PRODUCTS

CLART® PneumoVir y CLART® PneumoVir 2

CLART® PneumoVir and CLART® PneumoVir 2 are an in vitro diagnostics product for the detection and genotyping of multiple viruses that cause respiratory infections, by means of multiplex PCR followed by visualization in low-density arrays, based on CLART® technology.

Analysis information

Both Kits 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 diagnosis costs by bringing together multiple targets in a single assay.

   *Detection only available in CLART® PneumoVir 2

Advantages of CLART® PneumoVir 2

 – 2 hours less of analysis time compared with CLART® PneumoVir

– A new tube for detection of Coronavirus OC43 and NL63 and H7N9 subtype of Influenza A

Validated sample types

CLART® PneumoVir and CLART® PneumoVir 2 have 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

Both kits have sensitivity and specificity values higher than 90%,  that are a consequence of the presence within the array of each virus-specific probe in triplicate.

Quality control

CLART® PneumoVir and CLART® PneumoVir 2 ensures the quality of the results by including internal controls in each test:

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

Automatic reading and interpretation of results

Analysis if results is performed in a fully automatic wasy by SAICLART®, the GENOMICA image processing software for microarrays. This software can automatically detect and interpret all the targets present in the image, thus avoiding any subjectivity that might be introduced by the user. The user thus 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 & CLART® PneumoVir 2 kits 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.

Bibliography

1. “Tract Viral infections and Coinfections in Patients with Influenza like Illnesses by use of RT-PCR DNA Microarray Systems”. J. Clin. Microbiol. doi:10.1128/ JCM.00733-10.

2. “Characterization of viruses causing Human Respiratory Infections via Genomic Identification for in vitro diagnosis. CLINICAL ARRAYS/CLART PneumoVir”. Poster Session at ECCMID 2008, Barcelona.

3. “Myocarditis Caused by Human Parainfluenza Virus in an Immunocompetent Child Initially Associated with 2009 Influenza A (H1N1) Virus”. Journal of Clinical Microbiology, May 2011, p. 2072–2073

4.“Respiratory viruses in Children Admitted to Hospital Intensive Care Units: Evaluating the CLART® PneumoVir DNA Array”. Journal of Medical Virology 83: 150-155 (2011).

5. “Evaluation of viral co-infections in hospitalized and non-hospitalized children with respiratory infections using microarrays”. Clin Microbiol Infect, 10.1111/1469-0691.12015.

6. “Co-infección viral respiratoria en niños hospitalizados por infección respiratoria aguda y su impacto en la gravedad clínica”. Rev Chil Infect 2012; 29 (2): 169-174.

7. “Broad Respiratory Virus Detection in Infants Hospitalized for Bronchiolitis by Use of a Multiplex RT-PCR DNA Microarray System”. Journal of Medical Virology 84:979–985 (2012).