Hepatitis C Virus RNA Quantification by bDNA, Serum
Method Description Describes how the test is performed and provides a method-specific reference
The VERSANT HCV RNA 3.0 Assay (bDNA) is based on a target signal amplification method for the quantification of hepatitis C virus (HCV) RNA in human serum and plasma. In an overnight incubation, HCV RNA is liberated from virions, and its capture to a microwell is mediated by a set of specific, synthetic oligonucleotide capture probes (capture extenders). A set of target probes (label extenders) is also hybridized to the viral RNA during this incubation step. The 2 sets of target probes bind to the conserved 5'-untranslated and core regions of the HCV genome. These target probes have been specifically designed to capture and quantify HCV genotypes 1 through 6 equally. After overnight incubation, the preamplifier and amplifier probes are hybridized to the target probes (label extenders). Multiple copies of an alkaline phosphatase-conjugated probe (label probe) are then hybridized to the immobilized complex. Detection is achieved by incubating the complex with a chemiluminescent substrate and measuring the light emission generated by the bound alkaline phosphatase reacting with the chemiluminescent substrate. Light emission is directly proportional to the amount of HCV RNA present in each specimen. Results are recorded as relative light units by the VERSANT 440 Molecular System. A standard curve is defined by light emission from 5 analytical standards containing known concentrations of recombinant bacteriophage. Concentrations of HCV RNA in clinical specimens are then determined from this standard curve.(Package insert: VERSANT HCV RNA 3.0 Assay [bDNA], Siemens Healthcare Diagnostics Inc., Tarrytown, NY; 03210314 Rev. A, 2007-12)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Varies; 12 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
3 days (Monday, Wednesday), 4 days (Friday)
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test