Parasite Pathogens
In addition to bacterial and viral pathogens, some protozoa species are also known to be a major cause of gastrointestinal illness worldwide.
Traditional methods of diagnosis of these parasite infections have relied on either microscopic examination of faecal material or enzyme immunoassays, neither of which have shown to be particularly sensitive or specific in the detection of this widespread pathogens2.
Genetic Signatures' EasyScreen™ Gastrointestinal Parasite Detection Kit and GS1 automated workflow has been FDA 510(k) cleared for sale in the United States.
Clear HERE to learn more about the benefits of this unique workflow.
The most common protozoans that affect the gastrointestinal tract are Cryptosporidium spp., Giardia intestinalis, and Entamoeba histolytica1-3. Other protozoan agents that have been implicated in gastroenteritis in humans include Dientamoeba fragilis, Blastocystis hominis and Cyclospora cayetanensis.
The Genetic Signatures' EasyScreenTM Gastrointestinal Parasite Detection Kit (EP005) screens for 8 of the most common gastrointestinal parasites.
| EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005) | ||
|---|---|---|
| Dientamoeba fragilis | Blastocystis hominis | Enterocytozoon bieneusi |
| Cyclospora cayetanensis | Entamoeba histolytica | Encephalitozoon intestinalis |
| Cryptosporidium spp. | Giardia lamblia/intestinalis |
All kits also include an Extraction and Internal Positive Control for each sample to ensure the quality of the extracted DNA and to detect the presence of any inhibitors, respectively.
Regulatory
- The EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005) has FDA (510k) clearance for sale in the United States.
1 Haque R, Huston CD, Hughes M, Houpt E, Petri WA Jr. Current concepts: Amebiasis. N Engl J Med 2003;348:1565–1573.
2 Ortega YR, Adam RD.Giardia: Overview and update. Clin Infect Dis1997;25:545–549.
3 Kosek M, Alcantara C, Lima AA, Guerrant RL. Cryptosporidiosis: an update. Lancet Infect Dis 2001;1:262–269.
Bacterial Pathogens
Gastrointestinal infection is a major cause of morbidity in developed countries, and mortality in developing countries causing the death of about 2 million children under 5 each year1. Gastroenteritis can be caused by a wide range of infectious agents.
A wide range of pathogenic bacteria including Salmonella, Campylobacter and Shigella species, can cause gastroenteritis. The Genetic Signatures Analyte Specific Reagents (ASRs) range of targets have been designed to provide rapid and accurate detection of the most common bacterial, protozoan and viral agents involved in human pathogenesis.
All kits use real-time PCR assays and are compatible with nucleic acids isolated using the appropriate EasyScreen™ Sample Processing Kits.
The Enteric Bacteria Analyte Specific Reagents (ASRs) are rapid in vitro DNA amplification assays for the qualitative detection of bacterial DNA from stool of patients with diarrhoea or as a confirmatory test from cultured bacteria. The ASR's are divided into common detection groups.
Most bacterial agents that cause gastroenteritis are acquired via the food chain. According to the Centers for Disease Control and Prevention, in order of prevalence, infections are caused by Salmonella spp., followed by Campylobacter spp., Shigella spp., Escherichia coli, and Yersinia spp. Another cause of bacterial gastroenteritis is Clostridioides difficile and the hypervirulent variants that have emerged worldwide, which cause significant morbidity and mortality, particularly in the elderly, the immunocompromised and patients on long term antibiotic therapy.
| Gastrointestinal Bacterial Targets |
|---|
| Campylobacter spp. |
| Salmonella spp. |
| Shigella spp./Enteroinvasive E.coli (EIEC) |
| Toxigenic Clostridioides difficile |
| Yersinia enterocolitica |
| Listeria monocytogenes |
ASRs also include an Extraction and Internal Positive Control for each sample to ensure the quality of the extracted DNA and to detect the presence of any inhibitors, respectively.
Regulatory
- Analyte Specific Reagents (ASRs). Analytical and performance characteristics are not characterized.
- EasyScreenTM Sample Processing Kits are FDA-listed clinical concentrators.
Aeromonas spp. associated with gastroenteritis is a major public health concern especially for young children. The ability to grow and produce toxins at cold temperatures is fundamental to its status as an emerging food pathogen1.
In addition, Cholera is a life-threatening secretory diarrhea induced by an enterotoxin secreted by Vibrio cholerae. Cholera and the cholera enterotoxin are increasingly recognized as the prototypes for a wide variety of non-invasive diarrheal diseases, collectively known as the enterotoxic enteropathies. Similarly Vibrio cholerae and other Vibrio spp. may occasionally cause isolated outbreaks associated with shellfish and improperly prepared seafood or unsanitary conditions2.
Genetic Signatures' Enteric Bacterial Extended ASRs are designed for 3 of the most common gastroenteric pathogens from these species.
| Enteric Bacterial Extended targets |
|---|
| Aeromonas spp. |
| Vibrio cholera |
| Shiga toxins 1 and 2 |
ASRs include an Extraction and Internal Positive Control for each sample to ensure the quality of the extracted DNA and to detect the presence of any inhibitors, respectively.
Regulatory
- Analyte Specific Reagent (ASR). Analytical and performance characteristics are not established.
Viral Pathogens
Viral agents, most notably Norovirus and Rotavirus, are also common causes of diarrhoea in both adults and children respectively.
Human viral gastroenteritis can be caused by a wide range of etiological agents including Noroviruses, Rotaviruses, Adenoviruses, Astroviruses and Enteroviruses. Of these Norovirus is the most commonly isolated agent as the cause of acute viral gastroenteritis.
Traditional methods of diagnosis of these viral infections is through cultured growth or electron microscopy, both of which can be time consuming, leaving patients without a definitive diagnosis for several days.
Children under 5 years old are frequently infected with Rotavirus group A as well as Enterovirus which has also been associated with childhood diarrhoea1. Both Astrovirus, which contains at least 7 species, and Adenovirus types 40 and 41 are responsible for causing some cases of human gastroenteritis.
Genetic Signatures' Enteric Viral ASRs have been designed to detect 9 of the most common viral-causing gastroenteric species.
Enteric Viral Targets
| Astrovirus |
| Rotavirus A |
| Sapovirus |
| Norovirus GI |
| Enterovirus |
| Adenovirus universal |
| Bocavirus |
| Adenovirus 40/41 |
ASRs include both an Extraction Control and an Internal Positive Control for each sample to ensure the quality of the extracted DNA and to detect the presence of any inhibitors, respectively.
Regulatory
- Analyte Specific Reagents (ASRs). Analytical and performance characteristics are not characterized.
1Rao DC et al. Non-polio enterovirus association with persistent diarrhea in children as revealed by a follow-up study of an Indian cohort during the first two years of life. J Clin Virol. 2014 Sep;61(1):125-31
1World Health Organization Children’s environmental health. Available at http://www.who.int/ceh/en/.
2Haque R, Huston CD, Hughes M, Houpt E, Petri WA Jr. Current concepts: Amebiasis. N Engl J Med 2003;348:1565–1573.
Regulatory
- EasyScreenTM Pathogen Detection Kits are for research use only and are not available for in vitro diagnostic use in America. Genetic Signatures also supplies a range of Analyte Specific Reagents for customers in the USA/North America.
- Analyte Specific Reagents (ASRs). Analytical and performance characteristics are not characterized.
- EasyScreenTM Sample Processing Kits are FDA-listed clinical concentrators.
