BioPacific Diagnostic

Metabolic activity in the body constantly produces carbon dioxide (CO₂) as a byproduct, which is transported by the blood to the lungs for elimination. The CO₂ content of blood, or other body fluids, actually refers to the sum of bicarbonate ions (HCO₃-), carbonic acid (H₂CO₃) and dissolved CO₂ present, with bicarbonate ions (HCO₃) being the most predominant form. The determination of CO₂ levels, or bicarbonate concentrations, in clinical specimens provides vital information pertaining to the body’s acidbase balance. Elevated levels are associated with respiratory acidosis, while decreased levels are an indicator of respiratory alkalosis.

The DCL CO₂ L3K assay is an enzymatic method utilizing phosphoenolpyruvate carboxylase (PEPC) and a stabilized NADH analog. In the reaction, PEPC catalyzes the reaction between phosphoenolpyruvate and HCO₃- to yield oxaloacetate and inorganic phosphate. In the second step, oxaloacetate is reduced by a stable NADH analog to malate in the presence of malate dehydrogenase. The resulting decrease in absorbance between 405 and 415 nm is spectrophotometrically measured and directly proportional to the bicarbonate ion concentration in the test sample.

• Field-Proven Performance – The IVD industry’s most widely used liquid stable, enzymatic CO₂ assay, with a documented history of performance in the most demanding clinical laboratories world-wide.

• Breakthrough Technology – Use of the pioneering L3K technology results in a reagent system exhibiting incomparable lotto-lot consistencies and unparalleled onboard and calibration stability.

• Liquid Stable Format – Single vial, liquid stable technology eliminates the need for reagent reconstitution procedures, saving time, labor and reagent waste.

• Dependable Results – The assay demonstrates superior performance characteristics with regard to linearity, accuracy, precision and sensitivity.

• Negligible Interference Effects – Virtually no clinically significant interferences from ascorbic acid, lipemia, hemolysis or icterus.

• Testing Flexibility – Test either serum or plasma samples using fully automated testing procedures . . . an extensive listing of instrument applications is readily available.

• Minimal Sample Requirements – Each assay requires only three (3) μL of sample, making it ideal for pediatric and veterinary testing.

• Fast Turnaround Time – Generate accurate and reliable test results in only eight (8) minutes.

• Accommodating Packaging Design – Regardless of laboratory size or workload, a packaging format is available to fit your testing requirements.

• Reportable Range (NCCLS EP6-P) – The reportable range of the assay using automated procedures will depend on the sample to reagent ratio, as well as the instrument’s spectrophotometric system. However, for the majority of automated procedures, the assay provides a reportable range of 2.9 – 50.0 mEq/L.

• Accuracy (NCCLS EP9-P) – The performance of this method (y) on a Roche/Hitachi 717™ was compared with the performance of another commercially available method (x) on a Roche COBAS Mira®. A total of forty-five (45) patient serum samples, with values ranging from 15.4 – 43.7 mEq/L were tested. This study yielded a correlation coefficient of 0.9861, with a resulting linear regression equation of y =1.00(reference) – 0.42 mEq/L. In another study, the performance of method (y) using plasma samples was compared to this method (x) using serum samples on a Bayer ADVIA® 1650. Twenty-five (25) serum and plasma specimens were run, with values ranging from 17.1 – 25.3 mEq/L. This study yielded a correlation coefficient of 0.9636, with a linear regression equation of y =0.950(reference) – 1.35 mEq/L.

• Precision (NCCLS EP5-T2) – Precision estimates for Intra-Run performance were obtained on two (2) separate levels of commercially available control materials with concentrations of 13.5 mEq/L and 24.0 mEq/L, run a total of twenty (20) times. The resulting SD’s were 0.18 mEq/L and 0.40 mEq/L respectively, generating CV%’s of 1.3 and 1.7. Inter-run performance estimates were obtained on two levels of commercially available control materials, with concentrations of 14.1 mEq/L and 24.8 mEq/L, run separately in triplicate for a total of five ( 5) runs. The resulting SD’s were 0.24 mEq/L and 0.27 mEq/L respectively, generating CV%’s of 1.7 and 1.1.

PRODUCT	CATALOGUE NUMBER	PACKAGING CONFIGURATION
CO₂ L3K	299-30	6 x 30 mL
CO₂ L3K	299-17	5 x 100 mL [Hitachi Wedge]
CO₂ L3K	299-50	4 x 500 mL
CO₂ L3K	299-80	1 x 1,000 mL
CO₂ L3K	299-12	1 x 1,200 mL

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