AltoStar^® HEV RT-PCR Kit 1.5

AS0271543

In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar^® HEV RT-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 licensed with Health Canada and not FDA cleared or approved. Kits not available in all countries.

Key features

Detection and quantification of hepatitis E virus (HEV) specific RNA
CE-IVD marked in vitro diagnostic test
Analytical sensitivity reported in IU/ml

Limit of detection (LoD)

LoD plasma

3.41 IU/ml

Sample types

The following sample types are validated for use with the AltoStar^{^®}HEV RT-PCR Kit 1.5:

Human EDTA plasma

Human citrate plasma

Other workflows

The AltoStar^{^®}HEV RT-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^{^®}HEV RT-PCR Kit 1.5 are:

CFX96^™ Deep Well Dx System (Bio-Rad)

ABI Prism^® 7500 SDS (Applied Biosystems)

LightCycler^® 480 Instrument II (Roche)

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

AltoStar^® HEV RT-PCR Kit 1.5

Order No.	AS0271543
Rxns	96
Transportation	Dry ice
Regulatory status	CE-IVD