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FlexStar^® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5

Intended use

The FlexStar^® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of norovirus genogroup I (GI), norovirus genogroup II (GII) and rotavirus specific RNA in human stool specimens. It is intended to be used as an aid for diagnosis of norovirus and rotavirus infection. Validated for use with the AltoStar^® Automation System AM16 for nucleic acid extraction, the AltoStar^® Internal Control 1.5 and the FlexStar^® (RT-)PCR Amplification Mix 1.5.

Specifications

Key features

For detection and differentiation of norovirus genogroup I (GI), norovirus genogroup II (GII) and rotavirus specific RNA
Parallel detection of norovirus GI, norovirus GII and rotavirus specific RNA in a single reaction
CE-IVD marked in vitro diagnostic test
Analytical sensitivity reported in copies/ml

Limit of detection (LoD)

LoD norovirus GI	5,939 copies/ml
LoD norovirus GII	5,228 copies/ml
LoD rotavirus	11,133 copies/ml

Sample types

The following sample type is validated for use with the FlexStar^®Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5:

Human stool

For use with

CFX96™ Deep Well Dx System (Bio-Rad)
CFX96™ Dx System (Bio-Rad)
Rotor-Gene^® Q5/6 plex Platform (QIAGEN)
QuantStudio™ 5 Real-Time PCR System (Roche)

Order No

FS0071543

Rxns

Transportation

Dry ice

Regulatory status

CE-IVD

Kits not available in all countries. Products not licensed with Health Canada and not FDA cleared or approved.

Manuals FlexStar^® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5

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Associated documents FlexStar^® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5

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Manuals FlexStar^® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5

Language

FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 - DE
Language: German
Date: 2022-05
Panel: Gastrointestinal infections
Regulatory status: CE-IVD

FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 - EN
Language: English
Date: 2022-05
Panel: Gastrointestinal infections
Regulatory status: CE-IVD

FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 - ES
Language: Spanish
Date: 2022-05
Panel: Gastrointestinal infections
Regulatory status: CE-IVD

FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 - FR
Language: French
Date: 2022-05
Panel: Gastrointestinal infections
Regulatory status: CE-IVD

FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 - IT
Language: Italian
Date: 2022-05
Panel: Gastrointestinal infections
Regulatory status: CE-IVD

FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 - PT
Language: Portuguese
Date: 2022-05
Panel: Gastrointestinal infections
Regulatory status: CE-IVD

Associated documents FlexStar^® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5

Language

Type of document

FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 - DE - DoC
Language: German
Date: 2022-05-23
Panel: Gastrointestinal infections
Regulatory status: CE-IVD

FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 - EN - DoC
Language: English
Date: 2022-05-23
Panel: Gastrointestinal infections
Regulatory status: CE-IVD

FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 - ES - DoC
Language: Spanish
Date: 2022-05-23
Panel: Gastrointestinal infections
Regulatory status: CE-IVD

FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 - FR - DoC
Language: French
Date: 2022-05-23
Panel: Gastrointestinal infections
Regulatory status: CE-IVD

FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 - IT - DoC
Language: Italian
Date: 2022-05-23
Panel: Gastrointestinal infections
Regulatory status: CE-IVD

FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 - PT - DoC
Language: Portuguese
Date: 2022-05-23
Panel: Gastrointestinal infections
Regulatory status: CE-IVD

FlexStar^® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5

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