Diagnostic Tests
What Physicians Need to Know
IDx-DR for Diabetic Retinopathy Screening
Am Fam Physician. 2020 Mar 1;101(5):307-308.
IDx-DR is a software program that uses artificial intelligence (AI) to analyze retinal images taken with the Topcon TRC-NW400, a fully automated nonmydriatic retinal camera designed to obtain high-resolution color images of the retina and the anterior segment of the eye. It is approved by the U.S. Food and Drug Administration for diabetic retinopathy screening in adults 22 years and older with diabetes mellitus.
| Test | Indication | Population, age range, and frequency | Cost* |
|---|---|---|---|
IDx-DR | Screening for diabetic retinopathy | Adults 22 years and older with diabetes mellitus who have no history of diabetic retinopathy† Annual unless retinopathy detected | Patient: $101 Practice: The Topcon TRC-NW400 camera costs approximately $15,000 to $22,000 IDx-DR software (the fee charged per analyzed image is unavailable) |
*—Payment rate according to Healthcare Bluebook and Lombart Instrument Co.
†—This is the population indicated for IDx-DR software use. It is not indicated for diabetic retinopathy screening in general.
| Test | Indication | Population, age range, and frequency | Cost* |
|---|---|---|---|
IDx-DR | Screening for diabetic retinopathy | Adults 22 years and older with diabetes mellitus who have no history of diabetic retinopathy† Annual unless retinopathy detected | Patient: $101 Practice: The Topcon TRC-NW400 camera costs approximately $15,000 to $22,000 IDx-DR software (the fee charged per analyzed image is unavailable) |
*—Payment rate according to Healthcare Bluebook and Lombart Instrument Co.
†—This is the population indicated for IDx-DR software use. It is not indicated for diabetic retinopathy screening in general.
Accuracy
Primary care practices can provide diabetic retinopathy screening recommended by the American Diabetes Association using automated digital fundal cameras to obtain images that are transmitted to an ophthalmologist for review.1 The IDx-DR system has been studied previously in international primary care clinics and research trials.2–4 The system used by the University of Wisconsin–Madison Fundus Photograph Reading Center was the reference standard for grading severity of diabetic retinopathy, using a standard protocol from the Early Treatment Diabetic Retinopathy Study.5
The IDx-DR system was studied in 819 adults with diabetes and no previous diagnosis of diabetic retinopathy from 10 primary care practices.6 IDx-DR correctly identified 173 of the 198 patients with more than minimal diabetic retinopathy, with a sensitivity of 87% (95% CI, 82% to 92%) and specificity of 90% (95% CI, 87% to 92%). At a 24% prevalence
References
show all references1. Solomon SD, Chew E, Duh EJ, et al. Diabetic retinopathy: a position statement by the American Diabetes Association [published corrections appear in Diabetes Care. 2017;40(6):809, and Diabetes Care. 2017;40(9):1285]. Diabetes Care. 2017;40(3):412–418....
2. van der Heijden AA, Abramoff MD, Verbraak F, et al. Validation of automated screening for referable diabetic retinopathy with the IDx-DR device in the Hoorn Diabetes Care System. Acta Ophthalmol. 2018;96(1):63–68.
3. Abràmoff MD, Folk JC, Han DP, et al. Automated analysis of retinal images for detection of referable diabetic retinopathy. JAMA Ophthalmol. 2013;131(3):351–357.
4. Hansen MB, Abràmoff MD, Folk JC, et al. Results of automated retinal image analysis for detection of diabetic retinopathy from the Nakuru Study, Kenya. PLoS ONE. 2015;10(10):e0139148.
5. Lawrence MG. The accuracy of digital-video retinal imaging to screen for diabetic retinopathy: an analysis of two digital-video retinal imaging systems using standard stereoscopic seven-field photography and dilated clinical examination as reference standards. Trans Am Ophthalmol Soc. 2004;102:321–340.
6. Abràmoff MD, Lavin PT, Birch M, et al. Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary care offices. NPJ Digit Med. 2018;1:39.
7. Lombart Instrument Co. Mission, Kansas. January 27, 2020.
8. Centers for Medicare and Medicaid Services. Physician fee schedule. Accessed January 2, 2020. https://www.cms.gov/apps/physician-fee-schedule/search/search-results.aspx?Y=0&T=0&HT=0&CT=3&H1=92250&M=5
9. Healthcare Bluebook. Photography of eye. Accessed January 27, 2020. https://www.healthcarebluebook.com/ui/proceduredetails/772?directsearch=true&tab=ShopForCare
This series is coordinated by Kenny Lin, MD, MPH, deputy editor.
A collection of Diagnostic Tests published in AFP is available at https://www.aafp.org/afp/diagnostic.
Copyright © 2020 by the American Academy of Family Physicians.
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