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For In Vitro Diagnostic Use
The Abbott m2000 platform allows for full automation and consolidation of HCV GT II and viral load testing in the molecular laboratory.Abbott RealTime HCV Genotype II Package Insert (PDF – 1.3MB) For Information Only - Not a Controlled Copy
The Abbott RealTime HCV Genotype II assay consists of 2 reagent kits:
Covers All Major US Genotypes
The Abbott RealTime HCV Genotype II assay detects genotypes 1, 2, 3, 4, and 5 and subtypes 1a and 1b.
Accurate Genotype Detection
Accuracy of the Abbott RealTime HCV Genotype II assay was determined in comparison to a validated nucleotide sequencing reference method.
|HCV Genotype by SequencingOverall||Genotype Accuracy by Abbott|
|1||99.6 % (265/266)
1a – 99.3 (139/140)
1b – 99.1 (114/115)
The Abbott RealTime HCV GT II assay demonstrated less hands-on time and processing time than the LiPA v.2.0 RUO assay.
Indications and Limitations of 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
Warnings and Precautions
The Abbott RealTime HCV Genotype II assay is not for screening blood, plasma, serum or tissue donors for HCV.
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.
The Abbott RealTime HCV Genotype II assay detects genotypes 1, 2, 3, 4, 5, and 6, and subtypes 1a and 1b through the use of genotype-specific fluorescent-labeled oligonucleotide probes. It targets the 5'UTR for the classification of HCV genotypes 1, 2, 3, 4, 5, and 6, and the NS5B region to accurately subtype HCV genotypes 1a and 1b.The Abbott RealTime HCV Genotype II assay uses 5'UTR for genotype discrimination and NS5b region for subtype discrimination.
The Abbott RealTime HCV Genotype II assay uses a Minor Groove Binder (MGB). Probes with MGB groups form extremely stable duplexes with single-stranded DNA targets thus allowing increased mismatch discrimination to help differentiate the various HCV genotypes and subtypes.
The cycling conditions for the Abbott RealTime HCV Genotype II assay are optimized to achieve the best probe binding while maintaining good genotype and subtype discrimination.
Abbott RealTime HCV Genotype II assay cycling conditions
|Abbott RealTime HCV Genotype II assay performance|
|Target Regions||5'UTR for GT 1-5, NS5b for subtypes 1a, 1b|
|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)|
Creates efficiency from the lab tube through patient result. Includes m2000rt and m2000sp
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