Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
page
post
product
Home / Products / AltoStar / AltoStar® HEV RT-PCR Kit 1.5

AltoStar® HEV RT-PCR Kit 1.5

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.

Specifications

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.

 

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

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.

Manuals AltoStar® HEV RT-PCR Kit 1.5
Associated documents AltoStar® HEV RT-PCR Kit 1.5
Contact sales

Find your responsible sales representative.

Contact order processing

Order reagents, kits, instruments and implementation equipment for your workflow and laboratory routine.

Manuals AltoStar® HEV RT-PCR Kit 1.5
Language
AltoStar® HEV RT-PCR Kit 1.5 - DE
Language: German
Date: 2022-09
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HEV RT-PCR Kit 1.5 - EN
Language: English
Date: 2022-09
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HEV RT-PCR Kit 1.5 - ES
Language: Spanish
Date: 2022-09
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HEV RT-PCR Kit 1.5 - FR
Language: French
Date: 2022-09
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HEV RT-PCR Kit 1.5 - IT
Language: Italian
Date: 2022-09
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HEV RT-PCR Kit 1.5 - PL
Language: Polish
Date: 2022-09
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HEV RT-PCR Kit 1.5 - PT
Language: Portuguese
Date: 2022-09
Panel: Bloodborne infections
Regulatory status: CE-IVD
Associated documents AltoStar® HEV RT-PCR Kit 1.5
Language
Type of document
AltoStar® HEV RT-PCR Kit 1.5 - DE - DoC
Language: German
Date: 2022-18-05
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® HEV RT-PCR Kit 1.5 - EN - DoC
Language: English
Date: 2022-18-05
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® HEV RT-PCR Kit 1.5 - ES - DoC
Language: Spanish
Date: 2022-18-05
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® HEV RT-PCR Kit 1.5 - FR - DoC
Language: French
Date: 2022-18-05
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® HEV RT-PCR Kit 1.5 - IT - DoC
Language: Italian
Date: 2022-18-05
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® HEV RT-PCR Kit 1.5 - PT - DoC
Language: Portuguese
Date: 2022-18-05
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD