Calcium Gen.2

Catalog Number: 05168449190

SYSTEM INFORMATION

CA2: ACN 8698

S-CA2: ACN 8699 (STAT, reaction time: 3)

INTENDED USE

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

STORAGE AND STABILITY

CA2
Shelf life at 2-8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 6 weeks
On-board on the Reagent Manager: 24 hours
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: 4 weeks
On-board on the Reagent Manager: 24 hours

APPLICATION FOR SERUM AND PLASMA

cobas c 701/702 test definition
Assay type 2-Point End
Reaction time / Assay points 10 / 18-22 (STAT 3 / 6-10)
Wavelength (sub/main) 376/340 nm
Reaction direction Decrease
Units mmol/L (mg/dL)
Reagent pipetting Diluent (H2O)
R1 20 µL 160 µL
R3 (STAT R2) 20 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 3 µL
Decreased 3 µL
Increased 3 µL

cobas c 701/702 test definition
Assay type 2-Point End
Reaction time / Assay points 10 / 18-22 (STAT 3 / 6-10)
Wavelength (sub/main) 376/340 nm
Reaction direction Decrease
Units mmol/L (mg/dL)
Reagent pipetting Diluent (H2O)
R1 20 µL 160 µL
R3 (STAT R2) 20 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 2 µL
Decreased 4 µL 15 µL 135 µL
Increased 2 µL

Application for urine

CALIBRATION

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

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

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 urine 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 Quantitaion (LoQ)

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17-A2 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 the analyzers are given below. Results obtained in individual laboratories may differ.

PRECISION

Repeatability was determined using human samples and controls in an internal protocol (n = 21, 1 run). Intermediate precision was 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

Results for intermediate precision were obtained on the master system cobas c 501 analyzer.

Repeatability Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Human serum 1 0.59 (2.4) 0.01 (0.0) 2.0
Human serum 2 2.57 (10.3) 0.02 (0.1) 0.7
Human serum 3 4.54 (18.2) 0.02 (0.1) 0.4
Precinorm U 2.31 (9.3) 0.02 (0.1) 0.7
Precipath U 3.63 (14.6) 0.02 (0.1) 0.5

Intermediate precision Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Human serum 1 0.60 (2.4) 0.02 (0.1) 2.5
Human serum 2 2.55 (10.2) 0.02 (0.1) 0.9
Human serum 3 4.46 (17.9) 0.04 (0.2) 0.9
Precinorm U 2.25 (9.0) 0.02 (0.1) 0.8
Precipath U 3.51 (14.1) 0.03 (0.1) 0.9

Repeatability Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Human urine 1 0.56 (2.2) 0.03 (0.1) 5.9
Human urine 2 3.96 (15.9) 0.03 (0.1) 0.7
Human urine 3 5.29 (21.2) 0.04 (0.2) 0.8
Human urine 4 6.21 (24.9) 0.04 (0.2) 0.6
Control Level 1 1.91 (7.7) 0.02 (0.1) 1.2
Control Level 2 2.77 (11.1) 0.03 (0.1) 0.9

Intermediate precision Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Human urine 1 0.58 (2.3) 0.02 (0.1) 3.1
Human urine 2 3.92 (15.7) 0.05 (0.2) 1.2
Human urine 3 5.18 (20.8) 0.06 (0.2) 1.1
Human urine 4 6.09 (24.4) 0.08 (0.3) 1.3
Control Level 1 1.85 (7.4) 0.03 (0.1) 1.5
Control Level 2 2.72 (10.9) 0.04 (0.2) 1.3

METHOD COMPARISON

Calcium values for human serum, plasma and urine samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) using the Roche Calcium Gen.2 reagent were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).

Serum/plasma

Urine

Sample size (n) = 69
Passing/Bablok11 Linear regression
y = 0.995x + 0.023 mmol/L y = 0.991x + 0.031 mmol/L
t = 0.978 r = 1.00
The sample concentrations were between 0.27 and 4.72 mmol/L (1.1 and 18.9 mg/dL).

Sample size (n) = 61
Passing/Bablok11 Linear regression
y = 1.028x + 0.003 mmol/L y = 1.027x + 0.012 mmol/L
t = 0.990 r = 1.00
The sample concentrations were between 0.29 and 7.32 mmol/L (1.2 and 29.4 mg/dL).