The yellow color of the urine is due
largely to the pigment urochrome and small amounts of urobilin and uroerythrin.
Normal urine is essentially clear, and the presence of particulate matter in an
uncentrifuged urine needs to be explained microscopically. Normal urine has a faint,
aromatic odor of undetermined source.
2. Multiparameter chemstrip urine strips are inert plastic strips to which different
reagent papers are attached to indicate the determination of leukocytes, nitrite, pH,
glucose, ketones, urobilinogen, bilirubin, blood and specific gravity in the urine. A
brief discussion of each test principle follows:
2.1.
Leukocytes: Leukocytes in urine are detected by the action of esterase present
in granulocytic leukocytes. This catalyzes the hydrolysis of an indoxylcarbonic
acid ester to indoxyl. The indoxyl formed reacts with a diazonium salt to
produce a purple color.
2.2.
Nitrite: The nitrate is detected by reacting with the aromatic amine to produce
a diazonium salt that couples with sulfanilamide to produce a pink color. The
gram-negative bacteria in urine generate Nitrate.
2.3.
pH: The test strip contains the indicator methyl red and bromthymol blue.
These two give clearly distinguishable colors over the pH range of 5 to 9.
Colors range from orange through yellow and green to blue.
2.4.
Protein: The detection of protein is based on the "protein error of pH
indicators" principle. This principle states that at a constant pH, the
development of any green color is due to the presence of protein. Colors range
from yellow for a negative test through yellow-green and green-blue for
positive reactions.
Manual Urinalysis by Bayer 10-SG Dipstick U01 v.1
Page _ of 18
Effective: Date
2.5.
Glucose:
Glucose detection is based on the enzymatic glucose
oxidase/peroxidase (GOD/POD) method. The reaction utilizes the enzyme
glucose oxidase to catalyze the formation of gluconic acid and hydrogen
peroxide from the oxidation of glucose. Next, a second enzyme, peroxidase
catalyzes the reaction of hydrogen peroxide with the chromogen
tetramethylbenzidine to form a green dye. A positive reaction is indicated by a
color change from green to brown.
2.6.
Ketones: This test is based on the development of colors ranging from buff
pink for a negative reading to purple on the reaction of acetoacetic acid with
nitroprusside.
2.7.
Urobilinogen: Erlich reaction in which para-dimehtyl-aminobenzaldehyde
reacts with urobilinogen in a strongly acid medium to produce a pink-red color.
2.8.
Bilirubin: The detection of bilirubin is based on the coupling reaction of a
diazonium salt with bilirubin in an acid medium, various shades of tan
coloration.
2.9.
Blood: Peroxidase-like activity of hemoglobin, which catalyzes the reaction of
cumene-hydroperoxidase and tetramethyl-benzidine. This reaction produsces
colors ranging from orange through green to dark blue.
2.10. Specific Gravity: This test is based on the apparent pH change of certain pretreated polyelectrolyte in relation to ionic concentration. In the presence of an
indicator, colors range from blue-green in urine of low ionic concentration
through green and yellow-green in urine of increasing ionic concentration.
3. Multi-parameter urine test strips contain one (1) or more of the following chemicals:
phenol, diazodium salt, and nitroferricyanide. Avoid contact with the skin and
mucous membranes; flush affected areas with copious amounts of water.
U.1.10. EXPECTED RESULTS & REPORTABLE RANGE:
Analyte
Expected results for:
ALL AGES
Color
Reportable Range:
Yellow
Yellow - Other
Clear
Clear - Other
Glucose:
Negative
Negative - >1000 mg/dL
Bilirubin:
Negative
Negative - Large
Ketone:
Negative
Negative - >80 mg/dL
1.005 to 1.030.
<1.005 - >1.030
Blood:
Negative
Negative - Large
pH:
5.0 to 9.0
5.0 - >9.0 Units
Clarity
Specific gravity:
Manual Urinalysis by Bayer 10-SG Dipstick U01 v.1
Page _ of 18
Effective: Date
Protein:
Negative
Negative - >300 mg/dL
0.2 - 1.0 EU/dL
0.2 - >8.0 E.U./dL
Nitrite:
Negative
Negative or Positive
Leukocytes:
Negative
Negative - Large
Urobilinogen:
U.1.11. SOURCES OF ERROR:
1. Test urine within two (2) hours after collection. Prolonged delay of examination of
urinary sediment may result in cast dissolving, RBCs crenating or bursting, increased
bacteria, and crystals dissolving.
2. Do not touch the pads of the Multistix or allow prolonged exposure to air, this can
deteriorate the strips and give erroneous results.
3. Store multistix test strips in their original container for the indicated expiration dates.
Keep the container tightly closed and protected from moisture. Moisture can cause
deterioration and give erroneous results.
U.1.12. APPENDICES:
I. UA Quality Control Worksheet - Normal
II. UA Quality Control Worksheet - Abnormal
III. Parallel Testing Form
IV. Patient Manual Result Report
U.1.13. REFERENCES:
1. Stransinger, Susan K., Urinalysis and Body Fluids, Third Edition, F.A. Davis Book
Publisher, 1994, Pages 1 to 10 and 51 to 74.
2. Haber, Meryl H., Urinary Sediment: A Textbook Atlas, American Society of Clinical
Pathologist Book Publisher, 1994.
3. Multistix 10 with SG Package Insert, Bayer Corporation; Diagnostics Division, 1999.
4. Kova Trol: Human Urinalysis Controls Package Insert, Hycor Biomedical Inc., 2001.
5. Manual Urinalysis Microscopic Examination SOP, U.2.1
6. Specific Gravity Determinations by Refractometer SOP, U.5.1
7. Clinitest Determination of Reducing Substances in Urine SOP, U.6.1
Manual Urinalysis by Bayer 10-SG Dipstick U01 v.1
Page _ of 18
Effective: Date
8. Acetest Determination of Ketones in Urine SOP, U.8.1
9. Ictotest Determination of Bilirubin in Urine SOP, U.9.1
10. SSA Determination of Protein in Urine SOP, U.10.1
Manual Urinalysis by Bayer 10-SG Dipstick U01 v.1
Page _ of 18
Effective: Date
U.1.14. SOP VALIDATION
SOP NAME:
U.1. Routine Manual Urinalysis by Bayer-10SG MultiStix
Clear and specific title and principle:
Comments:
yes / no
All necessary supplies, equipment, and materials are listed:
Comments:
yes / no
SOP is sufficiently detailed to be understood but not overly complex:
Comments:
SOP text adequately describes process/procedure:
Comments:
SOP accomplishes purpose:
Comments:
yes / no
yes / no
yes / no
Reviewed by: (Name & Title)
Signature: __________________
Date: __________________
U.1.15. SOP CHANGE CONTROL
Date
Change
Manual Urinalysis by Bayer 10-SG Dipstick U01 v.1
QA
Page _ of 18
OIC
Med. Dir.
Effective: Date
U.1.16. SOP APPROVAL
SIGNATURE
DATE
PREPARER
QA COORDINATOR
LABORATORY OIC
MEDICAL DIRECTOR
U.1.17. ANNUAL REVIEW
REVIEWER SIGNATURE
DATE
REVIEWER SIGNATURE
DATE
U.1.18. DOCUMENT COPY CONTROL
Location
Copy
Location
Copy
1
8
2
9
3
10
4
5
6
7
SUPERSEDES:
DATE SOP RETIRED: __________
Manual Urinalysis by Bayer 10-SG Dipstick U01 v.1
Page _ of 18
Effective: Date
Your Lab Name
Appendix I
Urinalysis Dipstick and Microscopic Normal Control Log
Normal Control Lot#:
Expiration:
Month/Year:
Dipstick Lot#
Expiration:
Date in use:
Supervisor Review:
Dipstick Lot#
Expiration:
Date in use:
Review Date:
Bilirubin
Specific
Gravity
Date
Color/
Clarity
Glucose
Ketones
Blood
pH
Protein
Acceptable
Range:
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
Comments:
Refer to SOPs U.1.1 and U.2.1 for Urine Dipstick and Microscopic QC resulting procedures
Manual Urinalysis by Bayer 10-SG Dipstick U01 v.1
Page __ of 18
Effective: Date
Urobilin.
Nitrate
Leu.
Esterase
WBC/hpf
RBC/hpf
Crystals
Casts
Tech
Initials
Appendix II
Urinalysis Dipstick and Microscopic Abnormal Control Log
Abnormal Control Lot#:
Expiration:
Month/Year:
Dipstick Lot#
Expiration:
Date in use:
Supervisor Review:
Dipstick Lot#
Expiration:
Date in use:
Review Date:
Bilirubin
Specific
Gravity
Date
Color/
Clarity
Glucose
Ketones
Blood
pH
Protein
Acceptable
Range:
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
Comments:
Refer to SOPs U.1.1 and U.2.1 for Urine Dipstick and Microscopic QC resulting procedures
Manual Urinalysis by Bayer 10-SG Dipstick U01 v.1
Page _ of 18
Effective: Date
Urobilin.
Nitrate
Leu.
Esterase
WBC/hpf
RBC/hpf
Crystals
Casts
Tech
Initials
Your Lab Name
Appendix III
Urinalysis Dipstick Parallel Testing form
Technician: _______________________________
Date:
New Dipstick Lot#: __________________________
Exp. Date: _________________________________
Current Dipstick Lot#: _________________________
Exp. Date: _________________________________
Parallel Test Sample:
Patient
or
___________________________________
Control
Control Sample, Lot#_______________ Expiration Date: ________________________
Patient Sample ID# _______________________ Collection Date: _________________________
Reagent
Current Lot Result
New Lot Result
Difference*
Acceptable
Glucose
Yes /
No
Bilirubin
Yes /
No
Ketone
Yes /
No
Specific Gravity
Yes /
No
Blood
Yes /
No
pH
Yes /
No
Protein
Yes /
No
Urobilinogen
Yes /
No
Nitrite
Yes /
No
Leukocytes
Yes /
No
*Note: The acceptable difference between reagent lots is ±1-step from the current lot. Differences greater than one
step must be repeated to verify the results on both the current and new lots. If the difference is still greater than one
step, a quality control sample must be used for parallel testing and a supervisor review is required prior to accepting
the new lot or shipment.
New Lot Acceptable:
Yes
/
No
Comments:
Tech Signature:
Date:
Supervisor review :
Date:
Supervisor Comments:
Manual Urinalysis by Bayer 10-SG Dipstick U01 v.1
Page __ of 18
Effective: Date
Appendix IV - Patient Manual Urinalysis Result Report
Patient Information:
Sample Information:
Patient Name: _____________________________
Date Collected: ____________________________
___________________________________
Time Collected: ____________________________
ID#
Date of Birth: ______________________________
Ordering Physician & Clinic: _____________________
Patient Results
MultiStix Reagent Dipstick
Reference Range
Color
Yellow
Dk.Yellow
Straw
Amber
Other, Please indicate:
Yellow
Clarity
Clear
Slightly
Cloudy
Cloudy
Turbid
Other, Please indicate:
Clear
Glucose (mg/dL):
Negative
100
Bilirubin:
Negative
Small
Ketone (mg/dL):
Negative
Trace
Specific Gravity:
≤1.005
Blood:
Negative
pH:
5.0
5.5
6.0
250
Moderate
15
1.010
40
1.015
Trace
6.5
500
1.020
Small
7.0
1.025
≥1000
Negative
Large
Negative
≥80
Negative
≥1.030
1.005 to 1.030
Large
Negative
≥9.0
5.0 to 9.0
Moderate
7.5
8.0
8.5
Protein (mg/dL):
Negative
Trace
30
100
≥300
Negative
Urobilinogen (EU/dL):
0.2
1.0
2.0
4.0
≥8
0.2 - 1.0
Nitrite:
Negative
Leukocytes:
Negative
Positive
Trace
Small
Moderate
Negative
Large
Negative
Comments:
Tech Signature:
Supervisor review required for all
critical values.
Required?
Report Date/Time:
Yes / No
Signature:
Date:
Comments:
Manual Urinalysis by Bayer 10-SG Dipstick U01 v.1
Page _ of 18
Effective: Date