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For In Vitro Diagnostic Use
For HCV management, especially given the high cost of therapies, excellent performance at clinical decision points is critical for providing reliable results (at 25 IU/ML) to assess SVR. The Abbott RealTime HCV assay delivers accurate quantification of GT 1-6.
Abbott RealTime HCV Viral Load Package Insert (PDF - 0.6 MB)
For Information Only - Not a Controlled Copy
Leading Science
The Abbott RealTime HCV assay delivers accurate quantification of genotypes 1, 2, 3, 4, 5 and 6, and consists of three reagent kits:
Precisely Quantitates HCV Levels At Clinical Decision Points1
The Abbott RealTime HCV assay demonstrated greater precision than other HCV assays at clinical decision points (6 HCV genotype 1 samples, 10 aliquots measured in 10 independent runs, respectively).2
Reliably Assesses Viral Load
The Abbott RealTime HCV assay is highly precise in reliably assessing viral load.
Assay | Cv (25 IU/ML) |
RealTime (Abbott) | 27% |
CTM v2 (Roche) | 53% |
Versant (Siemens) | 49% |
Detection and Quantitation of HCV Genotypes
Correlation to Comparator Assay
HCV Viral Load Treatment Monitoring During Therapy3
Excellent analytical performance at clinical decision points (25 IU/ML) is important in providing reliable results in assessing SVR at these specific time points:
HCV Viral Load Treatment Monitoring Time Points
Indications and Limitations of Use
Intended Use
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.
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.
References
An Assay Designed with Leading Science
The unique combination of Abbott RealTime HCV assay design features ensures reliable detection of all major HCV genotypes with a high degree of precision.
Conserved Target Region
Unique Probe Design
In the absence of target, the probe achieves quenching through random coiling.
Optimal Cycling Conditions
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) |
Input Volume | 0.5mL |
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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