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 (at 25 IU/ML) to assess SVR. The Abbott RealTime HCV assay delivers accurate quantification of GT 1-6. 

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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%
 

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 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) recommends HCV RNA monitoring to assess:

  • Baseline viral load (just prior to therapy)
  • Treatment efficacy
  • Treatment success (end of treatment and SVR assessment)

HCV Viral Load Treatment Monitoring During Therapy4

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

HCV viral load treatment monitoring time points

EOT = end of treatment (week 12, 24, or 48). For IFN-free therapy regimens, week 2 testing is for patient adherence. VL = Viral Load, GT = Genotype, SVR = Sustained Virologic Response. For IFN-free therapy regimens, week 2 testing is for patient adherence, week 12 is assumed end of treatment (ED).EASL Clinical Practice Guidelines,Journal of Hepatology 2014 vol. 60 j 392-420. EASL HVC Treatment Recommendations, April 2014. Available at http://www.easl.eu/_newsroom/latest-news/easl-recommendations-on-treatment-of-hepatitis-c-2014. Accessed January 9, 2015. AASLD/IDSA/IAS-USA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed on January 29, 2014. AASLD/IDSA HCV Guidance Panel (2015), Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology, 62: 932–954. doi:10.1002/hep.27950
 

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.

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. European Association for the Study of the Liver. Recommendations on treatment of Hepatitis C, 2015. http://www.easl.eu/research/our-contributions/clinical-practice-guidelines/detail/recommendations-on-treatment-of-hepatitis-c-2015.  Accessed June 2016.  
  4. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatitis C virus infection. J Hepatol. 2014; 60(2):392-420.

 

 

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 12 IU/mL for the 0.5 mL sample volume
30 IU/mL for the 0.2 mL sample volume
Linear Range 12 IU/mL (1.08 log IU/mL) to 100 million IU/mL (log 8.0 IU/mL)
Precision Designed to achieve an inter-assay standard deviation (SD) of less than or equal to 0.25 log IU/mL of HCV RNA for samples containing HCV concentrations from 100 to 100 million IU/mL.
Inter-assay SD at 5.97 log IU/mL = 0.04
Inter-assay SD at 1.96 log IU/mL = 0.09
Specificity ≥ 99.5%1
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 Added to lysis buffer during extraction and detected at all levels
*Performance data shown from internal verification.
1The specificity of the Abbott RealTime HCV assay was evaluated by testing 56 HCV seronegative serum and 56 HCV seronegative plasma specimens. HCV RNA was not detected, resulting in 100% (112/112) specificity in this representative study.

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