Technicon Immuno I에 대한 평가

Abstract

Background :The Technicon Immuno I utilizes various enzymatic kinetic analysis with colorimetric detection and magnetic particles. We evaluated this fully automated random-access immunoassay system which can perform latex agglutination and magnetic-separation sandwich/competitive immunoassay. Method :We evaluated the assay precision, lower limits of detection, linearity, recovery, sample to sample carry-over, analytical interferences and comparison with other various methods for the following analytes: thyroxine (T4), thyroid stimulating hormone (TSH), free thyroxine (FT4), luteinizing hormone (LH), follicular stimulating hormone (FSH), prostate specific antigen (PSA), o-fetoprotein (AFP), carcino-embryonic antigen (CEA), CA 19-9, and digoxin. Result :Satisfactory results were obtained for within-run and between-day precision in most analytes. Lower limits of detection were slightly higher than claimed by the manufacturer. The linearity was acceptable, but there were proportional errors for CEA and FT4. The recovery rates were also good except for PSA. Sample to sample carry-over was not detected. No significant analytical interference was caused by hemoglobin (up to 2,000 mg/L), lipid (up to 85 mmol/L) and bilirubin (up to 325 pmol/L) except for digoxin, FT4 and PSA. The Technicon lmmuno I assay correlated well with the comparison methods in most analytes, but the proportional biases were found for PSA and LH. Conclusion :The Technicon lmmuno I is a satisfactory system for clinical use in most cases but more study would be requried for FT4. Especially, this system can replace the radioimmunoassay for FSH and LH.