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Home / Products / AltoStar / AltoStar® Parvovirus B19 PCR Kit 1.5

AltoStar® Parvovirus B19 PCR Kit 1.5

Intended use

The AltoStar® Parvovirus B19 PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of parvovirus B19 specific DNA in human plasma. It is intended to be used as an aid for diagnosis of parvovirus B19 infection and for monitoring of the parvovirus B19 load in individuals with parvovirus B19 infection.

Specifications

Key features

  • Detection and quantification of human parvovirus B19 specific DNA
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in IU/ml

 

Limit of detection (LoD)

LoD plasma 121 IU/ml


Sample types

The following sample types are validated for use with the AltoStar® Parvovirus B19 PCR Kit 1.5:

 

Human EDTA plasma

Human citrate plasma

 

 

Other workflows

The AltoStar® Parvovirus B19 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® Parvovirus B19 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® Parvovirus B19 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
AS0101543
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® Parvovirus B19 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.

Manuals AltoStar® Parvovirus B19 PCR Kit 1.5
Associated documents AltoStar® Parvovirus B19 PCR Kit 1.5
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Manuals AltoStar® Parvovirus B19 PCR Kit 1.5
Language
AltoStar® Parvovirus B19 PCR Kit 1.5 - DE
Language: German
Date: 2022-01
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® Parvovirus B19 PCR Kit 1.5 - EN
Language: English
Date: 2022-01
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® Parvovirus B19 PCR Kit 1.5 - ES
Language: Spanish
Date: 2022-01
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® Parvovirus B19 PCR Kit 1.5 - FR
Language: French
Date: 2022-01
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® Parvovirus B19 PCR Kit 1.5 - IT
Language: Italian
Date: 2022-01
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® Parvovirus B19 PCR Kit 1.5 - PL
Language: Polish
Date: 2022-01
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® Parvovirus B19 PCR Kit 1.5 - PT
Language: Portuguese
Date: 2022-01
Panel: Bloodborne infections
Regulatory status: CE-IVD
Associated documents AltoStar® Parvovirus B19 PCR Kit 1.5
Language
Type of document
AltoStar® Parvovirus B19 PCR Kit 1.5 - DE - DoC
Language: German
Date: 2022-05-18
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® Parvovirus B19 PCR Kit 1.5 - EN - DoC
Language: English
Date: 2022-05-18
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® Parvovirus B19 PCR Kit 1.5 - ES - DoC
Language: Spanish
Date: 2022-05-18
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® Parvovirus B19 PCR Kit 1.5 - FR - DoC
Language: French
Date: 2022-05-18
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® Parvovirus B19 PCR Kit 1.5 - IT - DoC
Language: Italian
Date: 2022-05-18
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® Parvovirus B19 PCR Kit 1.5 - PT - DoC
Language: Portuguese
Date: 2022-05-18
Panel: Bloodborne infections
Regulatory status: CE-IVD