Oed M, Amtmann R, Löwer Y, Schlett R, Mack M
Byk-Sangtec Diagnostica, Dietzenbach, Germany.
Anticancer Res. 1999 Jul-Aug;19(4A):2735-7.
An immunoassay utilizing chemiluminescence and paramagnetic particles has been developed for the new fully automated, random access LIAISON immunoanalyzer. The LIAISON hCG assay is a two-site immunolouminometric one-step assay using two highly specific monoclonal antibodies. Total incubation time is only 10 min. A specially designed unique Reagent Integral contains all specific reagents; the on-board stability of these reagents is given over a very long period (> 4 weeks). The assay works with a 2-point calibrated master curve. 30 microliters sample is added to 200 microliters tracer and 20 microliters antibody-coated magnetic particles. After 10 min incubation the particles are separated, washed and the chemiluminescent signal is generated. The time to first result is only 15 min. The assay with a unique extended standard range up to 5,000 ng/ml shows no high dose hook effect up to 500,000 mlU/ml (spiked sera). The assay detects both the intact molecule and the free beta subunit. The cross-reactivity to FSH, LH and TSH is less than 0.1%. Precision (within-run < 3%; between-run < 5%), linearity, recovery and sensitivity (< 0.5 mlU/ml) are excellent. The assay shows a very good correlation to the LIA-mat hCG (r = 0.996). In summary the LIAISON hCG assay together with the new LIAISON immunoanalyzer is a very rapid and accurate method for the quantitative determination of hCG/beta-hCG in serum.
已为新型全自动随机存取LIAISON免疫分析仪开发了一种利用化学发光和顺磁性颗粒的免疫测定法。LIAISON hCG测定法是一种两点免疫荧光定量一步测定法，使用两种高度特异性的单克隆抗体。总孵育时间仅为10分钟。一种专门设计的独特试剂组合包含所有特定试剂；这些试剂在仪器上的稳定性长达很长一段时间（>4周）。该测定法采用两点校准的主曲线。将30微升样品加入200微升示踪剂和20微升抗体包被的磁性颗粒中。孵育10分钟后，分离、洗涤颗粒并产生化学发光信号。首次出结果的时间仅为15分钟。该测定法具有独特的扩展标准范围，高达5000 ng/ml，在高达500000 mlU/ml（加标血清）时无高剂量钩状效应。该测定法可检测完整分子和游离β亚基。与FSH、LH和TSH的交叉反应率小于0.1%。精密度（批内<3%；批间<5%）、线性、回收率和灵敏度（<0.5 mlU/ml）都非常出色。该测定法与LIA-mat hCG显示出非常好的相关性（r = 0.996）。总之，LIAISON hCG测定法与新型LIAISON免疫分析仪一起是一种非常快速且准确的定量测定血清中hCG/β-hCG的方法。
