Automated Syndromic Testing Solutions for Gastrointestinal (GI) Infection
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.
The EasyScreen™ Detection Kits enable multiplex real-time PCR testing across a broad range of clinically relevant gastrointestinal targets, including bacterial, viral and parasite pathogens. The comprehensive menu provides flexibility in your workflow. Automation platforms such as the GS1 and GS-1000 systems cater for medium to high throughput demands, regardless of your sample type or number.
Contact us for more information on implementing this diagnostic solution in your laboratory.
Learn more about our gastrointestinal panels below.
EasyScreen™ Pan-Enteric targets (PE001)
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Norovirus GII Astrovirus Enterovirus |
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Sapovirus Norovirus GI Rotavirus A |
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Campylobacter spp. Salmonella spp. Shigella spp./Enteroinvasive E.coli (EIEC) |
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Giardia lamblia/intestinalis Entamoeba histolytica Cryptosporidium spp. |
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Clostridioides difficile (TcdA / TcdB) Yersinia spp. Adenovirus 40/41 |
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Escherichia coli O157:H7 (z3276) Shiga Toxin-1 (Stx1) Shiga Toxin-2 (Stx2) |
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ETEC (LT) ETEC (ST) EPEC (eaeA) |
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Aeromonas spp. Vibrio cholerae Vibrio spp. |
Regulatory
- The EasyScreenTM Pan-Enteric Detection Kit is for in vitro diagnostic use.
Bacterial Pathogens
A wide range of pathogenic bacteria including Salmonella, Campylobacter and Shigella species, can cause gastroenteritis. The Genetic Signatures EasyScreen™ range of gastrointestinal kits 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 multiplexed real-time PCR assays and are compatible with nucleic acids isolated using the appropriate EasyScreen™ Sample Processing Kits.
The EasyScreen™ Enteric Bacteria Detection Kits are 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.
EasyScreen™ Enteric Bacteria Detection Kit (EB001-MT) contains the reagents required for the detection of the target bacterial DNA sequences via Real-Time Polymerase Chain Reaction (RT-PCR).
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.
EasyScreen™ Enteric Bacteria targets (EB001-MT)
| Salmonella spp. | Yersinia enterocolitica |
| Shigella spp./Enteroinvasive E.coli (EIEC) | Listeria monocytogenes |
The kits also 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
- The EasyScreen™ Enteric Bacteria Detection Kits (EB001-MT) is for in vitro diagnostic use
Enteroaggregative Escherichia coli (EAEC) are a pathotype of Escherichia coli, which cause acute and chronic diarrhea in both the developed and developing world.1,2 They may also cause urinary tract infections.2 The pathogenesis of EAEC involves the aggregation of and adherence of the bacteria to the intestinal mucosa, where they elaborate enterotoxins and cytotoxins that damage host cells and induce inflammation that results in diarrhea. Pathogenesis is controlled by virulence-related genes such as aggR (aggregative adherence regulator) and aaiC (aggregative adherence island).
Conventional gastroenteritis diagnosis can in some instances take up to 5 days3 to provide a definitive result. The Genetic Signatures’ EasyScreen™ EAEC Detection Kit (EA001/EA001-MT) has been designed to provide rapid and accurate detection of the aggR and aaiC virulence factor genes associated with EAEC.
EasyScreen™ EAEC Detection Kit (EA001/EA001-MT)
| aaiC gene |
The kits also 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
- The EasyScreen™ EAEC Detection Kits (EA001-MT) is for research use only.
1 van Maarseveen NM, Wessels E, de Brouwer CS, Vossen A, and Claas E (2010). Diagnosis of viral
gastroenteritis by simultaneous detection of Adenovirus group F, Astrovirus, Rotavirus group A, Norovirus genogroups I and II and Sapovirus in two internally controlled multiplex real-time PCR assays. J Clin. Virol. 49: 205-210.2 Source: Australian Government Department of Health and Aging, “The Annual Cost of Foodborne illness in Australia”, March 2006.
3 Cunningham SA, Sloan LM, Nyre LM, Vetter EA, Mandrekar J and Patel R. 2010. Three-hour molecular
detection of Campylobacter, Salmonella, Yersinia and Shigella species in feces with accuracy as high as that of culture. J. Clin. Micro. 48: 2929-33.
Viral Pathogens
Viral agents, most notably Norovirus and Rotavirus, are also common causes of diarrhoea in both adults and children.
Human viral gastroenteritis can be also be caused by a wide range of etiological agents including Adenoviruses, Astroviruses and Enteroviruses.
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.
Genetic Signatures' molecular diagnostic solution for detecting viral gastrointestinal pathogens delivers same-day results, for 10 viral pathogen targets in a single test, and single workflow.
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' EasyScreen™ Enteric Viral Detection Kit (EV002-MT) has been designed to screen for 9 of the most common viral-causing gastroenteric species.
EasyScreen™ Enteric Viral Targets (EV002-MT)
| Norovirus GII | Rotavirus A |
| Adenovirus Universal | Sapovirus |
| Bocavirus | Enterovirus |
| Adenovirus 40/41 |
MThe kits also 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
The EasyScreen™ Enteric Viral Detection Kit (EV002-MT) is for in vitro diagnostic use
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
Gastrointestinal Parasite Pathogens
In addition to bacterial and viral pathogens, some parasite 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 ova and parasite microscopic examination (O&P exams) of faecal material or enzyme immunoassays. These traditional methods lack sensitivity, requiring more than three samples over multiple days to achieve the same level of sensitivity achieved by molecular methods2.
In comparison, Genetic Signatures' gastrointestinal parasite panels offer robust diagnostic solutions - requiring only one patient sample and a single diagnostic workflow to detect a range of gastrointestinal parasite pathogens in a single test.
Learn more about these solutions below.
Click here to access our free-on demand 3-part webinar series on Advances of Gastrointestinal Parasite Testing, featuring world-leading parasitologists.
The most common protozoans that affect the gastrointestinal tract of humans are Cryptosporidium spp., Giardia intestinalis, and Entamoeba histolytica1,2. Other protozoan agents that have been implicated in gastroenteritis in humans include Dientamoeba fragilis and Blastocystis hominis.
Traditional methods of diagnosis of these protozoan 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 pathogens3.
EasyScreen™ Enteric Protozoan targets (EP001-MT)
| Cryptosporidium spp. | Giardia lamblia/intestinalis |
| Blastocystis spp. |
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™ EntericProtozoan Detection Kit (EP001-MT) is for in vitro diagnostic use
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.
The Genetic Signatures' EasyScreenTM Enteric Protozoan Core Detection Kit (EP002-MT) screens for 3 of the most common gastrointestinal parasites.
EasyScreen™ Enteric Protozoan Core targets (EP002-MT)
| Entamoeba histolytica |
| Cryptosporidium spp. |
All kits 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™ Enteric Protozoan Core Detection Kit (EP002-MT) is for in vitro diagnostic use.
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.
Genetic Signatures' EasyScreenTM Enteric Protozoan Extended Detection Kit (EP005-MT) screens for 8 of the most common gastrointestinal parasites.
EasyScreen™ Enteric Protozoan Extended targets (EP005-MT)
| 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™ Enteric Protozoan Extended Detection Kit (EP005-MT) is for in vitro diagnostic use.
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.
Two species of enteric microsporidia, Encephalitozoon intestinalis and Enterocytozoon bieneusi are common causes of diarrhea worldwide. Traditional methods of diagnosis of these microsporidia 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 these widespread pathogens1.
The Genetic Signatures’ EasyScreen™ Enteric Microsporidia Detection Kit (EP004-MT) has been designed to provide rapid and accurate detection of both E. intestinalis and E. bieneusi from the stool of patients with diarrhoea or as a confirmatory test from cultured bacteria.
EasyScreen™ Enteric Microsporidia Detection Kit (EP004-MT)
| E. 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™ Enteric Microsporidia Detection Kit (EP004-MT) is for research use only.
1 Stark D, Beebe N, Marriott D, Ellis J, Harkness J. (2006). Evaluation of three diagnostic methods, including RealTime PCR, for the detection of Dientamoeba fragilis in stool specimens. J. Clin Microbiol; 44:232-235