GENERAL INTRODUCTION AND REMARKS

ICBS HEPATITIS B VIRUS (HBsAg) MASTER PANEL
& its Negative Panel

In March 2005, ICBS completed establishing its Hepatitis B Master Panel and its corresponding Negative panel. The members of the ICBS HBV Master Panel were selected from more than seven-hundred and twenty Hepatitis B plasma units which were collected from Brazil, Egypt, Ivory Coast, Jordan, Tunisia, USA and Vietnam.  These units were fully-characterized at the CDC as well as at the partnering laboratory of the Department of Medical Sciences at the Toshibha General Hospital in Japan.

The HBV positive panel includes a representation of worldwide genotypes A, B, C, D, E, F and their corresponding variety of subtypes.  This HBV positive panel is composed of: a) 146 individual HBsAg positive members (HBV- table 1) for the purpose of testing clinical sensitivity of HBsAg assays; b) 54 HBsAg positive members of the analytical panel (HBV Panel- table 2) for the purpose of testing analytical sensitivity of HBsAg assays, comprising a highly-specialized HBV Dilution series created from nine individual, carefully-selected members in a series of six dilutions each, precisely according to titer levels; and additionally c) 9 members of Negative Maxi-Pool of negative plasma obtained from the USA and the German Red Cross (HBV- table 2)  for the purpose of having corresponding matrix controls for each of the positive analytical panel members (Negative plasma samples originating from negative maxi plasma pool used for dilution to produce members of the analytical panel).

In addition a corresponding Negative panel (HBV- table 3) composed of 200 members (representing 200 individual non-infectious plasma units received from the American Red Cross in Washington D.C., U.S.A.), was manufactured for the purpose of testing specificity of HBsAg assays.

The evaluation results and relevant information are shown on this website in the following tables and files: CLICK HERE!