title: Interference with serum indices measurement, but not chemical analysis, on the Roche Modular by Patent Blue V.
abstract: BACKGROUND
  Patent Blue V is an inert dye increasingly being used during cancer surgery to identify the sentinel lymph node. We recently discovered three cases with falsely elevated lipaemic indices on the Roche Modular, following intramammary injection of Patent Blue. This, and other potential interferences by Patent Blue, is examined in this study.
  
  
  METHODS
  Serum samples which visually appeared normal, haemolysed or icteric were spiked with Patent Blue to a concentration of 7.3 mg/L and the effect on the lipaemic, haemolysis and icteric indices and routine chemical analyses (sodium, potassium, urea, creatinine, bilirubin, alanine aminotransferase, gamma-glutamyltransferase, aspartate aminotransferase, magnesium, creatine kinase, lactate dehydrogenase, amylase, albumin, calcium and phosphate) undertaken. Dose-response curves in the range of 4.9 mg/L to 22.7 mg/L of Patent Blue were established for normal, icteric and haemolysed pooled serum samples.
  
  
  RESULTS
  Significant positive interference by 7.3 mg/L of Patent Blue was observed in the lipaemic index, with an increase of 149 +/- 6.3 (mean +/- standard deviation [SD]; P < 0.001). Significant negative interference was observed in both the haemolysis and icteric indices, with decreases of 71 +/- 9.7 (P < 0.001) and 46 +/- 8.9 (P < 0.001), respectively. Patent Blue had a linear dose-response effect on the serum indices. No significant differences were observed in the chemical analyses assessed.
  
  
  CONCLUSIONS
  The effects observed on the Roche Modular serum index measurements with Patent Blue raises the novel concept of interference in methods routinely used to detect interference. Despite Patent Blue having no direct effect on chemical analysis, failure to reliably detect potential interference, particularly haemolysis, may lead to misleading results being issued.
authors.affiliation: Department of Clinical Biochemistry, Wythenshawe Hospital, Manchester, UK. denise.darby@nhs.net
authors.forename: Denise
authors.initials: D
authors.lastname: Darby
authors.forename: Christopher
authors.initials: C
authors.lastname: Broomhead
mesh_terms: D001774:Blood Chemical Analysis; D004396:Coloring Agents / Q000737:chemistry*; D006461:Hemolysis; D006801:Humans; D008207:Lymphatic Metastasis / Q000175:diagnosis; D012016:Reference Values; D012394:Rosaniline Dyes / Q000097:blood / Q000737:chemistry*
chemical_list: D004396:Coloring Agents; D012394:Rosaniline Dyes; C008769:sulfan blue