Division/Department/Section: Laboratory Reference Number: BH/LAB/CHEM/SOP/028

Section: Chemistry Issue date: 01-03- 2012

Subject: Lipase Version : 4
Roche Cobas c501 & Roche Cobas Integra 400 Plus
Page 1 of 16

APPROVALS
Name Designation Signature Date
Prepared By Marites Borbe Lirio Section Supervisor
10 OCT 2016

Prepared By Abeer Almansour Laboratory Supervisor 10 OCT 2016

Approved By Dr. Sundar Elayaperumal Laboratory Director 10 OCT 2016

1. PURPOSE:

Roche Lipase enzymatic test is an in vitro test for the quantitative determination of lipase in human
serum and plasma. It is diagnostic for investigation of pancreatic disorders, usually pancreatitis.

Lipases are glycoproteins with a molecular weight of 47000 daltons. They are defined as triglyceride
hydrolases which catalyze the cleavage of triglycerides to diglycerides with subsequent formation of
monoglycerides and fatty acids. In addition to α‑amylase, pancreatic lipases have for many
years been undeniably the most important clinical chemistry parameters for the differential diagnosis of
diseases of the pancreas. The lipase activity determination has gained increasing international
recognition because of its high specificity and rapid response. After acute pancreatitis the lipase activity
increases within 4‑8 hours, reaches a peak after 24 hours and decreases after 8 to 14 days. However,
there is no correlation between the lipase activity determined in serum and the extent of damage to the
pancreas.

Numerous methods have been described for the determination of lipase which determine the decrease
in substrate turbidimetrically or nephelometrically or determine degradation products.

This method is based on the cleavage of a specific chromogenic lipase substrate

1,2‑O‑dilauryl‑rac‑glycero‑3‑glutaric acid‑(6‑methylresorufin) ester emulsified with bile acids. The
pancreatic enzyme activity is determined specifically by the combination of bile acid and colipase used
in this assay.
Virtually no lipase activity is detected in the absence of colipase. Colipase only activates pancreatic
lipase, but not other lipolytic enzymes found in serum. The high amount of cholates ensures that the
esterases present in the serum do not react with the chromogenic substrate due to the highly negative
surface charge.

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Division/Department/Section: Laboratory Reference Number: BH/LAB/CHEM/SOP/028
Section: Chemistry Issue date: 01-03- 2012
Subject: Lipase Version : 4
Roche Cobas c501 & Roche Cobas Integra 400 Plus
Page 2 of 16

2. TEST PRINCIPLE:
2.1. Enzymatic colorimetric assay.
With 1,2‑O‑dilauryl‑rac‑glycero‑3‑glutaric acid‑(6‑methyl‑resorufin) ester as substrate. The
chromogenic lipase substrate 1,2‑O‑dilauryl‑rac‑glycero‑3‑glutaric acid‑(6‑methylresorufin)
ester is cleaved by the catalytic action of alkaline lipase solution to form
1,2‑O‑dilauryl‑rac‑glycerol and an unstable intermediate, glutaric acid‑(6‑methylresorufin) ester.
This decomposes spontaneously in alkaline solution to form glutaric acid and methylresorufin.
Addition of detergent and colipase increases the specificity of the assay for pancreatic lipase.

The color intensity of the red dye formed is directly proportional to the lipase activity and can be
determined photometrically.

3. RESPONSIBILITIES:

For the purposes of this Procedure:

3.1. Laboratory Director is required to:

3.1.1. Oversee all aspects of this Procedure.
3.1.2. Monitor the performance of laboratory staff members in relation to this Procedure.
3.2. Laboratory Technologists are required to:
3.2.1. Ensure they abide by the requirements of this Procedure.
3.2.2. Ensure they abide by all steps in these Procedures.

4. SPECIMEN:

4.1. Instruction for Specimen Collection:

4.1.1. Special Patient Preparation.
4.1.1.1. No special patient’s preparations.

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Division/Department/Section: Laboratory Reference Number: BH/LAB/CHEM/SOP/028
Section: Chemistry Issue date: 01-03- 2012
Subject: Lipase Version : 4
Roche Cobas c501 & Roche Cobas Integra 400 Plus
Page 3 of 16

4.2. Patient Identification.

4.2.1. Patients are identified using at least two identifiers before any procedures.
4.2.2. Refer to patient identification policy (BH-LAB-SPC-003)

4.3. Specimen type, storage, preservation, and Stability:

Specimen Type Stability & Storage
Serum Stable for 7 days at 15-25°C, 7 days at 2-8°C.

4.4. Criteria for Specimen Acceptability and Rejection:

4.4.1. Reject grossly hemolyzed specimens.
4.4.2. Reject insufficient quantity of sample for analysis.
4.4.3. Reject heat-inactivated specimens.
4.4.4. Inspect all samples for bubbles.
4.4.5. Refer to Specimen Assessment & Rejection Policy (BH/MS/LAB/GEN/001).
4.5. Transportation & Handling of Specimens:
4.5.1. Centrifuge serum samples after complete clot formation.
4.5.2. Ensure the patients’ samples are at ambient temperature (20-25°C) before measurement.
4.5.3. Because of possible evaporation effects, samples on the analyzers should be measured
within 2 hours.

5. EQUIPMENT, REAGENT AND SUPPLIES:

5.1. Equipment:
5.1.1. Roche Cobas c501
5.1.2. Roche Cobas Integra 400 plus

5.2. Working Solution:

LIPASE reagent cassette:
5.1.1. Each cassette is ready-to-use single unit, with a special 2D bar code
5.1.2. A single unit (reagent cassette) consists of two separate bottles (R1 and R2)
R1 BICINa buffer: 50 mmol/L, pH 8.0; colipase (porcine pancreas): ≥ 0.9
mg/L; Na‑deoxycholate: 1.6 mmol/L; calcium chloride: 10 mmol/L;
detergent; preservative
R2 Tartrate buffer: 10 mmol/L, pH 4.16;
1,2‑O‑dilauryl‑rac‑glycero‑3‑glutaric acid‑(6‑methylresorufin) ester:
0.27 mmol/L; taurodeoxycholate: 8.8 mmol/L; detergent; preservative
R1 is in position B and R2 is in position C.

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Division/Department/Section: Laboratory Reference Number: BH/LAB/CHEM/SOP/028
Section: Chemistry Issue date: 01-03- 2012
Subject: Lipase Version : 4
Roche Cobas c501 & Roche Cobas Integra 400 Plus
Page 4 of 16

5.3. Storage and stability:

5.3.1. Stability of LIPASE reagent cassette on Cobas
Unopened at 2-8oC up to the stated expiration date
o
After opening at 2-8 C 4 weeks
After opening on Cobas 4 weeks

5.3.2. Stability of Diluent NaCL 9 % reagent cassette on Cobas

Unopened at 2-8oC up to the stated expiration date
o
After opening at 2-8 C 12 weeks
After opening on Cobas 12 weeks

5.4. Consumables:
5.4.1. Hitachi Cups.
5.4.2. Disposable transfer pipettes.
5.4.3. Gloves.

5.5. Reagents:
5.5.1. PreciControl ClinChem Multi 1.
5.5.2. PreciControl ClinChem Multi 2.
5.5.3. C.f.a.s. Calibrator.
5.5.4. Lipase reagent pack.

6. ENVIRONMENTAL AND SAFETY CONTROLS:

6.1. Patient samples, control, and calibrators should be handled as infectious waste and should be
disposed as medical wastes. (Refer to Biomedical waste policy BH/ICM/P&P/038)
6.2. Empty reagents cassette should be disposed as medical waste.
6.3. Refer to MSDS for more details about safety and disposal measures.

7. CALIBRATIONS:
7.1. Calibration Material:
S1: H2O
S2: C.f.a.s.

7.2. Calibration Frequency:

7.2.1. Calibrate a test system when it is first placed in service.
7.2.2. New lot reagent calibration.
7.2.3. When recommended by manufacturer.

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Division/Department/Section: Laboratory Reference Number: BH/LAB/CHEM/SOP/028
Section: Chemistry Issue date: 01-03- 2012
Subject: Lipase Version : 4
Roche Cobas c501 & Roche Cobas Integra 400 Plus
Page 5 of 16

7.2.4. When quality control falls out of limit.

7.2.5. Maximum allowed periodicity interval for calibration is at least once in six months.
7.2.6. After major maintenance or service of the instrument as instructed by the vendor’s service
engineer.

7.3. Corrective Action:

7.3.1. Investigate the cause of calibration failure using corrective action log
(BH-LAB-IQC-FOR-001.1).
7.3.2. Recalibrate after investigation and rerun QC.
7.3.3. If not corrected contact service engineer.

7.4. Calibration Verification:

7.4.1. Enrolled in CVL for General Chemistry CAP Survey (LN-2), refer to calibration
verification CAP reports.
7.4.2. Required Frequency of Calibration Verification:
7.4.2.1. A change of reagent lots for chemically or physically active or critical components,
unless the laboratory can demonstrate that the use of different lots does not affect the
accuracy of patient/ client test results, and the range used to report patient/client test
data.
7.4.2.2. If QC materials reflect an unusual trend or shift or are outside of the laboratory's
acceptable limits, and other means of assessing and correcting unacceptable control
values fail to identify and correct the problem
7.4.2.3. After major maintenance or service.
7.4.2.4. When recommended by the manufacturer.

7.5. Traceability:
7.5.1. There is uncertainty associated with the numerical value assigned to the measured present
in the calibrator material used in the routine method.
7.5.2. The supplier provides traceability records of calibrators and the uncertainty assigned to
measure.
7.5.3. This method has been standardized manually against Roche reagent using calibrated pipettes
together with a manual photometer providing absolute values and the substrate-specific
absorptivity.

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Division/Department/Section: Laboratory Reference Number: BH/LAB/CHEM/SOP/028
Section: Chemistry Issue date: 01-03- 2012
Subject: Lipase Version : 4
Roche Cobas c501 & Roche Cobas Integra 400 Plus
Page 6 of 16

8. QUALITY CONTROL:
8.1. Internal QC:
8.1.1. QC Material:
NORMAL QC PreciControl ClinChem Multi 1
PATHOLOGIC QC PreciControl ClinChem Multi 2

8.1.2. QC Procedure:
8.1.2.1. Install The QC mistrial lot number in-use (QC> Install>down load).
8.1.2.2. Assign position for the QC rack (QC> Control>assign position).
8.1.2.3. Prepare the QC material a per manufacturer instructions.
8.1.2.4. Load the QC material using the assigned QC rack.
8.1.2.5. Press START button.
8.1.3. QC Frequency:
8.1.3.1. Once every 24 hours when the test is in use prior to reporting patient results.
8.1.3.2. Once per reagent kit.
8.1.3.3. After a change of analytically critical reagents.
8.1.3.4. After every calibration.
8.1.3.5. Change of a critical instrument component.

8.1.4. QC Confirmation of Acceptability:

8.1.4.1. Control results must be reviewed before reporting patient/client results.
8.1.4.2. It is implicit in quality control that patient/client test results will not be reported when
controls do not yield acceptable results.
8.1.4.3. Result of QC should be within acceptable limits defined by the manufacturer and
verified by technologist (Calculated limits).

8.1.5. QC Corrective Action:

8.1.5.1. Investigate the cause of QC failure using corrective action log
(BH-LAB-IQC-FOR-001.1).
8.1.5.2. Do appropriate corrective action.
8.1.5.3. If not corrected contact service engineer.

8.2. External QC:

8.2.1. The lab will participate in CAP PT program General Chemistry and Therapeutic Drug
Monitoring (C3).
8.2.2. Number of cycle’s: 3/year.

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Division/Department/Section: Laboratory Reference Number: BH/LAB/CHEM/SOP/028
Section: Chemistry Issue date: 01-03- 2012
Subject: Lipase Version : 4
Roche Cobas c501 & Roche Cobas Integra 400 Plus
Page 7 of 16

9. MEASUREMENT OF UNCERTAINTY:
There are two major sources of uncertainty which contribute to the total uncertainty of measurement of a
routine quantitative diagnostic method.

9.1. Imprecision:
9.1.1. Imprecision data obtained from the routine application of internal quality control is
recommended as the quantitative estimate of the uncertainty of measurement.
9.1.2. Historical Imprecision data calculation for established method: it is recommended that
minimum of six months internal QC data should be used to calculate routine
imprecision, updated at least annually where possible.
9.1.3. For new methods: evaluation data comprising at least 30 data points for each level of
QC material.
9.1.4. Record imprecision of measured as an estimate of uncertainty of measurement as (±
1.96 SD or ± 1.96 CV %).
9.1.5. Review Chemistry daily CV monitoring log sheet, BH-LAB-IQC-FOR-014.10
and Monthly precision monitoring form, BH-LAB-IQC-FOR-014.3.

10.PROCEDURE:
10.1. COBAS 6000 Start-Up:

10.1.1. Before start-up, it is important that the following conditions of the analyzer are checked.
10.1.2. Control unit:
10.1.2.1. There is sufficient paper in the printer.
10.1.3. Core unit:
10.1.3.1. The water supply is switched on.
10.1.3.2. Container for high concentrated waste is empty, clean and placed in the correct
position.
10.1.3.3. All connections and fittings of tubes and containers are connected properly and leak-
proof.
10.1.3.4. There are no racks on the rack loader, unloader, rack rotor, or conveyor line.
10.1.4. To start up the analyzer, switch on Main circuit breaker, then Power Switches.
10.1.5. Cobas 6000 can be started manually or automatically. The modules (c501, e 601, and
control unit) perform initialization and then enters standby mode (time approximately 12
min).
10.1.6. Bring the cooled reagents to approx. 20°C and place on the reagent disk (20°C) of the
analyzer.

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Division/Department/Section: Laboratory Reference Number: BH/LAB/CHEM/SOP/028
Section: Chemistry Issue date: 01-03- 2012
Subject: Lipase Version : 4
Roche Cobas c501 & Roche Cobas Integra 400 Plus
Page 8 of 16

10.1.7. Perform daily operations: inventory check, load reagents, and maintenance.

10.2. COBAS 6000 Testing Process:

10.2.1. If calibration needed:

10.2.1.1. Prepare calibrators
10.2.1.2. Install calibrator (from Install button in calibration window).
10.2.1.3. Assign calibrator rack (from Calibrator button in calibration
window).
10.2.1.4. Select calibration method (from Status button in calibration window).
10.2.1.5. Load assigned calibrators and start the analyzer (START button) after
validating the calibration, QC materials can be loaded, press START
button.
10.2.1.6. Review calibration results
10.2.2. Run and verify QC results (refer to 8.1.2. QC Procedure).
10.2.3. Load bar coded interfaced patient’s samples into sample rack (grey color rack).
10.2.4. Place the samples in the prepared sample racks. Ensure the sample barcodes are facing the
open slot in the rack so the barcode reader can scan them.
10.2.5. Place the routine sample racks onto a rack tray in the correct orientation, press START
button.
10.2.6. Tracking the sample while processing, allows the operator to search for any sample on the
analyzer, and to provide an overview of the samples in the unloader.
10.2.7. Use Manual order of patient’s sample if system is not interfaced or sample is not bar coded.
10.2.8. From Workplace > Test Selection, use this screen to select and assign rack/cup position and
order the test manually.
10.2.9. To run STAT samples, place the grey rack in the STAT port of the analyzer.
10.2.10. To view or edit results on the analyzer, use the Workplace > Data Review screen; all test
results in the database are displayed here.
10.2.11. To print a data report choose Workplace > Data Review > select patient report > print.

10.3. COBAS 6000 Shutdown Process:

10.3.1. After all test requests are completed, sampling stops. After the last result is calculated, the
analyzer remains in Rack Reception mode for a set span of time. Thereafter analyzer goes
into standby.
10.3.2. Press Shutdown Button to switch off the analyzer.
10.3.3. For full description refer to SOP for operation of Cobas 6000 Analyzer.

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Division/Department/Section: Laboratory Reference Number: BH/LAB/CHEM/SOP/028
Section: Chemistry Issue date: 01-03- 2012
Subject: Lipase Version : 4
Roche Cobas c501 & Roche Cobas Integra 400 Plus
Page 9 of 16

10.4. Cobas Integra400 plus start up:

10.4.1. At the beginning of each day, the system goes through a series of automatic service
actions. Typically, these actions are performed before the work day begins, so that
the instrument is ready to use when you start work.
10.4.2. Starting up and logging on to the system, always switch on the system components
in the following order: Monitor, Printer, Instrument, and computer.
10.4.3. Logged on and check Memo pad.
10.4.4. Check the Begin of Day report.
10.4.5. Load cleaners, diluents and ISE solutions, Check resources.
10.4.6. Perform service actions if recommended.
10.4.7. Load calibrators and controls if recommended.

10.5. Cobas Integra400 plus testing process:

10.5.1. Create order.
10.5.2. Load samples on board.
10.5.3. Start processing the samples.
10.5.4. Monitor schedules orders.
10.5.5. Validate results.
10.5.6. Print the final report if needed.

10.6. Cobas Integra400plus Shutdown Process:

10.6.1. Remove sample racks.
10.6.2. Complete the remaining service actions.
10.6.3. Log off.
10.6.4. For full description refer to Instrument Operation manual of Cobas Integra400 plus.

11. CALCULATION:
11.1. Results are determined via a calibration curve which is instrument-specifically generated by
2- Point calibration and a master curve provided via the reagent barcode.
11.2. The analyzer automatically calculates the analyte concentration of each sample.
11.3. Conversion factors: U/L x 0.0167 = μkat/L

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Division/Department/Section: Laboratory Reference Number: BH/LAB/CHEM/SOP/028
Section: Chemistry Issue date: 01-03- 2012
Subject: Lipase Version : 4
Roche Cobas c501 & Roche Cobas Integra 400 Plus
Page 10 of 16

12. REFERENCE RANGES:

LIPASE
Service Test Sex Min. Age in years Max. Age in years Low Value High Value Unit
83690 Lipase, Serum Both 0 28 days 13 34 U/L
83690 Lipase, Serum Both 29 days 1 yr. 13 31 U/L
83690 Lipase, Serum Both 12 17 13 55 U/L
83690 Lipase, Serum Both 18 100 13 60 U/L

13.CRITICAL VALUES:
13.1. N/A.

14. INSTRUCTION FOR REPORTING RESULT:

14.1. Units:
14.1.1. Lipase results reported in (U/L).

14.2. Laboratory Clinical Interpretation of the results:

14.2.1. Values below the detection limit are reported <3.0 U/L.
14.2.2. Values above the measuring range : >300 U/L.
14.2.3. After acute pancreatitis the lipase activity increases within 4‑8 hours, reaches a
peak after 24 hours and decreases after 8 to 14 days. However, there is no
correlation between the lipase activity determined in serum and the extent of
damage to the pancreas.
14.3. Dilution:
14.3.1. Samples with lipase concentrations above the measuring range can be diluted with of
Diluents NaCL 9 % reagent cassette.
14.3.2. Determine samples having higher activities via the rerun function. Dilution of samples via
the rerun function is a 1:10 dilution. Results from samples diluted using the rerun functions
are automatically multiplied by a factor of 10.

14.4. Analytical Measurement Range:

14.4.1. Measuring range is 3‑300 U/L (0.05‑5.01 μkat/L)

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Division/Department/Section: Laboratory Reference Number: BH/LAB/CHEM/SOP/028
Section: Chemistry Issue date: 01-03- 2012
Subject: Lipase Version : 4
Roche Cobas c501 & Roche Cobas Integra 400 Plus
Page 11 of 16

15. LIMITATIONS OF THE PROCEDURE / INTERFERENCES / CROSS

REACTIONS / POTENTIAL SOURCES OF VARIATION:

Icterus No significant interference up to an I index of 50 for conjugated and

unconjugated bilirubin (approximate conjugated and unconjugated bilirubin
concentration: 855 μmol/L (50 mg/dL)).
Hemolysis No significant interference up to an H index of 1000 (approximate
hemoglobin concentration: 620 μmol/L (1000 mg/dL)).
Lipemia (Intralipid):13 No significant interference up to an L index of 2000.
There is poor correlation between the L index (corresponds to turbidity) and
triglycerides concentration.No significant interference up to an H index of 200
(approximate hemoglobin concentration: 124 μmol/L or 200 mg/dL).
Contamination with erythrocytes will elevate results, because the analyte level
in erythrocytes is higher than in normal sera. The level of interference may be
variable depending on the content of analyte in the lysed erythrocytes.
Other: Drugs: No interference was found at therapeutic concentrations using
common drug panels.14,15.
Exception: Calcium dobesilate causes artificially low lipase results.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s
macroglobulinemia), may cause unreliable results.
For diagnostic purposes, the results should always be assessed in
conjunction with the patient’s medical history, clinical examination and other
findings.

16.PERFORMANCE SPECIFICATIONS:

16.1. Manufacturer Performance Specifications:

16.1.1. Precision
16.1.1.1. Cobas 6000 c501
Reproducibility was determined using human samples and controls in an internal protocol
(within-run n = 21, total n = 63).
The following results were obtained:

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Division/Department/Section: Laboratory Reference Number: BH/LAB/CHEM/SOP/028
Section: Chemistry Issue date: 01-03- 2012
Subject: Lipase Version : 4
Roche Cobas c501 & Roche Cobas Integra 400 Plus
Page 12 of 16

16.1.1.2. COBAS INTEGRA400 PLUS

Precision was determined using human samples and controls in an internal
protocol with repeatability and intermediate precision ( 3 aliquots per run, 1
run per day, 21 days).
The following results were obtained:

16.1.2. Method Comparison:

16.1.2.1. COBAS 6000 c501

Lipase values for human serum and plasma samples obtained on a Roche/Hitachi
cobas c 501 analyzer (y) were compared with those determined using the same
reagent on a Roche/Hitachi 917 analyzer (x).

Sample size (n) = 203

16.1.2.2. COBAS INTEGRA400 PLUS

Lipase values for human serum and plasma samples ontained on a COBAS
INTEGRA 700 ANALYZER with COBAS INTEGRA Lipase colorimetric
reagent were compared with those determined using the corresponding
reagent on a Roche/Hitachi 917 analyzer.

Sample size (n)=58.

The sample activities were between 13.8 and 277 U/L (0.230 and 4.65
ukat/L

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Division/Department/Section: Laboratory Reference Number: BH/LAB/CHEM/SOP/028
Section: Chemistry Issue date: 01-03- 2012
Subject: Lipase Version : 4
Roche Cobas c501 & Roche Cobas Integra 400 Plus
Page 13 of 16

16.2. Verified Performance Specifications:

The following performance verifications were verified at Burjeel Hospital
Laboratory department.

16.2.1. COBAS 6000 C501 INST1

Accuracy, Reportable range, and Linearity were The results are LINEAR over a range 19.0-261.0
analyzed over a measured range. U/L
Calibration verification was analyzed over a The accuracy test PASSED over range 19.0-261.0
measured range. U/L
Inter-run precision experiment done to Verify LIPASE passed.
manufacturer claimed total SD and medical
requirement at TEa Test passed.
Acceptance Criteria: Test Passed if user SD is lower
than verification value.
Instrument comparison Passed over the range 14-45 U/L
Carry over analysis Carry over experiment done and passes an error
limit of (3SD low-low result)

16.2.2. COBAS 6000 C501 INST2

Accuracy, Reportable range, and Linearity were The results are LINEAR over a range 8.07-231.30
analyzed over a measured range. U/L
Calibration verification was analyzed over a The accuracy test PASSED over range 8.07-
measured range. 231.30 U/L
Inter-run precision experiment done to Verify LIPASE passed.
manufacturer claimed total SD and medical
requirement at TEa Test passed.
Acceptance Criteria: Test Passed if user SD is lower
than verification value.
Instrument comparison Passed over the range 11.4-131.7 U/L
Carry over analysis Carry over experiment done and passes an error
limit of (3SD low-low result)

16.2.3. COBAS INTEGRA400 PLUS

Accuracy, Reportable range, and Linearity were The results are LINEAR over a range 5.920 to
analyzed over a measured range. 260.603 U/L
Calibration verification was analyzed over a The accuracy test PASSED over range 5.920 to
measured range. 260.603 U/L
Inter-run precision experiment done to Verify LIPASE passed.
manufacturer claimed total SD and medical
requirement at TEa Test passed.
Acceptance Criteria: Test Passed if user SD is lower
than verification value.
Instrument comparison Passed over the range 5.40-221.9 U/L
Carry over analysis Carry over experiment done and passes an error
limit of (3SD low-low result)

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Division/Department/Section: Laboratory Reference Number: BH/LAB/CHEM/SOP/028
Section: Chemistry Issue date: 01-03- 2012
Subject: Lipase Version : 4
Roche Cobas c501 & Roche Cobas Integra 400 Plus
Page 14 of 16

17. COMPUTER DOWNTIME OR MANUAL BACKUP PROCEDURES:

17.1. In case LIS (SAP) is down, urgent result will be released as manual report.
17.2. In case the test cannot be done, such as unavailability of reagents or consumables, or
prolonged instrument downtime, the sample will be sent to an accredited collaborating
laboratory for analysis.
18. RELEVANT DOCUMENT AND FILES:

18.1. Corrective Action Log for Control, Calibration, and monthly Precision ;
BH-LAB-IQC-FOR-001.1.
18.2. Specimen Rejection Form;BH-LAB-GEN-FOR-001.1.
18.3. Critical Result Form; BH-LAB-DOC-FOR-016.1.
18.4. Chemistry daily CV monitoring log sheet; BH-LAB-IQC-FOR-014.10
18.5. Monthly precision monitoring form; BH-LAB-IQC-FOR-014.3

19. REFERENCES:
19.1. Roche LIPC Reagent insert sheet, for Cobas.
19.2. CAP Chemistry and Toxicology Checklist- 2016
19.3. Uncertainty of Measurement in Quantitative Medical Testing,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1934961/

20. APPENDICES:
20.1. None.

21. DISTRIBUTION:

DISTRIBUTION

No. of Copies 1 Laboratory Department

Name Signature Date
Received By Marites Lirio
10 OCT 2016

burjeel hospital llc po box 7400 abu dhabi uae t +971 2 508 5555 f +971 2 508 5556 www.burjeel.com
Division/Department/Section: Laboratory Reference Number: BH/LAB/CHEM/SOP/028
Section: Chemistry Issue date: 01-03- 2012
Subject: Lipase Version : 4
Roche Cobas c501 & Roche Cobas Integra 400 Plus
Page 15 of 16

22. REVISION HISTORY:

# Version Date Change Made by Reason for Change Clause Changed
1. 1 April 2012 Abeer Almansour New SOP Issued New SOP Issued
2. 2 April 2014 Abeer Almansour Change template Burjeel Logo changed only
Ms. Abeer New format & new 3.3, 5.4 & 6 added
(Lab.Supervisor) laboratory director, New section added
& new sections added, 1. Purpose.
Unsa Ahmed Reference number 3. Responsibilities
3. 3 01-03-2015 (Asst.Quality Officer) modified. 11. Critical Values
14. Relevant/Associated
Documents and forms
18. Revision History
19. Review History
Review and Update Modified & added clauses in new
version:
content
1.purpose
4.2;4.3 Specimen
5.2 Reagent & supplies
7.1; 7.4.1 Calibration verification
10.1.5, 10.2.2, 10.2.9., 10.2.11., 10.3.,
10.4-10.6 Procedure
12. Reference range
Miss Marites Lirio 14.2.3;14.2.4 Instruction for reporting
result
(Section .Supervisor) 15. Limitations of the
& Procedure/Interferences/Cross
4. 4 01-10-2016 reactions /Potential sources of
Unsa Ahmed
variation
(Asst.Quality Officer) 18.4; 18.5 Relevant document and
files.
19.2-19.3 References

New section added:

6. Environmental and safety controls

9.Measurement of uncertainty
16. Performance specifications
17. Computer Downtime or manual
back up procedures

burjeel hospital llc po box 7400 abu dhabi uae t +971 2 508 5555 f +971 2 508 5556 www.burjeel.com
Division/Department/Section: Laboratory Reference Number: BH/LAB/CHEM/SOP/028
Section: Chemistry Issue date: 01-03- 2012
Subject: Lipase Version : 4
Roche Cobas c501 & Roche Cobas Integra 400 Plus
Page 16 of 16

23. REVIEW HISTORY:

Review Version# Reviewed By Signature Approved By Signature Next
Date Review
02/2015 3 Dr. Rupesh Dr. Sundar 02-2017
Wahane Elayaperumal
10/2016 4 Dr. Rupesh Dr. Sundar 10-2018
Wahane Elayaperumal

burjeel hospital llc po box 7400 abu dhabi uae t +971 2 508 5555 f +971 2 508 5556 www.burjeel.com