AMPIPROBE®HCV assay kit

In a validation study approved by the New York State Department of Health, the AMPIPROBE® HCV assay was determined to have the following sensitivity:LOD serum – 5.46 IU/mL via 95% Probit analysisLOD plasma – 7.91 IU/mL via 95% Probit analysisLOQ serum – 10 IU/mL via 95% hit rate analysisLOQ plasma – 10 IU/mL via 95% hit rate analysisIn the same validation study, the linear range of both serum and plasma was determined to be 5 to 25,000,000 IU/mL.

The AMPIPROBE ® HCV assay is capable of quantifying viral RNA from HCV genotypes 1-6. In a validation study approved by the NYS DOH, for genotype inclusivity, the AMPIPROBE ® HCV assay detected genotypes 1a, 1b, 2a, 3a, 4acd, 5a, and 6 at concentrations of 15 IU/mL or greater with a hit rate of ≥95%.

The AMPIPROBE ® HCV assay is compatible with any properly calibrated qPCR thermal cycler capable of exciting and reading emissions from FAM/Green and CY5/Red. It has been validated for use on the following instruments: QIAGEN Rotor-Gene Q and Applied Biosystems ® 7500.

AMPIPROBE ® HCV Primer Mix Negative Control HCV High Control HCV Medium Control HCV Low Control Internal Control Card Insert with values of HCV High, Medium, and Low Controls