Calcium Gen.2

Catalog Number: 05061482190

SYSTEM INFORMATION

Test CA2, test ID 0-042 for serum and plasma

Test CA2U, test ID 0-043 for urine

INTENDED USE

In vitro test for the quantitative determination of calcium in human serum, plasma, and urine on COBAS INTEGRA systems.

STORAGE AND STABILITY

Shelf life at 2-8 °C See expiration date on cobas c pack label
COBAS INTEGRA 400 plus system
On-board in use at 10-15 °C 6 weeks
COBAS INTEGRA 800 system
On-board in use at 8 °C 6 weeks

APPLICATION FOR SERUM, PLASMA, AND URINE

COBAS INTEGRA 400 PLUS TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode R1-S-SR
Reaction direction Decrease
Wavelength A/B 340/378 nm
Calc. first/last 33/36
Unit mmol/L

PIPETTING PARAMETERS

Serum/plasma Diluent (H2O)
R1 20 µL 130 µL
Sample 3 µL 30 µL
SR 20 µL
Total volume 203 µL
Urine Diluent (H2O)
R1 20 µL 130 µL
Sample 2 µL 30 µL
SR 20 µL
Total volume 202 µL

Serum/plasma Diluent (H2O)
R1 20 µL 130 µL
Sample 3 µL 30 µL
SR 20 µL
Total volume 203 µL
Urine Diluent (H2O)
R1 20 µL 130 µL
Sample 2 µL 30 µL
SR 20 µL
Total volume 202 µL

COBAS INTEGRA 800 TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode R1-S-SR
Reaction direction Decrease
Wavelength A/B 340/378 nm
Calc. first/last 43/46
Unit mmol/L

PIPETTING PARAMETERS

Serum/plasma Diluent (H2O)
R1 20 µL 130 µL
Sample 3 µL 30 µL
SR 20 µL
Total volume 203 µL
Urine Diluent (H2O)
R1 20 µL 130 µL
Sample 2 µL 30 µL
SR 20 µL
Total volume 202 µL

CALIBRATION

Traceability: This method has been standardized against the SRM 956 c level 2 reference material.

Calibrator Calibrator f.a.s.
Use deionized water as zero calibrator.
Calibration mode Linear regression
Calibration replicate Duplicate recommended
Calibration interval Each reagent lot and as required following quality control procedures

LIMITS AND RANGES

Measuring range

Serum/plasma

0.20-5.0 mmol/L (0.8-20.1 mg/dL)

Urine

0.20-7.5 mmol/L (0.8-30.1 mg/dL)

Determine samples having higher concentrations 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

Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ)

The Limit of Blank and Limit of Detection were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17-A requirements.

The Limit of Blank is the 95th percentile value from n ³ 60 measurements of analyte-free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte-free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 30 %. It has been determined using low concentration calcium samples.

SPECIFIC PERFORMANCE DATA

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

PRECISION

Repeatability and intermediate precision were determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP5 requirements (2 aliquots per run, 2 runs per day, 21 days). The following results were obtained:

Serum/plasma

Urine

Repeatability Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Human serum 1 0.59 (2.4) 0.02 (0.1) 2.9
Human serum 2 2.53 (10.1) 0.05 (0.2) 1.8
Human serum 3 4.48 (18.0) 0.08 (0.3) 1.8
Precinorm U 2.29 (9.2) 0.03 (0.1) 1.4
Precipath U 3.59 (14.4) 0.06 (0.2) 1.7

Intermediate precision Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Human serum 1 0.59 (2.4) 0.02 (0.1) 3.5
Human serum 2 2.53 (10.1) 0.05 (0.2) 1.9
Human serum 3 4.48 (18.0) 0.09 (0.4) 2.1
Precinorm U 2.29 (9.2) 0.04 (0.2) 1.8
Precipath U 3.59 (14.4) 0.07 (0.3) 1.9

Repeatability Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Human urine 1 0.56 (2.2) 0.01 (0.0) 1.9
Human urine 2 4.00 (16.0) 0.03 (0.1) 0.8
Human urine 3 5.31 (21.3) 0.06 (0.2) 1.2
Human urine 4 6.30 (25.3) 0.09 (0.4) 1.4
Control Level 1 1.81 (7.3) 0.03 (0.1) 1.4
Control Level 2 2.70 (10.8) 0.03 (0.1) 1.3

Intermediate precision Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Human urine 1 0.56 (2.2) 0.02 (0.1) 3.3
Human urine 2 4.00 (16.0) 0.06 (0.2) 1.5
Human urine 3 5.31 (21.3) 0.08 (0.3) 1.5
Human urine 4 6.30 (25.3) 0.13 (0.5) 2.1
Control Level 1 1.81 (7.3) 0.03 (0.1) 1.7
Control Level 2 2.70 (10.8) 0.04 (0.2) 1.5

METHOD COMPARISON

Calcium values for human serum, plasma and urine samples obtained on a COBAS INTEGRA 800 analyzer using the Roche Calcium Gen.2 reagent (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).

Serum/plasma
Sample size (n) = 69
Passing/Bablok11 Linear regression
y = 1.036x - 0.008 mmol/L y = 1.040x - 0.018 mmol/L
t = 0.969 r = 1.00
The sample concentrations were between 0.33 and 4.76 mmol/L (1.3 and 19.1 mg/dL).

Urine
Sample size (n) = 60
Passing/Bablok11 Linear regression
y = 1.043x + 0.002 mmol/L y = 1.036x + 0.015 mmol/L
t = 0.987 r = 1.00
The sample concentrations were between 0.28 and 7.06 mmol/L (1.1 and 28.3 mg/dL).