Frisolone J, Sylvia L M, Gelwan J, Pal S, Pellechia C
College of Pharmacy, St. John's University, Jamaica, NY 11439.
Clin Pharm. 1988 Jun;7(6):444-9.
The incidence and magnitude of false-positive serum digoxin concentrations (SDCs) determined by three digoxin assays in patients with liver disease were studied. Patients with biochemical evidence of liver disease were enrolled in the study if they had never received a cardiac glycoside, were not pregnant, were not receiving spironolactone, did not have moderate to severe renal impairment, and did not have transient elevations in liver function test results. Blood specimens from each patient were assayed for apparent SDCs in triplicate using a fluorescence polarization immunoassay (FPIA, TDx Digoxin II, Abbott) and a digoxin radioimmunoassay (RIA, GammaCoat I125, Clinical Assays) and in duplicate using a fluorometric enzyme immunoassay (Dade Stratus, American Dade). Forty-two patients met the study criteria. The percentage of patients exhibiting detectable apparent SDCs (greater than or equal to 0.2 ng/mL) was 57% with RIA, 55% with FPIA, and 28% with the fluorometric enzyme immunoassay. Apparent SDCs ranged from 0.2 to 0.6 ng/mL (RIA), 0.2 to 1.56 ng/mL (FPIA), and 0.2 to 0.38 ng/mL (fluorometric enzyme immunoassay). Values obtained using the fluorometric enzyme immunoassay were significantly different from the apparent SDCs determined using RIA and FPIA; however, no significant difference was found between the values obtained using RIA and FPIA. Significant correlations were found between the apparent SDCs determined using RIA and serum bilirubin values and between the apparent SDCs determined using the fluorometric enzyme immunoassay and alkaline phosphatase values. Of the three assay methods tested, the fluorometric enzyme immunoassay showed the least cross-sensitivity to digoxin-like immunoreactive substance (DLIS).(ABSTRACT TRUNCATED AT 250 WORDS)
研究了三种地高辛检测方法测定肝病患者血清地高辛浓度（SDC）假阳性的发生率及幅度。有肝病生化证据的患者，若从未接受过强心苷治疗、未怀孕、未服用螺内酯、无中度至重度肾功能损害且肝功能检查结果无短暂升高，则纳入本研究。对每位患者的血标本，采用荧光偏振免疫分析法（FPIA，TDx地高辛II，雅培公司）和地高辛放射免疫分析法（RIA，GammaCoat I125，临床检验公司）一式三份检测表观SDC，采用荧光酶免疫分析法（达德Stratus，美国达德公司）一式两份检测。42例患者符合研究标准。RIA法检测出可检测到的表观SDC（大于或等于0.2 ng/mL）的患者百分比为57%，FPIA法为55%，荧光酶免疫分析法为28%。表观SDC范围为0.2至0.6 ng/mL（RIA法）、0.2至1.56 ng/mL（FPIA法）和0.2至0.38 ng/mL（荧光酶免疫分析法）。荧光酶免疫分析法测得的值与RIA法和FPIA法测定的表观SDC有显著差异；然而，RIA法和FPIA法测得的值之间未发现显著差异。RIA法测定的表观SDC与血清胆红素值之间以及荧光酶免疫分析法测定的表观SDC与碱性磷酸酶值之间存在显著相关性。在所测试的三种检测方法中，荧光酶免疫分析法对地高辛样免疫反应物质（DLIS）的交叉敏感性最低。（摘要截取自250字）
