Background As with many studies carried out in European countries, a quality assurance program has been established by the National Center for Clinical Laboratories in China （NCCL）. The results showed that the external quality assessment significantly improves laboratory performance for quantitative evaluation of hepatitis C virus （HCV） RNA. Methods Serum panels were delivered twice annually to the clinical laboratories which performed HCV RNA detection in China. Each panel made up of 5 coded samples. All laboratories were requested to carry out the detection within the required time period and report on testing results which contained qualitative and/or quantitative test findings, reagents used and relevant information about apparatus. All the positive samples were calibrated against the first International Standard for HCV RNA in a collaborative study and the range of comparison target value （TG） designated as ±0.5 log. Results The numbers of laboratories reporting on qualitative testing results for the first and second time external quality assessment were 168 and 167 in the year of 2003 and increased to 209 and 233 in 2007; the numbers of laboratories reporting on quantitative testing results were 134 and 147 in 2003 and rose to 340 and 339 in 2007. Deviation between the mean value for quantitative results at home in 2003 and the target value was above 0.5 log, which was comparatively high. By 2007, the target value was close to the national average except for the low concentrated specimens （10^3 IU/ml）. The percentage of results within the range of GM±0.5 log10 varied from 8.2% to 93.5%. Some laboratories had some difficulties in the exact quantification of the lowest （3.00 log IU/ml） as well as of the highest viral levels （6.37 log IU/ml） values, very near to the limits of the dynamic range of the assays. Conclusions The comparison of these results with the previous study confirms that a regular participation in external quality assessment （EQA） assures the achievement of a hig
WANG Lu-nan ZHANG Rui SHEN Zi-yu CHEN Wen-xiang LI Jin-ming
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.
WANG Lu-nanWU Jian-minDENG WeiSHEN Zi-yuCHEN Wen-xiangLI Jin-ming
