What is in the Respiratory Panel?

The Respiratory Panel is a real-time PCR-based assay that enables simultaneous detection of over 30 viral and bacterial respiratory pathogens. The test is structured across eight multiplexed tubes, each using four fluorophores (FAM, HEX, ROX, Cy5) to detect up to four targets per reaction.

Bacterial Targets Include:

• Streptococcus pneumoniae, Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae

• Pseudomonas aeruginosa, Acinetobacter baumannii, Legionella pneumophila, Salmonella spp.

• Bordetella spp., Chlamydia spp., Streptococcus agalactiae, Streptococcus pyogenes

Viral Targets Include:

• SARS-CoV-2, Influenza A (including H1N1, H3N2), Influenza B & C

• Respiratory Syncytial Virus A/B, Parainfluenza 1–4, Adenovirus, Enterovirus, Human Metapneumovirus

• Rhinovirus, Human Bocavirus, Human Parechovirus, Coronavirus (alpha & beta)

This expansive coverage helps labs detect co-infections, manage respiratory outbreaks, and ensure faster clinical decision-making.

Role of Different Targets in Disease

Bacterial Pathogens

Bacteria like S. pneumoniae, H. influenzae, and K. pneumoniae are common causes of community-acquired pneumonia. P. aeruginosa and A. baumannii often cause hospital-acquired respiratory infections, especially in ventilated patients. Detection of Legionella or Mycoplasma is critical in atypical pneumonia cases.

Viral Pathogens

Viruses such as SARS-CoV-2, Influenza A/B, and RSV dominate seasonal respiratory infections and outbreaks. Parainfluenza, Metapneumovirus, and Rhinovirus commonly affect children and immunocompromised individuals. Emerging viruses like Bocavirus and Parechovirus are increasingly recognized in severe pediatric respiratory illness.

With the Respiratory Panel, all these pathogens are detected in a single workflow, enabling labs to deliver complete and actionable reports to clinicians.

About the TRUPCR® Respiratory Panel Kit

The TRUPCR® Respiratory Panel Kit is a CE-IVD certified in vitro diagnostic assay developed to identify key respiratory pathogens using multiplex real-time PCR. Key components of the kit include:

• Eight pre-aliquoted multiplex tubes with validated primer/probe sets
• Four-channel fluorescence system per tube
• Human RNaseP gene for internal control of extraction and amplification
• Hot-start polymerase to enhance specificity and sensitivity
• AI-based interpretation software (optional, RUO) for automated reporting and QC analysis

Each pathogen target is based on conserved regions of microbial genomes, ensuring broad strain coverage and minimal cross-reactivity with non-target species.

Principle and Workflow

Step-by-Step Workflow:

1. Sample Collection & Extraction
   Respiratory specimens (BAL, tracheal aspirate, sputum, nasopharyngeal swab in VTM) are processed using standard nucleic acid extraction protocols.
2. Multiplex PCR Setup
   Extracted nucleic acid is added to eight tubes pre-loaded with specific master mixes and primers/probes targeting distinct pathogens.
3. Real-Time Amplification
   PCR runs on any compatible qPCR instrument, with real-time signal detection across FAM, HEX, ROX, and Cy5 channels.
4. Automated Analysis (Optional)
   Using the RUO TRUPCR® Interpretation Software:

• Improper amplification is flagged using ML-based algorithms
• Final reports are auto-generated with amplification curves and Ct values
• Issues like threshold errors or failed reactions are highlighted

This minimizes manual result validation, enabling faster reporting in clinical labs.

Clinical Application

The Respiratory Panel is ideal for a range of diagnostic applications, including:

• Hospital and emergency labs for rapid triage of respiratory cases
• Outbreak response (COVID-19, flu seasons, RSV spikes)
• Pediatric and geriatric care settings where co-infections are common
• ICU diagnostics for ventilator-associated pneumonia
• Antimicrobial stewardship programs to reduce empirical therapy

By covering all major respiratory pathogens in one test, the TRUPCR® Respiratory Panel reduces the need for sequential testing, shortens diagnosis time, and helps clinicians make more targeted treatment decisions.