Enteric Pathogen Screening Kits

Gastrointestinal disease can be caused by a wide range of infectious agents including viral, bacterial and protozoan. Thus the diagnosis of infectious gastrointestinal disease can be challenging and involve specialists in microbiology, virology and parasitology.

It has been estimated that there are 16.8 million gastroenteritis cases per year in Australia resulting in 250,000 visits to hospital Emergency Departments, 15,000 hospitalisations and 80 deaths [1].

In order to simplify the detection of causative agents of infectious gastrointestinal disease we have developed EasyScreen™  real-time PCR screening assays for all major gastroenteritis pathogens. All assays share a universal sample processing method and incorporate our previously described 3base™ technology [2].

Conventional gastroenteritis diagnosis can in some instances take up to 5 days [3]  to provide a definitive result. To reduce this our assays offer sample to result turnaround time in as little as 3 hours.

Genetic Signatures EasyScreen™ Enteric Pathogen Screening kits offer the following advantages:

  • An integrated automatable sample processing method
    A complete workflow is offered from clinical specimen to reportable result. In this way results are also standardised from lab to lab.
  • Rapid detection
    From specimen to result in 3-5 hours, with minimal hands-on time, compared to days for some traditional methods
  • In-built controls
    High level of confidence in results as extraction failure and inhibition controls reduce the likelihood of false negative results
  • Real-Time PCR format
    No post-PCR handling, virtually eliminating potential for contamination
  • Thorough coverage of common pathogens
    Up to 22 gastroenteritis causing pathogens are simultaneously detected from the one specimen preparation
  • Open platform
    Compatible with most automated sample preparation systems and real-time PCR instruments commonly found in pathology laboratories

The  EasyScreen™ Enteric Pathogen Screening kits include:

Product#EasyScreen™ KitMicroorganisms Detected
EB001 & EB001-HTEnteric Bacteria Detection(i) Salmonella spp.
(ii) Campylobacter spp.
(iii) Shigella spp./Enteroinvasive E.coli (EIEC)
(iv) Yersinia enterocolitica.
(v) toxigenic C. difficile and
(vi) Listeria monocytogenes
EP001 & EP001-HTEnteric Protozoan Detection(i) Cryptosporidium spp.,
(ii) Giardia intestinalis,
(iii) Dientamoeba fragilis,
(iv) Entamoeba histolytica and,
(v) Blastocystis hominis
EV002 & EV002-HTEnteric Viral Detection(i) Norovirus GI
(ii) Norovirus GII
(iii) Astrovirus
(iv) Rotavirus A
(v) Sapovirus
(vi) Enterovirus
(vii) Bocavirus
(viii) Adenovirus and
(ix) Adenovirus (40 + 41 only)
CDD001C. difficile DetectionToxigenic C. difficile (targets both tcdA and tcdB)
CDD002C. difficile ReflexHypervirulent C. difficile incl. ribotype 027 & 078 targeting:
(i) tcdC gene deletion at position 117,
(ii) binary toxin gene (cdtA) and
(iii) gyrA gene mutation (fluoroquinolone resistance)

All kits are sufficient for 100RXNs or 500RXNs for HT (384 well format) kits.

All EasyScreen™ Enteric Pathogen Screening Kits are for use with nucleic acids that have been prepared using EasyScreen™ Sample Processing Kits.

For more information about the EasyScreen™ Workflow and Compatibility with Nucleic Acid Extraction and Real-Time PCR platforms visit our EasyScreen™ Workflow page.

Regulatory

The EasyScreen™ Detection Kits EB001, EP001, EV002, CDD001 & CDD002 (& corresponding HT formats) are for in vitro diagnostic use.

[1] Source: Australian Government Department of Health and Aging, “The Annual Cost of Foodborne illness in Australia”, March 2006

[2] Baleriola C, Millar D, Melki J, Coulston N, Altman P, Rismanto N and Rawlinson W. 2008. Comparison of a novel HPV test with the Hybrid Capture II (hcII) and a reference PCR method shows high specificity and positive predictive value for 13 high-risk human papillomavirus infections. J. Clin. Virol. 42:22-6 2008

[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