Exact Diagnostics HIV-1 Verification Panel #HIVP200

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HIVP200 image edx

Overview

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

Safety Data Sheet

Safety Data Sheet

Description

Description

Exact Diagnostics HIV-1 Verification Panel Summary
Catalog Number HIVP200
Analyte Inactivated HIV-1
Matrix True EDTA Plasma
Preservative ProClin® 300
Storage -20°C or Below
Fill Volume 1.4mL
Number of Vials Per Kit 7 Vials
Number of Uses Single Use
Shelf Life 24 Months from Date of Manufacture
Traceability 3rd WHO International Standard
Precautions Biological Risks
Regulatory Status In Vitro Diagnostic Use

 

Exact Diagnostics HIV-1 Panel Components Concentration
EDX HIV-1 Panel Member 1 100 cp/mL
EDX HIV-1 Panel Member 2 600 cp/mL
EDX HIV-1 Panel Member 3 6,000 cp/mL
EDX HIV-1 Panel Member 4 60,000 cp/mL
EDX HIV-1 Panel Member 5 600,000 cp/mL
EDX HIV-1 Panel Member 6 2,000,000 cp/mL
EDX HIV-1 Panel Member 7 6,000,000 cp/mL

 

INTENDED USE:
The Exact Diagnostics HIV-1 Verification Panel 1.4mL is a standard for various molecular assays. The Exact Diagnostics HIV-1 Verification Panel 1.4mL is calibrated against the 3rd WHO International Standard for HIV-1 (10/152). The Exact Diagnostics HIV-1 Verification Panel 1.4mL is used to establish points of reference (qualitative and quantitative) for the measurement of Human Immunodeficiency Virus (HIV-1) RNA. The Exact Diagnostics HIV-1 Verification Panel 1.4mL allows laboratories to evaluate their molecular assay and test for operator proficiency.

PRODUCT DESCRIPTION:
The Exact Diagnostics HIV-1 Verification Panel 1.4mL contains whole, intact virus that has been heat inactivated. The Exact Diagnostics HIV-1 Verification Panel 1.4mL is intended to test the entire process of a molecular assay including extraction, detection, and amplification.

The Exact Diagnostics HIV-1 Verification Panel 1.4mL is reported in copies per milliliter (cp/mL). The Exact Diagnostics HIV-1 Verification Panel 1.4mL is manufactured according to ISO 17511:2003. The Exact Diagnostics HIV-1 Verification Panel 1.4mL 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.