HBsAg autologous red cell agglutination assay

Three lot of HBsAg autologous red cell agglutination kits (ARCA kit) have been qualified in lab, clinical trial and the stability confirmation have been performed. The sensitivity of the kits is 1ng/ml HBsAg. A, B, O, AB type of peripheral blood or antiagglutinated specimens can be used for assay. No Holk effect has been found. The repeated rate of 10 samples assayed for five times reached 100%. The specimens collected from HAV, HCV, Schistosoma Japonicum infected patients or RF positive patients do not interfere the test. The specificity of the kits is very high. 1712 clinical specimens were inspected comparing with the EIA kits in market. The relativity between the two methods is 0.985. 18 of the 26 specimens which two methods did not accord with each other have been confirmed. The false positive and missing detected for ARCA kits is 1, 3 and for EIA kits are 6, 8 respectively. ARCA kits are stable in 4 degrees C and 22 degrees C for more than one year. The kits can stand in 35 degrees C, 45 degrees C for 45 and 10 days without losing activity respectively.