RealTime HCV Genotype II

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.

icon-pdf.png Abbott RealTime HCV Genotype II Package Insert (PDF – 1.3MB) For Information Only - Not a Controlled Copy
Description
 

The Abbott RealTime HCV Genotype II assay consists of 2 reagent kits: 

  • Abbott RealTime HCV Genotype II Amplification Reagent Kit
  • Abbott mSample Preparation 

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.

us-distribution-of-genotypes-pie-chart.jpg

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)
Subtyping Accuracy
1a – 99.3 (139/140)
1b – 99.1 (114/115)
2 99.1% (110/111)
3 100.0% (86/86)
4 98.7% (76/77)
5 100.0% (24/24)
Overall 99.5% (561/564)

 

realtime-hcv-automated-efficiency-objective-results-chart.jpgThe 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

Intended 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

  • Human serum or plasma (ACD-A, CPD, potassium EDTA, or sodium EDTA) specimens may be used with the Abbott RealTime HCV Genotype II assay. The use of other anticoagulants has not been validated with the Abbott RealTime HCV Genotype II assay.
  • As with any diagnostic test, results from the Abbott RealTime HCV Genotype II assay should be interpreted in conjunction with other clinical and laboratory findings. A specimen with a result of “HCV not detected” cannot be presumed to be negative for HCV RNA.
  • A specimen with an interpretation of “No Genotype Result” cannot be presumed to be negative for the tested genotypes. Multiple genotype assay results may be caused by a mixed genotype infection, recombination of HCV genotypes, or assay probe cross-reactivity.
  • The Abbott RealTime HCV Genotype II assay is capable of detecting both genotypes in a genotype mixture when the concentrations of both genotypes are near equal; however, the assay may not detect the lower concentration genotype.
  • Performance has not been established with the Abbott RealTime HCV Genotype II assay for HCV genotype 6 specimens.

Warnings and Precautions

The Abbott RealTime HCV Genotype II assay is not for screening blood, plasma, serum or tissue donors for HCV. 

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.

Design
 

Target Region

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.

rt-hcv-gt-II-targetreg.gifThe Abbott RealTime HCV Genotype II assay uses 5'UTR for genotype discrimination and NS5b region for subtype discrimination.
 

Probe Design

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.

realtime-hcv-minor-groove-binder.jpg
Probe design 
 
Optimal Cycling Conditions

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. 

realtime-hcv-gt-cycling-conditions.jpg
Abbott RealTime HCV Genotype II assay cycling conditions

Specifications
 
Abbott RealTime HCV Genotype II assay performance
Target Regions 5'UTR for GT 1-5, NS5b for subtypes 1a, 1b
Sensitivity 500 IU/mL
Accuracy 99.5% compared to sequencing
Specificity 100%*
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)
*Performance of Abbott RealTime HCV Genotype II with HCV negative specimens was evaluated by analyzing 370 unique HCV negative specimens; 135 HCV serologically-negative serum and 235 HCV serologically-negative plasma specimens. The observed specificity was 100% (370/370).

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