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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 to assess SVR.
The Abbott RealTime HCV assay delivers accurate quantification of GT 1-6 using human serum, plasma, and Dried Blood Spot (DBS) samples.
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% |
* Plasma/serum
Detection and Quantitation of HCV Genotypes
Genotype dilution linearity was demonstrated by diluting six specimens, one of each genotype 1 through 6, to target concentrations of 5.0 log IU/ml, 3.5 log IU/ml, 2.0 log IU/ml, and 1.0 log IU/ml. Four replicates were tested at each concentration of each genotype. The correlation coefficients ranged from 0.994 to 0.998.
Correlation to Comparator Assay
Specimens (plasma/serum) from 131 HCV infected patients were tested with the Abbott RealTime HCV assay and a comparator assay per NCCLS Document EP9-A2.
EASL HCV Viral Load Testing Recommendations3
The European Association for the Study of the Liver (EASL) recommendations on HCV RNA monitoring:
Intended Use
The Abbott RealTime HCV viral load assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantitation of hepatitis C viral ribonucleic acid (HCV RNA) in human serum and plasma from HCV-infected individuals. The Abbott RealTime HCV viral load assay is intended for use as an aid in the management of HCV-infected patients undergoing antiviral therapy. The Abbott RealTime HCV viral load 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.
Intended Use for DBS
The Abbott RealTime HCV assay is an in vitro reverse transcription polymerase chain reaction (RT-PCR) assay for the quantitation of hepatitis C viral RNA (HCV RNA) in whole blood spotted on cards as dried blood spots (DBS) (ie, obtained via venipuncture or capillary blood) from HCV infected individuals. The Abbott RealTime HCV assay is intended for use as an aid in the management of HCV-infected patients undergoing antiviral therapy. The Abbott RealTime HCV assay is not for screening blood, plasma, serum or tissue donor for HCV, or to be used as a diagnostic test to confirm the presence of HCV infection.
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
The target sequence for the Abbott RealTime HCV assay is in the 5´UTR region of the HCV genome. This region is specific for HCV and is highly conserved. The primers are designed to hybridize to the 5´UTR region with the fewest possible mismatches among HCV genotypes 1-6.
Unique Probe Design
In the absence of target, the probe achieves quenching through random coiling.
In presence of target, the probe prefers to hybridize to the target sequence, allowing fluorescent detection; cleavage is not required.
Optimal Cycling Conditions
The cycling conditions for RealTime HCV encompass a low temperature read cycle. This read cycle allows the probe to tolerate mismatches more effectively than a probe required to bind during the extension phase.
| ABBOTT REALTIME HCV PERFORMANCE* | |
| Sensitivity | 462 IU/mL for the 70 µL sample volume (DBS) 12 IU/mL for the 500 µL sample volume (Plasma/Serum) 30 IU/mL for the 200 µL sample volume (Plasma/Serum) |
| Linear Range | 462 IU/mL to 1.0E+08 IU/mL (DBS) 12 IU/mL to 1.0E+08 IU/mL (500 µL Plasma/Serum) 30 IU/mL to 1.0E+08 IU/mL (200 µL Plasma/Serum) |
| Precision | ≤ 0.25 log IU/mL SD |
| Specificity | Overall: 100% |
| Genotype Detection | Accurate quantification of genotypes 1, 2, 3, 4, 5 and 6 |
| Standardization | Second World Health Organization international standard for HCV RNA (NIBSC 96/798) |
| Internal Control | Armored RND (Pumpkin kinase) |
| Calibrator | 2 Calibrator levels - single use tubes |
| Control | One negative, one low positive and one high positive control |
| Sample Input Volume | DBS: 70 µL Whole blood / 1.3 mL DBS Elution Buffer Plasma/Serum: 200 µL or 500 µL |
*Abbott RealTime HCV Package Insert 51-602124/R10 and Abbott Realtime HCV with DBS Package Insert 51-608440/R1
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Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.
