Welch Allyn RETeval-DR, Directions For Use Manual

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Performance metrics with primary care prevalence
Percent of tested sample
Predictive power of
test
Positive test Negative test
RETeval
cutoff value
Sensitivity Specificity Positive Negative True False True False
LCL 65% 62% 6% 97% 2.2% 27% 59% 0.1%
UCL 99% 72% 17% 99.9% 6.2% 36% 69% 1.7%
20.0 83% 78% 15% 99% 3.6% 21% 75% 0.7%
LCL 59% 74% 9% 97% 2.0% 17% 71% 0.1%
UCL 96% 82% 23% 99.9% 5.9% 25% 79% 2.1%
21.2 73% 84% 17% 99% 3.1% 15% 80% 1.2%
LCL 47% 80% 9% 97% 1.7% 12% 76% 0.4%
UCL 90% 87% 27% 99.5% 5.3% 19% 84% 2.8%
LCL and UCL represent the lower and upper 95% confidence limits, respectively.
References
Centers for Disease Control and Prevention. 2011. National Diabetes Fact Sheet, 2011.
Edited by US Department of Health and Human Services, Centers for Disease Control
and Prevention.
Maa, A. Y., W. J. Feuer, C. Q. Davis, E. K. Pillow, T. D. Brown, R. M. Caywood, J. E.
Chasan, and S. R. Fransen. 2016. "A novel device for accurate and efficient testing for
vision-threatening diabetic retinopathy." J Diabetes Complications 30 (3):524-32. doi:
10.1016/j.jdiacomp.2015.12.005.
Wilkinson, C. P., F. L. Ferris, 3rd, R. E. Klein, P. P. Lee, C. D. Agardh, M. Davis, D. Dills,
A. Kampik, R. Pararajasegaram, J. T. Verdaguer, and Group Global Diabetic Retinopathy
Project. 2003. "Proposed international clinical diabetic retinopathy and diabetic macular
edema disease severity scales." Ophthalmology 110 (9):1677-82. doi: 10.1016/
S0161-6420(03)00475-5.
Zhang, X., J. B. Saaddine, C. F. Chou, M. F. Cotch, Y. J. Cheng, L. S. Geiss, E. W. Gregg,
A. L. Albright, B. E. Klein, and R. Klein. 2010. "Prevalence of diabetic retinopathy in the
United States, 2005-2008." JAMA 304 (6):649-56. doi: 10.1001/jama.2010.1111.
Warranty
Welch Allyn, Inc. warrants that the RETeval-DR product meets its labeled specifications
and will be free from defects in materials and workmanship that occur within 1 year of
shipment. This warranty does not cover damage caused by: 1) attempted disassembly or
repair by anyone not authorized by Welch Allyn, 2) failure to follow instructions for use
and maintenance, or 3) accidental drops or impacts. If the RETeval-DR product covered
by this warranty malfunctions due to a defect in material or workmanship within the 1
54 Appendices Welch Allyn
®
RETeval-DR
™