目的:确定在学术医学中心系统中使用实验室开发的测试(LDTs)的频率。
方法:回顾性分析来自学术医学中心(医院,门诊诊所,和癌症中心)完成。措施包括测定类型,测定方法,监管地位,测试订单量,住院与门诊设置,并提供医疗专业。
结果:在2021年订购的3,016,928项测试中,2,831,489项(93.9%)被清除,已批准,和/或经美国食品和药物管理局(FDA)授权;116,583(3.9%)为LDTs;68,856(2.3%)为标准方法。使用总共1,954种不同的测定进行这些测试顺序。其中,983(50.3%)为FDA检测,880(45.0%)为LDTs,91例(4.7%)为标准方法。实验室开发的测试在门诊和住院环境中更常见,并且与大学医院相比,癌症中心的测试量比例更高(5.6%vs3.6%,分别)。前167个LDT测定占LDT体积的90%(104,996个订单)。在20种最常订购的LDT中,有质谱分析和用于免疫受损患者护理的测试。内部/家庭医学订购的订单数量最多(1,044,642),订购的LDT比例最低(3.2%)之一。
结论:在所研究的学术卫生系统中,实验室开发的测试仅占全部实验室测试的一小部分。
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.