Exact Diagnostics BKV LOD #BKVLOD

Exact Diagnostics BKV LOD

Overview

Material used to determine the analytical sensitivity of the assay for Polyomavirus BK Virus (BKV) DNA (10 x 1.0 mL)

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Description

Description

Exact Diagnostics BKV LOD Summary
Catalog Number BKVLOD
Analyte Inactivated BKV
Matrix True EDTA Plasma
Preservative ProClin® 300
Storage -70°C or Below
Fill Volume 1.0mL
Number of Vials Per Kit 10 Vials
Number of Uses Single Use
Shelf Life 24 Months from Date of Manufacture
Traceability 1st WHO International Standard
Precautions Biological Risks
Regulatory Status In Vitro Diagnostic Use


INTENDED USE:
The Exact Diagnostics BKV LOD is calibrated against the 1st WHO International Standard for BK Virus (BKV) (14/212)1. The Exact Diagnostics BKV LOD is used to determine the analytical sensitivity of the assay for Polyomavirus BK Virus (BKV) DNA. The Exact Diagnostics BKV LOD allows laboratories to evaluate their molecular assay and test for operator proficiency.

PRODUCT DESCRIPTION:
The Exact Diagnostics BKV LOD contains whole, intact virus that has been heat inactivated. The control is intended to test the entire process of a molecular assay including extraction, detection, and amplification. The Exact Diagnostics BKV LOD is formulated in True EDTA Plasma that is nonreactive for HBV DNA, HCV RNA, HIV-1 RNA, BKV DNA, HBsAg and antibodies for HIV-1/2, and HCV.

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