INSTRUCTIONS FOR USE AMYL

VITROS Chemistry Products AMYL Slides Amylase

120 2670
811 2724

Rx ONLY

Intended Use
For in vitro diagnostic use only.
VITROS Chemistry Products AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine
using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Summary and Explanation of the Test

Amylase is an amylolytic digestive enzyme produced by the exocrine pancreas and salivary glands. Amylase is increased
in acute pancreatitis, pancreatic abscess or pseudocyst, pancreatic trauma, amyloidosis, pancreatic neoplasm, common-
bile-duct obstruction, and after thoracic surgery. Increased amylase activity may be found in mumps parotitis and renal
insufficiency. 1

Principles of the Procedure

The VITROS AMYL Slide method is performed using the VITROS AMYL Slides and the VITROS Chemistry Products
Calibrator Kit 3 on VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
The VITROS AMYL Slide is a multilayered, analytical element coated on a polyester support.
A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers.
The spreading layer contains the dyed starch substrate (dye covalently linked to amylopectin) for the reaction. The amylase
in the sample catalyzes the hydrolysis of this dyed starch into smaller dyed saccharides. These dyed saccharides diffuse
into the underlying reagent layer.
The reflection density of the dyed saccharides in the reagent layer is measured by reflectance spectrophotometry at 2.3
and 5 minutes. The difference in the slide’s reflection density between the two readings is proportional to sample amylase
activity.

Test Type and Conditions

Approximate Reaction Sample

Test Type VITROS System Incubation Time Temperature Wavelength Volume
5600, 4600, 5 minutes
Two-point rate 5,1 FS, 950, 37 °C (98.6 °F) 540 nm 10 µL
250/350

Not all products and systems are available in all countries.

Reaction Scheme
amylase
dyed amylopectin dyed saccharides

Warnings and Precautions

For in vitro diagnostic use only.
WARNING: Take care when handling materials and samples of human origin. Since no test
method can offer complete assurance that infectious agents are absent, consider
all clinical specimens, controls, and calibrators potentially infectious. Handle
specimens, solid and liquid waste, and test components in accordance with local
regulations and CLSI Guideline M29 2or other published biohazard safety
guidelines.

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 AMYL INSTRUCTIONS FOR USE
Amylase Reagents

For specific warnings and precautions for calibrators, quality control materials, and other components, refer to the
Instructions for Use for the appropriate VITROS product, or to other manufacturer’s product literature.

Reagents
Slide Diagram
Slide Ingredients 1. Upper slide mount
2. Spreading layer (BaSO4)
Reactive Ingredients per cm2 • dyed amylopectin
• buffer, pH 7.2
Dyed amylopectin 340 µg. 3. Reagent layer: buffer, pH 7.2
4. Support Layer
Other Ingredients 5. Lower slide mount
Pigment, binders, buffers, mordant, surfactants and stabilizer.

Reagent Handling
Caution: Do not use slide cartridges with damaged or incompletely sealed packaging.

• Inspect the packaging for signs of damage.

• Be careful when opening the outer packaging with a sharp instrument so as to avoid damage to the individual product
packaging.

Reagent Preparation
IMPORTANT: The slide cartridge must reach room temperature, 18–28 °C (64–82 °F), before it is
unwrapped and loaded into the slide supply.
1. Remove the slide cartridges from storage.
2. Warm the wrapped cartridge at room temperature for 30 minutes when taken from the refrigerator or 60 minutes from the
freezer.
3. Unwrap and load the cartridge into the slide supply.
Note: Load the cartridges within 24 hours after they reach room temperature, 18–28 °C
(64–82 °F).

Reagent Storage and Stability

VITROS AMYL Slides are stable until the expiration date on the carton when they are stored and handled as specified. Do
not use beyond the expiration date.

Reagent Storage Condition Stability

Unopened Refrigerated 2–8 °C (36–46 °F) ≤ 4 weeks
Frozen ≤-18 °C (≤0 °F) Until expiration date
Opened On-analyzer System turned on ≤ 2 weeks
On-analyzer System turned off ≤ 2 hours
Verify performance with quality control materials:
• If the system is turned off for more than 2 hours.
• After reloading cartridges that have been removed from the slide supply and stored for later use.

Specimen Collection, Preparation and Storage

Specimens Recommended
• Serum
• Plasma: Heparin 3
• Urine
Note: Plasma activities are approximately 20 U/L higher than serum activities. 3

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Specimen Collection, Preparation and Storage Amylase

IMPORTANT: Certain collection devices have been reported to affect other analytes and tests. 4
Owing to the variety of specimen collection devices available, Ortho-Clinical
Diagnostics is unable to provide a definitive statement on the performance of its
products with these devices. Confirm that your collection devices are compatible
with this test.

Specimens Not Recommended

• Plasma: 5
– Citrate
– EDTA
– Fluoride oxalate
• Urine:
– Boric acid/sodium formate
– Glacial acetic acid
– Concentrated hydrochloric acid

Serum and Plasma

Specimen Collection and Preparation
Collect specimens using standard laboratory procedures. 6, 7

Note: For details on minimum fill volume requirements, refer to the operating
instructions for your system.
Patient Preparation
No special patient preparation is necessary.
Special Precautions
Centrifuge specimens and remove the serum or plasma from the cellular material within 4 hours of collection. 8
Specimen Handling and Storage
• Handle and store specimens in stoppered containers to avoid contamination and evaporation.
• Mix samples by gentle inversion and bring to room temperature, 18–28 °C (64 –82 °F), prior to analysis.
IMPORTANT: Do not freeze the specimen.

Specimen Storage and Stability: Serum and Plasma 8

Storage Temperature Stability
Room temperature 18–28 °C (64–82 °F) ≤ 7 days
Refrigerated 2–8 °C (36–46 °F) ≤ 1 month
Frozen ≤-18 °C (≤0 °F) Not recommended

Urine
Specimen Collection and Preparation
Collect specimens using standard laboratory procedures. 9
Note: For details on minimum fill volume requirements, refer to the operating
instructions for your system.
Patient Preparation
No special patient preparation is necessary.
Special Precautions
None
Specimen Handling and Storage
• Handle and store specimens in stoppered containers to avoid contamination and evaporation.
• Mix samples by gentle inversion and bring to room temperature, 18–28 °C (64–82 °F), prior to analysis.
IMPORTANT: Do not freeze the specimen.

Specimen Storage and Stability: Urine 8

Storage Temperature Stability
Room temperature 18–28 °C (64–82 °F) ≤ 7 days
Refrigerated 2–8 °C (36–46 °F) ≤ 1 month
Frozen ≤-18 °C (≤0 °F) Not recommended

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 AMYL INSTRUCTIONS FOR USE
Amylase Testing Procedure

Testing Procedure
Materials Provided
VITROS Chemistry Products AMYL Slides

Materials Required but Not Provided

• VITROS Chemistry Products Calibrator Kit 3
• Quality control materials, such as VITROS Chemistry Products Performance Verifier I and II for serum and plasma
• VITROS Chemistry Products Specialty Diluent
• Isotonic saline
• VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline) (for on-analyzer dilution)
• VITROS Chemistry Products FS Diluent Pack 3 (Specialty Diluent/Water) (for on-analyzer dilution)

Operating Instructions
• Check reagent inventories at least daily to ensure that quantities are sufficient for the planned workload.
• For additional information, refer to the operating instructions for your system.
IMPORTANT: Bring all fluids and samples to room temperature, 18–28 °C (64–82 °F), prior to
analysis.

Sample Dilution
If amylase activities exceed the system’s measuring (reportable or dynamic) range or if the result is flagged with a DP code
(substrate depletion), follow the instructions that follow for the appropriate sample.

Serum and Plasma

Manual Sample Dilution

1. Dilute the sample with VITROS Specialty Diluent or a patient sample with a low amylase activity.
2. Reanalyze.
3. If necessary, correct for amylase activity in the diluent.
4. Multiply the results by the dilution factor to obtain an estimate of the original sample’s amylase activity.
On-Analyzer Sample Dilution (VITROS Integrated, VITROS 5,1 FS/4600 and VITROS 250/350 Systems only)
Refer to the operating instructions for your system for more information on the On-Analyzer Dilution Procedure. For
VITROS Integrated and VITROS 5,1 FS/4600 Chemistry Systems, use VITROS Chemistry Products FS Diluent Pack 3 for
the dilution.

Urine
Manual Sample Dilution

1. Dilute the urine sample with isotonic saline.

2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample’s amylase activity.
On-Analyzer Sample Dilution (VITROS Integrated, VITROS 5,1 FS/4600 and VITROS 250/350 Systems only)
Refer to the operating instructions for your system for more information on the On-Analyzer Dilution Procedure. For
VITROS Integrated and VITROS 5,1 FS/4600 Chemistry Systems, use VITROS Chemistry Products FS Diluent Pack 2 for
the dilution.

Calibration
Required Calibrators
VITROS Chemistry Products Calibrator Kit 3
Note: The same VITROS Calibrator Kit is used to calibrate both serum and urine
amylase. However, specific supplementary assigned values (SAVs) are applied
for each body fluid.

Calibrator Preparation, Handling, and Storage

Refer to the Instructions for Use for VITROS Calibrator Kit 3.

Calibration Procedure
Refer to the operating instructions for your system.

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Quality Control Amylase

When to Calibrate
Calibrate:
• When the slide lot number changes.
• When critical system parts are replaced due to service or maintenance.
• When government regulations require.
For example, in the USA, CLIA regulations require calibration or calibration verification at least once every six months.
The VITROS AMYL test may also need to be calibrated:
• If quality control results are consistently outside acceptable range.
• After certain service procedures have been performed.
For additional information, refer to the operating instructions for your system.

Calculations
Reflectance from the slide is read at 540 nm at two fixed time points during the incubation period, and the change in
reflectance between these two readings is calculated. Once a calibration has been performed for each slide lot, amylase
activity in unknown samples can be determined using the software-resident two-point rate math model and the change in
reflectance calculated for each unknown test slide.

Validity of a Calibration
Calibration parameters are automatically assessed by the system against a set of quality parameters detailed in the
Coefficients and Limits screen on VITROS 250/350/950 Systems (on the VITROS Integrated and VITROS 5,1 FS/4600
Systems, see the Review Assay Data screen). Failure to meet any of the pre-defined quality parameters results in a failed
calibration. The calibration report should be used in conjunction with quality control results to determine the validity of a
calibration.
Measuring (Reportable or Dynamic) Range

Conventional and SI Units Alternate Units

(U/L) (μkat/L)
Serum 30–1200 0.5–20.0
Urine 30–1200 0.5–20.0
For out-of-range samples, refer to “Sample Dilution.”

Traceability of Calibration
Values assigned to the VITROS Chemistry Products Calibrator Kit 3 for amylase are traceable to the paranitrophenol
maltopentaoside method 10 at 37 °C.

Quality Control
Quality Control Material Selection
IMPORTANT: VITROS Performance Verifiers are recommended for use with VITROS Chemistry
and Integrated Systems. Evaluate the performance of other commercial control
fluids for compatibility with this test before using for quality control.
• Control materials other than VITROS Performance Verifiers may show a difference when compared with other amylase
methods if they:
– Depart from a true human matrix.
– Contain high concentrations of preservatives, stabilizers, or other nonphysiological additives.
• Serum controls with porcine or bovine amylase may give lower values that may vary from method to method. 12
• Enzyme activity might also vary with enzyme source, diluent temperature, and activation time during reconstitution.
• Do not use control materials stabilized with ethylene glycol.

Quality Control Procedure Recommendations

• Choose control levels that check the clinically relevant range.
• Analyze quality control materials in the same manner as patient samples, before or during patient sample processing.
• To verify system performance, analyze control materials:
– After calibration.
– According to local regulations or at least once each day that the test is being performed.
– After specified service procedures are performed. Refer to the operating instructions for your system.
• If control results fall outside your acceptable range, investigate the cause before deciding whether to report patient
results.

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 AMYL INSTRUCTIONS FOR USE
Amylase Results

• For general quality control recommendations, refer to Statistical Quality Control for Quantitative Measurements:
Principles and Definitions; Approved Guideline-Third Edition 11 or other published guidelines.
• For additional information, refer to the operating instructions for your system.

Quality Control Material Preparation, Handling, and Storage

Refer to the Instructions for Use for VITROS Chemistry Products Performance Verifier I and II or to other manufacturer's
product literature.

Results
Reporting Units and Unit Conversion
The VITROS Chemistry and Integrated Systems may be programmed to report AMYL results in conventional, SI, and
alternate units.

Conventional and SI Units Alternate Units

U/L µkat/L (U/L x 0.0167)

Limitations of the Procedure

Known Interferences
The VITROS AMYL Slide method was screened for interfering substances following NCCLS Protocol EP7. 14, 15 None have
been identified.
For substances that were tested and did not interfere, refer to “Specificity.”

Other Limitations
Certain drugs and clinical conditions are known to alter amylase activity in vivo. For additional information, refer to one of
the published summaries. 16, 17

Expected Values
Reference Interval
The serum reference interval is the central 95% of results from an internal study of 98 apparently healthy individuals from a
working population (55 females and 43 males).
No significant differences between results from the male and female populations were observed.
The urine reference interval is the results from an internal study of 95 apparently healthy adults from a working population
(48 females and 47 males).

Conventional and SI Units Alternate Units

(U/L) (μkat/L)
Serum* 30–110** 0.5–1.8
Urine*** 32–641 0.5–10.7
*Plasma concentrations are approximately 20 U/L higher than serum concentrations. 3
**Adults; normal intervals for children < 1 year old are lower. 13
***2–4 hour specimens.
Each laboratory should confirm the validity of these intervals for the population it serves.

Performance Characteristics
Method Comparison
The plots and data tables below for serum and urine show the results of a method comparison study for serum and urine
samples analyzed on the VITROS 750 System with those analyzed using the Paranitrophenol Maltopentaoside
comparative method. 10 Testing followed NCCLS Protocol EP9. 18
The tables, for serum and urine respectively, summarize the results of regression analyses of data obtained from
measurements with both the VITROS 250 and 950 Systems compared to measurements with the VITROS 750 System.
Regression analyses of data for serum and urine samples measured on the VITROS 5,1 FS System compared to
measurements with the VITROS 950 System are also provided.

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Performance Characteristics Amylase

In addition, the tables for serum and urine summarize the regression analysis of comparisons of results for serum, plasma
and urine samples measured on the VITROS 5600 Integrated System and the VITROS 5,1 FS Chemistry System. Testing
followed NCCLS Protocol EP9. 19

Serum
Conventional and SI Units Alternate Units

VITROS 750 System (µkat/L)

VITROS 750 System (U/L)

Comparative Method: Paranitrophenol Maltopentaoside Comparative Method: Paranitrophenol Maltopentaoside

(U/L) (μkat/L)

Conventional and SI Units (U/L) Alternate Units (µkat/L)

Correlation Range of Range of
n Slope Coefficient Sample Activity Intercept Sy.x Sample Activity Intercept Sy.x
750 vs. comparative
method 210 1.00 0.998 33–1191 +0.8 21.7 0.6–19.9 +0.01 0.36
250 vs. 750 87 0.99 0.997 37–1039 +5.6 21.5 0.6–17.4 +0.09 0.36
950 vs. 750 116 1.00 0.999 31–1178 +1.7 4.9 0.5–19.7 +0.03 0.08
5,1 FS vs. 950 110 1.02 1.000 35–1147 -2.7 9.3 0.6–19.2 -0.05 0.16
5600 vs. 5,1 FS 108 0.98 0.998 33–1164 +2.2 14.0 0.6–19.4 +0.04 0.23
Analytical processing hardware and software algorithms on the VITROS 4600 Chemistry System are designed to the same
specifications as those applied to the VITROS 5,1 FS Chemistry System. Assay performance on the VITROS 4600 System has been
demonstrated to be comparable to that on the VITROS 5,1 FS System. All performance characteristics for VITROS 5,1 FS System are
therefore applicable to the VITROS 4600 System.

Urine
Conventional and SI Units Alternate Units
VITROS 750 System (µkat/L)
VITROS 750 System (U/L)

Comparative Method: Paranitrophenol Maltopentaoside Comparative Method: Paranitrophenol Maltopentaoside

(U/L) (μkat/L)

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 AMYL INSTRUCTIONS FOR USE
Amylase Performance Characteristics

Conventional and SI Units (U/L) Alternate Units (µkat/L)

Correlation Range of Range of
n Slope Coefficient Sample Activity Intercept Sy.x Sample Activity Intercept Sy.x
750 vs. comparative
method 200 0.99 0.994 32–1168 +3.9 34.4 0.5–19.5 +0.07 0.57
250 vs. 750 31 1.02 0.997 31–1117 +12.8 24.1 0.5–18.7 +0.21 0.40
950 vs. 750 87 1.02 0.999 31–1138 +0.9 4.9 0.5–19.0 +0.02 0.08
5,1 FS vs. 950 115 1.04 0.999 39–1140 +0.9 12.6 0.7–19.0 +0.02 0.21
5600 vs. 5,1 FS 109 0.98 0.998 34–1115 -1.3 15.3 0.6–18.6 -0.02 0.26
Analytical processing hardware and software algorithms on the VITROS 4600 Chemistry System are designed to the same
specifications as those applied to the VITROS 5,1 FS Chemistry System. Assay performance on the VITROS 4600 System has been
demonstrated to be comparable to that on the VITROS 5,1 FS System. All performance characteristics for VITROS 5,1 FS System are
therefore applicable to the VITROS 4600 System.

Precision
Precision was evaluated with quality control materials on VITROS 250/350, 950, and 5,1 FS Systems following NCCLS
Protocol EP5. 20 Precision was also evaluated with quality control materials on VITROS 5600 Integrated System following
NCCLS protocol EP5. 21
The data presented are a representation of test performance and are provided as a guideline. Variables such as sample
handling and storage, reagent handling and storage, laboratory environment, and system maintenance can affect
reproducibility of test results.

Serum
Conventional and SI Units (U/L) Alternate Units (µkat/L)
Mean Within Within Lab Mean Within Within Lab Within Lab No.
Activity Day SD* SD** Activity Day SD* SD** CV%** Observ. No. Days
82 2.3 2.7 1.4 0.04 0.04 3.3 79 20
250
450 4.6 8.1 7.5 0.08 0.14 1.8 78 20
40 1.5 1.8 0.7 0.03 0.03 4.5 92 23
750 72 1.5 1.9 1.2 0.03 0.03 2.6 92 23
318 4.6 6.6 5.3 0.08 0.11 2.1 92 23
74 2.3 2.4 1.2 0.04 0.04 3.3 92 23
950
325 5.5 6.0 5.4 0.09 0.10 1.9 92 23
74 3.2 3.9 1.2 0.05 0.06 5.2 88 22
5,1 FS
313 6.5 7.8 5.2 0.11 0.13 2.5 88 22
78 2.4 3.3 1.3 0.04 0.06 4.2 88 22
5600
318 4.5 11.1 5.3 0.08 0.19 3.5 88 22
* Within Day precision was determined using two runs/day with at least two replications.
** Within Lab precision was determined using a single lot of slides and calibrating weekly.
Analytical processing hardware and software algorithms on the VITROS 4600 Chemistry System are designed to the same
specifications as those applied to the VITROS 5,1 FS Chemistry System. Assay performance on the VITROS 4600 System has been
demonstrated to be comparable to that on the VITROS 5,1 FS System. All performance characteristics for VITROS 5,1 FS System are
therefore applicable to the VITROS 4600 System.

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References Amylase

Urine
Conventional and SI Units (U/L) Alternate Units (µkat/L)
Mean Within Within Lab Mean Within Within Lab Within Lab No.
Activity Day SD* SD** Activity Day SD* SD** CV%** Observ. No. Days
50 0.7 1.1 0.8 0.01 0.02 2.2 88 22
250 121 1.6 1.6 2.0 0.03 0.03 1.3 84 21
175 2.5 9.9 2.9 0.04 0.16 5.7 84 21
44 1.1 1.2 0.7 0.02 0.02 2.7 92 23
750
91 1.8 2.0 1.5 0.03 0.03 2.2 92 23
45 1.2 1.4 0.7 0.02 0.02 3.2 92 23
950
93 1.9 2.4 1.6 0.31 0.04 2.6 92 23
36 1.4 2.0 0.6 0.02 0.03 5.6 88 22
5,1 FS
87 2.9 3.1 1.4 0.05 0.05 3.5 88 22
46 1.1 1.4 0.8 0.02 0.02 3.0 88 22
5600
117 1.8 3.8 2.0 0.03 0.06 3.2 88 22
* Within Day precision was determined using two runs/day with at least two replications.
** Within Lab precision was determined using a single lot of slides and calibrating weekly.
Analytical processing hardware and software algorithms on the VITROS 4600 Chemistry System are designed to the same
specifications as those applied to the VITROS 5,1 FS Chemistry System. Assay performance on the VITROS 4600 System has been
demonstrated to be comparable to that on the VITROS 5,1 FS System. All performance characteristics for VITROS 5,1 FS System are
therefore applicable to the VITROS 4600 System.

Specificity
Substances that do not Interfere
The substances listed in the table were tested with VITROS AMYL Slides and found not to interfere, bias <9 U/L, at the
concentration shown.

Compound Concentration Compound Concentration

Acetylsalicylic acid 30 mg/dL 1665 µmol/L Hydroxyurea 300 mg/L 3.9 mmol/L
Ascorbic Acid 3 mg/dL 170 µmol/L Hypaque 500 mg/dL 8.2 mmol/L
Bilirubin 40 mg/dL 684 µmol/L Intralipid 800 mg/dL 8 g/L
Cholesterol 500 mg/dL 12.9 mmol/L Mitomycin 2.4 mg/L 7 µmol/L
Dextran 1000 mg/dL 250 µmol/L Sulfasalazine 30 mg/L 75 µmol/L
Ethanol 300 mg/dL 65.2 mmol/L Total Protein 10 g/dL 100 g/L
5-Fluorouracil 125 mg/L 961 µmol/L Triglycerides 800 mg/dL 9 mmol/L
Hemoglobin 320 mg/dL 3.2 g/L Urea nitrogen 100 mg/dL 36 mmol/L

References
1. Tietz NW (ed). Fundamentals of Clinical Chemistry ed. 3. Philadelphia: WB Saunders; 394-395; 1987.
2. CLSI. Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline – Fourth Edition.
CLSI document M29-A4. Wayne, PA: Clinical and Laboratory Standards Institute; 2014.
3. Doumas BT, et al. Differences Between Values for Plasma and Serum in Tests Performed in the Ektachem 700 XR
Analyzer, and Evaluation of “Plasma Separator Tubes (PST).” Clin. Chem. 35:151–153; 1989.
4. Calam RR. Specimen Processing Separator Gels: An Update. J Clin Immunoassay. 11:86–90; 1988.
5. Tietz NW (ed). Fundamentals of Clinical Chemistry. ed. 5. Philadelphia: WB Saunders; 376; 2001.
6. CLSI. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard – Sixth
Edition. CLSI document H3-A6 (ISBN 1-56238-650-6). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898 USA; 2007.
7. NCCLS. Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard –
Fifth Edition. NCCLS document H4-A5 [ISBN 1-56238-538-0]. CLSI, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898 USA, 2004.
8. Clinical Laboratory Handbook for Patient Preparation and Specimen Handling. Fascicle VI: Chemistry/Clinical
Microscopy. Northfield, IL: College of American Pathologists; 1992.
9. NCCLS. Urinalysis and Collection, Transportation, and Preservation of Urine Specimens; Approved Guideline. NCCLS
Document GP16. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA; 1995.
10. Mauck LA. A Kinetic Colorimetric Method for the Determination of Total Amylase Activity in Serum. Clin. Chem.
31:1007; 1985.

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Amylase Glossary of Symbols

11. CLSI. Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline – Third
Edition. CLSI document C24-A3 (ISBN 1-56238-613-1). CLSI, 940 West Valley Road, Suite 1400, Wayne, PA
19087-1898 USA; 2006.
12. Lee VW, Willis C. Activity of Human and Nonhuman Amylases on Different Substrates Used in Enzymatic Kinetic
Assay Methods—a Pitfall in Interlaboratory Quality Control. Am. J. Clin. Path. 77:290–296; 1982.
13. Gillard BK, Simbala JA, Goodnick L. Reference Intervals for Amylase Isoenzymes in Serum and Plasma of Infants and
Children. Clin. Chem. 29:1119; 1983.
14. NCCLS. Interference Testing in Clinical Chemistry. CLSI Document EP7. CLSI, 940 West Valley Road, Suite 1400,
Wayne, PA 19087-1898 USA; 1986.
15. CLSI. Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition. CLSI Document EP7-A2.
Wayne, PA: Clinical and Laboratory Standards Institute; 2005.
16. Young DS. Effects of Drugs on Clinical Laboratory Tests. ed. 4. Washington D.C.: AACC Press; 1995.
17. Friedman RB, Young DS. Effects of Disease on Clinical Laboratory Tests. Washington, D.C.: AACC Press; 1990.
18. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. CLSI Document EP9.
CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA; 1995.
19. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS document
EP9-A2 [ISBN 1-56238-472-4]. CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA;
2002.
20. CLSI. User Evaluation of Precision Performance with Clinical Chemistry Devices. CLSI Document EP5. CLSI, 940
West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA; 1992.
21. NCCLS. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second
Edition. NCCLS document EP5-A2 [ISBN 1-56238-542-9]. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA
19087-1898 USA; 2004

Glossary of Symbols

Revision History
Date of Revision Version Description of Technical Changes*
2015-10-12 10.0 • Updated EC Representative address.
• Added USA to legal manufacture address

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Revision History Amylase

Date of Revision Version Description of Technical Changes*

2015-01-09 9.0 • Prescription Use Statement added
• Known Interferences:
– updated wording
– added reference
– removed table
• Substances that Do Not Interfere: added Hemoglobin
• References:
– updated M29
– added reference 15
2014-09-05 8.0 Glossary of Symbols: added Date of Manufacture
2012-02-28 7.0 Glossary of Symbols: updated
2010-11-01 6.0 Added information for the VITROS 4600 Chemistry System
2009-10-14 5.0 Method Comparison – Urine: corrected µkat value
2008-10-24 4.0 • Added information for the VITROS 5600 Integrated System
• Test Type and Conditions – Added statement
• Method Comparison – Added information on sample types
• References – Updated
• Glossary of Symbols – Updated
• Minor wording and formatting changes
2005-03-31 3.1 – English Known Interferences — removed unnecessary footnote
only
2004-09-13 3.0 • Added VITROS 5,1 FS Chemistry System
• Principles of the Procedure – wording update
• Specimen Requirements, Special Precautions – wording update
• Known Interferences – added section
• Specificity – added Intralipid; updated Bilirubin
• References – added reference 14
• Glossary of Symbols – updated data
2003-06-30 2.0 • New organization and sections consistent with IVD Directive
• Specimens Not Recommended – urine: added boric acid/sodium formate;
removed hexamethylenetetramine and mercuric oxide
• Urine: Specimen Collection and Preparation – removed “Keep refrigerated
until analysis.”
• Sample Dilution – removed 2% bovine serum albumin in saline, pH 7.4 as an
acceptable diluent
• Reference Interval – updated wording
• Method Comparison – serum and urine: updated 750 System versus
comparative method, 250/350 versus 750 System and all plots
• Precision – serum and urine: updated data for 750 System; urine: corrected
the value for the Within Lab CV% for the 950 System
• References – added 2, 4, 5, 16, 17
2002APR19 1.0 – English New format, technically equivalent to 11/96.
only
* The change bars indicate the position of a technical amendment to the text with respect to the previous version of the document.

When this Instructions For Use is replaced, sign and date below and retain as specified by local regulations or laboratory
policies, as appropriate.

Signature Obsolete Date

Version 10.0 Pub. No. MP2-16_EN 11 of 12

 AMYL INSTRUCTIONS FOR USE
Amylase Revision History

Ortho-Clinical Diagnostics
Felindre Meadows
Pencoed
Bridgend
CF35 5PZ
United Kingdom

Ortho-Clinical Diagnostics, Inc.

100 Indigo Creek Drive
Rochester, NY 14626
USA

VITROS is a registered trademark of Ortho-Clinical Diagnostics,

Inc.
© Ortho-Clinical Diagnostics, Inc., 2002-2015

12 of 12 Pub. No. MP2-16_EN Version 10.0