Razatos Gerasimos, Luthi Ruth, Kerrigan Sarah
New Mexico Department of Health, Scientific Laboratory Division, Toxicology Bureau, P.O. Box 4700, Albuquerque, NM 87196-4700, USA.
Forensic Sci Int. 2005 Oct 4;153(1):17-21. doi: 10.1016/j.forsciint.2005.04.030.
The Scientific Laboratory Division (SLD) of the Department of Health acts by mandate as the regulatory agency for the Implied Consent Program for the State of New Mexico. The Laboratory is responsible for all blood and breath alcohol testing activities for law enforcement statewide. The geographical size and the nature of the state, characterized by a highly rural population, demands portable breath alcohol testing equipment. Moreover, future expansion and success of the breath-testing program has focused on instrument portability and data management as critical issues amongst law enforcement agencies and the courts. Thus, the Implied Consent Section of the SLD evaluated the performance of the Intoxilyzer 8000, a portable instrument, against the Intoxilyzer 5000, a stationary instrument, which is currently approved for use. Instrument performance was evaluated at various ethanol concentrations, ranging from 0.04 to 0.55 g/100mL in blood or g/210 L breath. Special attention was placed on instrument performance at the per se and aggravated DWI levels of 0.08 g/100mL and 0.16 g/dL, respectively, due to their legal significance. Precision and accuracy were evaluated using in-house ethanol controls in a wet bath simulator. Coefficients of variation using the Intoxilyzer 8000 ranged from 0.30 to 1.3% (n=102), while CVs for the Intoxilyzer 5000 were 0.7-2.1% (n=102). Calibration stability was assessed in addition to the distribution of data at concentrations between 0.04 and 0.55 g/210 L. Accuracy was 100-102% for the Intoxilyzer 5000 and 99-101% using the Intoxilyzer 8000. Linear regression analysis of more than 700 comparative measurements revealed an R(2) of 1.000 (y=1.005x-0.001), where the Intoxilyzer 5000 and the Intoxilyzer 8000 were plotted on the x- and y-axis respectively. Instrument response to mouth alcohol and volatile interferences was also investigated. Potential interferences were evaluated alone or in combination with ethanol using a wet bath simulator at 34.0 degrees C. The effects of extreme temperature and altitude were also examined using wet bath simulators and dry gas calibrant. Accuracy and precision were evaluated at high and low temperatures. High altitude performance was evaluated at 3534 m above sea level at a local ski resort. In addition to the scientific study, field evaluations were also conducted by law enforcement personnel. Based upon the results of the study, the Intoxilyzer 8000 was approved as an evidential breath alcohol analyzer in the State of New Mexico.
新墨西哥州卫生部科学实验室司（SLD）受委托作为该州默示同意计划的监管机构。该实验室负责全州执法部门的所有血液和呼气酒精检测活动。该州地域广阔且以农村人口居多的特点，需要便携式呼气酒精检测设备。此外，呼气测试项目未来的扩展和成功将仪器便携性和数据管理视为执法机构和法院的关键问题。因此，SLD的默示同意部门评估了便携式Intoxilyzer 8000与目前已获批使用的固定式Intoxilyzer 5000的性能。在血液中乙醇浓度为0.04至0.55 g/100mL或呼气中乙醇浓度为0.04至0.55 g/210L的各种浓度下对仪器性能进行了评估。由于其法律意义，特别关注了在法定酒驾水平为0.08 g/100mL和加重酒驾水平为0.16 g/dL时的仪器性能。在水浴模拟器中使用内部乙醇对照评估精密度和准确度。Intoxilyzer 8000的变异系数范围为0.30%至1.3%（n = 102），而Intoxilyzer 5000的变异系数为0.7%至2.1%（n = 102）。除了评估0.04至0.55 g/210L浓度之间的数据分布外，还评估了校准稳定性。Intoxilyzer 5000的准确度为100%至102%，Intoxilyzer 8000的准确度为99%至101%。对700多次比较测量进行线性回归分析得出R²为1.000（y = 1.005x - 0.001），其中Intoxilyzer 5000和Intoxilyzer 8000分别绘制在x轴和y轴上。还研究了仪器对口腔酒精和挥发性干扰物的响应。使用34.0摄氏度的水浴模拟器单独或与乙醇组合评估潜在干扰物。还使用水浴模拟器和干气校准剂检查了极端温度和海拔的影响。在高温和低温下评估准确度和精密度。在当地一个滑雪胜地海拔3534米处评估了高海拔性能。除了科学研究外，执法人员还进行了现场评估。根据研究结果，Intoxilyzer 8000在新墨西哥州被批准为证据呼气酒精分析仪。
