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Aptima HCV Quant Dx Assay

The Aptima HCV Quant Dx assay is licensed for the
confirmation of active infection and viral load monitoring on the
fully automated Panther system.
 
• Ultrasensitive, highly precise performance over a wide
linear range, across all major genotypes.
 
• Validated sample dilution protocols allow you to run
samples with as little as 240(L (for viral load use only).
 
• Minimize operator hands-on time with true sample-to-result
automation on the Panther system.
 
This assay is not available for sale in the U.S. Please contact
your local sales representative for product availability.
 
About
The Aptima HCV Quant Dx assay is an in vitro nucleic acid amplification test (NAAT) for
the detection andquantitationofHCVRNA in fresh and frozen human serum or
plasmaon the fully automated Panther system.The Aptima HCV Quant Dx assay is
indicated for use as an aid in the diagnosis of HCV infection and for use as an aid in
the management of HCV infected patients undergoing HCV antiviral drug therapy.
 
• Streamline and simplify HCV testing within your lab with the versatility of a single
assay for both confirmation of active infection AND viral load monitoring
 
• QuantifyHCV RNA—across all major genotypes—with ultrasensitivity and high
precision over a wide linear range.
 
• Strategic design with three levels of protection:
  • Redundant target capture oligos to protect against potential mutations.
  • Longer oligos for extra protection against single base mismatches.
  • Multiple amplification primers for broad genotype coverage.

Diagnostic and Confirmatory Testing of HCV

The Aptima HCV Quant Dx assay is indicated for use as an aid in the management of
HCV infected patients undergoing HCV antiviral drug therapy.1The assay measures
HCV RNA levels at baseline, during treatment, and after treatment to determine
sustained virological response (SVR).2The results from the Aptima HCV Quant Dx assay
must be interpretedwithin the context of all relevant clinical and laboratory findings.

Management of HCV infected patients

The Aptima HCV Quant Dx assay is indicated for use as an aid in the management of
HCV infected patients undergoing HCV antiviral drug therapy.1The assay measures
HCV RNA levels at baseline, during treatment, and after treatment to determine
sustained virological response (SVR).2The results from the Aptima HCV Quant Dx assay
must be interpretedwithin the context of all relevant clinical and laboratory findings.
 
The Aptima HCV Quant Dx assay is not intended for use as a screening test for
thepresence of HCV in blood or blood products.
Performance

Ultrasensitivity for Treatment Management

The Aptima HCV Quant Dx assay’s Limit of Detection (LoD) is 4.3 IU/mL in plasma (3.9 IU/mL in serum).

(All tables and figures in this section can be found in the Aptima HCV Quant Dx package insert.)

LoD of the Aptima HCV Quant Dx Assay Using the WHO 2nd International Standard

LoD Across HCV Genotypes 1-6


 

Lower Limit of Quantitation (LLoQ)

The LLoQ of the Aptima HCV Quant Dx assay is 10 IU/mL. 

Verification of LLOQ by HCV Genotype (plasma)

 

Confidence in Performance Across a Broad Linear Range

The linear range was established by testing panels of HCV Armored RNA diluted in HCV-negative human plasma and serum.  The linear range of the Aptima HCV Quant Dx assay is 1.0 to 8.0 log IU/mL.

Linearity Across Genotypes 1-6 

(transcript diluted in buffer)

Reliable Quantitation

In addition to accurate quantitation, the Aptima HCV Quant Dx assay offers precise quantitation across the linear range. Precision is maintained in plasma samples with low-viremia with narrow CV of 11.34% in samples with only 1.23 log IU/mL.

Precision of the Aptima HCV Quant Dx Assay

Flexibility with Validated Dilution Protocols for High Titer Plasma Samples

Diagnostic Performance

Diagnostic Agreement Between Aptima HCV Quant Dx Assay and Comparator Assay

References

1. Peiffer K-H, et al. The Importance of HCV RNA measurement for tailoring treatment duration." Digest Liver Dis. 2013;45(S5):323-31. doi:10.1016/j.dld.2013.07.007.
2. EASL. Recommendations on Treatment of Hepatitis C 2014. http://www.easl.eu/discover/news/easl-recommendations-on-treatment-of-he.... Published April 2014. Accessed 2015.

Glossary

HCV: Hepatitis C Virus
RNA: ribonucleic acid