Analysis of lidocaine on the COBAS INTEGRA.
A new fluorescence polarization (FP) immunoassay was developed for the COBAS INTEGRA to quantitate lidocaine in serum and sodium heparin derived plasma. The COBAS INTEGRA, a random and continuous access clinical analyzer, performs the new lidocaine assay at a throughput of 300 tests per hour. Comparison studies with the Abbott TDx Lidocaine assay yielded a correlation coefficient of 0.99 and a regression value of INTEGRA = -0.01 + 0.95 TDx, n = 69. The assay was found to be linear throughout the concentration range of 0 to 10 micrograms/ml using CASCO STANDARDS's DOCUMENT TDM 1 Linearity Test Set and the COBAS-FP TDM Calibration Verification Test Set. The new lidocaine assay exhibited good precision as determined by the National Committee for Clinical Laboratory Standards (NCCLS) protocol EP5-T2 with total percent coefficient of variation (%CV) values of less than 4 percent across the assay range. Interference was less than 10 percent for abnormal levels of total protein (2.1 to 10 g/dl), lipid (up to 2200 mg/dl triglyceride), hemoglobin (up to 10 g/dl), and icteric samples (up to 17.5 mg/dl bilirubin). Finally, the standard curve was stable for greater than 25 weeks which was attributable to the on-board reagent cooling and a unique cassette closure system.
Liu-Allison
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LY
Drug Monitoring Research and Product Development, Roche Diagnostic Systems, Inc., Somerville, NJ 08876, USA.
Hui
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RA
Schwenzer
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KS
D001322:Autoanalysis / Q000295:instrumentation* / Q000592:standards; D002624:Chemistry, Clinical / Q000295:instrumentation* / Q000592:standards; D006493:Heparin; D006801:Humans; D007202:Indicators and Reagents; D008012:Lidocaine / Q000097:blood*; D010949:Plasma / Q000737:chemistry; D011786:Quality Control; D012680:Sensitivity and Specificity
D007202:Indicators and Reagents; D006493:Heparin; D008012:Lidocaine