Rex J H, Hanson L H, Amantea M A, Stevens D A, Bennett J E
Clinical Mycology Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 20892.
Antimicrob Agents Chemother. 1991 May;35(5):846-50. doi: 10.1128/AAC.35.5.846.
An improved bioassay for fluconazole was developed. This assay is sensitive in the clinically relevant range (2 to 40 micrograms/ml) and analyzes plasma, serum, and cerebrospinal fluid specimens; bioassay results correlate with results obtained by high-pressure liquid chromatography (HPLC). Bioassay and HPLC analyses of spiked plasma, serum, and cerebrospinal fluid samples (run as unknowns) gave good agreement with expected values. Analysis of specimens from patients gave equivalent results by both HPLC and bioassay. HPLC had a lower within-run coefficient of variation (less than 2.5% for HPLC versus less than 11% for bioassay) and a lower between-run coefficient of variation (less than 5% versus less than 12% for bioassay) and was more sensitive (lower limit of detection, 0.1 micrograms/ml [versus 2 micrograms/ml for bioassay]). The bioassay is, however, sufficiently accurate and sensitive for clinical specimens, and its relative simplicity, low sample volume requirement, and low equipment cost should make it the technique of choice for analysis of routine clinical specimens.
开发了一种改进的氟康唑生物测定法。该测定法在临床相关浓度范围（2至40微克/毫升）内具有敏感性，可分析血浆、血清和脑脊液标本；生物测定结果与高压液相色谱法（HPLC）所得结果相关。对加标的血浆、血清和脑脊液样本（作为未知样本进行检测）进行生物测定和HPLC分析，所得结果与预期值高度一致。对患者样本进行分析时，HPLC和生物测定法得出了等效结果。HPLC的批内变异系数较低（HPLC小于2.5%，而生物测定法小于11%），批间变异系数也较低（分别为小于5%和小于12%），且灵敏度更高（检测下限为0.1微克/毫升，而生物测定法为2微克/毫升）。然而，该生物测定法对临床标本具有足够的准确性和敏感性，其相对简单、样本量需求低以及设备成本低的特点，使其成为常规临床标本分析的首选技术。
