This study further broadens the CALIPER database by performing transference and verification for 52 biochemical assays on the Roche cobas 6000 and the Roche Modular P. Previously, CALIPER reference intervals for several biochemical markers were successfully transferred from Abbott assays to Roche, Beckman, Ortho, and Siemens assays. The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has recently established pediatric age- and sex-specific reference intervals for over 85 biochemical markers on the Abbott Architect system. Higgins, Victoria Chan, Man Khun Nieuwesteeg, Michelle Hoffman, Barry R Bromberg, Irvin L Gornall, Doug Randell, Edward Adeli, Khosrow Transference of CALIPER pediatric reference intervals to biochemical assays on the Roche cobas 6000 and the Roche Modular P. TextabstractTo evaluate the analytical performance and explore the clinical applicability of the new Roche cobas AmpliPrep/ cobas TaqMan HCV test, v2.0 (CAP/CTM v2.0), a platform comparison was performed on panels and diagnostic samples with the Roche cobas AmpliPrep/ cobas TaqMan HCV test (CAP/CTM Performance evaluation of the new Roche cobas AmpliPrep/ cobas TaqMan HCV test, version 2.0, for detection and quantification of hepatitis C virus RNA The new cobas HBV real-time PCR assay on the cobas 4800 System showed reliable analytical performances. Correlation was very high between the two systems in both serum and plasma samples (correlation coefficient =0.995). LOB, LOD and LOQ were all acceptable within the observed proportion rate (85%). Linearity (coefficient of determination, R2) was 0.999. Repeatability and total imprecision (coefficient of variation) ranged from 0.5% to 3.8% and from 0.5% to 3.5%, respectively. Correlation between the two systems was compared using 205 clinical samples (102 sera and 103 EDTA plasma). Detection capability, including limit of blank (LOB), limit of detection (LOD) and limit of quantitation (LOQ), was verified using the 4th WHO International Standard for HBV DNA for NAT (NIBSC code: 10/266). Precision was evaluated using three levels of cobas HBV/HCV/HIV-1 Control Kit, and linearity was evaluated across the anticipated measuring range (10.0-1.0Ã-109 IU/mL) at seven levels using clinical samples.
We evaluated the analytical performance of the cobas HBV NAAT ( Roche Diagnostics GmbH, Mannheim, Germany) on the cobas 4800 System in comparison with COBAS AmpliPrep/ COBAS TaqMan HBV Test (CAP/CTM HBV). Hepatitis B virus (HBV) nucleic acid amplification testing (NAAT) is important for the diagnosis and management of HBV infection. Kim, Hanah Hur, Mina Bae, Eunsin Lee, Kyung-A Lee, Woo-In
Performance evaluation of cobas HBV real-time PCR assay on Roche cobas 4800 System in comparison with COBAS AmpliPrep/ COBAS TaqMan HBV Test. Combination of the Total Nucleic Acid Isolation Kit on the COBAS AmpliPrep instrument with the LightCycler Parvovirus B19 Quantification Kit provides a reliable and time-saving tool for sensitive and accurate detection of parvovirus B19 DNA. Identification of a persistent parvovirus B19-infected individual by the polymerase chain reaction among 51 anti-parvovirus B19 IgM-negative samples underlines the importance of additional nucleic acid testing in pregnancy and its superiority to serology in identifying the risk of parvovirus B19 transmission via blood or blood products. Relative sensitivity and specificity in routine samples from pregnant women are 100% and 93%, respectively. The lower detection limit is 234 IU/ml at a 95% hit-rate, linear range approximately 104-1010 IU/ml, and overall precision 16 to 40%. The kit combination processes 72 samples per 8-hour shift. Nucleic acids were extracted using the Total Nucleic Acid Isolation Kit ( Roche Diagnostics) and amplified with the LightCycler Parvovirus B19 Quantification Kit. We report the analytical performance of the LightCycler Parvovirus B19 Quantification Kit ( Roche Diagnostics) using nucleic acids isolated with the COBAS AmpliPrep instrument. The COBAS AmpliPrep instrument ( Roche Diagnostics GmbH, D-68305 Mannheim, Germany) automates the entire sample preparation process of nucleic acid isolation from serum or plasma for polymerase chain reaction analysis. Schorling, Stefan Schalasta, Gunnar Enders, Gisela Zauke, Michael Quantification of Parvovirus B19 DNA Using COBAS AmpliPrep Automated Sample Preparation and LightCycler Real-Time PCR
0 kommentar(er)
