AltoStar^® JCV PCR Kit 1.5

AS0041543

In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar^® JCV PCR Kit 1.5 has received a new product number and Global Trade Item Number (GTIN). The new product number reflects the desired change in regulatory status. All other product characteristics as well as the product performance remain unchanged. The kit is chemically identical to its already existing counterpart and contains the same kit components.

Products not FDA cleared or approved. Kits not available in all countries.

Key features

Detection and quantification of JC virus (JCV) specific DNA
CE-IVD marked in vitro diagnostic test
Analytical sensitivity reported in IU/ml

Limit of detection (LoD)

LoD plasma

3.6 IU/ml

Sample types

The following sample types are validated for use with the AltoStar^® JCV PCR Kit 1.5:

Human EDTA plasma

Human citrate plasma

Other workflows

The AltoStar^® JCV PCR Kit 1.5 can be used with compatible workflows (manual or automated). Real-time PCR instruments that have been validated for use with the AltoStar^® JCV PCR Kit 1.5 are:

CFX96^™ Deep Well Dx System (Bio-Rad)

CFX96^™ Dx System (Bio-Rad)

ABI Prism^® 7500 SDS (Applied Biosystems)

LightCycler^® 480 Instrument II (Roche)

QuantStudio^™ 5 Real-Time PCR System (Applied Biosystems)

Rotor-Gene^® Q5/6 plex Platform (QIAGEN)

The AltoStar^® JCV PCR Kit 1.5 can be used with nucleic acid extraction systems other than the AltoStar^® AM16. Alternative procedures used for nucleic acid extraction have to be validated by the user.

Intended use

The AltoStar^® JCV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of JC virus (JCV) specific DNA in human plasma. It is intended to be used as an aid for diagnosis of JCV infection and for monitoring of the JCV load in individuals with JCV infection.

AltoStar^® JCV PCR Kit 1.5

Order No.	AS0041543
Rxns	96
Transportation	Dry ice
Regulatory status	CE-IVD