The Need for Standardization of Antiretinal Antibody Detection and Measurement

Abstract

The demonstration of specific autoantibodies in the context of clinical findings is an essential step in the diagnosis of many human diseases. Autoimmune retinopathy, including cancer-associated retinopathy (CAR), is associated with various autoantibodies against retinal proteins. 1 Adamus G. Ren G. Weleber R.G. Autoantibodies against retinal proteins in paraneoplastic and autoimmune retinopathy. BMC Ophthalmol. 2004; 4: 5 Crossref PubMed Scopus (176) Google Scholar Some autoantigens are retina-tissue specific, such as recoverin or rhodopsin; others may be also present in other than retinal tissues, such as α-enolase; Establishing a relationship between the presence of serum antibodies and ocular presentation is important in the diagnosis of retinopathy. Therefore, testing for antiretinal autoantibodies is important. In principle, we agree with Forooghian and associates 2 Forooghian F. MacDonald I.M. Heckenlively J.R. et al. The need for standardization of antiretinal antibody detection and measurement. Am J Ophthalmol. 2008; 146: 489-495 Abstract Full Text Full Text PDF Scopus (49) Google Scholar that we need a standardized method for antiretinal antibody testing. However, we have come a long way from random testing of antiretinal autoantibodies without appropriate controls and verifications, as the authors suggest in this paper. Because of the need for a clinically available diagnostic test for antiretinal antibodies, the Ocular Immunology Laboratory, located at Oregon Health & Science University, obtained Clinical Laboratory Improvement Amendments (CLIA) certification in 2005 for testing antiretinal antibody and anti–optic nerve autoantibody by Western blotting and immunohistochemistry. For the last 3 years we have been using a standardized protocol with appropriate controls. Thus far, our laboratory has performed 975 tests on 637 patients with retinopathy with and without cancer. Specific autoantibodies against known antigens are always confirmed using the available purified antigens. Our service has been used by ophthalmologists around the world and such organizations as Mayo and Athena reference laboratories. ReplyAmerican Journal of OphthalmologyVol. 147Issue 3PreviewIn order for antiretinal antibody testing to have utility in the clinical diagnostic setting, assays for these autoantibodies need to be standardized and validated. As suggested in our original paper, Adamus and associates in their letter have highlighted the importance of the Clinical Laboratory Improvement Amendments (CLIA) in this process. Enacted by Congress, CLIA mandates universal requirements for all U.S. clinical laboratory testing sites in order to promote quality testing. To achieve this goal, CLIA specifies a set of minimum, good laboratory practices: 1) having trained and competent personnel; 2) following manufacturers' procedural directions; 3) applying quality assurance principles; 4) documenting all activities; and 5) participating in external quality assessments. Full-Text PDF