Ijaz Hayder, Waquaruddin Ahmed, Syed Ejaz Alam.
Comparison of Different ICT Kits for HBsAg and Anti HCV Using Gold Standard ELISA.
Pak J Med Res Jan ;51(3):72-6.

Objectives: To compare rapid tests (ICT) with 4th generation ELISA (gold standard) for hepatitis B and C infection. Settings: Biochemistry and Serology Laboratory of the Pakistan Medical Research Council, Research Centre, Jinnah Post Graduate Medical Centre, Karachi. Study was done over six months. Materials and Methods: ELISA confirmed 200 samples for HBsAg and 200 for Anti-HCV were selected, making a total of 400 samples. Out of 400 samples, 200 were positive and 200 negative on ELISA. These samples were further tested on three different brands of most frequently used rapid ICT Kits for HBsAg and Anti HCV. The sensitivity, specificity, negative predictive value, positive predictive value and cost effectiveness were compared using 4th generation ELISA as gold standard. The Rapid kits for HBsAg that were analysed included Acon (USA), Determine (Abbott) and Intec (China) and for Anti HCV they were Acon (USA), Membrane (Canada) and Nobis (Germany). Results: Out of 100 positive and 100 negative tests for HBsAg confirmed on ELISA, all rapid kits showed comparable results with ELISA. The sensitivity and negative predictive value of Intec China (98%) and Determine Abbot (98%) were similar to each other however, these were higher when compared to Acon USA (95%). The rapid kit by Intec China was cheaper to the other two rapid kits and was therefore, the most cost effective rapid kit. The specificity and positive predictive value of all three HBsAg ICT kits was 100% and in agreement with ELISA. Out of 100 HCV positive and 100 HCV negative cases confirmed on ELISA, the rapid test by Acon USA showed maximum sensitivity. The sensitivity and negative predictive values of Acon USA were higher (93%) as compared to Membrane - Canada (89%) and Nobis- Germany (86%). The specificity and positive predictive values of Acon were comparatively lower (93%) but did not significantly vary when compared with Membrane Canada (97%) and Nobis German (96%). Conclusions: The rapid ICT Kits for HbsAg and anti HCV were equally sensitive and specific when compared with ELISA. These rapid kits are cheaper and easy to perform and their use should be encouraged especially in rural setting. Policy statement: ELISA confirmed rapid HBV, HCV kits being cheaper but sensitive and specific should be used for screening cases especially in rural setting.

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