Hepatitis B test kit 09011 series

HBVclinicalserum

RTA HBV Real-Time PCR Kit is an in vitro nucleic acid amplification assay for the quantification of Hepatitis B Virus DNA in human serum or plasma. The kit is designed to be used as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy to assess response to treatment in conjunction with all relevant clinical and laboratory finding. RTA HBV Real-Time PCR Kit has been validated for use with RTA Viral DNA Isolation Kit or RTA Viral Nucleic Acid Isolation Kit for its best performance. RTA Real Time PCR Kits are certified and marked with CE-IVD by “MDC Medical Device Certification” Notified Body (0483) in Stuttgart/Germany together with the confirmation of Paul Ehrlich Institute of Germany to meet specific quality and purity requirements in diagnostic market. FEATURES Genotype Detection Accurate quantitation of genotypes A, B, C, D, E, F, G, H Sample Type Serum and Plasma (EDTA) Standardization WHO International HBV standard (10/264) Internal Control Added to lysis buffer during extraction. Storage -20°C Shelf Life 18 monthss from production date HBV PERFORMANCE Sensitivity Bio-Rad CFX96-IVD ABI 7500 Rotorgene Stratagene Mx3000/Mx3005pp Light Cycler 10,0 IU/ml 12,8 IU/m l27,0 IU/ml 22,1 IU/ml Lineer Range Bio-Rad CFX96-IVD ABI 7500 Rotorgene Stratagene Mx3000/Mx3005pp Light Cycler 9,9 – 1 x 109 IU/ml 15,2 – 1 x 109 IU/ml 27 – 1 x 109 IU/ml 24 – 1 x 109 IU/ml 25,1 – 1 x 109 IU/ml 25,1 IU/ml