Rychert Jenna, Schmidt Robert L, Genzen Jonathan R
Department of Pathology, University of Utah Health, Salt Lake City, UT, USA.
ARUP Laboratories, Salt Lake City, UT, USA.
Am J Clin Pathol. 2023 Sep 1;160(3):297-302. doi: 10.1093/ajcp/aqad051.
To determine the frequency of use of laboratory-developed tests (LDTs) in an academic medical center system.
Retrospective analysis of 2021 test order data from an academic medical center (hospital, outpatient clinics, and cancer center) was done. Measures included assay type, assay methodology, regulatory status, test order volume, inpatient vs outpatient setting, and provider medical specialty.
Of the 3,016,928 tests ordered in 2021, 2,831,489 (93.9%) were tests cleared, approved, and/or authorized by the US Food and Drug Administration (FDA); 116,583 (3.9%) were LDTs; and 68,856 (2.3%) were standard methods. These test orders were performed using a total of 1,954 distinct assays. Of these, 983 (50.3%) were FDA assays, 880 (45.0%) were LDTs, and 91 (4.7%) were standard methods. Laboratory-developed tests were more commonly ordered in the outpatient vs inpatient setting and represented a higher proportion of the test volume at the cancer center compared with the university hospital (5.6% vs 3.6%, respectively). The top 167 LDT assays accounted for 90% of the LDT volume (104,996 orders). Among the 20 most frequently ordered LDTs were mass spectrometry assays and tests used in the care of immunocompromised patients. Internal/family medicine placed the greatest number of orders (1,044,642) and ordered one of the lowest proportions of LDTs (3.2%).
Laboratory-developed tests made up a small percentage of the total laboratory tests ordered within the academic health system studied.
确定学术医疗中心系统中实验室自建检测方法（LDTs）的使用频率。
对一家学术医疗中心（医院、门诊诊所和癌症中心）2021年的检测订单数据进行回顾性分析。分析指标包括检测类型、检测方法、监管状态、检测订单量、住院与门诊环境以及医疗服务提供者的医学专业。
在2021年订购的3,016,928项检测中，2,831,489项（93.9%）是经美国食品药品监督管理局（FDA）批准、认可和/或授权的检测；116,583项（3.9%）是实验室自建检测方法；68,856项（2.3%）是标准方法。这些检测订单总共使用了1,954种不同的检测方法。其中，983种（50.3%）是FDA检测方法，880种（45.0%）是实验室自建检测方法，91种（4.7%）是标准方法。与大学医院相比，实验室自建检测方法在门诊环境中比住院环境中更常被订购，且在癌症中心的检测量中占比更高（分别为5.6%和3.6%）。前167种实验室自建检测方法占实验室自建检测量的90%（104,996份订单）。在最常订购的20种实验室自建检测方法中，包括质谱分析检测方法和用于免疫功能低下患者护理的检测方法。内科/家庭医学科的订单数量最多（1,044,642份），但订购的实验室自建检测方法比例最低（3.2%）。
在所研究的学术医疗系统中，实验室自建检测方法在总实验室检测订单中占比很小。
