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使用Access自动分析仪进行化学发光检测的随机和连续进样免疫分析

Random and continuous-access immunoassays with chemiluminescent detection by Access automated analyzer.

作者信息

Patterson W, Werness P, Payne W J, Matsson P, Leflar C, Melander T, Quast S, Stejskal J, Carlson A, Macera M

机构信息

Sanofi Diagnostics Pasteur, Chaska, MN 55318-1084.

出版信息

Clin Chem. 1994 Nov;40(11 Pt 1):2042-5.

PMID:7955376
Abstract

The Access Immunoassay System is an automated random and continuous-access analyzer for use with heterogeneous enzyme immunoassays. The instrument stores refrigerated reagent packs for as many as 24 different immunoassays. Throughput is 50-100 tests per hour. One- and two-step, and sandwich and competitive formats, each with various incubation times, can be accommodated, and sample sizes can vary from 10 to 200 microL. A paramagnetic microparticle solid phase combines with a chemiluminescent substrate for signal generation. Within-run CVs for noninfectious disease assays were 2.0% to 9.2%; total CVs were 3.4% to 11.1%. Regression analysis of method comparison studies with established procedures yielded slopes of 0.84 to 1.12 and correlation coefficients > or = 0.94 for 12 of 14 assays (range 0.83-0.99). Compared with culture methods, the Access assay for Chlamydia in urogenital specimens demonstrated sensitivity, specificity, and positive and negative predictive values of 90%, 99.7%, 95%, and 99%, respectively.

摘要

Access免疫分析系统是一款用于异质酶免疫分析的自动化随机连续进样分析仪。该仪器可冷藏保存多达24种不同免疫分析的试剂包。每小时的检测通量为50 - 100次。它能采用一步法和两步法,以及夹心和竞争法,每种方法具有不同的孵育时间,样本量可在10至200微升之间变化。顺磁性微粒固相与化学发光底物结合以产生信号。非感染性疾病检测的批内变异系数为2.0%至9.2%;总变异系数为3.4%至11.1%。与既定程序进行方法比较研究的回归分析显示,14项检测中的12项(范围为0.83 - 0.99)斜率为0.84至1.12,相关系数≥0.94。与培养方法相比,Access对泌尿生殖系统标本中衣原体的检测显示敏感性、特异性、阳性预测值和阴性预测值分别为90%、99.7%、95%和99%。

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