RPS Adeno Detector HS for Diagnosing Adenoviral Conjunctivitis

03:24 EDT 25th May 2015 | BioPortfolio

Summary

The RPS Adeno Detector HS will be demonstrated to be more sensitive and specific than the RPS Adeno Detector™.

Description

To engage in a multi-center, prospective, masked clinical trial to investigate a non-invasive rapid pathogen screening test, the RPS Adeno Detector HS's ability to detect the presence of the adenovirus (ADV) antigen in cases of acute conjunctivitis by comparing it to both the RPS Adeno Detector™ and the polymerase chain reaction (PCR).

Currently, acute conjunctivitis is primarily a clinical diagnosis. Cultures are rarely performed due to the significant time delay in receiving results. Recently, the RPS Adeno Detector™ was both FDA cleared and CLIA waived. It is an antigen-based immunoassay that has the ability to detect the presence of ADV at the point of care. RPS Inc has made modifications to the sampling to pad and test strip to facilitate better antigen collection and release, respectively. It is believed that these changes will lead to better sensitivity, specificity, and ease of use of the test.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Conjunctivitis

Intervention

Immunoassay

Location

Manatee Eye Clinic
Bradenton
Florida
United States
34208

Status

Completed

Source

Rapid Pathogen Screening

Results (where available)

View Results

Links

Clinical Trials [55 Associated Clinical Trials listed on BioPortfolio]

ADenoVirus Initiative Study in Epidemiology in France

The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs ...

FST-100 in the Treatment of Acute Viral Conjunctivitis

This randomized, double masked, multi-center study is being conducted to support the safety and efficacy of FST-100 for the treatment of acute viral conjunctivitis. The study intends to sh...

A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis

This is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.

Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis

Medications available for the treatment of seasonal allergic conjunctivitis include antihistamines. These medicines block the release of histamine, a substance in the body that is released...

AL-15469A for the Treatment of Bacterial Conjunctivitis

The purpose of the study is to determine whether AL-15469A is safe and effective in the treatment of bacterial conjunctivitis.

PubMed Articles [281 Associated PubMed Articles listed on BioPortfolio]

Plasma vitamin D levels of patients with allergic rhino-conjunctivitis with positive skin prick test.

Allergic rhino-conjunctivitis (ARC) and allergic rhinitis are inflammatory diseases that develop through immunoglobulin E in the rhino-ocular mucosa due to allergy. The main symptoms are runny nose, n...

Deep subconjunctival injection of gentamicin for the treatment of bacterial conjunctivitis in macaques (Macaca mulatta and Macaca fascicularis).

Infectious conjunctivitis occurs in a number of domestic and laboratory animal species and is usually treated topically with eye drops or eye ointments, which must be administered several times a day ...

Comparison of the QMS® analyzer with HPLC-UV for the quantification of lamotrigine concentrations in human plasma samples.

Recently, a turbidimetric immunoassay method has been developed for use in the form of a QMS lamotrigine (LTG) commercial immunoassay. The present study was designed to evaluate the performance of thi...

Ocular Itch Relief with Alcaftadine 0.25% Versus Olopatadine 0.2% in Allergic Conjunctivitis: Pooled Analysis of Two Multicenter Randomized Clinical Trials.

The efficacy and safety of the once-daily topical ophthalmic solutions, alcaftadine 0.25% and olopatadine 0.2%, in preventing ocular itching associated with allergic conjunctivitis were evaluated.

Acute Increase of Children's Conjunctivitis Clinic Visits by Asian Dust Storms Exposure - A Spatiotemporal Study in Taipei, Taiwan.

Adverse health impacts of Asian dust storms (ADS) have been widely investigated and discussed in respiratory disease, but no study has examined the association between ADS events and their impact on e...

Medical and Biotech [MESH] Definitions

Conjunctivitis due to hypersensitivity to various allergens.

A highly contagious disease characterized by subconjunctival hemorrhage, sudden swelling of the eyelids and congestion, redness, and pain in the eye. Epidemic conjunctivitis caused by Enterovirus 70 (EV-70) was first described in Africa in 1969. It is caused also by Coxsackievirus A24 variant (CA24v). Epidemics by this organism have appeared most frequently in Asia.

An infection of the eyes characterized by the presence in conjunctival epithelial cells of inclusion bodies indistinguishable from those of trachoma. It is acquired by infants during birth and by adults from swimming pools. The etiological agent is CHLAMYDIA TRACHOMATIS whose natural habitat appears to be the genito-urinary tract. Inclusion conjunctivitis is a less severe disease than trachoma and usually clears up spontaneously.

An immunoenzyme test for the presence of drugs and other substances in urine and blood. The test uses enzyme linked antibodies that react only with the particular drug for which the sample is being tested.

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