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.
Parainfluenza 4 subtyping:
Influenza A, subtyping:
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.
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.