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SENSITIVITY:
The test has been shown to be potent to detect at least 30 IU/ml using a HCV positive serum.
Principle:
HCV-diagnosis-by-PCR-is-based-on-the-amplification-of-specific-regions-of-pathogen-genome.-In-Real-Time-PCR-(RT-
PCR)-the-amplified-product-is-detected-via-the-fluorescent-dyes,-which-specifically-binds-to-the-5`-oligonucleotides.
An-Internal-Control-(IC)-is-run-with-each-sample.-The-HCV-and-IC-specific-probes-are-each-labelled-with-different-fluor
ophore,-thus-allowing-for-simultaneous-detection-of-both-amplified-product-at-each-cycle.-The-non-competitive-Internal-
Control-(IC)-is-detected-at-all-HCV-levels.-In-this-way-inhibition-in-the-sample-could-be-observed.-The-homogenous-for
mat-and-sealed-PCR-tubes-eliminate-chances-of-contamination-by-amplified-products.
To-obtain-results-in-copies/ml,-multiply-IU/ml-value-with-1.21.
Formula:-Results-in-IU/ml-`x-1.21-=-copies/ml.
RELIABILITY:
Due to the co-purification and amplification of synthetic internal control RNA maximum reliability of the HCV
quantification kit is granted the absence of PCR inhibitor as well as the correct performance of the extraction can be
detected. Using ready to use virus comp controls a confident quantification of HCV in human serum or plasma samples
is accomplished.
NOTE:
The titer of circulation HCV in blood fluctuates in accordance with the virus latency & variable results may occur in
different phase of viral infection. Therefore clinical correlation is very important Lab to Lab variation may occur due to
difference in sensitivity, specificity and reproducibility of different assay technique used .