Vaughan L M, Weinberger M M, Milavetz G
Drug Intell Clin Pharm. 1986 Feb;20(2):118-21. doi: 10.1177/106002808602000204.
Dry reagent technology and reflectance photometry are combined in the Ames Seralyzer to offer a solid-phase plastic strip assay methodology. Light reflected from serum placed on the antibody-impregnated strip is quantitated with a two-point standard curve to display a theophylline result in 90 seconds. The accuracy and precision of the Seralyzer for serum theophylline are compared to the enzyme-multiplied immunoassay technique (Emit) which is commonly used to determine drug concentrations. Liquid calibrators (5 and 25 micrograms/ml) and liquid-spiked sera (10, 15, and 20 micrograms/ml) were measured six times daily simultaneously by both methods for twenty days. Eighty patient samples (theophylline range: 0-33 micrograms/ml) were measured twice each during the twenty days. Acceptable assay limits were established and maintained by measuring 15 micrograms/ml spiked sera prior to and during the evaluation period. All within-run and between-run means for the Seralyzer and Emit were within +/- 1 microgram/ml of the spiked value. All ranges of within-run and between-run means were within +/- 2 micrograms/ml of the spiked value. Mean between-run coefficients of variation for the Seralyzer at the 5, 10, 15, 20, and 25 micrograms/ml values were 11.5, 6.7, 4.9, 4.6, and 4.9 percent, respectively. Linear regression on the 80 patient samples gave a slope of 1.02, intercept of -0.28, and correlation of 0.984. The Seralyzer's accuracy and precision compare favorably with Emit for theophylline determinations greater than 7.5 micrograms/ml.
在Ames自动分析仪中，干式试剂技术与反射光度法相结合，提供了一种固相塑料条检测方法。置于浸渍抗体的试纸上的血清反射的光，通过两点标准曲线进行定量，以在90秒内显示茶碱检测结果。将自动分析仪检测血清茶碱的准确性和精密度，与常用于测定药物浓度的酶放大免疫分析技术（Emit）进行比较。两种方法每天同时对液体校准品（5和25微克/毫升）和加样血清（10、15和20微克/毫升）进行6次测量，持续20天。在这20天内，对80份患者样本（茶碱浓度范围：0 - 33微克/毫升）各进行两次测量。在评估期之前和期间，通过测量15微克/毫升的加样血清来确定并维持可接受的检测限度。自动分析仪和Emit的所有批内和批间均值与加样值的偏差均在±1微克/毫升以内。所有批内和批间均值的范围与加样值的偏差均在±2微克/毫升以内。自动分析仪在5、10、15、20和25微克/毫升浓度值时的批间变异系数均值分别为11.5%、6.7%、4.9%、4.6%和4.9%。对80份患者样本进行线性回归分析，得到斜率为1.02，截距为 - 0.28，相关系数为0.984。对于茶碱浓度大于7.5微克/毫升的测定，自动分析仪的准确性和精密度与Emit相当。
