Sensitivity and specificity of the AdenoPlus test for diagnosing adenoviral conjunctivitis

Autor: Christopher E. Starr, Thomas Boland, Michael DellaVecchia, Marguerite B. McDonald, William Trattler, Robert Sambursky, Shachar Tauber, Jodi Luchs, Murray Friedberg
Rok vydání: 2013
Předmět:
Adult
Male
medicine.medical_specialty
Virus Cultivation
Adolescent
medicine.drug_class
Antibiotics
Viral Conjunctivitis
Fluorescent Antibody Technique
Diagnostic Techniques
Ophthalmological

Immunofluorescence
Gastroenterology
Polymerase Chain Reaction
Sensitivity and Specificity
law.invention
Adenovirus Infections
Human

Conjunctivitis
Viral

Young Adult
Randomized controlled trial
Double-Blind Method
law
Predictive Value of Tests
Internal medicine
medicine
Humans
False Positive Reactions
Prospective Studies
Prospective cohort study
Child
Antigens
Viral

Polymerase chain reaction
Aged
Aged
80 and over

medicine.diagnostic_test
business.industry
Adenoviruses
Human

Reproducibility of Results
Middle Aged
Clinical trial
Ophthalmology
Predictive value of tests
Child
Preschool

Tears
Immunology
Acute Disease
DNA
Viral

Female
business
Zdroj: JAMA ophthalmology. 131(1)
ISSN: 2168-6173
Popis: 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
Databáze: OpenAIRE