RealTime HCV Viral Load

CE Marked

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 now also available for Dried Blood Spot (DBS) sample

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Description
 

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:

  • Abbott RealTime HCV Amplification Reagent Kit
  • Abbott RealTime HCV Control Kit 
  • Abbott RealTime HCV Calibrator Kit 

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.

Abbott RealTime HCV assay range of uncertainty

 ASSAY CV (25 IU/ML)*
RealTime (Abbott) 27%
CTM v2 (Roche) 53%
Versant (Siemens) 49%
 
 * Plasma/serum

Detection and Quantitation of HCV Genotypes

rtimehcv-detectandquantitation.gifAbbott RealTime HCV assay detection and quantitation

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

rtimehcv-correltocomparator.gifChart comparing Abbott RealTime HCV assay to a 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:

  • A sensitive molecular method with a lower limit of detection ≤15 IU/mL should be used to monitor HCV RNA levels in serum or plasma.
  • In low- or middle-income countries and in specific settings in high-income countries, a qualitative HCV RNA assay with a lower limit of detection ≤1,000 IU/mL (3.0 Log10 IU/mL) can be used to provide broad affordable access to HC diagnosis and care.
  • Whole blood sampled on dried blood spots can be used as an alternative to serum or plasma obtained by venipuncture for HCV RNA testing.
  • In patients treated with an IFN-free regimen, HCV RNA or HCV core antigen levels should be measured at base-line and 12 or 24 weeks after the end of therapy (to assess SVR12 or SVR24, respectively).

 

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

  1. Wiesmann F et al. Variation analysis of six HCV viral load assays using low viremic HCV samples in the range of the clinical decision points for HCV protease inhibitors. Med Microbiol Immunol. 2015 Aug;204(4):515-25. DOI 10.1007/s00430-014-0364-z. Epub 2014 Nov 15.
  2. Adapted from Wiesmann F et al. Poster #465. ESCV 2013. Comparison of viral load assays for the quantification of HCV genotypes 1-4 in the setting of low viremic samples.
  3. EASL Recommendations on Treatment of Hepatitis C 2018. European Association for the Study of the Liver. Journal of Heppatology. 
Design
 

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. 

Abbott RealTime HCV assay design 

Conserved Target Region

Abbott RealTime HCV assay target sequence

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

: Abbott RealTime HCV probe design
In the absence of target, the probe achieves quenching through random coiling.

 
Abbott RealTime HCV probe design
In presence of target, the probe prefers to hybridize to the target sequence, allowing fluorescent detection; cleavage is not required.
 

Optimal Cycling Conditions

Abbott RealTime HCV 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.
 
Specifications
 
 
 
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 from 1.0E+04 to 1.0E+08 IU/mL (DBS)

≤ 0.25 log IU/mL SD from 100 to 1.0E+08 IU/mL (Plasma/Serum)

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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