Kilale A.M., Range N.S., Ngowi P.H., Kahwa A.M., Mfinanga S.G.
National Institute for Medical Research, Muhimbili Medical Research Centre, P. 0. Box 3436, Dar es Salaam, Tanzania
Kilale, A.M., National Institute for Medical Research, Muhimbili Medical Research Centre, P. 0. Box 3436, Dar es Salaam, Tanzania; Range, N.S., National Institute for Medical Research, Muhimbili Medical Research Centre, P. 0. Box 3436, Dar es Salaam, Tanzania; Ngowi, P.H., National Institute for Medical Research, Muhimbili Medical Research Centre, P. 0. Box 3436, Dar es Salaam, Tanzania; Kahwa, A.M., National Institute for Medical Research, Muhimbili Medical Research Centre, P. 0. Box 3436, Dar es Salaam, Tanzania; Mfinanga, S.G., National Institute for Medical Research, Muhimbili Medical Research Centre, P. 0. Box 3436, Dar es Salaam, Tanzania
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 ELISA Axsym. 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.
hepatitis B surface antigen; antigen detection; article; Bayes theorem; blood donor; blood sampling; diagnostic kit; diagnostic test accuracy study; diagnostic value; enzyme linked immunosorbent assay; Hep cell II test kit; hepatitis B; human; intermethod comparison; predictive value; sensitivity and specificity