title: Sensitivity and specificity of the AdenoPlus test for diagnosing adenoviral conjunctivitis.
abstract: 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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  AdenoPlus is sensitive and specific at detecting adenoviral conjunctivitis.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00921895.
authors.affiliation: Manatee Sarasota Eye Clinic and Laser Center, Sarasota, Bradenton, FL 34202, USA. robsambo@yahoo.com
authors.forename: Robert
authors.initials: R
authors.lastname: Sambursky
authors.forename: William
authors.initials: W
authors.lastname: Trattler
authors.forename: Shachar
authors.initials: S
authors.lastname: Tauber
authors.forename: Christopher
authors.initials: C
authors.lastname: Starr
authors.forename: Murray
authors.initials: M
authors.lastname: Friedberg
authors.forename: Thomas
authors.initials: T
authors.lastname: Boland
authors.forename: Marguerite
authors.initials: M
authors.lastname: McDonald
authors.forename: Michael
authors.initials: M
authors.lastname: DellaVecchia
authors.forename: Jodi
authors.initials: J
authors.lastname: Luchs
mesh_terms: D000208:Acute Disease; D000258:Adenovirus Infections, Human / Q000175:diagnosis* / Q000821:virology; D000260:Adenoviruses, Human / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000956:Antigens, Viral / Q000032:analysis; D002648:Child; D002675:Child, Preschool; D003236:Conjunctivitis, Viral / Q000175:diagnosis* / Q000821:virology; D004279:DNA, Viral / Q000032:analysis; D003941:Diagnostic Techniques, Ophthalmological; D004311:Double-Blind Method; D005189:False Positive Reactions; D005260:Female; D005455:Fluorescent Antibody Technique; D006801:Humans; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction / Q000379:methods; D011237:Predictive Value of Tests; D011446:Prospective Studies; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013666:Tears / Q000821:virology*; D014776:Virus Cultivation / Q000379:methods; D055815:Young Adult
chemical_list: D000956:Antigens, Viral; D004279:DNA, Viral