Catalog Number: 05446376191
In vitro test for the quantitative determination of bicarbonate (HCO3-) in human serum and plasma on Roche/Hitachi cobas c systems.
|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|
|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|
|Reagent pipetting||Diluent (H2O)|
|R1||50 µL||130 µL|
|Sample volumes||Sample||Sample dilution|
Traceability: This method has been standardized against a primary standard.
|Calibrators||S1: H2OS2: Ammonia/Ethanol /CO2 Calibrator|
|Calibration frequency||2-point calibrationafter 14 days on boardafter reagent lot change as required following quality control procedures|
Lower limits of measurement
Lower detection limit of the test:
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.
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
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.
|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|
|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|
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
|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.|