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- Abbott REAL-TIME PCR
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|Product Name||Unit Size||Order Number||GTIN|
The Abbott RealTime HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the Abbott mSample Preparation System reagents and with the Abbott m2000sp and m2000rt instruments for the quantitation of hepatitis C viral (HCV) RNA in human serum or plasma (EDTA) from HCV-infected individuals. Specimens containing HCV genotypes 1 – 6 have been validated for quantitation in the assay.
The Abbott RealTime HCV assay is intended for use as an aid in the management of HCV-infected patients undergoing antiviral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non-sustained virological response to HCV therapy. The results from the RealTime HCV assay must be interpreted within the context of all relevant clinical and laboratory findings.
Assay performance characteristics have been established for individuals treated with peginterferon alfa-2a or 2b plus ribavirin. No information is available on the assay’s predictive value when other therapies are used. Assay performance for determining the state of HCV infection has not been established.
The Abbott RealTime HCV assay is not for screening blood, plasma, serum or tissue donors for HCV, or to be used as a diagnostic test to confirm the presence of HCV infection.
Limitations of the Procedure
Warnings and Precautions
The Abbott RealTime HCV assay is not for screening blood, plasma, serum, or tissue donors for HCV, or to be used as a diagnostic test to confirm the presence of HCV infection.
The Abbott RealTime HCV reagents are intended to be used only on the Abbott m2000 System consisting of the Abbott m2000sp for sample processing and the Abbott m2000rt for amplification and detection.
To learn more about Abbott RealTime HCV please visit: https://www.molecular.abbott/us/en/products/infectious-disease/realtime-hcv-viral-load
|Abbott RealTime HCV Performance*|
|Limit of Detection (LOD)||12 IU/mL|
|Limit of Quantitation (LOQ)||12 IU/mL|
|Linear Range||12 IU/mL (1.08 log IU/mL) to 100 million IU/mL (8.0 log IU/mL)|
|Target Region||5' utr|
|Genotype Detection||Accurate quantification of genotypes 1, 2, 3, 4, 5 and 6|
|Internal Control||Added to lysis buffer during extraction and detected with all samples|
|Calibration||External two point|
|Specimen Type||Human serum and plasma (EDTA)|
|Precision||SD: less than or equal 0.25 log IU/mL|
|Standardization||Second World Health Organization international standard to HCV RNA (NIBSC 96/798)|
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