title: Establishment of norvancomycin fluorescence polarization immunoassay for therapeutic drug monitoring.
abstract: To establish a rapid and simple fluorescence polarization immunoassay method for determination of norvancomycin serum concentration, we collected 300 serum samples from the patients receiving norvancomycin in the hospitals localized in Shanghai, China. The drug concentrations were measured by the established HPLC method and FPIA with vancomycin kit. A FPIA algorithm for the determination of norvancomycin concentration was established according to the correlation between the FPIA and HPLC results. The methods and algorithm were validated in another 70 clinical samples. HPLC determination showed a good linear correlation within the range of 0.5-100 mg l(-1) of norvancomycin concentrations. The method was validated via extraction recovery, intra- and inter-day methodological recovery and stability of norvancomycin in serum. Correlation analysis between the measurements of HPLC and FPIA in 300 serum samples gave the linear regression equation: (concentration by HPLC)=0.760 × (concentration by FPIA)-0.577 (P<0.001, R(2)=0.982). An algorithm was derived from this correlation for measuring the serum norvancomycin concentrations with FPIA. When it was validated in additional 70 serum samples from patients, 'FPIA algorithm' showed good accuracy versus HPLC: 'FPIA algorithm'=0.93 (HPLC)+0.63, R(2)=0.962, and 94.3% of the results from FPIA algorithm fell within the range of -20%/+20% of HPLC. This algorithm developed in this study can be easily used for determination of norvancomycin using TDx analyzer with vancomycin kit indirectly. It may also be useful for norvancomycin therapeutic drug monitoring.
authors: Institute of Antibiotics, Huashan Hospital, Fudan University, Key Laboratory of Clinical Pharmacology of Antibiotics, Ministry of Health, Shanghai, China.
authors: Xiao-Jie
authors: XJ
authors: Wu
authors: Jing
authors: J
authors: Zhang
authors: Ji-Cheng
authors: JC
authors: Yu
authors: Guo-Ying
authors: GY
authors: Cao
authors: Yao-Guo
authors: YG
authors: Shi
authors: Ying-Yuan
authors: YY
authors: Zhang
authors: Ming-Gui
authors: MG
authors: Wang
mesh_terms: D000328:Adult; D000465:Algorithms; D000900:Anti-Bacterial Agents / Q000097:blood; D016903:Drug Monitoring / Q000379:methods*; D005260:Female; D016231:Fluorescence Polarization Immunoassay / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D014640:Vancomycin / Q000031:analogs & derivatives* / Q000097:blood
chemical_list: D000900:Anti-Bacterial Agents; D014640:Vancomycin; C511195:norvancomycin