Broussard L A, Hanson L
Department of Medical Technology, Louisiana State University Medical Center, New Orleans 70112, USA.
Clin Lab Sci. 1997 Mar-Apr;10(2):83-6.
To establish optimal performance parameters (ratios of sample and reagents, reaction time, and distinction of absorbance values between calibrators) on the Roche Cobas Mira analyzer for the evaluation of Diagnostic Reagents Inc enzyme immunoassay reagents for urine screening of amphetamines, cannabinoids, cocaine metabolite, opiates, and phencyclidine.
Laboratory in a physician's office.
Two laboratorians analyze a daily average of 25 urine samples for employment screening purposes. PRODUCT COMPARISON: DRI reagents were compared to Syva EMIT reagents.
Within-run and between-run precision at the cutoff concentration for DRI reagents ranged from 1.1% to 1.6% CV and 2.2% to 5.7% CV respectively. Results (positive or negative) using DRI or Syva EMIT reagents were identical for cannabinoids, cocaine metabolite, opiates and PCP. Direct comparison for amphetamines was not possible because of different cutoff concentrations of the 2 reagents systems.
DRI reagents are acceptable alternatives to EMIT reagents for the analysis of amphetamines, cannabinoids, cocaine metabolite, opiates and phencyclidine in urine on the Cobas Mira analyzer. Utilization of DRI reagents for more than 12 months demonstrated the reliability of the reagents and allowed cost comparison.
DRI = Diagnostic Reagents Inc; EMIT = enzyme multiplied immunoassay technique; d.a.u. = drugs of abuse; PCP = phencyclidine; GC/MS = gas chromatography/mass spectrometry.
在罗氏Cobas Mira分析仪上确定最佳性能参数（样本与试剂比例、反应时间以及校准品吸光度值的差异），以评估诊断试剂公司用于尿液中苯丙胺、大麻素、可卡因代谢物、阿片类药物和苯环利定筛查的酶免疫分析试剂。
医生办公室实验室。
两名实验室技术人员为就业筛查目的每天平均分析25份尿液样本。
将诊断试剂公司的试剂与Syva EMIT试剂进行比较。
诊断试剂公司试剂在临界浓度下的批内精密度和批间精密度的变异系数分别为1.1%至1.6%和2.2%至5.7%。使用诊断试剂公司或Syva EMIT试剂检测大麻素、可卡因代谢物、阿片类药物和苯环利定的结果（阳性或阴性）相同。由于两种试剂系统的临界浓度不同，无法对苯丙胺进行直接比较。
在Cobas Mira分析仪上，诊断试剂公司的试剂是用于尿液中苯丙胺、大麻素、可卡因代谢物、阿片类药物和苯环利定分析的EMIT试剂的可接受替代品。使用诊断试剂公司的试剂超过12个月证明了试剂的可靠性，并可进行成本比较。
DRI = 诊断试剂公司；EMIT = 酶放大免疫分析技术；d.a.u. = 滥用药物；PCP = 苯环利定；GC/MS = 气相色谱/质谱联用
