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.