Flexible Syndromic Testing Solutions for Gastrointestinal (GI) Infection
The EasyScreen™ Pan-Enteric Pathogen Detection Kit enables multiplex real-time PCR testing across 26 clinically relevant gastrointestinal targets, including bacterial, viral and protozoan GI pathogens. The comprehensive menu and configurable GI panels provides the ultimate flexibility in your workflow. Multiple automation platforms, such as the GS1-HT 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 GI 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
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 EasyScreen™ range of 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 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 kits are divided into common detection panels, with specific bacterial [classes] and reflex kits to allow speciation where clinically important.
EasyScreen™ Enteric Bacteria Detection Kit (EB001/EB001-HT) 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/EB001-HT)
| 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/EB001-HT) is for in vitro diagnostic use
Escherichia coli can be an innocuous resident of the gastrointestinal tract, it also has the pathogenic capacity to cause significant diarrheal and extraintestinal diseases1. Outbreaks are common in developed and developing countries, and they sometimes have fatal consequences. Many of these pathotypes are a major public health concern1.
The Genetic Signatures EasyScreen™ Enteropathogenic E.coli Detection Kit (EB004) screens for six major diarrheagenic E.coli-causing pathogens.
EasyScreen™ Enteropathogenic E.coli targets (EB004)
| Stx-1 | ETEC (ST) |
| Stx-2 | EPEC (eae) |
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™ Enteropathogenic E.coli Detection Kit (EB004) is for In Vitro Diagnostic (IVD) Use Only
1Croxen M.A, Law R.J., Scholz R., Keeney K.M., Wlodarska M., and Finlay B.B Recent Advances in Understanding Enteric Pathogenic Escherichia coli. American Society for Microbiology- Clinical Microbiology Reviews 2013 Oct; 26(4):822-80
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/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.
The EasyScreen™ C. difficile Detection Kit (CDD001) offers a high- performance IVD assay for toxigenic C. difficile through the detection of both the tcdA and tcdB toxin genes.
Simultaneous detection of both tcdA and tcdB is important as mutations and deletions have been described in both genes, and therefore detecting only one of the genes increases the chance of false negative results.
The device is intended as an aid in the diagnosis of C. difficile infection (CDI).
EasyScreen™ C.difficile targets (CDD001)
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™ C.difficile Detection Kits (CDD001) is for in vitro diagnostic use
Genetic Signatures has developed the EasyScreen™ C.difficile Reflex Kit (CDD002), to be performed in conjunction with, or as a reflex test of the EasyScreen™ C.difficile Detection Kit (CDD001), which detects toxigenic C.difficile.
This reflex assay helps to determine the presence of hypervirulent or epidemic strains of C.difficile by detecting three additional biomarkers.
The additional information obtained by using the EasyScreen™ C.difficile Reflex Kit (CDD002) allows for the rapid diagnosis of strains with these genetic markers and identifies them as potentially hypervirulent.
This will aid physicians in deciding on the best possible treatment regimes for infected patients and importantly alert carers to limit the spread of the disease within the hospital environment.
EasyScreen™ C.difficile Reflex targets (CDD002)
| tcdC gene deletion at position 117 |
| binary toxin gene (cdtA) |
| gyrA gene mutation (fluoroquinolone resistance) |
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™ C.difficile Reflex Kit (CDD002) is for in vitro diagnostic use
Protozoan 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 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 pathogens2.
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/EP001-HT)
| 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/EP001-HT) 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) screens for 3 of the most common gastrointestinal parasites.
EasyScreen™ Enteric Protozoan Core targets (EP002)
| 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) 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.
The Genetic Signatures' EasyScreenTM Enteric Protozoan Extended Detection Kit (EP005) screens for 8 of the most common gastrointestinal parasites.
EasyScreen™ Enteric Protozoan Extended targets (EP005)
| 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) 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/EP004-HT) 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/EP004-HT)
| 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/EP004-HT) 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
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' EasyScreen™ Enteric Viral Detection Kit (EV002/EV002-HT) has been designed to screen for 9 of the most common viral-causing gastroenteric species.
EasyScreen™ Enteric Viral Targets (EV002/EV002-HT)
| Norovirus GII | Rotavirus A |
| Adenovirus Universal | Sapovirus |
| Bocavirus | Enterovirus |
| Adenovirus 40/41 |
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 Viral Detection Kit (EV002/EV002-HT) is for in vitro diagnostic use
