Kidd Brian A, Hoffman Gabriel, Zimmerman Noah, Li Li, Morgan Joseph W, Glowe Patricia K, Botwin Gregory J, Parekh Samir, Babic Nikolina, Doust Matthew W, Stock Gregory B, Schadt Eric E, Dudley Joel T
J Clin Invest. 2016 May 2;126(5):1734-44. doi: 10.1172/JCI86318. Epub 2016 Mar 28.
Clinical laboratory tests are now being prescribed and made directly available to consumers through retail outlets in the USA. Concerns with these test have been raised regarding the uncertainty of testing methods used in these venues and a lack of open, scientific validation of the technical accuracy and clinical equivalency of results obtained through these services.
We conducted a cohort study of 60 healthy adults to compare the uncertainty and accuracy in 22 common clinical lab tests between one company offering blood tests obtained from finger prick (Theranos) and 2 major clinical testing services that require standard venipuncture draws (Quest and LabCorp). Samples were collected in Phoenix, Arizona, at an ambulatory clinic and at retail outlets with point-of-care services.
Theranos flagged tests outside their normal range 1.6× more often than other testing services (P < 0.0001). Of the 22 lab measurements evaluated, 15 (68%) showed significant interservice variability (P < 0.002). We found nonequivalent lipid panel test results between Theranos and other clinical services. Variability in testing services, sample collection times, and subjects markedly influenced lab results.
While laboratory practice standards exist to control this variability, the disparities between testing services we observed could potentially alter clinical interpretation and health care utilization. Greater transparency and evaluation of testing technologies would increase their utility in personalized health management.
This work was supported by the Icahn Institute for Genomics and Multiscale Biology, a gift from the Harris Family Charitable Foundation (to J.T. Dudley), and grants from the NIH (R01 DK098242 and U54 CA189201, to J.T. Dudley, and R01 AG046170 and U01 AI111598, to E.E. Schadt).
目前在美国，临床实验室检测已通过零售渠道直接提供给消费者并被开具处方。人们对这些检测提出了担忧，涉及这些场所所使用检测方法的不确定性，以及缺乏对通过这些服务获得的检测结果的技术准确性和临床等效性进行公开、科学的验证。
我们对60名健康成年人进行了一项队列研究，以比较一家提供手指采血血液检测的公司（Theranos）与两家需要标准静脉穿刺采血的主要临床检测服务机构（Quest和LabCorp）在22项常见临床实验室检测中的不确定性和准确性。样本在亚利桑那州凤凰城的一家门诊诊所和提供即时检测服务的零售场所采集。
Theranos将检测结果标记在其正常范围之外的频率比其他检测服务机构高1.6倍（P < 0.0001）。在评估的22项实验室测量中，15项（68%）显示出显著的机构间差异（P < 0.002）。我们发现Theranos与其他临床服务机构之间的血脂检测结果不相等。检测服务、样本采集时间和受试者的差异显著影响了实验室结果。
虽然存在实验室操作标准来控制这种差异，但我们观察到的检测服务之间的差异可能会潜在地改变临床解释和医疗保健的利用。提高检测技术的透明度和评估将增加其在个性化健康管理中的效用。
这项工作得到了伊坎基因组学与多尺度生物学研究所的支持，哈里斯家族慈善基金会的一笔赠款（给J.T. 达德利），以及美国国立卫生研究院的赠款（R01 DK098242和U54 CA189201，给J.T. 达德利；R01 AG046170和U01 AI111598，给E.E. 沙德特）。
