Evaluation of a rapid test kit for detection of HBsAg/eAg in whole blood: a possible method for pre-donation testing.

ABSTRACT

In many developing countries where hepatitis B is endemic, positivity rate for HBsAg in donor blood is high, and in some places, up to 20% of donated blood has to be discarded for being HBsAg positive. This degree of wastage may be financially crippling for some developing countries. Pre-donation testing may be useful, so that donors who test HBsAg positive are deferred and wastage of costly blood bags is reduced. The study is to evaluate the suitability of the AMRAD kit, for pre-donation testing for HBsAg. One hundred and one (101) healthy blood donors were screened for HBsAg/eAg using the test kit. The same specimens were screened using Monolisa (ELISA) kits for HBsAg and eAg as the standard. True positive (TrP), False negative (FN), True negative (TrN) and, false positive (FP) values were then found, from which, sensitivity and specificity, were derived. The AMRAD test kit detected 93 specimens as negative and 8 specimens as positive for HBsAg as against 94 negatives (TrN) and 7 positives (TrP) by monolisa. Thus, one false positive (FP) result was found in using the kit while no false negative (FN) occurred. The findings in this preliminary study suggest that AMRAD kit may be a useful predonation screening test for HBsAg.