- Vysis FISH
- Abbott REAL-TIME PCR
- Ordering Information
Indications and Limitations of UseIntended Use
The Abbott RealTime HCV Genotype II 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 qualitative identification of hepatitis C virus (HCV) genotypes 1, 1a, 1b, and 2 -5 in plasma or serum from individuals chronically infected with HCV. The Abbott RealTime HCV Genotype II is intended for use as an aid in the management of HCV-infected individuals and in guiding the selection of therapeutic treatment indicated for the above listed genotypes. The assay is intended for use on patients who are chronically infected with HCV, are being considered for antiviral treatment, and are positive for HCV RNA. The Abbott RealTime HCV Genotype II assay is not for screening blood, plasma, serum or tissue donors for HCV.
Limitations of the Procedure
CAUTION: United States Federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; and use is restricted to, by, or on the order of a physician.
To learn more about RealTime HCV Genotype II please visit: https://www.molecular.abbott/us/en/products/infectious-disease/realtime-hcv-genotype-II
|Abbott RealTime HCV Genotype II assay performance|
|Target Regions||5'UTR for GT 1-5, NS5b for subtypes 1a, 1b|
|Limit of Detection||500 IU/mL|
|Accuracy||99.5% compared to sequencing|
|Standardization||Second World Health Organization International Standard for Hepatitis C Virus RNA|
|Internal Control||Yes; processed through sample prep with each sample|
|External Control||Yes; Negative, Positive|
|Results Reported||Qualitative - Genotype Call|
|Specimen Type||Serum or plasma (ACD-A, CPD, potassium EDTA, or sodium EDTA)|
|Process Time||5.5 hours (24 tests)|
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