Immunoblotting and Goldmann-Witmer Coefficient for Ocular Toxoplasmosis (COPILOT)

Comparison of Immunoblotting (IgA and IgG) and the Goldmann-Witmer Coefficient for Diagnosis of Ocular Toxoplasmosis in Immunocompetent Patients

Ocular toxoplasmosis (OT) is a common cause of posterior uveitis worldwide. The diagnosis of OT is based on clinical findings, but in most cases, laboratory tests are required to confirm the etiology, especially when other diseases are suspected. The aim of this study was to evaluate which methods, between the Goldmann-Witmer coefficient (GWC) and immunoblotting (IB) with both IgG and IgA, in aqueous humour (AH) samples, can be the most sensitive to diagnose OT, in current practice, especially in the first three weeks.

Study Overview

• Status: Completed
• Conditions: Ocular Toxoplasmosis
• Intervention / Treatment: Procedure: Aqueous humour sampling

Detailed Description

Goldmann-Witmer coefficient (GWC): compares the levels of intraocular antibody (igG) production to that serum, as measured by ELISA.

GWC = (Level of specific IgG in aqueous humour/level of specific IgG in serum)/(Total IgG in aqueous humour/Total IgG in serum)

0.5 to 2: No intraocular antibody production, 2 to 4: Suggestive of intraocular antibody production, > 4: Diagnostic of intraocular antibody production to a specific microbial pathogen

• Study Type: Observational
• Enrollment (Actual): 87

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Service d'ophtalmologie, Hôpital de la Croix-Rousse (HCL)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who had underwent aqueous humor and serum sample for ocular toxoplasmosis

Description

Inclusion Criteria:

• Patients who had underwent aqueous humor and serum sample for ocular toxoplasmosis diagnosis

Exclusion Criteria:

• Immunocompromised patients

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Ocular Toxoplasmosis	Procedure: Aqueous humour sampling; Aqueous humour sampling with Goldman-Witmer coefficient and immunoblotting
Patients without Ocular Toxoplasmosis	Procedure: Aqueous humour sampling; Aqueous humour sampling with Goldman-Witmer coefficient and immunoblotting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Goldmann-Witmer coefficient and immunoblotting results	All tests realized in patients were performed before their repartition in the two groups as well as the biologist could not know the status of the patient. Sensitivity and specificity were calculated for each test.	Assessment of each test result at the inclusion of the patient

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): May 31, 2014
• Study Completion (Actual): May 31, 2014

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Eye Diseases; Parasitic Diseases; Coccidiosis; Protozoan Infections; Eye Infections; Eye Infections, Parasitic; Toxoplasmosis; Toxoplasmosis, Ocular
• Other Study ID Numbers: COPILOT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No