Exact Diagnostics CMV

Exact Diagnostics CMV

Overview

A family of controls, verification panels and verification panel bundle to support monitoring the presence and determining the accuracy and sensitivity of assays for the presence of Cytomegalovirus (CMV) DNA

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Description

Description

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The EDX Cytomegalovirus (CMV) 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 CMV 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 1st WHO International Standard for Cytomegalovirus (09/162)
  • 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.
CMVP100: 400 IU/mL-4,000,000 IU/mL
CMVP200: 200 IU/mL-4,000,000 IU/mL

Analytes

  • Inactivated CMV

 

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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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items

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CMVP100

Panel used to establish points of reference (qualitative and quantitative) for the measurement of Cytomegalovirus (CMV) DNA. (5 x 1.0 mL)

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CMVP200

Panel used to establish points of reference (qualitative and quantitative) for the measurement of Cytomegalovirus (CMV) DNA. (6 x 1.4 mL)

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EDX CMV Verification Bundle
CMVB200

Verification Bundle offering 4 CMVP200 Verification Panels, 2 Kits of 1E3IU/mL Precision Controls (18 Vials), 2 Kits of 5E5IU/mL Precision Controls (18 Vials), and 2 Kits of CMV 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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molecular bulk urine negative control
12019386

Independent external quality run control to monitor the absence of Adenovirus (ADV), BK virus (BKV), Candida auris (C. auris), Chlamydia trachomatis (CT), Cytomegalovirus (CMV), John Cunningham virus (JCV), Mycoplasma genitalium (MG), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Zika virus (ZKV) in various molecular assays. (1x 50 mL)

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CMV 1E3 Precision
CMVL201

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

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CMV 5E5 Precision
CMVH202

Precision panel used to determine accuracy of the assay for the presence of Cytomegalovirus (CMV) DNA at the target concentration of 5E5 IU/mL. (9 x 1.4 mL)

Documents

Documents

Number Description Options
Q-1673
Exact Diagnostics products catalog