Lyophilized standards for the calibration of real time PCR assay for hepatitis C virus RNA  

作　　者：WANG Lu-nan WU Jian-min DENG Wei SHEN Zi-yu CHEN Wen-xiang LI Jin-ming 

机构地区：[1]Clinical Laboratory, Union Hospital, Tongji Medical College ofHuazhong University of Science ＆ Technology, Wuhan 430022,China [2]National Center for Clinical Laboratory, Beijing Hospital, Beijing100730, China

出　　处：《Chinese Medical Journal》2006年第22期1910-1914,共5页中华医学杂志（英文版）

基　　金：This work was supported partly by a grant from the National Natural Science Foundation of China (No. 30371365).

摘　　要：Background Since October 1997, an international standard for hepatitis C virus （HCV） nucleic acid amplification technology assay, 96/790, has been available. We compared a series of lyophilized standards with known HCV RNA concentrations against the international standard in fluorescence quantitative PCR detection. Methods A series of lyophilized sera were calibrated by ROCHE COBAS AMPLICOR HCV Monitor test against the international standard and sent to various manufacturers to analyse the samples using their own kits. Then calibration curves from the series were compared with that obtained from the external standard calibration curve with the manufacture＇s series. Results The standard calibration curve with the series of lyophilized serum showed an excellent correlation （R^2〉0.98）, slope and intercept that were similar to those from the manufacture＇s series. When the standard calibration curve from the series of lyophilized standards were used to define the values of the given sample, lower coefficients of variation between kits from different manufactures were obtained. Conclusion The results showed that the lyophilized standards could be used to setup the standard calibration curve for clinical HCV RNA quantitative PCR detection.Background Since October 1997, an international standard for hepatitis C virus （HCV） nucleic acid amplification technology assay, 96/790, has been available. We compared a series of lyophilized standards with known HCV RNA concentrations against the international standard in fluorescence quantitative PCR detection. Methods A series of lyophilized sera were calibrated by ROCHE COBAS AMPLICOR HCV Monitor test against the international standard and sent to various manufacturers to analyse the samples using their own kits. Then calibration curves from the series were compared with that obtained from the external standard calibration curve with the manufacture＇s series. Results The standard calibration curve with the series of lyophilized serum showed an excellent correlation （R^2〉0.98）, slope and intercept that were similar to those from the manufacture＇s series. When the standard calibration curve from the series of lyophilized standards were used to define the values of the given sample, lower coefficients of variation between kits from different manufactures were obtained. Conclusion The results showed that the lyophilized standards could be used to setup the standard calibration curve for clinical HCV RNA quantitative PCR detection.

关 键 词：polymerase chain reaction CALIBRATION hepatitis C reference standards 

分 类 号：R512.63[医药卫生—内科学]