Can the nucleic acid amplification test (NAT) be an alternative to the serologic tests? A prospective study, the results of 18,200 blood donors from the Turkish Red Crescent

Abstract

Aim: Serologic tests having high sensitivity and specificity are used in order to prevent contamination with infectious agents from blood and blood products for transfusion safety. The present serologic tests have problems such as low sensitivity and weak detection capacity of infectious agents in the "window period". We aimed to test the use of NAT (Nucleic Acid Amplification Test) in routine blood screening in the Blood Bank.

Method: We used the Procleix Ultrio (Chiron Ltd., USA) test kit based TMA (Transcription Mediated Amplification) for the NAT study of serum samples from 18,200 donors who came to the Turkish Red Crescent between February 2007 and September 2008. The NAT positive samples were studied twice. The discrimination of HIV, HCV and HBV NAT positive samples was performed by the Procleix Discrimination (Chiron Ltd., USA) test. Otherwise, Micro ELISA were used in parallel for routine serological screening of Anti-HIV, Anti-HCV, and HBsAg with Vironoste HIV Uni-form, AG/Ab innotest HCV Ab and Hepanostika Ultra HBsAg test kits.

Results: The results of serum samples with serology (+) and NAT (+) (13/18,200 and 0.05%) for anti-HIV, anti-HCV and HBsAg were higher than in other NAT studies; we also detected that a transfusion risk can occur in every 1400 transfusions.