Elsevier

Ophthalmology

Volume 113, Issue 10, October 2006, Pages 1758-1764
Ophthalmology

Original Article
The RPS Adeno Detector for Diagnosing Adenoviral Conjunctivitis

https://doi.org/10.1016/j.ophtha.2006.06.029Get rights and content

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.

Section snippets

Description of the RPS Adeno Detector

The RPS Adeno Detector is based on the principle of lateral flow immunochromatography. Two antigen-specific antibodies capture viral antigens or particles. The RPS Adeno Detector detects common epitopes on the hexon protein of the adenovirus within a conserved region among the serotypes.27, 28, 29, 30, 31, 32, 33, 34 This allows the RPS Adeno Detector to detect all known serotypes. One antibody is immobilized in the detection zone of the device. The second antibody is labeled with colloidal

Results

A total of 186 consecutive patients with acute conjunctivitis were tested at 5 clinical sites. Study patients were 64.5% (n = 120) female and 35.5% (n = 66) male, and the age ranged from 1 to 84 years of age, with a mean age of 41.8 years. Adenovirus was confirmed by PCR in 25.3% of all patients with a red eye at presentation.

In reference to cell culture (CC-IFA), the RPS Adeno Detector demonstrated a sensitivity of 37 of 42 (88%) and a specificity of 121 of 133 (91%), and an overall agreement

Discussion

Historically, the true gold standard for adenovirus conjunctivitis diagnosis is cell culture (CC-IFA). For many physicians, PCR now is considered the new gold standard. Culture has many potential shortcomings because it relies on an adequate collection of viable virus, survival of the virus during transport, growth of the virus on the medium, and recognition of the cytopathic effect by the technician.20 Newer PCR techniques, however, are able to amplify small amounts of viral DNA and therefore

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    Manuscript no. 2006-119.

    Rapid Pathogen Screening, Inc., South Williamsport, Pennsylvania, paid for all laboratory studies.

    None of the principal investigators has any financial interest.

    1

    Dr Sambursky is the medical director and a shareholder of Rapid Pathogen Screening.

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