化学发光免疫法和放免分析法测定血清地高辛浓度的比较

目的 :探索化学发光免疫法 (CLIA)和放免分析法 (RIA)测定血清地高辛的相关性。方法 :采用CLIA和RIA测定血清地高辛浓度。结果 :两者测定值 ,经配对t检验 ,P >0 0 5 ;经回归分析呈线性关系 ,方程为YCLIA=0 97XRIA- 0 0 3 ,r =0 9886(n =3 6) ,在 0～ 4 0ng·mL-1间线性良好 ,差异无显著意义 (P >0 0 5 )。两者的最低检测浓度为 0 0 1ng·mL-1,日内、日间RSD均 <10 % ,回收率 >95 %。结论 :2种方法测定地高辛血药浓度同样准确、可信 ,可互相替代     

化学发光免疫分析在T3、T4测定中的应用

化学发光免疫分析法(ChemiluminesentImmunoassayAssay,CLIA)是一种微量生物活性物质定量测定技术,具有灵敏度高、特异性强、重复性好、测定范围较宽、试剂稳定性好、操作简单以及易于自动化等优点。CLIA是取代放射免疫分析法(RIA)的首选方法之一。用CLIA取代RIA时,应建立本实验室CLIA检查项目的正常参考值范围。长期以来,各实验室已对RIA检查项目建立了自已的正常参考值范围。我们对35例T3、T4 (三碘甲腺原氨酸、甲状腺素)检查样本同时进行RIA测定和CLIA测定[1],以了解CLIA是否可引用RIA的正常参考值范围及在CLIA操作…     

化学发光免疫法与放射免疫法检测血清AFP临床分析

目的探讨化学发光免疫法（CLIA）较放射免疫法（RIA）的优越性。方法采用放射免疫法（RIA）和化学发光免疫法（CLIA）平行测定52例临床送检血清标本的甲胎蛋白（AFP）含量。结果放射免疫法和化学发光免疫法之间无显著差异（P〉0.05）,相关性好（r=0.995）。结论化学发光免疫法的精密度和准确性均优于放射免疫法。     

化学发光免疫测定技术用于甲状腺肿瘤患者免疫检验中的价值

目的 分析甲状腺肿瘤患者采用化学发光免疫（CLIA）测定法性免疫检测的价值。方法 对2021年1～12月我院收治的80例疑似甲状腺肿瘤患者行免疫检验,采用免疫放射分析法（RIA）、CLIA检验,将其结果与最终病理结果对比以评价诊断效能。通过2种方式测定甲状腺激素、甲状腺球蛋白水平/个数,探讨不同方法的诊断价值。结果 最终确诊的甲状腺肿瘤患者71例。RIA、CLIA检验结果分别确诊58例、69例。其中CLIA检验诊断效能指标、甲状腺激素、甲状腺球蛋白水平/个数、抗体阳性检出率均高于RIA检验,P <0.05。CLIA检验平均耗时短于RIA检验,P <0.05。结论 免疫检测是甲状腺肿瘤重要诊断方式之一,应用CLIA测定法能够获得较为理想的效果,诊断优势显著、操作时间更短,准确性、简便性方面均更符合临床需求。同时,CLIA相较于RIA测定更能反映各项甲状腺指标,生化免疫阳性率敏感,是一种可行性较强的免疫检验技术。     

儿童地高辛血药浓度监测及影响因素分析

目的:观察地高辛血药浓度监测对患儿个体化用药的作用.方法:应用化学发光免疫法(CLIA)测定地高辛血药浓度,并对结果进行分析.结果:161例患儿中在有效血药浓度范围内(0.8～2.0 ng/mL)为79例(占49.1%),小于0.8 ng/mL 74例(占46.0%),大于2.0 ng/mL 8例(占4.9%).结论:应从患儿个体的药效学、药动学出发,结合血药浓度监测及临床观察,在注重防止地高辛中毒反应的同时,使患儿的治疗达到有效、合理、安全.     

229例地高辛血药浓度监测结果分析

目的 了解本院地高辛血药浓度监测病人的结果与临床疗效的关系,分析影响地高辛血药浓度的因素,为临床安全用药提供科学依据。方法 用放射免疫分析法(radioimmunoassay,RIA)监测地高辛的血药浓度,结合临床资料进行统计和分析。结果 在229例地高辛血药浓度监测病人的结果中,位于治疗血药浓度范围内的有152例(占66.38％),低于治疗血药浓度范围的有53例(占23.14％),高于治疗血药浓度范围的有24例(占10.48％)。结论 地高辛吸收个体差异大,治疗指数低,安全范围窄,及时监测血药浓度,对临床治疗有一定的指导意义。     

环孢素血药浓度监测方法评价

目前测定环抱素血药张度的方法主要有高效液相色谱法（HPLC）、荧光偏振免疫法（FPIA）、高效液相质谱联用法（HPLC／Ms）、高效毛细管电泳（HPCE）、放射免疫法（RIA）和受体结合法（RBA）。各种监测方法各具优缺点,监测结果具有一定的相关性。实际工作中应根据测定的需求。结合实验室仪器设备条件．选择具体的监测方法。     

229例地高辛血药浓度监测结果分析

目的了解本院地高辛血药浓度监测病人的结果与临床疗效的关系,分析影响地高辛血药浓度的因素,为临床安全用药提供科学依据.方法用放射免疫分析法(radioimmunoassay,RIA)监测地高辛的血药浓度,结合临床资料进行统计和分析.结果在229例地高辛血药浓度监测病人的结果中,位于治疗血药浓度范围内的有152例(占66.38%),低于治疗血药浓度范围的有53例(占23.14%),高于治疗血药浓度范围的有24例(占10.48%).结论地高辛吸收个体差异大,治疗指数低,安全范围窄,及时监测血药浓度,对临床治疗有一定的指导意义.     

196例地高辛血药浓度监测及影响因素分析

目的讨论嘉兴地区人群影响血清地高辛浓度（SDC）的因素,为临床合理用药提供参考。方法收集2007年1月至2010年9月196例用CLIA法测得地高辛血药浓度监测表并翻阅病程记录,手工统计并分析。结果 50%的患者血清地高辛浓度处于有效范围以内,20%以上的患者出现中毒现象,其中又以女性为主。结论 SDC个体差异较大,影响因素较多。女性较男性易于发生地高辛中毒反应,不同病因、病理生理因素以及合用药物均能影响血清地高辛浓度,应当设计个体给药方案,是确保临床效果和用药安全的重要措施。药师在地高辛的合理用药中应发挥更多的作用。     

两种方法检测血浆甲状腺球蛋白的效果比较

目的 比较放射免疫分析法(RIA)和化学发光免疫分析法(CUA)在测定血浆甲状腺球蛋白(TG)中的应用效果.方法 对健康者(对照组,50例)、甲状腺肿瘤组(46例)、甲状腺功能亢进(甲亢)组(50例)及其他甲状腺疾病组(52例)分别采用RIA和CLIA检测血浆TG浓度,比较两种检测方法的灵敏性和符合率.结果 RIA和CLIA检测结果中甲状腺肿瘤组、甲亢组及其他甲状腺疾病组TG水平与对照组差异均有统计学意义(t=16.35、8.36、6.54、18.65、10.25、8.32,均P＜0.05).CLIA检测甲状腺肿瘤组和其他甲状腺疾病组灵敏性明显高于RIA(x2=5.32:.64,均P＜0.05).RIA测定总符合率为89.39％ (177/198), CLIA测定总符合率为96.97％ (192/198),两种方法差异有统计学意义(x2 =8.94,P＜0.05).结论 CLIA在检测血清TG浓度上具有很高的灵敏度,与RIA有较高的符合率,可以替代RIA.     

Measuring endogenous digoxin-like substance and exogenous digoxin in the serum of low-birth-weight infants

The interference with three serum digoxin assay methods of endogenous digoxin-like substance (EDLS) in the serum of low-birth-weight (LBW) infants was assessed. The serum from 5-mL blood samples obtained from each of 19 LBW infants was divided into four 0.5-mL portions. Each portion was spiked with 10 microL of a distilled water-ethanol solution with or without digoxin to produce final digoxin concentrations of 0 (control), 0.49, 0.98, or 1.96 ng/mL. Each portion in each patient was then analyzed by radioimmunoassay (RIA), fluorescence polarization immunoassay (FPIA), and radial partition immunoassay (RPIA) using the control portions to measure EDLS. Serum digoxin concentrations measured by each assay method were calculated by subtracting the EDLS concentrations in the control portions from the measured digoxin concentrations in the spiked samples. The mean +/- S.D. concentrations of EDLS measured by RIA and FPIA were 0.26 +/- 0.13 ng/mL and 0.33 +/- 0.16 ng/mL, respectively. Of the 19 control samples assayed by RPIA, 18 had EDLS concentrations less than 0.1 ng/mL; one sample reflected an apparent concentration of 0.11 ng/mL. Mean recovered digoxin concentrations by RIA at each spiked digoxin concentration were significantly different from those obtained by FPIA and RPIA. A low but significant correlation was noted between EDLS concentrations in serum samples assayed by RIA and FPIA. The RPIA method appears to be preferred over the RIA and FPIA methods used in this study for serum digoxin analysis in LBW infants because of acceptable accuracy and minimal interference by EDLS.     

荧光偏振免疫法和放射免疫分析法测定血液中地高辛浓度的比较

采用荧光偏振免疫分析法和放射免疫分析法测定血液中地高辛浓度，两法测定结果相似，差异无显著意义（Ｐ＞０．０５）。对较低的血药浓度，荧光偏振免疫分析法的灵敏度较高，且操作简单、快速。     

Effect of Chinese medicines Chan Su and Danshen on EMIT 2000 and Randox digoxin immunoassays: wide variation in digoxin-like immunoreactivity and magnitude of interference in digoxin measurement by different brands of the same product

Chan Su is a Chinese medicine prepared from the skin gland of a Chinese toad and is used in treating arrhythmia and other heart diseases. Danshen is prepared from the Chinese medicinal plant and is used for various cardiovascular diseases including angina pectoris. The authors studied the potential interference of such medicines with the widely used EMIT 2000 (Dade Behring; Deerpark, IL) digoxin assay and the recently marketed Randox digoxin assay (Randox Laboratories Ltd, Antrim, United Kingdom) (both run on the Bayer ADVIA 1650 analyzer) (Bayer Diagnostics, Tarrytown, NY) and compared their results with an FPIA (Abbott Laboratories) and a chemiluminescent immunoassay (CLIA; Bayer Diagnostics) for digoxin. Aliquots of drug-free serum were supplemented with 1 microL ethyl acetate extract of Danshen or aqueous extract of Chan Su, and apparent digoxin concentrations were measured by all four digoxin immunoassays (FPIA, EMIT, Randox, CLIA). The authors also supplemented aliquots of several different serum pools prepared from patients taking digoxin with very small amounts of Chan Su or Danshen extract and compared digoxin values with the control digoxin values (serum pool containing no Chinese medicine). The authors observed no interference of Danshen in either EMIT, Randox, or CLIA assay but observed an interference with the FPIA assay. On the other hand, the authors observed high interference of Chan Su in the FPIA assay but moderate interference with the EMIT 2000 and Randox digoxin assays. CLIA assay was again free from any interference. The authors also observed a wide variation in digoxin-like immunoreactivity and magnitude of interference in digoxin immunoassay in different brands of Chan Su and Danshen, indicating poor quality control in manufacturing of these Chinese medicines. Taking advantage of the high protein binding of digoxin-like immunoreactive components of Chan Su, the authors further demonstrated that interference of Chan Su in EMIT 2000 and Randox assays can be mostly eliminated by monitoring free digoxin.     

Development of radioimmunoassay for measurement of serum digoxin in digitalized patients using novel anti-digoxin antiserum

There is an antiserum elicited by digoxin 3'-hemisuccinate-bovine serum albumin (BSA) conjugate possessing high specificity for digoxin. Our study focused on development of RIA using this novel antiserum for measurement of digoxin in serum from digitalized patients. The property of the new antiserum was investigated by RIA with digoxin 3'-hemisuccinyl-[3H]leucine. The separation of bound and free fractions was performed using a dextran-coated charcoal suspension. The new antiserum bound approximately 50% of digoxin 3'-hemisuccinyl-[3H]leucine with a final dilution of 1:30000. The intra- and inter-assay coefficients of variation were <9% in the range of 0.52-4.17 ng/ml. The mean digoxin concentration in serum samples (n=35) from digitalized patients was estimated to be 0.68 ng/ml, which was lower than its measurement of digoxin with the commercial antidigoxin BSA serum and monoclonal anti-digoxin. It is apparent that the RIA described here has sufficient precision. The RIA system was available for the measurement of digoxin in serum from digitalized patients.     

Lack of apparent effect of assay methodology on the pharmacokinetics of digoxin

The purpose of this study was to determine if serum digoxin concentration data using three different automated immunoassay methods would produce similar pharmacokinetic values in normal volunteer subjects. Area under the curve (AUC), steady-state volume of distribution/bioavailability ratio (Vd/F), terminal elimination rate constant (beta), clearance/bioavailability ratio (CL/F), maximum digoxin concentration (Cmax), minimum digoxin concentration (Cmin), and time of peak (Tp) were evaluated. Ten healthy volunteers received digoxin capsules 0.2 mg daily for 10 days. On day 10, 16 serial blood samples were collected over a 24-h dosing interval and analyzed by radioimmunoassay (RIA) (Concept 4, Micromedic Systems), fluorescence polarization immunoassay (FPIA) (TDx, Abbott Laboratories), and affinity column-mediated immunoassay (ACMIA), (aca, duPont Instruments). When comparing RIA and FPIA, the mean of the percent differences for AUC, Vd/F, beta, and CL/F were 9, 4, 10, and 6%, respectively. The mean of the percent differences were 2, 3, 44, and 6%, respectively, when comparing RIA and ACMIA. However, none of these differences were statistically significant. Although a trend toward higher Cmax values by RIA was noted, there was no statistical difference in Cmax, Cmin, and Tp. Orthogonal regression of all serum digoxin concentrations showed that FPIA = 0.76 RIA + 0.19, r = 0.967 (p less than 0.001); and ACMIA = 0.92 RIA + 0.04, r = 0.943 (p less than 0.001). At serum digoxin concentrations less than 1 ng/ml, FPIA overestimated RIA results (p less than 0.005), while ACMIA was approximately equal to the RIA results.(ABSTRACT TRUNCATED AT 250 WORDS)     

Rapid detection of oleander poisoning using digoxin immunoassays: comparison of five assays

Oleander is an ornamental shrub that grows in the United States, Australia, India, Sri Lanka, China, and other parts of the world. All parts of the plant are poisonous because the presence of cardiac glycoside oleandrin. Despite its toxicity, oleander extract is used in folk medicines. Because of its structural similarity, oleandrin cross-reacts with the fluorescence polarization immunoassay (FPIA) for digoxin. We studied the potential of detecting oleandrin in serum using 5 common digoxin immunoassays (FPIA, MEIA, both from Abbott; Beckman digoxin assay on Synchron LX, Chemiluminescent assay, CLIA from Bayer Diagnostics) and a recently FDA-approved turbidimetric assay on the ADVIA 1650 analyzer (Bayer). Aliquots of drug-free and digoxin-like immunoreactive substances (DLIS)-free serum pools were supplemented with ethanol extract of oleander leaves or oleandrin (Sigma Chemicals) in amounts expected in vivo after severe overdose. We observed significant apparent digoxin concentration with FPIA, Beckman, and the new turbidimetric assay (1 mL drug-free serum supplemented with 5.0 microL of oleander extract: apparent digoxin 2.36 ng/mL by the FPIA, 0.32 ng/mL by the MEIA, 0.93 ng/mL by the Beckman, 0.82 ng/mL by the new turbidimetric assay). The CLIA showed no cross-reactivity. Similar observations were made when serum pools were supplemented with oleandrin. Because cross reactivity should be tested in the presence of the primary analyte, we supplemented serum pools prepared from patients receiving digoxin with oleander extract or oleandrin. The measured digoxin concentrations were falsely elevated with the FPIA, Beckman, and turbidimetric assays, the highest false elevation being observed with the FPIA. Surprisingly, apparent digoxin concentrations were falsely lowered when MEIA was used. Digibind neutralizes free apparent digoxin concentration in vitro in serum pools supplemented with oleander extract, and this effect can be measured by the FPIA. We conclude that FPIA is most sensitive to detect the presence of oleander in serum. In contrast, the CLIA (no cross-reactivity) should be used for monitoring digoxin in a patient receiving digoxin and self-medicated with a herbal remedy containing oleander.     

New enzyme-linked immunosorbent digoxin assay on the ADVIA IMS 800i system is virtually free from interference of endogenous digoxin-like immunoreactive factors

Endogenous digoxin-like immunoreactive factors (DLIF) may crossreact with antidigoxin antibody and falsely elevate immunoassay results. Recently, a new enzyme-linked immunosorbent chemiluminescent assay for digoxin has been available for use on the ADVIA IMS (Integrated Modular System) 800i analyzer (Bayer Diagnostics). We studied potential interference of DLIF with this new digoxin assay. We analyzed 30 serum specimens from patients who have pathologic conditions that may increase serum DLIF concentrations. These patients were never exposed to digoxin or other agents that may lead to a measurable digoxin concentration. We also analyzed 10 specimens from neonates, 10 cord blood specimens, and 10 amniotic fluid specimens. Apparent digoxin concentrations were measured using the new enzyme-linked immunosorbent digoxin assay (IMS-Digoxin), a fluorescence polarization immunoassay (FPIA), and also a chemiluminescent immunoassay (CLIA, run on ACS:180(R) system from Bayer Diagnostics). We observed measurable apparent digoxin levels with the FPIA in 4 uremic patients (range 0.21-0.36 ng/mL, digoxin equivalent), 7 patients with liver disease (range 0.21-0.72 ng/mL), and 3 patients in the third trimester of pregnancy (0.22-0.66 ng/mL). We also observed measurable DLIF concentrations with the FPIA in 2 neonates (0.22 and 0.36 ng/mL), 5 cord blood specimens (range 0.21-1.18 ng/mL), and 5 amniotic fluid specimens (0.21-0.50 ng/mL). None of these DLIF-positive specimens showed any measurable digoxin concentration using the IMS-Digoxin or the CLIA assay. When serum specimens containing elevated concentrations of DLIF but no digoxin (as measured by FPIA) were supplemented with known concentrations of digoxin, we observed falsely elevated digoxin concentrations, as expected, only by the FPIA. In contrast, we observed a good agreement between the target and observed concentrations when the new IMS-Digoxin or the CLIA assay was used. We conclude that the IMS-Digoxin assay is free from interference of DLIF.     

Interference of endogenous digoxin-like immunoreactive factors in serum digoxin measurement is minimized in a new turbidimetric digoxin immunoassay on ADVIA 1650 analyzer

Endogenous digoxin-like immunoreactive factors (DLIF) cross-react with antidigoxin antibody and falsely elevate or lower measured serum digoxin concentrations, depending on the assay design. Recently, Bayer Diagnostics released a turbidimetric assay for digoxin on the ADVIA 1650 analyzer. We studied potential interference of DLIF with this new digoxin assay. We analyzed 40 serum specimens from patients who have pathologic conditions that may increase serum DLIF concentrations. These patients were never exposed to digoxin or other agents that may lead to a measurable digoxin concentration. We also analyzed five specimens from autopsy and five specimens from neonates. Apparent digoxin concentrations were measured using the new turbidimetric digoxin assay, the fluorescence polarization immunoassay (FPIA, Abbott Laboratories, Abbott Park, IL), and also the chemiluminescent immunoassay (CLIA, Bayer Diagnostics). We observed measurable apparent digoxin levels with the FPIA in 5 uremic patients (range 0.24-0.86 ng/mL), 6 patients with liver disease (range 0.21-0.72 ng/mL), in 3 patients in the third trimester of pregnancy (0.21-26 ng/mL), and in 3 neonates (range 0.21-0.46 ng/mL). Four out of 5 autopsy specimens showed measurable apparent digoxin concentrations (0.23-0.81 ng/mL). In contrast, only 1 specimen (a uremic patient) showed an apparent digoxin concentration of 0.26 ng/mL with the turbidimetric digoxin immunoassay (FPIA value 0.86 ng/mL, CLIA value 0.32 ng/mL). Because DLIF is absent in the protein-free ultrafiltrate, we also measured free digoxin concentrations in DLIF-positive patients to ensure that the apparent digoxin concentrations were caused by DLIF. We observed no apparent digoxin concentrations in the protein-free ultrafiltrate in any DLIF-positive specimens. When serum specimens containing elevated concentrations of DLIF but no digoxin were supplemented with a known concentration of digoxin, we observed falsely elevated digoxin concentrations by the FPIA, as expected. In contrast, we observed a good agreement between the target and observed concentrations when the new turbidimetric assay was used. We conclude that DLIF has minimal effect on serum digoxin measurements by the new turbidimetric assay.     

Interference of digoxin-like immunoreactive substances with three digoxin immunoassays in patients with various degrees of renal function

The effect of renal function and digoxin use in adult patients on interference from digoxin-like immunoreactive substances (DLIS) with three digoxin immunoassays was studied. Hospital patients entered into the study were categorized into the following groups according to renal function: group I (serum creatinine less than 1.5 mg/dL), group II (serum creatinine 1.5-2.5 mg/dL), group III (serum creatinine greater than 2.5 mg/dL, not on hemodialysis), and group IV (serum creatinine greater than 2.5 mg/dL, on maintenance hemodialysis). Medical records were reviewed to determine whether or not patients were receiving digoxin. Excess sera for analysis of serum digoxin concentrations (SDCs) was collected from routine laboratory tests. Serum samples were assayed singly by fluorescence polarization immunoassay (FPIA, Digoxin I, Abbott), radioimmunoassay (RIA, Micromedic), and affinity-column-mediated immunoassay (ACMIA, aca, E.I. du Pont). Correlation of SDCs obtained by RIA and ACMIA with FPIA results was determined using linear-regression analysis. A total of 177 patients met the study criteria; 98 were receiving digoxin. In patients on digoxin, SDCs by RIA were significantly higher than those obtained by FPIA in group II and III patients. SDCs obtained by ACMIA correlated well with and were not significantly different from those obtained by FPIA in any of the patient groups. Maximum differences and mean absolute differences in SDCs obtained by RIA were greater than those for ACMIA when compared with FPIA values in all patient groups. Over 40% of patients with renal dysfunction not on digoxin had false-positive SDCs by RIA; the highest of these values was seen in groups II and III.(ABSTRACT TRUNCATED AT 250 WORDS)     

False-positive serum digoxin concentrations determined by three digoxin assays in patients with liver disease

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)