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 À1 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)¼0.760Â(concentration by FPIA)-0.577 (Po0.001, R 2 ¼0.982). 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'¼0.93 (HPLC)+0.63, R 2 ¼0.962, and 94.3% of the results from FPIA algorithm fell within the range of À20%/+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.

Therapeutic drug monitoring of free vancomycin concentration in practice: A new analytical technique based on the HFCF–UF sample separation method

“…The volume of ultrafiltration solution could be controlled by the inner diameter of the hollow fiber tube, avoiding the influence of the ultrafiltration solution volume on the accuracy of analysis. Compared with the protein precipitation method (Lima et al, 2018; Wu et al, 2012), the sensitivity of this method was 2–4 times higher, and the accuracy could reach 95.1%, surpassing 82.6% of CF–UF (Parker et al, 2017). The centrifugation time in this study was 5 min, shorter than the 20 min reported in the literature (Kees et al, 2014).…”

Monitoring of the Antipsychotic Therapy Effectiveness

“…ИФА нашел свое развитие в виде флуоресцентного поляризационного иммуноанализа [41], который основан на возрастании поляризации флуоресценции небольших флуоресцеин-меченных молекул антигена (трейсеров) при их взаимодействии со специфическими антителами. Если в тестируемом образце содержится лекарственное вещество, то трейсер будет конкурировать с ним за связывание с антителами, и значение поляризации флуоресценции будет Наиболее современным хроматографическим методом аналитического определения лекарственных веществ является жидкостная хромато-масс-спектрометрия, особенно в тандемном варианте (ЖХ-МС-МС) [42].…”

Draft Genome Sequence of Norvancomycin-Producing Strain Amycolatopsis orientalis CPCC200066

“…Norvancomycin shows pharmacological properties and antibacterial activities similar to those of vancomycin, which exhibits significant inhibitory activity against Gram-positive cocci and bacilli , especially to methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-resistant Staphylococcus epidermidis (MRSE). Due to its potential clinical application, norvancomycin was commercially developed by the North China Pharmaceutical Company and has been widely used in China to treat endocarditis, osteomyelitis, and other severe infections caused by S. aureus (including methicillin-resistant strains) ( 2 ) for >3 decades. Genome sequencing of A. orientalis CPCC200066 may provide information for discovering the biosynthetic gene cluster for norvancomycin.…”