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1、Chiron 与与 Roche 方法比较方法比较COMPARISON OF THE CHIRON PROCLEIX TIGRIS AND ROCHE CO BAS S 201 NUCLEIC ACID TESTING SYSTEMS FOR SIMULTANEOUS D ETECTION OF HIV/HCV RNA AND HBV DNA A.R Margaritis1, S Brown1, C.R Seed1, P Kiely1, B DAgostino1, C.K Lin2, A.J Keller1 1 Australian Red Cross Blood Service, Austra
2、lia; 2 Hong Kong Red Cross Blo od Transfusion Service, Kowloon, Hong Kong Background Since July 2002 the Australian Red Cross Blood Service (ARCBS) has perform ed HIV-1 and HCV nucleic acid testing (NAT) for the Hong Kong Red Cross Blood Transfusion Service (HKRCBTS). The high HBV prevalence in Hong
3、 K ong, along with the development of multiplex assays incorporating simultaneo us HIV, HCV and HBV nucleic acid detection, motivated the current study t 1. Estimate the prevalence of HBV DNA positive / HBsAg negative (Yield) donors in the Hong Kong blood donor population. 2. Evaluate the operationa
4、l performance of two multiplex NAT assays and their respective testing platforms. Materials and Methods The HBV NAT yield rate was estimated from 10,397 HKRCBTS blood donor samples concurrently tested by ARCBS on Chirons PROCLEIX ULTRIO a ssay as individual donor samples using the fully automated TI
5、GRIS platform, and on Roches Cobas TaqScreen Multiplex (MPX) test in pools of 6 (PDT6) using the modular automated s 201 platform. Reactive samples were assigned a final HIV, HCV and HBV status based on pre-defined viral confirmatory algori thms. Analytical sensitivity was assessed by probit analysi
6、s of diluted internatio nal standards. Operational performance was compared based on multiple factors, including daily workflow analysis, invalid sample rates and failed run rates. Results There were 72 HBV DNA positive samples detected in this study which were also HBsAg positive (Abbott PRISM). Se
7、venty one were detected by the UL TRIO assay and 72 by the TaqScreen MPX test. Each system independently detected 2 HBV NAT yield samples for a combined HBV NAT yield rate of 4 in 10,397 (0.04%). The TaqScreen MPX test detected one additional reactive sample that remains unresolved. The 95% detectio
8、n limits for HIV-1, HBV and HCV were 42.2, 12.2 and 2.0 IU/mL respectively for the PROCLEIX ULTRI O assay and 50.5, 8.4 and 6.0 IU/mL for the Cobas TaqScreen MPX test us ing individual donor testing (IDT) on both systems. The invalid test and failed run rates were 0.05% and 2.92% for the TIGRIS syst
9、em and 2.39% and 5.5 3% for the Cobas s 201. Conclusions 1. Based on this study, the estimated HBV NAT yield rate in Hong Kong b lood donors is 0.04%. Although implementing either assay alone would be exp ected to detect only half (0.02%) of these yield donors, the consensus outcome is an incrementa
10、l increase in blood safety for the HKRCBTS. 2. There appears to be no difference in clinical sensitivity for HBV in Hong Kong blood donors when testing in pools of 6 on the MPX assay and IDT on the ULTRIO assay. 3. When testing in IDT on both systems there was no significant difference between the 9
11、5% detection limits for HIV-1 and HBV however the PROCLEI X ULTRIO assay had a significantly (p0.05) lower 95% detection limit fo r HCV. 4. Workflow analysis demonstrated that testing completion times for daily w orkload of 200 donor samples (IDT vs. PDT6) did not differ markedly betwee n the two systems. 5. Based on a lower invalid sample and failed run rate, the TIGRIS system demonstrated better overall operational performance.
