Molecular Infectious Disease Testing

Molecular Testing for the detection of Respiratory Pathogens
Real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus)

Viral Respiratory Infections


Viral respiratory acute infections are common and contribute significantly to morbidity and mortality worldwide.


Respiratory viruses account for about 30% of pneumonia cases in adult patients, hospitalized in ICU, with mortality rates comparable to those of bacterial pneumonia.


In children, especially those younger than 2 years, respiratory illnesses frequently cause pneumonia.


Despite the fact that Influenza viruses are a known cause of respiratory illness, many other pathogens may cause significant impact on patient health. Respiratory syncytial virus (RSV) is the most common cause of severe respiratory illness in young children, as well as a leading cause of death in those aged 65 years and older.

Benefits of Using Respiratory Pathogen Panel (RPP) For Detection Of Respiratory Viruses

Traditional Methods

  • For diagnosing viral respiratory tract infections, historically have used traditional methods such as direct fluorescent-antibody assay (DFA) and culture for the detection of respiratory viruses.
  • With these methods, such as DFA and culture, that use microscopy, turnaround times for results are slow, especially in laboratories handling large volumes of respiratory specimens.
  • These methods also are limited by the availability of monoclonal antibodies for newly discovered viruses.

Respiratory Pathogen Panel ( RPP) 17 Pathogens From A Single Swab

  • Respiratory Pathogens Panel (RPP) , is a rapid molecular test that at the same time detects and identifies the following common causes of respiratory disease directly from a nasopharyngeal swab in under two hours.
  • The test is performed on the automated VERIGENE System utilizing reverse transcription polymerase chain reaction (RT-PCR) and microarray hybridization.


Pathogens Detected from a Nasopharyngeal Swab


Influenza A
Influenza A H1
Influenza A H3
Influenza B
Human Metapneumovirus
Parainfluenza 1
Parainfluenza 2
Parainfluenza 3
Parainfluenza 4


Bordetella pertussis
Bordetella parapertussis/Bordetella bronchiseptica
Bordetella holmesii

Real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus)

  • Streptococcus pyogenes (S. pyogenes), also denoted to as Group A ß-hemolytic streptococcus (GAS), is a global human pathogen that causes a broad spectrum of diseases. Millions of infections and over 500,000 deaths worldwide can be endorsed to GAS each year .
  • S. pyogenes infection can take place in almost any human body tissue, though it most commonly infects the upper respiratory tract and skin lesions.


Up to 15% of school-aged children may carry the bacteria but are asymptomatic and are still capable of spreading the infection

A diagnosis for GAS cannot be made based on the clinical features of pharyngitis alone since many viral agents such as rhinovirus or adenovirus often present similarly to a GAS infection.

Culture is the gold standard for diagnosis; it takes approximately two days to complete and has a sensitivity of 90% to 95%.

 The current rapid strep tests have a sensitivity that ranges from 70% to 90% (false negative rate of 10% to 30%)

The goal of a molecular test for GAS pharyngitis is to ameliorate the turn-around time and rise the sensitivity of detection related with rapid antigen-based assays, by this means dropping the spread of GAS and reducing incorrect antibiotic use.

Group A Strep Assay uses Luminex Corporation’s real-time PCR chemistry in combination with ARIES® Systems. The System is capable of automated nucleic acid extraction and purification, real-time PCR detection of nucleic acid sequences, and data analysis.

Group A Strep Assay using real time PCR can directly detect Streptococcus pyogenes from nucleic acid isolated from throat swab specimens.

ARIES® cassettes contain all of the reagents needed to run PCR testing on a sample. The extraction, purification, amplification, detection reagents, and Sample Processing Control (SPC) are all contained in the cassette. ARIES® cassettes  can be stored at room temperature, disregarding the necessity for freezing and thawing of reagents that take up freezer space and add time to formulation.