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CLART PneumoVir

CLART PneumoVir

CLART® PneumoVir is an in Vitro diagnostics product for the detection and genotyping of multiple viruses that cause respiratory infections, simultaneously by using multiplex PCR and subsequent visualization with CLART ® technology, based on low-density microarrays.

Viruses detected

Adenovirus
Metapneumovirus A
Metapneumovirus B
Parainfluenza 1
Parainfluenza 2
Parainfluenza 3

Parainfluenza 4 subtyping:

  1. Parainfluenza 4A
  2. Parainfluenza 4B
Rhinovirus
RSV A
RSV B
Bocavirus
Coronavirus 229E
Enterovirus

Influenza A, subtyping:

  1. Seasonal H1N1
  2. Seasonal H3N2
  3. New H1N1
Influenza B
Influenza C

Analysis information

CLART® PneumoVir simultaneously detects and subtypes multiple respiratory viruses in a single trial. The information obtained allows a rapid and a proper management of infection avoiding both, the unnecessary and unspecific use of antibiotics as well as the generation of potential resistances.

Similarly, it enables a reduction in costs of the diagnosis to bring together multiple targets in a single assay.

 

Validated sample types

The kit PneumoVir CLART ® has been developed and validated for the detection of different respiratory viruses types present in the following samples:

  • Nasopharyngeal wash .
  • Nasopharyngeal exudate .
  • Bronchoalveolar lavage.

High sensitivity and specificity

CLART ® PneumoVir has a sensitivity and specificity higher than 90% due, among others, to the presence of 120 probes printed on the array that enables the identification, at least in triplicate, of each virus.

 

Quality control

CLART® PneumoVir ensures the quality of the results by including internal controls in each test:

 

  1.  Amplification control in each amplification tube: avoid false negative results.
  2.  Biotin markers: they have a dual aim; firstly, act as reference system for the automatic alignment of the array grid and, secondly, serve as control of the reagents performance.

 

Automatic reading and interpretation of results

The analysis is performed in a fully automatic way by the SAICLART®, the GENOMICA image processing software for microarrays. This software can detect and interpret automatically all the targets present in the image, thus avoiding any subjectivity that could introduce the user intervention. That way, user obtains the results in a fast, simple and reproducible way, presented in clear and concise reports that can be printed or exported to the laboratory information management system (LIMS).

 

CLART® PneumoVir kit fulfills all the requirements of EU guideline 98/79/EC specific for medical devices and in vitro diagnostic products and has the Declaration of Conformity according to Annex III of the mentioned guideline.

Category
Department
Medical specialty
Required sample
Nasopharyngeal Wash
Έκκριση φάρυγγα
Έκκριση ρινοφάρυγγα
Turn around time
2 days
Technology
CLART