title: A new format of the CATT test for the detection of human African Trypanosomiasis, designed for use in peripheral health facilities.
abstract: OBJECTIVE
  To test the reproducibility and thermostability of a new format of the Card-Agglutination Test for Trypanosomiasis (CATT) test for Human African Trypanosomiasis (HAT), designed for use at primary health care facility level in endemic countries.
  
  
  METHODS
  A population of 4217 from highly endemic villages was screened using the existing format of the CATT test (CATT-R250) on whole blood. All those testing positive (220) and a random sample of negatives (555) were retested in the field with the new format (CATT-D10). Inter-format reproducibility was assessed by calculating kappa. All samples testing positive on whole blood with either method were further evaluated in Belgium by CATT titration of serum by two observers, using both old and new format. CATT-D10 test kits were incubated under four temperature regimens (4, 37, 45 degrees C and fluctuating) with regular assessments of reactivity over 18 months.
  
  
  RESULTS
  Inter-format reproducibility of CATT-D10 vs. CATT-R250 on whole blood performed by laboratory technicians in the field was excellent with kappa values of 0.83-0.89. Both inter- and intra-format reproducibility assessed by CATT titration were excellent, with 96.5-100% of all differences observed falling within the limits of +/-1 titration step. After 18 months, reactivity of test kits incubated under all four temperature regimens was still well above the minimum threshold considered acceptable.
  
  
  CONCLUSIONS
  The CATT-D10 is thermostable and can be used interchangeably with the old format of the CATT test. It is highly suitable for use in peripheral health facilities in HAT-endemic countries.
authors.affiliation: Department of Public Health, Epidemiology and Disease Control Unit, Institute of Tropical Medicine, Antwerp, Belgium. ehasker@itg.be
authors.forename: E
authors.initials: E
authors.lastname: Hasker
authors.forename: P
authors.initials: P
authors.lastname: Mitashi
authors.forename: R
authors.initials: R
authors.lastname: Baelmans
authors.forename: P
authors.initials: P
authors.lastname: Lutumba
authors.forename: D
authors.initials: D
authors.lastname: Jacquet
authors.forename: V
authors.initials: V
authors.lastname: Lejon
authors.forename: V
authors.initials: V
authors.lastname: Kande
authors.forename: J
authors.initials: J
authors.lastname: Declercq
authors.forename: W
authors.initials: W
authors.lastname: Van der Veken
authors.forename: M
authors.initials: M
authors.lastname: Boelaert
mesh_terms: D000372:Agglutination Tests / Q000379:methods; D003223:Congo / Q000453:epidemiology; D004355:Drug Stability; D019353:Endemic Diseases; D006358:Hot Temperature; D006801:Humans; D008403:Mass Screening / Q000379:methods; D008507:Medically Underserved Area; D011320:Primary Health Care / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D014353:Trypanosomiasis, African / Q000175:diagnosis* / Q000453:epidemiology
chemical_list: D011933:Reagent Kits, Diagnostic