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Clinical Trials |

Sensitivity and Specificity of the AdenoPlus Test for Diagnosing Adenoviral Conjunctivitis

Robert Sambursky, MD; William Trattler, MD; Shachar Tauber, MD; Christopher Starr, MD; Murray Friedberg, MD; Thomas Boland, MD; Marguerite McDonald, MD; Michael DellaVecchia, MD, PhD; Jodi Luchs, MD
JAMA Ophthalmol. 2013;131(1):17-21. doi:10.1001/2013.jamaophthalmol.513.
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Objective To compare the clinical sensitivity and specificity of the AdenoPlus test with those of both viral cell culture (CC) with confirmatory immunofluorescence assay (IFA) and polymerase chain reaction (PCR) at detecting the presence of adenovirus in tear fluid.

Methods A prospective, sequential, masked, multicenter clinical trial enrolled 128 patients presenting with a clinical diagnosis of acute viral conjunctivitis from a combination of 8 private ophthalmology practices and academic centers. Patients were tested with AdenoPlus, CC-IFA, and PCR to detect the presence of adenovirus.

Main Outcome Measures The sensitivity and specificity of AdenoPlus were assessed for identifying cases of adenoviral conjunctivitis.

Results Of the 128 patients enrolled, 36 patients' results were found to be positive by either CC-IFA or PCR and 29 patients' results were found to be positive by both CC-IFA and PCR. When compared only with CC-IFA, AdenoPlus showed a sensitivity of 90% (28/31) and specificity of 96% (93/97). When compared only with PCR, AdenoPlus showed a sensitivity of 85% (29/34) and specificity of 98% (89/91). When compared with both CC-IFA and PCR, AdenoPlus showed a sensitivity of 93% (27/29) and specificity of 98% (88/90). When compared with PCR, CC-IFA showed a sensitivity of 85% (29/34) and specificity of 99% (90/91).

Conclusion AdenoPlus is sensitive and specific at detecting adenoviral conjunctivitis.

Application to Clinical Practice An accurate and rapid in-office test can prevent the misdiagnosis of adenoviral conjunctivitis that leads to the spread of disease, unnecessary antibiotic use, and increased health care costs. Additionally, AdenoPlus may help a clinician make a more informed treatment decision regarding the use of novel therapeutics.

Trial Registration clinicaltrials.gov Identifier: NCT00921895

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Figure. AdenoPlus steps. Sample collection (A), assembly of the test (B), activation of the test by dipping in buffer solution (C), and positive (1 red line and 1 blue line) and negative (1 blue line) test results.

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