Bicarbonate Liquid

Catalog Number: 05446376191

SYSTEM INFORMATION

INTENDED USE

In vitro test for the quantitative determination of bicarbonate (HCO3-) in human serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

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 Rate
Reaction time / Assay points 10 / 3-15 (STAT 4 / 3-15)
Wavelength (sub/main) 505/415 nm
Reaction direction Decrease
Unit mmol/L
Reagent pipetting Diluent (H2O)
R1 50 µL 130 µL
Sample volumes Sample Sample dilution
Sample Diluent (H2O)
Normal 2 µL
Decreased 2 µL
Increased 4 µL

CALIBRATION

Traceability: This method has been standardized against a primary standard.

Calibrators S1: H2OS2: Ammonia/Ethanol /CO2 Calibrator
Calibration mode Linear
Calibration frequency 2-point calibrationafter 14 days on boardafter reagent lot change as required following quality control procedures

LIMITS AND RANGES

Measuring range

2-50 mmol/L

Lower limits of measurement

Lower detection limit of the test:

2 mmol/L

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

Values below the lower detection limit (< 2 mmol/L) will not be flagged by the instrument.

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:

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

Repeatability Meanmmol/L SDmmol/L CV%
Ammonia/Ethanol/CO2 Control Normal 23.0 0.2 0.7
Ammonia/Ethanol/CO2 Control Abnormal 32.4 0.3 1.0
Human serum A 11.1 0.2 1.4
Human serum B 25.1 0.4 1.5
Human serum C 43.1 0.4 0.9

Intermediate precision Meanmmol/L SDmmol/L CV%
Ammonia/Ethanol/CO2 Control Normal 17.6 0.2 1.3
Ammonia/Ethanol/CO2 Control Abnormal 30.5 0.4 1.4
Human serum 3 9.90 0.23 2.3
Human serum 4 26.3 0.3 1.3

METHOD COMPARISON

Bicarbonate values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the same reagent on a Roche/Hitachi cobas c 501 analyzer (x).

Sample size (n) = 134

Passing/Bablok15 Linear regression
y = 0.979x + 0.706 mmol/L y = 0.976x + 0.786 mmol/L
t = 0.965 r = 0.999
The sample concentrations were between 2.26 and 48.8 mmol/L.