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Sensitivity and Specificity of Red Reflex Test in Newborn Eye Screening. OBJECTIVES: To validate the sensitivity of an isolated red reflex test in detection of ocular abnormalities of the anterior and posterior segments in newborns. STUDY DESIGN: Red reflex test and comprehensive eye examinations including external inspection, pupil examination, hand-held slit lamp examination, and RetCam fundus imaging (Clarity Medical Systems, Pleasanton, California) were performed in 7641 newborns. All results were documented as negative or positive. Sensitivity and specificity of red reflex test were calculated by the use of comprehensive eye examinations as the reference standard. Anterior abnormalities were separated from posterior abnormalities, and the sensitivity of red reflex test for each group was calculated. RESULTS: The proportion of abnormalities that were correctly classified by red reflex test was greater in anterior segment group (sensitivity = 99.6%, 95% CI 97.1%-100%) than in the posterior group (sensitivity = 4.1%, 95% CI 3.3%-5.1%, χ2 = 1521.382, φ = 0.836, P < .001). CONCLUSIONS: The red reflex test was a useful universal screening tool in detection of anterior abnormalities; however, the test has limitations in detection of posterior abnormalities. The generalization of these results to infants and children and observers with varying levels of expertise may need to be established further.