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)
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 Agreement Between Aptima HCV Quant Dx Assay and Comparator Assay