ABSTRACT
Objective To assess the limit of detection(LOD),sensitivity and specificity of collodial gold immunochrom-atography(GICA)products purchased from two manufacturers under special environmental conditions.Methods The sensitivity and specificity of GICA made in InTec Products, INC.and Beijing WANTAI Biological Pharmacy Enterprise Co., LTD.for detecting HBsAg, anti-HCV and anti-Treponema pallidum(TP)serum samples were evaluated under different conditions(conventional facilities,simulated hot and humid environments and simulated low pressure and hypoxia environments)according to the protocol of kits.LOD was estimated by detecting the standard materials obtained from the National Center for Clinical Laboratory(NCCL)of China.Results LOD for syphilis improved from 2 NCU to 1 NCU using GICA from InTec Products in hot and humid environments.The extreme conditions did not influence the specificity of GICA from the two manufacturers in the course of detection of clinical samples,but the sensitivity of detection was affected.For InTec Products,the sensitivity of hepatitis B virus and syphilis detection was improved in hot and humid environments,but was reduced in low pressure and hypoxia environments.In addition,the sensitivity of hepatitis C virus detection by InTec Products decreased in hot and humid environments.As for WANTAI products,the sensitivity of hepatitis B virus detection was reduced under extreme conditions and that of hepatitis C virus was only influenced by hot and humid environments. Interestingly, extreme conditions had no impact on the sensitivity of syphilis.Conclusion LOD of InTec Products is better than that of the WANTAI products for detection of standard materials from blood-borne diseases.In the process of detecting clinical samples,the sensitivity of the two manufacturers′GICA is influenced by extreme conditions, with the specificity unchanged.Overall, WANTAI products are more stable than those of InTec, and are also less influenced by extreme conditions.