Exact Diagnostics HIV

Exact Diagnostics HIV

Overview

A family of unassayed external controls, verification panels and verification panel bundles to support monitoring the presence and determining the accuracy and sensitivity of assays for the presence of HIV-1 and HIV-2 RNA

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Description

Description

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The EDX HIV-1 and HIV-2 Verification Panels, Bundles, 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 HIV-1 and HIV-2 RNA. 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 HIV-1 (10/152)
  • Calibrated against the 2nd WHO International Standard for HIV-2 (16/296)
  • 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 stability when stored at 2-8°C

Dynamic Ranges.
HIVP100: 100 cp/mL-6,000,000 cp/mL
HIVP200: 100 cp/mL-6,000,000 cp/mL

Analyte

  • Inactivated HIV-1
  • Inactivated HIV-2

 

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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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HIVP100

Verification Panel used to establish points of reference (qualitative and quantitative) for the measurement of HIV-1 RNA. (7 x 1.0mL)

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HIVP200 image edx
HIVP200

Verification Panel used to establish points of reference (qualitative and quantitative) for the measurement of HIV-1 RNA. (7 x 1.4mL)

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Exact Diagnostics HIV-1/HIV-2 Verification Panel 
HIVQP200

The Exact Diagnostics HIV-1/HIV-2 Verification Panel is used to monitor the presence of Human Immunodeficiency Virus (HIV-1) RNA and Human Immunodeficiency Virus (HIV-2) RNA at various concentrations. Panel Offers HIV-1 3X, 5X, 10X LOD; HIV-2 3X, 5X, 10X LOD; HIV-1/HIV-2 2.5X, 5X, 10X LOD (12 x 1.4 mL)

For research use only. Not for use in diagnostic procedures.

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HIVB200

Bundle offers 4 HIVP200 Verification Panels, 2 Kits of 1E3cp/mL Precision Controls (18 Vials), 2 Kits of 1E5cp/mL Precision Controls (18 Vials), and 2 Kits of HIV-1 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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HIV-1 1E3 Precision
HIVL201

Precision panel used to determine the accuracy of the assay for the presence of Human Immunodeficiency Virus (HIV-1) RNA at the target concentration of 1E3 cp/mL. (9 x 1.4 mL)

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HIV-1 1E5 Precision
HIVH202

Precision panel used to determine the accuracy of the assay for the presence of Human Immunodeficiency Virus (HIV-1) RNA at the target concentration of 1E5 cp/mL. (9 x 1.4 mL)

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HIV LOD
HIVLOD

Material used to determine the analytical sensitivity of the assay for Human Immunodeficiency Virus (HIV-1) RNA. (10 x 1.0 mL)

Documents

Documents

Number Description Options
Q-1673
Exact Diagnostics products catalog