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Exact Diagnostics Analytical Measurement Range Bundle

Exact Diagnostics Analytical Measurement Range Bundle

An Analytical Measuring Range bundle to support monitoring the presence of HBV (DNA), HCV (RNA) and HIV-1 RNA

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Overview

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The EDX Analytical Measurement Range Bundle have been calibrated using digital PCR. The verification Analytical Measurement Range Bundle is used to establish points of reference (qualitative and quantitative) that are used in the determination of values in the measurement of HBV, HVC and HIV-1 RNA.

  • HBV: Calibrated against the 3rd WHO International Standard for Hepatitis B (10/264)
  • HCV: Calibrated against the 4th WHO International Standard for Hepatitis C (06/102)
  • HIV: Calibrated against the 3rd WHO International Standard for HIV-1 (10/152)
  • True EDTA Plasma

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Analytes

  • Inactivated HBV
  • Recombinant HCV
  • Inactivated HIV-1

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

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AMRP100
The EDX Analytical Measurement Range Bundle, is comprised of EDX’s HBVAMR, HCVAMR, and HIVAMR
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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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