title: KEMRI Hep-cell II hepatitis B surface antigen screening kit.
abstract: BACKGROUND
  Kenya is a high hepatitis B virus (HBV) endemic zone. Prevention of HBV transmission by transfusing safe blood is necessary. Kits for screening hepatitis B surface antigen (HBsAg) are usually imported and are expensive. Hence it has been difficult to screen donated and patient blood samples all over Kenya.
  
  
  OBJECTIVE
  To produce a HBsAg screening kit locally in order to be able to screen donated and patient blood samples all over Kenya.
  
  
  METHODS
  A laboratory based study.
  
  
  METHODS
  Centre for Virus Research (CVR), Kenya Medical Research Institute (KEMRI), Nairobi.
  
  
  METHODS
  Purified HBsAg from plasma of carriers obtained from National Public Health Laboratories Services (NPHLS) was used to minimise guinea pigs to produce antihepatitis B (anti HBs) antibody. The anti HBs was then used to sensitise sheep red blood cells (SRBC). The final product was freeze dried (lyophilised) and its sensitivity and specificity was compared with other commercial kits.
  
  
  RESULTS
  The sensitivity and specificity of KEMRI Hep-cell II was found to be 98% and 99%, respectively. The kit was found to be stable and potent for one year whether kept 4 degrees C, 37 degrees C or room temperature.
  
  
  CONCLUSIONS
  KEMRI Hep-cell II was successfully produced locally. The sensitivity and specificity were comparable to other commercial kits. The kit was stable and potent for one year between temperature of 4 degrees C and 37 degrees C. The kit required only simple apparatus to carry out the test hence it can be used anywhere in Kenya. It was also cheap and affordable.
authors.affiliation: Virus Research Centre, Kenya Medical Research Institute, Nairobi.
authors.forename: F A
authors.initials: FA
authors.lastname: Okoth
authors.forename: P M
authors.initials: PM
authors.lastname: Kaiguri
authors.forename: E
authors.initials: E
authors.lastname: Mathenge
authors.forename: J
authors.initials: J
authors.lastname: Tuei
authors.forename: S
authors.initials: S
authors.lastname: Muchiri
authors.forename: N
authors.initials: N
authors.lastname: Owino
authors.forename: G
authors.initials: G
authors.lastname: Kamau
authors.forename: J
authors.initials: J
authors.lastname: Kulundu
authors.forename: A
authors.initials: A
authors.lastname: Njuguna
authors.forename: P M
authors.initials: PM
authors.lastname: Tukei
authors.forename: M
authors.initials: M
authors.lastname: Yano
authors.forename: T
authors.initials: T
authors.lastname: Naruse
mesh_terms: D002353:Carrier State / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology / Q000276:immunology* / Q000517:prevention & control; D019353:Endemic Diseases / Q000517:prevention & control / Q000706:statistics & numerical data; D006509:Hepatitis B / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology / Q000276:immunology* / Q000517:prevention & control; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006801:Humans; D007630:Kenya / Q000453:epidemiology; D008403:Mass Screening / Q000191:economics / Q000379:methods*; D011933:Reagent Kits, Diagnostic / Q000191:economics / Q000592:standards*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D006514:Hepatitis B Surface Antigens; D011933:Reagent Kits, Diagnostic