AIT test has no problem in the detection of anti-ribosomal P – authors' response

Excerpt

In a recent article, Jearn and Kim assessed the ability of indirect immunofluorescence on a novel human macrophage cell line (IT-1) in an autoimmune target (AIT) assay to predict the presence of anti-ribosomal P (anti-Rib-P) antibodies [1], based on a previously described cytoplasmic and/or nucleolar staining pattern [2]. Despite the clearance of the AIT test by the South Korea Food and Drug Administration, to the best of our knowledge this test is not widely used as a screening method – neither is it approved by the Food and Drug Administration (FDA) USA or is it a Communauté Européenne (CE) certified method for the detection of antinuclear antibodies. By contrast, many laboratories rely on HEp-2 cell substrates that are widely available as FDA and CE approved diagnostic kits from a variety of manufacturers. …