Laboratory Evaluation of Representative Disease State Assays on the Abbott ARCHITECT® i2000® Analyzer

W e report here the results of our evaluation of representative disease state assays on the Abbott ARCHITECT i2000 analyzer. The ARCHITECT i-series is a family of immunoassay analyzers under development by Abbott Laboratories (North Chicago, IL, USA). The first instrument available from this family is the i2000 analyzer. The i2000 analyzer is a random access, modular instrument with a maximum throughput of 200 tests per hour and a time to first result of 29 minutes. It is capable of running two step, one step, and automated pretreatment protocols. Modular instrument design allows multiple i2000 analyzers to be combined to form i4000, i6000, and i8000 analyzers with maximum throughputs of 400, 600, and 800 tests per hour, respectively. As either an individual module or multiple integrated modules, the instrument is run by one operator using a single system control center (SCC). The SCC has Windows NT based data management software that is touch screen driven. All assays utilize paramagnetic microparticles for analyte capture, and chemiluminescent detection based on a new class of acridinium compound (sulfonyl acridinium carboxamides) with improved aqueous solubility and stability. The i2000 analyzer has onboard, refrigerated storage for up to 25 reagent kits per module, and reagents are available for a wide range of assays. The purpose of our study was to perform a laboratory evaluation of representative thyroid (TSH, Free T4), fertility (Total b-hCG, FSH, LH, Prolactin, Testosterone) and metabolic (Ferritin) assays on the i2000 analyzer. Our evaluation of these assays included sensitivity, precision, and method comparison testing. In addition, we performed a preliminary evaluation of three i2000 tumor marker assays (Total PSA, Free PSA, and CEA) by comparing specimen correlation to other commercially available methods.