Gastrointestinal Pathogen Panel, Real-Time PCR

The Gastrointestinal Pathogen Panel, Real-Time PCR test contains 1 test with 9 biomarkers.

Name: Verigene® Enteric Pathogens Nucleic Acid Test (EP) - Gastrointestinal Pathogen Panel, Real-Time PCR

Purpose: This test is designed to rapidly identify the presence of common pathogenic bacteria and viruses in individuals exhibiting symptoms of gastrointestinal infection. It is particularly useful in diagnosing specific agents of gastrointestinal illness and is an essential tool in the management of acute gastroenteritis, especially during outbreaks.

Patient Preparation
Patient should not use antacids, barium, bismuth, antibiotics, anti-malarial agents, antidiarrheal medication or oily laxatives prior to specimen collection. After administration of any of these compounds, specimen collection should be delayed for 5 to 10 days or at least two weeks after barium or antibiotics.

Preferred Specimen(s): 5 mL liquid or soft stool collected in Cary-Blair stool culture transport medium

Test Methodology: The test employs a multiplexed, real-time PCR technique, allowing for the qualitative detection and identification of multiple pathogens simultaneously.

Sample Type: 5 mL liquid or soft stool collected in Cary-Blair stool culture transport medium

Indicated For: Individuals showing signs and symptoms of gastrointestinal infection. The test is intended as an aid in the diagnosis of gastrointestinal illnesses and should be used in conjunction with other clinical, laboratory, and epidemiological data. It is not recommended for monitoring the progression of these infections.

Target Pathogens: Expanded Target Pathogens Description for Gastrointestinal Pathogen Panel, Real-Time PCR:

1. Campylobacter Group: This group primarily includes Campylobacter jejuni and Campylobacter coli, which are responsible for a significant portion of bacterial gastroenteritis cases worldwide. Infection typically results in symptoms like diarrhea, abdominal pain, and fever. The bacteria are commonly transmitted through undercooked poultry, unpasteurized milk, and contaminated water.
2. Salmonella Species: These bacteria are known to cause salmonellosis, characterized by diarrhea, fever, and abdominal cramps. Transmission often occurs through the consumption of contaminated food, particularly eggs, poultry, and meat. Salmonella infections can range from mild to severe, occasionally leading to hospitalization.
3. Shigella Species: Shigella is a key cause of bacillary dysentery or shigellosis. This infection is marked by severe abdominal pain, fever, and bloody diarrhea. Shigella is highly contagious and spreads through direct contact or contaminated food and water, especially in areas with poor sanitation.
4. Vibrio Group: This group includes various species such as Vibrio cholerae, the causative agent of cholera, and Vibrio parahaemolyticus, associated with gastrointestinal illness linked to seafood. Symptoms can range from mild gastroenteritis to severe, watery diarrhea and dehydration.
5. Yersinia enterocolitica: This bacterium causes yersiniosis, which can lead to a range of symptoms, from mild self-limiting gastroenteritis to more severe conditions like mesenteric lymphadenitis, mimicking appendicitis. It's often transmitted through contaminated food, particularly pork.
6. Shiga Toxin 1 and 2: These toxins are produced by certain strains of E. coli (e.g., E. coli O157:H7). Infections can lead to severe abdominal pain, bloody diarrhea, and potentially life-threatening complications like hemolytic uremic syndrome (HUS), which can cause kidney failure.
7. Norovirus GI/GII: Norovirus is a highly contagious virus causing acute gastroenteritis. It leads to sudden onset of nausea, vomiting, and diarrhea. Often spread through contaminated food or water, and close contact with infected individuals, norovirus infections are particularly problematic in crowded environments like hospitals and cruise ships.
8. Rotavirus A: This virus is a leading cause of severe diarrhea among infants and young children globally. The infection spreads through the fecal-oral route and can cause severe dehydration. Symptoms include watery diarrhea, vomiting, fever, and abdominal pain. Vaccination has reduced the incidence of rotavirus infections significantly.

Reference Range(s)

If Campylobacter Group, Salmonella Species, Shigella Species, Vibrio Group, Yersinia enterocolitica, Shiga toxin 1 or Shiga toxin 2 is Detected, then Isolate Referral/Public Health will be performed at no additional charge.

Significance: This comprehensive panel aids in the rapid and accurate identification of major bacterial and viral agents responsible for gastrointestinal infections, facilitating timely and appropriate treatment interventions. It is especially valuable in public health settings for managing outbreaks of gastrointestinal illnesses.

Clinical Significance

Gastrointestinal Pathogen Panel, Real-Time PCR - Acute diarrhea caused by bacterial and viral infection represents a significant worldwide healthcare burden. The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection. The test is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological information; however, is not to be used to monitor these infections. The test also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.

Alternative Name(s)

Enteric Pathogen Panel, GI Panel, Chronic Diarrhea, Unresolved Diarrhea, Gastroenteritis, Infectious Diarrhea Panel