Exact Diagnostics HCV Verification Panel #HCVP100

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HCVP100 edx image

Overview

Verification Panel used to establish points of reference (qualitative and quantitative) for the measurement of Hepatitis C Virus (HCV) RNA. (7 x 1.0mL)

Safety Data Sheet

Safety Data Sheet

Description

Description

Exact Diagnostics HCV Verification Panel Summary
Catalog Number HCVP100
Analyte Recombinant HCV
Matrix True EDTA Plasma
Preservative ProClin® 300
Storage -20°C or Below
Fill Volume 1.0mL
Number of Vials Per Kit 7 Vials
Number of Uses Single Use
Shelf Life 36 Months from Date of Manufacture
Traceability 4th WHO International Standard
Precautions Biological Risks
Regulatory Status In Vitro Diagnostic Use

 

Exact Diagnostics HCV Panel Components Concentration
EDX HCV Panel Member 1 100 IU/mL
EDX HCV Panel Member 2 300 IU/mL
EDX HCV Panel Member 3 3,000 IU/mL
EDX HCV Panel Member 4 30,000 IU/mL
EDX HCV Panel Member 5 300,000 IU/mL
EDX HCV Panel Member 6 3,000,000 IU/mL
EDX HCV Panel Member 7 30,000,000 IU/mL

 

INTENDED USE:
The Exact Diagnostics HCV Verification Panel is a standard for various molecular assays. The Exact Diagnostics HCV Verification Panel is calibrated against the 4th WHO International Standard for Hepatitis C (06/102)1 . EDX HCV Verification Panel is used to establish points of reference (qualitative and quantitative) for the measurement of Hepatitis C Virus (HCV) RNA. The Exact Diagnostics HCV Verification Panel allows laboratories to evaluate their molecular assay and test for operator proficiency.

PRODUCT DESCRIPTION:
The Exact Diagnostics HCV Verification Panel contains whole, intact virus. The Exact Diagnostics HCV Verification Panel is developed using recombinant, noninfectious virus which contains the HCV 5’ UTR insertion. The Exact Diagnostics HCV Verification Panel is intended to test the entire process of a molecular assay including extraction, detection, and amplification.

The Exact Diagnostics HCV Verification Panel is reported in International Units per milliliter (IU/mL). The Exact Diagnostics HCV Verification Panel is manufactured according to ISO 17511:2003. EDX HCV Verification Panel is formulated in True EDTA Plasma that is non-reactive for HBV DNA, HCV RNA, HIV-1 RNA, HBsAg and antibodies for HIV-1/2, and HCV.