The RPS adeno detector for diagnosing adenoviral conjunctivitis.

PURPOSE

To compare the sensitivity, specificity, and accuracy of the RPS Adeno Detector (Rapid Pathogen Screening Inc., South Williamsport, PA) against both viral cell culture with confirmatory immunofluorescence staining (CC-IFA) and the polymerase chain reaction (PCR) for diagnosing adenoviral conjunctivitis.

DESIGN

Prospective, nonrandomized, masked, multicenter clinical trial.

PARTICIPANTS

One hundred eighty-six consecutive patients from 5 clinical centers seeking treatment within 1 week of developing a red eye and thought to have acute conjunctivitis.

METHODS

The RPS Adeno Detector is a 10-minute in-office lateral flow immunoassay. Patients were tested with the RPS Adeno Detector, CC-IFA, and PCR to detect the presence of adenovirus.

MAIN OUTCOME MEASURES

The sensitivity, specificity, and accuracy of the RPS Adeno Detector were assessed for identifying cases of adenoviral conjunctivitis.

RESULTS

Compared with CC-IFA, the RPS Adeno Detector was 88% sensitive and 91% specific at detecting adenoviral conjunctivitis. Using PCR as a reference method, the sensitivity of the RPS Adeno Detector increased to 89% and the specificity increased to 94%. Compared with PCR, CC-IFA was found to be 91% as sensitive and 100% as specific.

CONCLUSIONS

The RPS Adeno Detector demonstrated sufficient sensitivity and specificity to be used in the physician's office for the detection of adenoviral conjunctivitis.