a-Amylase EPS ver.2

Catalog Number: 03183742122

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

AMYL2: ACN 570

SAMY2: ACN 566 (STAT, reaction time: 7)

For cobas c 502 analyzer:

AMYL2: ACN 8570

SAMY2: ACN 8566 (STAT, reaction time: 7)

INTENDED USE

In vitro test for the quantitative determination of a-amylase in human serum, plasma and urine on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

AMYL2
Shelf life at 2-8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 12 weeks
Diluent NaCl 9 %
Shelf life at 2-8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 12 weeks

APPLICATION FOR SERUM, PLASMA AND URINE

cobas c 311 test definition
Assay type Rate A
Reaction time / Assay points 10 / 22-32 (STAT 7/ 22-32)
Wavelength (sub/main) 700/415 nm
Reaction direction Increase
Unit U/L (µkat/L)
Reagent pipetting Diluent (H2O)
R1 100 µL
R2 20 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 4 µL
Decreased 8 µL 15 µL 135 µL
Increased 4 µL

cobas c 501 test definition
Assay type Rate A
Reaction time / Assay points 10 / 30-47 (STAT 7 / 30-47)
Wavelength (sub/main) 700/415 nm
Reaction direction Increase
Unit U/L (µkat/L)
Reagent pipetting Diluent (H2O)
R1 100 µL
R2 20 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 4 µL
Decreased 8 µL 15 µL 135 µL
Increased 4 µL

cobas c 502 test definition
Assay type Rate A
Reaction time / Assay points 10 / 30-47 (STAT 7 / 30-47)
Wavelength (sub/main) 700/415 nm
Reaction direction Increase
Unit U/L (µkat/L)
Reagent pipetting Diluent (H2O)
R1 100 µL
R2 20 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 4 µL
Decreased 8 µL 15 µL 135 µL
Increased 8 µL

CALIBRATION

Traceability: This method has been standardized against Roche system reagent using calibrated pipettes together with a manual photometer providing absolute values and substrate-specific absorptivity, e.

Calibrators S1: H2OS2: C.f.a.s.
Calibration mode Linear
Calibration frequency 2-point calibrationafter reagent lot changeas required following quality control procedures

LIMITS AND RANGES

Measuring range

Serum/plasma/urine

3-1500 U/L (0.05-25.0 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:5 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 5.

Lower limits of measurement

Lower detection limit of the test

3 U/L (0.05 µkat/L)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying three standard deviations above that of the lowest standard (standard 1 + 3 SD, repeatability, n = 21).

SPECIFIC PERFORMANCE DATA

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

PRECISION

Precision was determined using human samples and controls in an internal protocol with repeatability

(n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:

Serum/plasma

Urine

Repeatability MeanU/L (µkat/L) SDU/L (µkat/L) CV%
Precinorm U 83.2 (1.39) 0.8 (0.01) 0.9
Precipath U 182 (3.09) 1 (0.02) 0.6
Human serum 1 34.5 (0.576) 0.4 (0.007) 1.2
Human serum 2 97.9 (1.63) 0.7 (0.01) 0.7

Intermediate precision MeanU/L (µkat/L) SDU/L (µkat/L) CV%
Precinorm U 84.0 (1.40) 1.1 (0.02) 1.3
Precipath U 184 (3.08) 3 (0.05) 1.5
Human serum 3 35.1 (0.586) 0.9 (0.015) 2.4
Human serum 4 98.9 (1.65) 1.6 (0.03) 1.6

Repeatability MeanU/L (µkat/L) SDU/L (µkat/L) CV%
Control level 1 50.6 (0.845) 0.5 (0.008) 0.9
Control level 2 164 (2.74) 1 (0.02) 0.6
Urine 1 21.4 (0.357) 0.2 (0.003) 1.1
Urine 2 68.5 (1.14) 0.7 (0.01) 0.9

Intermediate precision MeanU/L (µkat/L) SDU/L (µkat/L) CV%
Control level 1 51.8 (0.865) 0.9 (0.015) 1.7
Control level 2 168 (2.81) 2 (0.03) 1.1
Urine 3 24.5 (0.409) 0.5 (0.008) 1.9
Urine 4 67.0 (1.12) 2.8 (0.05) 4.2

METHOD COMPARISON

Amylase values for human serum, plasma and urine 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).

Serum/plasma

Sample size (n) = 79

Urine

Sample size (n) = 88

Passing/Bablok20 Linear regression
y = 0.999x + 2.83 U/L y = 0.998x + 4.75 U/L
t = 0.969 r = 0.998
The sample activities were between 51.7 and 1409 U/L (0.863 and 23.5 µkat/L).

Passing/Bablok20 Linear regression
y = 0.986x + 0.423 U/L y = 0.982x + 2.03 U/L
t = 0.987 r = 1.000
The sample activities were between 33.6 and 1248 U/L (0.561 and 20.8 µkat/L).