title: Evaluation of the KEMRI Hep-cell II test kit for detection of hepatitis B surface antigens in Tanzania.
abstract: Hepatitis B surface antigen (HBsAg) is one of the most important serological markers used to diagnose acute and chronic hepatitis B infection. The objective of the current evaluation was to assess the operational characteristics of the Kenya Medical Research Institute (KEMRI) Hep-cell II against an ELISA Exsym HBsAg in the detection of hepatitis B surface antigens. To evaluate the Hep-cell II test, blood samples were collected from blood donors and processed for detection of HBsAg using Hep-cell II based on the test principle and procedure outlined by the manufacturer. ELISA Axsym HBsAg test was used as golden standard. Of the 400 samples tested, 287 (71.8%) were positive by Hep-cell test and 295 (73.8%) were positive by the ELISAAxsym. Hep-cell test had a sensitivity of 98.6% and specificity of 95.96%. Similar values of sensitivity and specificity of the Hep-cell test were obtained even when Bayesian Analysis Model was applied. The positive and negative predictive values of Hep-cell test were 98.61% and 95.96%, respectively. The positive and negative diagnostic likelihood ratios of Hep-cell test were 24.4% and 0.0145, respectively. In conclusion, the Hep-cell test is useful for detecting hepatitis B virus and the high likelihood ratio observed suggests that it may be useful in blood screening. However, it may be necessary to evaluate for cost-effectiveness and robustness in field conditions before the test is recommended for use.
authors.affiliation: National Institute for Medical Research, Muhimbili Medical Research Centre, P. O. Box 3436, Dar es Salaam, Tanzania. kilale@yahoo.com
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Kilale
authors.forename: Nyagosya S
authors.initials: NS
authors.lastname: Range
authors.forename: Prosper H
authors.initials: PH
authors.lastname: Ngowi
authors.forename: Amos M
authors.initials: AM
authors.lastname: Kahwa
authors.forename: Sayoki G
authors.initials: SG
authors.lastname: Mfinanga
mesh_terms: D001782:Blood Donors; D019353:Endemic Diseases / Q000517:prevention & control / Q000706:statistics & numerical data; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006509:Hepatitis B / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000191:economics / Q000379:methods*; D011933:Reagent Kits, Diagnostic / Q000191:economics / Q000592:standards*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013636:Tanzania / Q000453:epidemiology
chemical_list: D006514:Hepatitis B Surface Antigens; D011933:Reagent Kits, Diagnostic