Respiratory Diagnostics

Respiratory Diagnostics

The analysis of respiratory infections is a major focus of clinical laboratory diagnostics, as they are among the leading causes of death worldwide. Respiratory diseases are divided into two groups based on the infection site:

• Infections of the upper respiratory tract (e.g., nasal mucosa, sinuses)
• Infections of the lower respiratory tract (e.g., trachea, bronchi, lungs)

The majority of infections (approx. 80 %) are caused by viruses; however, bacterial pathogens can also trigger respiratory diseases. Primarily influenza viruses – but also other viruses such as RSV, hMPV, MERS-CoV and SARS-CoV – cause respiratory infections. Bacterial pathogens such as legionella, pneumococci and mycobacterium tuberculosis are also of concern. Transmission is mainly from person to person through droplets or aerosols.

Symptoms may include fever, cough, headache, pharyngitis, sinusitis, bronchitis or pneumonia. Prompt respiratory diagnosis is important to limit further infections and thus the spread of the infection. In addition, outbreaks provide an opportunity to test the effectiveness of vaccines, as studies can be conducted to determine whether vaccinated individuals are less likely to become ill than unvaccinated individuals.

COVID-19 Pandemic

SARS-CoV-2 virus, which was identified at the beginning of 2020, is the trigger for the worldwide COVID-19 pandemic. As of June 2021, 175 million cases and 3.77 million deaths have been recorded worldwide. The pathogen belongs to the group of beta-coronaviruses, which are widespread among mammals and birds. The main route of transmission is respiratory ingestion of particles containing the virus, which are produced when breathing, coughing, speaking, singing and sneezing. Since December 2020, new genetic variants of the SARS-CoV-2 virus have been discovered, which are characterised by increased transmissibility and, in some cases, increased case fatality rates.

Transmission can also occur in areas where food is prepared. This can occur through contaminated surfaces, as replication-competent SARS-CoV-2 viruses have been shown to remain infectious for a long time. SureFast^® SARS-CoV-2 PLUS is an AOAC-RI certified real-time PCR detection test for cleaning verification in food production.

Detection Methods

CONGEN develops detection systems for the targeted detection of respiratory pathogens and their genetic variants. The multiplex real-time PCR kits within the RIDA^®GENE product line detect them through simple and rapid screening. In addition to specific pathogen detection, the sensitive tests include an internal control (ICD or ICR). This control is used for extraction and/or amplification control. Since the tests can be used on all common real-time devices and have the same temperature profile, it is possible to check several parameters with one PCR test.

CONGEN manufactures medical devices in accordance with DIN ISO 13485 that enable rapid detection of various human pathogens. As required by DIN ISO 13485, the CE-certified tests are evaluated through regular participation in INSTAND and QCMD Proficiency Tests.

The products for the detection of respiratory pathogens and their genetic variants are available worldwide through R-Biopharm.

Available test kits