title: Comparison of result judgment algorithm of test for interfering factors in the bacterial endotoxins test among Chinese, Japanese, European, American, and Indian pharmacopeias.
abstract: BACKGROUND
  The bacterial endotoxins test (BET) is a method used to detect or quantify endotoxins (lipo-polysaccharide, LPS) and is widely used in the quality control of parenteral medicines/vaccines and clinical dialysis fluid. It is also used in the diagnosis of endotoxemia and in detection of environment air quality control. Although BET has been adopted by most pharmacopoeias, result judgment algorithms (RJAs) of the test for interfering factors in the BET still differ between certain pharmacopoeias. We have evaluated RJAs of the test for interfering factors for the revision of BET described in the Chinese Pharmacopoeia 2010 (CHP2010).
  
  
  METHODS
  Original data from 1 748 samples were judged by RJAs of the Chinese Pharmacopoeia 2010, the Japanese Pharmacopoeia 2011 (JP2011), the European Pharmacopoeia 7.0 (EP7.0), the United States Pharmacopoeia 36 (USP36), and the Indian Pharmacopoeia 2010 (IP2010), respectively. A SAS software package was used in the statistical analysis.
  
  
  RESULTS
  The results using CHP2010 and USP36, JP2011, EP7.0, and IP2010 had no significant difference (P = 0.7740). The results using CHP2010 of 1 748 samples showed that 132 samples (7.6%) required an additional step; nevertheless there was no such requirement when using the other pharmacopeias. The kappa value of two RJAs (CHP2010 and EP7.0) was 0.6900 (0.6297-0.7504) indicating that the CHP2010 and other pharmacopoeias have good consistency.
  
  
  CONCLUSIONS
  The results using CHP2010 and USP36, JP2011, EP7.0, and IP2010 have different characteristics. CHP2010 method shows a good performance in Specificity, mistake diagnostic rate, agreement rate, predictive value for suspicious rate, and predictive value for passed rate. The CHP2010 method only had disadvantages in sensitivity compared with other pharmacopeias. We suggest that the Chinese pharmacopoeia interference test be revised in accordance with the USP36, JP2011, EP7.0, and IP2010 judgment model.
authors.affiliation: National Institute for Food and Drug Control, Beijing 100050, China.
authors.forename: Yusheng
authors.initials: Y
authors.lastname: Pei
authors.affiliation: National Institute for Food and Drug Control, Beijing 100050, China.
authors.forename: Tong
authors.initials: T
authors.lastname: Cai
authors.affiliation: National Institute for Food and Drug Control, Beijing 100050, China.
authors.forename: Hua
authors.initials: H
authors.lastname: Gao
authors.affiliation: National Institute for Food and Drug Control, Beijing 100050, China.
authors.forename: Dejiang
authors.initials: D
authors.lastname: Tan
authors.affiliation: University of Kentucky, Lexington, KY, 40506-0055, USA.
authors.forename: Yuchen
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: National Institute for Food and Drug Control, Beijing 100050, China.
authors.forename: Guolai
authors.initials: G
authors.lastname: Zhang
mesh_terms: D000328:Adult; D000465:Algorithms; D044466:Asian People; D017586:Diskectomy; D004731:Endotoxins / Q000378:metabolism; D005260:Female; D006801:Humans; D055959:Intervertebral Disc Degeneration / Q000601:surgery; D007405:Intervertebral Disc Displacement / Q000601:surgery; D017116:Low Back Pain / Q000601:surgery; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies
chemical_list: D004731:Endotoxins