HIMALAYA DIAGNOSTIC CLINIC PVT. LTD VERSION NO.

1
STANDARD OPERATING PROCEDURE URINE ANALYSIS COPY NO. 1
DATE OF ISSUE:
05/04/2025
CONTROLLED COPY | Page 1 of 28

Contents
URINALYSIS..........................................................................................................................................................3
PURPOSE - The microscopic examination of urine sediment.................................................................................4
U.2.4. EQUIPMENT & REAGENTS.................................................................................................................4
CALIBRATION: Not applicable.............................................................................................................................5
U.2.6. PROCEDURE..........................................................................................................................................6
U.2.7. EXPECTED / CRITICAL RESULTS & REPORTABLE RANGE:......................................................10
1. CRITICAL VALUES:...................................................................................................................................13
U.2.9. PROCEDURAL NOTES:...........................................................................................................................14
5.11.1. Cast matrices:.........................................................................................................................................16
5.11.2. Cast Inclusions:......................................................................................................................................16
5.11.3. Cast Pigments:........................................................................................................................................17
5.11.4. Cellular Casts:................................................................................................................................17
6. SOURCES OF ERROR:........................................................................................................................18
U.2.10. APPENDICES:......................................................................................................................................18
U.2.11. REFERENCES:......................................................................................................................................18
U.2.11. REFERENCES:.........................................................................................................................................19
1 DETECTION OF B-HCG IN URINE............................................................................................................21
2 SCOPE AND PURPOSE...............................................................................................................................21
3 RESPONSIBILITIES.....................................................................................................................................21
4 REFERENCES..............................................................................................................................................21
5 DEFINITIONS...............................................................................................................................................21
6 RELATED DOCUMENTS............................................................................................................................21
7 ACTIONS AND METHODS.........................................................................................................................22
a. Principle of test......................................................................................................................................22
b. Personnel to do the task / level of training required...............................................................................22
c. Specimen requirements..........................................................................................................................22
c. Equipment.........................................................................................................................................................22
Prepared by : Reviewed by: Authorized by:
Anish Magar Suraj Gautam Dr. Sujan Sharma
Lab Technologist Lab Incharge MD. Pathologist
 HIMALAYA DIAGNOSTIC CLINIC PVT. LTD VERSION NO. 1
STANDARD OPERATING PROCEDURE URINE ANALYSIS COPY NO. 1
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e. Materials/Reagents.........................................................................................................................................22
f. Quality Control..............................................................................................................................................22
g. Method/Procedure..........................................................................................................................................23
e. Result Reporting............................................................................................................................................23
g. Guide to interpretation...................................................................................................................................23
8 HEALTH AND SAFETY......................................................................................................................23

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Anish Magar Suraj Gautam Dr. Sujan Sharma
Lab Technologist Lab Incharge MD. Pathologist
 HIMALAYA DIAGNOSTIC CLINIC PVT. LTD VERSION NO. 1
STANDARD OPERATING PROCEDURE URINE ANALYSIS COPY NO. 1
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URINALYSIS
MANUAL URINALYSIS MICROSCOPIC
EXAM 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 microscopic examination of the centrifuged urine sediment includes the study of
formed elements, such as WBC’s, RBC’s, casts and crystals.
3. The macroscopic examination of urine includes physical appearance, such as
color, character and clarity. Manual Urinalysis Dipstick SOP for macroscopic testing and
reporting procedures.

4. 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. Manual Urinalysis Dipstick SOP for qualitative
testing and reporting procedures.

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Anish Magar Suraj Gautam Dr. Sujan Sharma
Lab Technologist Lab Incharge MD. Pathologist
 HIMALAYA DIAGNOSTIC CLINIC PVT. LTD VERSION NO. 1
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PURPOSE - The microscopic examination of urine sediment.

SPECIMENS
1.Use fresh well-mixed urine collected by clean-catch method into a sterile container.
2.The specimen should be unpreserved and un-centrifuged.
3. All urine specimens should reach the laboratory within one (1) hour after
collection and be properly labeled.
4. Urine specimens should 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.
5.2. Mislabeled samples.
5.3. Improperly collected samples. For example, urine samples with preservatives,
specimens collected in nonsterile 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 12 mL’s.
The required minimum volume for microscopic examination is 0.50 ml. In the event that
less than <0.50ml. In the event that less than <0.50ml is received, perform testing on un-
centrifuged urine and comments as noted in section U.2.7.
5.5 In the event that are unacceptable sample is received, another sample must be
requested

U.2.4. EQUIPMENT & REAGENTS

1.Equipment:
1.1 Kova System - Kova slides, pipettes & tubes.
1.2. Centrifuge with timer
1.3. Microscope with 10x and 40x objectives
1.4. Lens paper or lint free tissues
1.5. Log sheets
1.6. Laboratory markers and pens
1.7. Clean gauze (4 x 4)
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2.Reagents – Non

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CALIBRATION: Not applicable

U.2.5. 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. Whenever test results appear questionable.

1.2. A Normal and Abnormal Kova Control will be performed at least once 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 are stable
at this temperature for up to four (4) months.
1.3.4. Only one freeze/thaw cycle is permitted. Aliquots must be at room
temperature before testing. Do not use a warming block to thaw.
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.2.7 for the patient testing procedure. Record the results on the Urinalysis Quality

Prepared by : Reviewed by: Authorized by:

Anish Magar Suraj Gautam Dr. Sujan Sharma
Lab Technologist Lab Incharge MD. Pathologist
 HIMALAYA DIAGNOSTIC CLINIC PVT. LTD VERSION NO. 1
STANDARD OPERATING PROCEDURE URINE ANALYSIS COPY NO. 1
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Control Worksheets. See appendix 3 & 4. 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. Re-examine the specimen using a different field of view.
1.7.2. Adjust the coarse/fine focus as needed to improve the view and repeat testing.
1.7.3. Check for signs of contamination in the controls.
1.7.4. Repeat the procedure with freshly reconstituted Kova controls.
1.7.5. 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.
1.7.6. Record all QC values (both in and out of range) and corrective actions on the
Quality Control Worksheets.

1.8. Parallel Testing:

All new 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. Results are considered acceptable if they are within their lot
number quality control limits.

U.2.6. PROCEDURE

1. Remove the specimens/controls from the refrigerator or freezer, as applicable,

and allow them come to room temperature for atleast 30 miunutes 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.

Prepared by : Reviewed by: Authorized by:

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Lab Technologist Lab Incharge MD. Pathologist
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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. If a macroscopic examination & urine chemistry testing is ordered refer to U.01.1

Manual Urinalysis Dipstick Testing SOP for testing and reporting procedures. The
microscopic examination is performed after dipstick testing unless the provider requests
otherwise.

7. If Clintest, Acetest or Ictotest is required as listed below or requested by the

provider, perform testing on uncentrifuged urine prior to performing the microscopic exam.
Refer to individual confirmatory test SOPs as listed in the references.

8. The Clinitest confirmatory test is required for 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.

Backup tests and/or microscopic examination must be performed on urine that tests positive for
the following

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Positive Result Backup Test Microscopic Exam

Blood N/A Yes

Nitrite N/A Yes

Ketones Acetest No

Glucose Clinitest No

Bilirubin Ictotest No

Protein 3% Sulfosalicyclic Yes

Acid
Leukocyte N/A Yes
Esterase

8.1. Urine with cloudy or hazy appearance.

8.2. Microscopic examination requested by the patient’s physician.
8.3. Urine specimens received from Pediatric Clinic.
8.4. Catheterized and Suprapubic aspiration samples.
8.5. Urine specimens received from Physical Exam Clinic.
9. Pour 12-ml of specimen into a sterile Kova tube and label the tube with the LIS specimen label.
If the total specimen volume is 0.50 mL or less, do not pour the sample into a Kova tube.
Perform testing from the specimen cup as indicated in the following steps.
10. Testing
10.1. Volumes greater than 0.50 mL
10.1.1. Perform Dipstick, Clinitest, Acetest, or Ictotest as required or requested.
10.1.2. Cap the Kova sample and centrifuge at 1500 rpm for 5 minutes.
10.1.3. Remove the sample from the centrifuge and discard the cap.

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10.1.4. If 3% SSA testing is required or requested, perform testing on the supernatant according to the
U.10.1. 3% SSA SOP.
10.1.5. Decant and discard the supernatant while retaining the sediment pellet in the conical portion
of the Kova tube. There will be a small volume of fluid retained above the sediment.
The total volume retained in the Kova system tube after decanting the supernatant should be
approximately 0.5 mL.

10.1.6. Use a Kova disposable pipette to resuspend the sediment pellet.

10.1.7. Proceed with testing in step 13.3.
10.2. Volumes less than 0.50 mL - swirl the sample in the specimen cup to mix well.
10.3. Use a Kova pipette to aspirate sample from the well mixed specimen.
10.4. Place one (1) drop of the sediment on the Kova slide so that the urine sediment is
drawn under the preformed Kova cover slip.

10.5. Place the Kova slide under the microscope with the low power objective (10X
lens) and observe the sediment for the presence of casts. Observe at least ten (10) fields
and take the average number of casts seen for each type.

10.6. Switch to high power objective (40X lens) to observe the sediment for the
presence of epithelial cells, WBCs, RBCs, bacteria, crystals, yeast, trichomonas, mucus,
and spermatozoa.

10.7. Scan approximately 8-10 fields and take the average per field for each type of sediment.
10.8. QNS specimens - report the following canned comments as applicable.

1.1. QNS specimens - report the following canned comments as applicab

1.1.1. If the volume was 0.5 mL, enter [12ML] - Minimum specimen volume is 12 mL. Urine
sediment results may be falsely decreased due to a submitted sample volume less than 12 mL’s.
1.1.2. If the volume was <0.5ml, enter (UNSPUN)-Testing performed on uncentrifuged urine
due to a submitted volume is less than 0.5ml. Minimum required specimen volume is 12ml.
Urine sediment results may be fasley decreased.
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1.2. Review the results and enter data on the manual microscopic patient result form
(appendix IV). See section U.2.8 for Expected and Critical Results - Abnormal results will be
flagged.
1.3. Enter all results in the LIS. Do not certify any results until all urinalysis testing ordered
on the patient sample is complete.
1.4. Urine samples are retained at 2-10°C for 24 hours in the Hematology refrigerator.

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U.2.7. EXPECTED / CRITICAL RESULTS & REPORTABLE RANGE:

1. The following bolded analytes require a result entry during the microscopic
results even if they are not seen during the microscopic exam. Report “none” or 0-1 or
0-2 as indicated. All other analytes are optional entry if seen during the microscopic
exam.

Analyte Expected Result Reportable Range

Hyaline Cast 0-1 0-1,1-3,3-5,5-10,10-25,25-

50 or >50/LPF. Quantify
each cast type separately.

Granular Cast None Same as Above

Cellular Cast None Same as Above

Waxy Cast None Same as Above

Epithelial Cells 0-2 0-2,2-5,5-10,10-25,25-50,

>50/HPF

Leuckocytes 0-2 0-2,2-5,5-10,10-25,25-50,

>50/HPF

RED BLOOD 0-2 0-2, 2-5, 5-10, 10-25, 25-

CELLS 50,
or greater than (>) 50/
HPF

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BACTERIA None/Few None, Few, Trace,

Moderate or Many

MUCUS None/Light Light, Moderate or Heavy

Crystals None Few, Moderate or Many

for each crystal type.

Spermatozoa Males only few Few, Moderate, or Many.

Yeast None Light, Moderate or Many.

Report any budding yeast
or hyphea seen using
comments as noted
below.
Trichomonas None Few, Moderate or Many.
May only be reported if
motile.

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2. If budding yeast or hyphea are present, add the following canned comments:
2.1. [Budding] - Budding yeast present.
2.2. [Hyphea] - Hyphae present.

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3. The presence of sperm in the urine of a female child under 16 years old is a critical
value. Supervisor confirmation is required before reporting any suspected sperm to the
physician. The physician must be notified in accordance with critical value procedures
before sperm is reported in the LIS. The urine must be retained at 2-10°C until the patient’s
physician and laboratory director authorizes disposal. In no instance will the urine be
destroyed until duly authorized.

4. If a urine dipstick is performed, compare the results obtained on the microscopic

with the multi-parameter reagent strip with the following facts in mind:
4.1. Urine with RBCs seen on the microscopic exam should have a positive occult
blood on the reagent strip.
4.2. Urine with casts should have elevated specific gravity and positive protein.
4.3. Urine with crystals should have elevated specific gravity.
4.4. Urine with positive nitrite should have bacteria on the microscopic.

1. CRITICAL VALUES:

1.1. When the following values are encountered after a urinalysis testing, immediately
notify the physician or senior ward/clinic nurse of the values encountered.

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Analyte Critical Results: All ages unless otherwise noted

Waxy Cast Any

Red Blood Cell Cast Any

Cystine Crystal Any

Tyrosine Crystal Any

Leucine Crystal Any

Sperm Any-Female <16yrs old

1.2. Critical values must be reported in accordance with the laboratory critical value policy.

1.2.1. All critical microscopic sediment must be verified by the laboratory supervisor
before reporting to the physician/nurse and before certifying results in the LIS.

1.2.2. All results must be read back by the physician/nurse and the notification & read
back documented in the LIS.

1.2.3. The pathologist must also be notified within 2 hours and will determine if a
pathologist review is required

U.2.9. PROCEDURAL NOTES:

1. Normal Characteristics of the Urine: The yellow color of the urine is due largely to
the pigment urochrome and small amounts of urobilin and uroerythrin. Normal urine is
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essentially clear, and the presence of particulate matter in uncentrifuged urine needs to be
explained microscopically. Normal urine has a faint, aromatic odor of undetermined source.

2. Microscopic Sediment:

2.1. RBCs: Normally 0-2 RBCs/HPF may be seen in urine from males and non-
menstruating females. Increased numbers may indicate renal hematuria.

2.2. WBCs: Normally 0-5 WBCs/HPF may be seen in urine of normal males with
slightly higher ranges in females. Increased numbers may indicate renal disease or acute
infection.

2.3. Epithelial cells: A few epithelial cells are normal and indicate normal sloughing off
of aging cells. Increased numbers may indicate renal disease, urinary tract infection, or
poor technique in specimen collection.

2.4. Casts: 0-1 hyaline cast/LPF is found in normal urine. Increased numbers or more
advanced types indicate proteinuria.

2.5. Bacteria: A few bacteria are normally seen due to poor technique in collection of the
specimen. Increased numbers may indicate kidney, bladder, or urinary tract infection.

2.6. Crystals: The following crystals may be seen in normal or abnormal urine as noted
below. Use urine pH and solubility information to aid in identification, as needed. Also use
appropriate image and literature resources to assist with identification.

Normal Abnormal

Acidic Urine Alkaline Urine Acidic Urine Alkali

ne
Urine

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Amorphous Amorphous Cystine None

Urates Phosphate

Uric Acid Triple Phosphate Tyrosine

Calcium Oxalate Ammonium Biurates Leucine

Calcium Phosphorus Sulfonamide

Calcium Bicarbonates

2.7. Mucus: Light mucus is normally found in urine and can sometimes be confused
with hyaline casts.

2.8. Spermatozoa: A few are normally found in urine from normal males. Increased
numbers are found in prostatic disease.

2.9. Trichomonas: Normally not found in urine. Presence of trichomonas is abnormal

and may indicate infection.

5.10. Yeast: 0-1/HPF or few per high power field are normal in females. Increased
numbers indicate infection.

5.11. Casts are classified according to their matrix, inclusions, pigments and cells present.

5.11.1. Cast matrices:

5.11.1.1. Hyaline casts: Are translucent cylindrical structures composed of
mucoprotein. Increased numbers are seen with renal diseases and transiently with exercise,
fever, congestive heart failure, and diuretic therapy.
5.11.1.2. Waxy casts: These differ from hyaline casts in that they are easily
visualized because of their high refractive index. Waxy casts are homogeneously smooth in
appearance. Their margins are sharp, their ends are blunt, and cracks or convolutions are
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frequently seen along the lateral margins. Waxy casts are commonly associated with tubular
inflammation and chronic renal failure. They are also found during acute or chronic renal
allograft rejection
5.11.2. Cast Inclusions:
5.11.2.1. Granular casts are semitransparent cylinders containing small (fine) or
large (coarse) granules. These granules represent plasma protein aggregates. Granular casts
appear with glomerular or tubular diseases.
5.11.2.2. Fatty casts are semitransparent or granular cylinders containing large highly
refractive vacuoles or droplets. Visible fat droplets are triglycerides or cholesterol esters.
These are commonly seen when there is heavy proteinuria and are a feature of the nephrotic
syndrome.
5.11.2.3. Crystal Casts: Crystalline inclusion in a semitransparent or granular
cylinder. These casts indicate disposition of crystals in the tubule or collecting duct.

5.11.3. Cast Pigments:

5.11.3.1. Hemoglobin (Blood) casts: Appears yellow to red; sometimes the color is
very pale and difficult to interpret. These casts are associated with glomerular disease.
5.11.3.2. Myoglobin casts: These cast are red-brown in color and occur with
myoglobinuria following acute muscle damage.
5.11.3.3. Bilirubin and other drug casts: Bilirubin is seen in urine when there is
obstructive jaundice, and will color casts as deep yellow brown. Drugs such as
phenazopyridine (Pyridium) cause a bright yellow to orange color in acid urine and will
color casts and cells.

5.11.4. Cellular Casts:

5.11.4.1. Erythrocyte (Red Blood Cell) casts: Semitransparent or granular cylinders

containing distinct erythrocyte. Disorders reflected in the presence of erythrocyte casts in
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the sediment may include acute glomerulonephritis, IgA nephropathy, lupus nephritis,
subacute bacterial endocarditis, and renal infarction.

5.11.4.2. Leukocyte (White Blood Cell) Casts: Semitransparent or granular

cylinders containing leukocytes. They may be seen pyelonephritis, glomerular diseases,
interstitial nephritis, lupus nephritis, and nephrotic syndrome.
6. SOURCES OF ERROR:

6.1. Urine should be tested within two (2) hours after collection. Prolonged testing delay
may result in cast dissolution, RBC crenation or bursting, increased bacteria, and crystals
dissolution.

6.2. Fill the Kova slide chamber with the pipette placed parallel to the slide and dispense
the specimen drop in the corner of the well. Samples placed in the center of the well can
cause air bubbles to form resulting in sample distortion during examination.

U.2.10. APPENDICES:

1. SOP Validation Form and SOP Change Control

2. SOP Approval
3. Urinalysis Normal Quality Control Worksheet
4. Urinalysis Abnormal Quality Control Worksheet
5. Quality Control Parallel Testing Worksheet
6. Patient Result Form
7. Urine Crystal Properties

U.2.11. 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.
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Lab Technologist Lab Incharge MD. Pathologist
 HIMALAYA DIAGNOSTIC CLINIC PVT. LTD VERSION NO. 1
STANDARD OPERATING PROCEDURE URINE ANALYSIS COPY NO. 1
DATE OF ISSUE:
05/04/2025
CONTROLLED COPY | Page 21 of 28

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

U.2.11. REFERENCES:

4. KovaTrol: Human Urinalysis Controls Package Insert, Hycor Biomedical Inc., 2001.
5. Manual Urinalysis by Bayer 10-SG Multistix SOP, U.1.1
6. Specific Gravity Determinations by Refractometer SOP, U.5.1
7. Clinitest Determination of Reducing Substances in Urine SOP, U.6.1
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.

Prepared by : Reviewed by: Authorized by:

Anish Magar Suraj Gautam Dr. Sujan Sharma
Lab Technologist Lab Incharge MD. Pathologist
 HIMALAYA DIAGNOSTIC CLINIC PVT. LTD VERSION NO. 1
STANDARD OPERATING PROCEDURE URINE ANALYSIS COPY NO. 1
DATE OF ISSUE:
05/04/2025
CONTROLLED COPY | Page 22 of 28

Standard Operating Procedures

of
Urinary Pregnancy Test
Prashanti Health Care
Center Pvt.Ltd.

Kathmandu, Nepal

Prepared by : Reviewed by: Authorized by:

Anish Magar Suraj Gautam Dr. Sujan Sharma
Lab Technologist Lab Incharge MD. Pathologist
 HIMALAYA DIAGNOSTIC CLINIC PVT. LTD VERSION NO. 1
STANDARD OPERATING PROCEDURE URINE ANALYSIS COPY NO. 1
DATE OF ISSUE:
05/04/2025
CONTROLLED COPY | Page 23 of 28

1 DETECTION OF B-HCG IN URINE

2 SCOPE AND PURPOSE

Diagnosis of pregnancy, missed abortion, threatened abortion and ectopic pregnancy.

3 RESPONSIBILITIES
The head of department has overall responsibility for the performance of this assay.
Routine running, staffing and Quality Assurance are the responsibility of a senior member
of staff under the direction of the head of department. Review and updating of the Standard
Operating procedure is the responsibility of the Point of Care Testing Manager with
reference to current documentation.

4 REFERENCES

1. Danielian P.J et alia. (1994) A protocol for the management of early ectopic pregnancy
using a rapid 1 hour quantitative serum β-hCG assay. J Obstet Gynecol. 14, 99-102.
2. Cole L A. et alia. (1994) Detecting and monitoring trophoblastic disease. J Reprod Med.
39. 193-200. 3. see references on pack insert.

5 DEFINITIONS

β-HCG: -Beta Human Chorionic Gonadatropin, the hormone measured as an indicator of

pregnancy.

PoCT: -Point of care Testing, pathology investigations performed outside the laboratory
setting. QC: -Quality Control, materials or processes used to check to check system
performance.
EQA: - External Quality Assurance, materials/processes used to check system performance
that are supplied by an external source.

6 RELATED DOCUMENTS
Medical Devices
Policy.
Infection Control
Policy.

Prepared by : Reviewed by: Authorized by:

Anish Magar Suraj Gautam Dr. Sujan Sharma
Lab Technologist Lab Incharge MD. Pathologist
 HIMALAYA DIAGNOSTIC CLINIC PVT. LTD VERSION NO. 1
STANDARD OPERATING PROCEDURE URINE ANALYSIS COPY NO. 1
DATE OF ISSUE:
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One Step hCG Pregnancy Urine Test AC-FHC-U102 instruction leaflet (attached).

Prepared by : Reviewed by: Authorized by:

Anish Magar Suraj Gautam Dr. Sujan Sharma
Lab Technologist Lab Incharge MD. Pathologist
 HIMALAYA DIAGNOSTIC CLINIC PVT. LTD VERSION NO. 1
STANDARD OPERATING PROCEDURE URINE ANALYSIS COPY NO. 1
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7 ACTIONS AND METHODS

a. Principle of test.
High sensitivity testing based on an immunochemical sandwich assay, relying on the
recognition and formation of specific antibody – hCG - antibody+dye complexes on a
porous carrier. The membrane is coated with mouse anti-hCG in the Test Band region and
goat anti-mouse in the Control Band region, and a monoclonal anti-hCG/colloidal gold
conjugate is coated in the sample application region. When urine is added to the sample
well it migrates along the membrane mixing with and carrying the coloured gold-conjugate.
If the urine contains >10 mIU/mL of hCG then a visually detectable line will form in the
Test Band region. If the level of hCG in the sample is less than 10 mIU/mL then no line will
be visible, but in both cases a line must be detected at the Control Band region to
demonstrate that test function is satisfactory.

b. Personnel to do the task / level of training required

Staff should only undertake the procedure if they have had the relevant training.

c. Specimen requirements
Volume Required: 1 mL fresh urine. Early morning samples are best as they are more
concentrated, very dilute urines should be avoided e.g. post ultrasound scanning.
Storage: Samples may be stored in a container, without additive, refrigerated at 2--8°C for
2 days or longer frozen. N.B. Samples must be brought to room temperature and mixed
before testing

c. Equipment
Depends on the Quality of Cassette

e. Materials/Reagents
No further materials needed

f. Quality Control
External WEQAS scheme only.

Prepared by : Reviewed by: Authorized by:

Anish Magar Suraj Gautam Dr. Sujan Sharma
Lab Technologist Lab Incharge MD. Pathologist
 HIMALAYA DIAGNOSTIC CLINIC PVT. LTD VERSION NO. 1
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g. Method/Procedure
Refer to kit insert attached

e. Result Reporting
Results must be entered clearly into the notes as positive or negative and the date, time and
person performing the test must also be recorded. As stated in the pack insert the result
must not be read after 10mins.

f. Reference Ranges See below

g.Guide to interpretation
In early pregnancy, hCG will double in concentration in approximately 24h. Thus in normal
pregnancies hCG will reach 20 iu/L in 4-5 days (visible as a weak positive). However, the
detection of hCG at this level does not necessarily indicate a viable pregnancy, because as
many as 33% of implantations spontaneously abort.
An ectopic pregnancy will show a much slower rise or even plateau with hCG values lower
than for a comparable stage of normal pregnancy. A fall in concentration will suggest a
failing pregnancy or miscarriage. The time post miscarriage before the levels become
undetectable will depend on the peak level of hCG reached. Raised levels of hCG are also
present in other conditions e.g. hydatidiform moles/choriocarcinoma.
Current practice has brought about the requesting of quantitative serum hCG. These are
currently available on request from Biochemistry but are only routinely available for
ectopic pregnancy screening (when abdominal ultrasound scans are negative) with two
serum samples 48h apart. The assay of a sample urgently is generally not indicated but can
be provided after discussion with Biochemistry.

8 HEALTH AND SAFETY

Some components may contain human source material and other potentially hazardous
ingredients that necessitate certain precautions:
Handle all components and all patient samples as recommended for any potentially
infectious human serum or blood specimen in the Department of Health and Human
Services(HHS) Publication No. (CDC) 93-8395, Follow Universal Precautions when
handling patient specimens as detailed by the Infection Control Manual.

Prepared by : Reviewed by: Authorized by:

Anish Magar Suraj Gautam Dr. Sujan Sharma
Lab Technologist Lab Incharge MD. Pathologist
 HIMALAYA DIAGNOSTIC CLINIC PVT. LTD VERSION NO. 1
STANDARD OPERATING PROCEDURE URINE ANALYSIS COPY NO. 1
DATE OF ISSUE:
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CONTROLLED COPY | Page 27 of 28

Use disposable gloves. Wipe up spills promptly and decontaminate affected surfaces. Avoid
generation of aerosols. Follow appropriate waste handling regulations applicable to your
area (see Safety Code of Practice).

References:
http://www.chm.bris.ac.uk/safety/msds.htm
http://www.chm.bris.ac.uk/safety/coshh.htm
http://physchem.ox.ac.uk/MSDS

Prepared by : Reviewed by: Authorized by:

Anish Magar Suraj Gautam Dr. Sujan Sharma
Lab Technologist Lab Incharge MD. Pathologist