Self-Ordering Laboratory Testing Limitations When a Physician Is not Part of the Model

被引:2
作者
Holmes, Daniel T. [1 ,2 ]
机构
[1] St Pauls Hosp, Dept Pathol & Lab Med, 1081 Burrard St, Vancouver, BC V6Z 1Y6, Canada
[2] Univ British Columbia, Dept Pathol & Lab Med, G105-2211 Wesbrook Mall, Vancouver, BC V6T 2B5, Canada
关键词
Direct-to-consumer testing; Genetics; Genomics; FDA; US Food and Drug Administration; CLIA-waived; Point of care; LYME-DISEASE; CHRONIC-FATIGUE;
D O I
10.1016/j.cll.2019.11.002
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
This review discusses considerations related to laboratory diagnostic testing purchased directly by consumers without the care and oversight of a medical doctor. There are necessary tensions between the patient, physician, laboratory medical professional (physician or scientist), laboratory as a corporate entity (where applicable), and manufacturers of diagnostic equipment. When the physician, in particular, the primary care physician, is removed from this relationship, there is a significant opportunity of exploitation of the patient. All downstream investigations following direct-to-consumer testing, including attendant risk, are offloaded onto the traditional medical system, caring physician(s), and patients themselves. This process places patients at risk of iatrogenic harm.
引用
收藏
页码:37 / +
页数:14
相关论文
共 53 条
[1]   Direct-to-Consumer Testing 2.0: Emerging Models of Direct-to-Consumer Genetic Testing [J].
Allyse, Megan A. ;
Robinson, David H. ;
Ferber, Matthew J. ;
Sharp, Richard R. .
MAYO CLINIC PROCEEDINGS, 2018, 93 (01) :113-120
[2]  
[Anonymous], 2018, PHYS TREATM SELF FAM
[3]  
[Anonymous], 2019, CHOOS WIS PROM CONV
[4]  
[Anonymous], 2016, Fortune
[5]  
[Anonymous], 2018, ROCH DIAGN REC COAG
[6]  
[Anonymous], 2019, 2 NAT C SER DIAGN LY
[7]   CHRONIC FATIGUE AND THE CHRONIC-FATIGUE-SYNDROME - PREVALENCE IN A PACIFIC-NORTHWEST HEALTH-CARE SYSTEM [J].
BUCHWALD, D ;
UMALI, P ;
UMALI, J ;
KITH, P ;
PEARLMAN, T ;
KOMAROFF, AL .
ANNALS OF INTERNAL MEDICINE, 1995, 123 (02) :81-88
[8]   Randomized Trial of a Fitbit-Based Physical Activity Intervention for Women [J].
Cadmus-Bertram, Lisa A. ;
Marcus, Bess H. ;
Patterson, Ruth E. ;
Parker, Barbara A. ;
Morey, Brittany L. .
AMERICAN JOURNAL OF PREVENTIVE MEDICINE, 2015, 49 (03) :414-418
[9]  
Cameron Daniel, 2004, Expert Rev Anti Infect Ther, V2, pS1
[10]  
Clarke SE, 2012, BRIT J BIOMED SCI, V69, P83