Scientific Publications by FDA Staff

Biochem Biophys Res Commun 2007 May 18;356(4):1017-23

Microarray multiplex assay for the simultaneous detection and discrimination of hepatitis B, hepatitis C, and human immunodeficiency type-1 viruses in human blood samples.

Hsia CC, Chizhikov VE, Yang AX, Selvapandiyan A, Hewlett I, Duncan R, Puri RK, Nakhasi HL, Kaplan GG

Hsia CC (reprint author), US FDA, Ctr Biol Evaluat & Review, Div Emerging & Transfus Transmitted Dis, Bethesda, MD 20892 USA US FDA, Ctr Biol Evaluat & Review, Div Emerging & Transfus Transmitted Dis, Bethesda, MD 20892 USA US FDA, Ctr Biol Evaluat & Review, Div Viral Prod, Bethesda, MD 20892 USA US FDA, Ctr Biol Evaluat & Review, Div Cellular & Gene Therapies, Bethesda, MD 20892 USA

Hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus type-1 (HIV-1) are transfusion-transmitted human pathogens that have a major impact on blood safety and public health worldwide. We developed a microarray multiplex assay for the simultaneous detection and discrimination of these three viruses. The microarray consists of 16 oligonucleotide probes, immobilized on a silylated glass slide. Amplicons from multiplex PCR were labeled with Cy-5 and hybridized to the microarray. The assay detected 1 International Unit (IU), 10IU, 20IU of HBV, HCV, and HIV-1, respectively, in a single multiplex reaction. The assay also detected and discriminated the presence of two or three of these viruses in a single sample. Our data represent a proof-of-concept for the possible use of highly sensitive multiplex microarray assay to screen and confirm the presence of these viruses in blood donors and patients.