Clinical evaluation of micro-scale chip-based PCR system for rapid detection of hepatitis B virus.
The polymerase chain reaction (PCR) is widely used to amplify a small amount of DNA in samples for genetic analysis. Rapid and accurate amplification is prerequisite for broad applications including molecular diagnostics of diseases, food safety, and biological warfare tests. We have developed a rapid real-time micro-scale chip-based PCR system, which consists of six individual thermal cycling modules capable of independent control of PCR protocols. The PCR volume is 1 microl and it takes less than 20 min to complete 40 thermal cycles. To test utility of a chip-based PCR system as a molecular diagnostic device, we have conducted the first large-scale clinical evaluation study. Three independent clinical evaluation studies (n = 563) for screening the hepatitis B virus (HBV) infection, the most popular social epidemic disease in Asia, showed an excellent sensitivity, e.g. 94%, and specificity, e.g. 93%, demonstrating micro-scale chip-based PCR can be applied in molecular diagnostics.
Cho
Yoon-Kyoung
YK
Bio Lab, Samsung Advanced Institute of Technology, P.O. Box 111, Suwon 440-600, Republic of Korea.
Kim
Jintae
J
Lee
Youngsun
Y
Kim
Young-A
YA
Namkoong
Kak
K
Lim
Heekyun
H
Oh
Kwang W
KW
Kim
Suhyeon
S
Han
Jungim
J
Park
Chinsung
C
Pak
Y Eugene
YE
Ki
Chang-Seok
CS
Choi
Jong Rak
JR
Myeong
Hyeon-Koon
HK
Ko
Christopher
C
D004279:DNA, Viral / Q000032:analysis*; D006509:Hepatitis B / Q000175:diagnosis* / Q000821:virology; D006515:Hepatitis B virus / Q000235:genetics*; D006801:Humans; D020411:Oligonucleotide Array Sequence Analysis / Q000295:instrumentation*; D016133:Polymerase Chain Reaction / Q000295:instrumentation*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012825:Silicon
D004279:DNA, Viral; D012825:Silicon