Exact Diagnostics HBV

Exact Diagnostics HBV

Overview

A family of unassayed external controls, verification panels and verification panel bundle to support monitoring the presence and determining the accuracy and sensitivity of assays for the presence of Hepatitis B Virus (HBV) DNA

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Description

Description

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The EDX HBV Verification Panel and Run Controls have been calibrated using digital PCR. The verification panel is used to establish points of reference (qualitative and quantitative) that are used in the determination of values in the measurement of Hepatitis B Virus (HBV) DNA. Routine use of the Run Controls allow laboratories to evaluate the day-to-day and lot-to-lot variation of their molecular assay and test for operator proficiency.

  • Verification Panel offers a wide dynamic range
  • Calibrated against the 3rd WHO International Standard for Hepatitis B (10/264)
  • Calibrated with digital droplet PCR
  • High quality matrix to ensure lot-to-lot reproducibility
  • True EDTA Plasma
  • 36 month shelf life from date of manufacture
  • 24 hour stablity when stored at 2-8°C

Dynamic Ranges.
HBVP100: 100 IU/mL-100,000,000 IU/mL
HBPV200: 100 IU/mL-100,000,000 IU/mL

Analyte

  • Inactivated HBV

 

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Refer to My eInserts or the package insert (IFU) of currently available lots for specific analyte and stability claims.

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HBVP100
Verification Panel used to establish points of reference (qualitative and quantitative) for the measurement of Hepatitis B Virus (HBV) DNA. (7 x 1.0mL)
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HBVP200

Verification Panel used to establish points of reference (qualitative and quantitative) for the measurement of Hepatitis B Virus (HBV) DNA. (7 x 1.4mL)

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HBVB200

Bundle offers 4 HBVP200 Verification Panels, 2 Kits of 1E3IU/mL Precision Controls (18 Vials), 2 Kits of 1E5IU/mL Precision Controls (18 Vials), and 2 Kits of HBV LOD (20 Vials).

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NEG000

Unassayed external control used to monitor the absence of Adenovirus, BKV, CMV, EBV, HBV, HCV, HHV-6, HIV-1, HSV-1/2, JC Virus, VZV, and Zika Virus for various molecular assays. (5 x 1.0mL)

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NEG050

Unassayed external control used to monitor the absence of Adenovirus, BKV, CMV, EBV, HBV, HCV, HHV-6, HIV-1, HSV-1/2, JC Virus, VZV, and Zika Virus for various molecular assays. (1 x 50.0 mL)

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HBV 1E3 Precision
HBVL201

Precision panel used to determine the accuracy of the assay for the presence of Hepatitis B Virus (HBV) DNA at the target concentration of 1E3 IU/mL. (9 x 1.4 mL)

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HBV 1E6 Precision
HBVH202

Precision panel used to determine the accuracy of the assay for the presence of Hepatitis B Virus (HBV) DNA at the target concentration of 1E6 IU/mL. (9 x 1.4 mL)

Documents

Documents

Number Description Options
Q-1673
Exact Diagnostics products catalog