We thank Dr Forooghian for his correspondence in regard to our recent article, “Consensus on the Diagnosis and Management of Nonparaneoplastic Autoimmune Retinopathy Using a Modified Delphi Approach.” We agree with him that much remains to be achieved in the realm of detecting antiretinal antibodies (ARA) in a standardized, sensitive, and specific method in order for ARA testing to be clinically useful and relevant.

In the current correspondence and previously, Dr Forooghian emphasizes the need for clinical validation of ARA testing. We completely agree that, in addition to standardization, validation of ARA testing is extremely important. However, clinical validation requires a gold standard (a reliable clinical phenotype), which, as of yet, does not exist for autoimmune retinopathy. Thus, it will be difficult to validate ARA testing without a consensus on clinical diagnosis and a standardized approach to ARA testing. As a first step, we aimed to standardize the clinical diagnosis by obtaining consensus on the “definition” of AIR in an attempt to allow comparison between studies and decrease the heterogeneity of patient cohorts. We also attempted to achieve consensus on the ARA assays; however, supermajority consensus could not be obtained. The panel agreed on the fact that a 2-stage system (screening and confirmation) should be considered, but the specifics were not further addressed in this study. We agree with the lack of data on the pathogenicity of ARAs; however, obtaining consensus regarding this was beyond the scope of this first panel. Nevertheless, we agree that much work is needed to prove pathogenicity of numerous ARAs that have so far been reported to be “associated” with AIR.

The Clinical Laboratory Improvement Amendments (CLIA) program originated to develop standards that ensure accurate and reliable testing for patient care. Although CLIA includes the practice of good laboratory techniques, as Forooghian points out, it does not mean the testing is standardized across laboratories or that it is clinically validated. We agree on these issues and believe that CLIA approval is not sufficient (although it is necessary) to establish standardization and validation. It is also important to mention that clinicians need a CLIA-approved laboratory in order to use results for clinical decision making. The utility of such results in clinic was not addressed in this study.

Our efforts should be viewed as only the first steps in trying to understand the complex clinical features of AIR and to recognize the work that needs to be done in both clinical and basic science fields. We recommend that clinicians use the assay for ARA testing if all other Essential and any Supportive criteria for the diagnosis of AIR are present and that results should be interpreted in the clinical context. It is our hope that, through standardization of diagnostic criteria, we can move forward and work together to gain a better understanding of the pathogenesis of AIR.

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Jan 5, 2017 | Posted by in OPHTHALMOLOGY | Comments Off on Reply

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