A customer reported discrepant test results with ih-cell i-ii-iii between echo (device manufactured by a competitor) and ih-1000 during validation of the instrument.The echo gave a 3+ positive result and two ih-1000 analyzers gave negative results during processing an antibody screening.Additionally performed tube liss and tube peg testing both gave negative results.The customer did neither return the supposedly defective product nor the patient samples that had caused false negative test results.We did not receive any sample for the investigation, so our quality laboratory tested lot ih-cell i-ii-iii, #8719011 with ih-card ahg anti-igg, lot: 8623020 (the same lot that was used by the customer).After examination of the antigenicity of the rrbcs, 4 different anti-jka antibodies were tested, partly diluted.All positive and negative reactions were correct.We did not observe any false negative reaction.We found further references in literature: "a number of antibodies with blood group spicificity have been described that reacted only, or much strongly, in the presence of one of the materials: e.G.: paraben (as in liss) / antibody specificity: (anti-jk a).Methyl esters of hydroxybenzoic acid (as in liss) / antibody specificity: (anti-jk a)" applied blood group serology (peter d.Issit+david j.Anstee)."some of the more interesting antibodies associated with the kidd system are those that appear to be liss related because of the parabens (parabens are substances added to preserve reagents that may result in some discrepant serological results) added to these reagents.These antibodies were detected during routine antibody screening procedures and appeared to have no clinical significance.Judd and colleagues theorized that the jka antigen is altered in the presence of paraben.Paraben-related compounds are widely used as preservatives." textbook of blood banking and transfusion medicine (sally v.Rudmann).Our research showed that a number of publications regarding this issue exist.Regarding these indications, we assume, that the echo is picking up a "paraben anti-jk a".Testing by our quality control laboratory confirmed the correct functionality of the allegedly defective lot of ih-cell i-ii-iii, #8719011.The instruction for use contains the following limitation: "low frequency antigens may not always be present on ih-cell i-ii-iii, ih-cell i-ii, and ih-cell pool.Therefore, negative reactions with the screening reagent red blood cells do not always indicate the absence of unexpected antibodies".A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.
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