Improving Your Infectious Disease Screening

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™ Bacterial Pathogen detection

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 Bacterial 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

EasyScreen™ Enteric E.coli Detection Kit

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™ Enteric E.Coli Detection Kit (EB004) screens for six major diarrheagenic E. coli causing pathogens.

 

EasyScreen™ Enteric 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™ Enteric E.coli Detection Kits (EB004) is for research 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

EasyScreen™ Enteric Pathogenic Bacteria Detection Kit

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' EasyScreen™ Enteric Pathogenic Bacteria Detection Kit (EB005) has been designed to screen for 3 of the most common gastroenteric pathogens from these species.

 

EasyScreen™ Enteric Pathogenic Bacteria targets (EB005)

Vibrio cholera
Vibrio spp.

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 Pathogenic Bacteria Detection Kits (EB005) is for research use only.

1Daskalov H. The importance of Aeromonas hydrophila in food safety. Food Control. 2006;17(6):474–483.
2Finkelstein R.A., Chapter 24 Cholera, Vibrio cholerae O1 and O139, and Other Pathogenic Vibrios Medical Microbiology. 4th edition 1996.

EasyScreen™ C. difficile Detection Kit

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

EasyScreen™ C. difficile Reflex Kit

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 EasyScreenC.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.

 

EasyScreenC.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.

EasyScreen™ Enteric Protozoan Detection Kit

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.

EasyScreen™ Enteric Protozoan Core Kit

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 research use only.

EasyScreen™ Enteric Protozoan Extended Detection Kit

The most common protozoans that affect the gastrointestinal tract are Cryptosporidium spp., Giardia intestinalis, and Entamoeba histolytica1-3Other 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 research use only.

    1 Haque R, Huston CD, Hughes M, Houpt E, Petri WA Jr. Current concepts: Amebiasis. N Engl J Med 2003;348:1565–1573.
    Ortega YR, Adam RD.Giardia: Overview and update. Clin Infect Dis1997;25:545–549.
    Kosek M, Alcantara C, Lima AA, Guerrant RL. Cryptosporidiosis: an update. Lancet Infect Dis 2001;1:262–269.

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.

EasyScreen™ Enteric Viral Detection Kit

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


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.