title: [Evaluation of SD BIOLINE tetanus kit].
abstract: BACKGROUND
  Point-of-care-testing (POCT) kits for tetanus toxoid antibody are used in emergency departments to evaluate the immunization status of patients with tetanus. The objective of this study was to evaluate the analytical performance and the utility of SD BIOLINE tetanus kit (Standard Diagnostic Inc., Yongin, Korea), as a POCT.
  
  
  METHODS
  A total of 326 peripheral blood specimens (whole blood, 319; serum, 326) from healthy subjects and patients were used. SD BIOLINE tetanus kit was evaluated for precision, accuracy, effect of specimens, operator variance, and the total processing time. The results from SD BIOLINE tetanus kit were compared with those from 2 quantitative ELISA kits.
  
  
  RESULTS
  Compared with ELISA kits, SD BIOLINE tetanus kit revealed a sensitivity of 88-97%, specificity of 87-92%, positive predictive value of 81-89%, negative predictive value of 90-98%, and kappa agreement of 0.78-0.82. SD BIOLINE tetanus kit also showed an excellent precision and a high accuracy. It showed a high concordance rate between whole blood and serum specimens. The total processing time of SD BIOLINE tetanus kit was 30-40 min.
  
  
  CONCLUSIONS
  SD BIOLINE tetanus kit showed an excellent analytical performance. With its rapid turnaround time and the ease of handling and interpretation, SD BIOLINE tetanus kit seems appropriate for the evaluation of tetanus immunization status as a POCT device. However, education for operators and standardized guidelines for result interpretation should be emphasized.
authors: Department of Laboratory Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors: Jee-Eun
authors: JE
authors: Lee
authors: Soo-Youn
authors: SY
authors: Lee
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D019095:Point-of-Care Systems; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013742:Tetanus / Q000175:diagnosis* / Q000517:prevention & control; D013745:Tetanus Toxoid / Q000276:immunology*
chemical_list: D000907:Antibodies, Bacterial; D011933:Reagent Kits, Diagnostic; D013745:Tetanus Toxoid