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Certest Offers Sensitive, Useful and Cheap CE-IVD Multiplex Assay for Rapid Diagnosis of Atypical Pneumonia

By Labmedica International staff writers
15 Sep 2021

Image: Viasure Real-time PCR kit (Photo courtesy of CerTest Biotec)CerTest Biotec (Zaragoza, Spain) has developed and validated the CE-IVD multiplex assay VIASURE C. pneumoniae, M. pneumoniae & L. pneumophila real time PCR kit for the detection of principal pathogens implicated in atypical pneumoniae.

One of the most challenging issues in the management of patients with atypical pneumoniae is the rapid identification of the microbial etiology to guide and personalize the initial antimicrobial therapy. A critical factor in the selection of a diagnostic assay for respiratory infections is the time required to obtain the test result. Only those diagnostic tests that provide results within the first 24 hours can actually assist the clinician to guide the initial antimicrobial therapy.

DNA amplification using the polymerase chain reaction (PCR) is a technique with the potential to offer rapid results in the diagnosis of bacterial pneumonia. Multiplex Real-time PCR is highly sensitive technique for the rapid detection of RNA/DNA in clinical specimens. This technique is particularly advantageous for the detection of fastidious or difficult to culture organisms such as these three atypical pathogens. Several conventional PCR assays and multiplex assays have been developed and have demonstrated sensitivity and specificity better than microbiologic tests. However, a small number of these contain the needed CE-IVD marking necessary for use in clinical diagnosis.

CerTest’s CE-IVD multiplex assay VIASURE C. pneumoniae, M. pneumoniae & L. pneumophila real time PCR detection kit has been developed and validated for the detection of the principal pathogens implicated in atypical pneumoniae. The clinical validation demonstrated that the molecular assay is a sensitive, useful, cheap, and above all a rapid diagnostic tool for the management of atypical pneumonia patients. Moreover, the type of respiratory sample is not a limiting factor as the molecular assay accurately detects the pathogens in upper and lower respiratory samples. Additionally, the multiplex strategy offers an obvious and important clinical advantage as it minimizes the risk that the causative search is biased by overlapping clinical presentations of distinct causes. The application of the CE-IVD multiplex assay VIASURE C. pneumoniae, M. pneumoniae & L. pneumophila real time PCR detection kit from CerTest is expected to significantly improve diagnostics for atypical pneumonia-associated bacterial pathogens.




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CERTEST BIOTEC

Certest Biotec, S.L. develops and manufactures IVD products in the human clinical testing field, including rapid tests. It offers a wide range of products for real time PCR that allow identification of causal pathogens causing infectious diseases and are suitable for use in physicians’ offices, laboratories and hospitals.
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