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GI PANEL PCR (Qualitative)

Synonym(s):

​Campylobacter, Salmonella, Vibrio, E.coli 0157, Norovirus, Rotavirus

Description

Indications

​To assist in identifying the etiologic agent(s) of infectious gastroenteritis, by simultaneous detection of 22 common gastrointestinal pathogens including viruses, bacteria and parasites.

Pathogens covered by this assay include:

  • Bacteria
    o   Campylobacter sp. (eg. C.jejuni, C.coli and C.upsaliensis)
    o   Clostridium difficile (toxin A/B)
    o   Plesiomonas shigelloides
    o   Salmonella sp. 
    o   Yersinia enterocolitica
    o   Vibrio sp. (eg. V.parahaemolyticus, V.vulnificus and V.cholerae)
    o   Vibrio cholerae
    o   Enteroaggregative Escherichia coli (EAEC)
    o   Enteropathogenic Escherichia coli (EPEC)
    o   Enterotoxigenic Escherichia coli (ETEC) lt/st
    o   Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2
    o   Escherichia coli O157
    o   Shigella sp./Enteroinvasive Escherichia coli (EIEC)
  • Viruses
    o   Adenovirus F 40/41
    o   Astrovirus
    o   Norovirus GI/GII
    o   Rotavirus A
    o   Sapovirus (I, II, IV and V)
  • Parasites
    o   Cryptosporidium sp.
    o   Cyclospora cayetanensis
    o   Entamoeba histolytica
    o   Giardia lamblia

Please note that other than for the protozoan parasites listed above, this assay does not detect other enteric parasites, e.g. helminthic ova/larvae, microsporidia, etc. For patients with strongly suspected Clostridium difficile-associated diarrhoeal disease (CDAD), currently available stand-alone C.difficile PCR is the preferred test as it is more cost-effective.

Specimen Required

​1 mL of fresh stool sample or stool sample in Cary Blair medium. Please note that sample types other than stool samples have not been validated on this new assay and will generally be rejected.

Storage and Transport

​Refrigerate sample at 2-8°C until transfer to laboratory. Do not freeze. Send sample at 2 - 8°C. Sample should reach the laboratory as soon as possible preferably within 24 hours after collection.

Method

​Multiplex real-time PCR

Test Results

​Detected, Not detected or Inconclusive

Reference Interval / Value

Turnaround Time

​Next working day

Day(s) Test Set up

​Mondays to Saturdays (except public holidays)

Remarks

Performance Characteristics:

Analytical sensitivity (at 95% confidence level):

  • Vibrio cholerae - 8,000 CFU/mL
  • Yersinia enterocolitica - 50,000 CFU/mL
  • E.coli O157 - 10,000 CFU/mL
  • Shigella sonnei - 100 CFU/mL
  • Salmonella typhi - 5,000 CFU/mL

 

Analytical Specificity:

No cross reactivity demonstrated with Epstein-Barr Virus, Herpes Simplex Virus 1 and 2, Cytomegalovirus, Human Herpesvirus 6, Influenza A and Influenza B viruses, Enterovirus, Toxoplasma gondii, Clostridium perfringens, Listeria monocytogenes, Aeromonas hydrophila, Bacillus cereus, Staphylococcus aureus, Proteus mirabilis, Proteus vulgaris, other Escherichia coli, Candida albicans, Enterococcus faecalis.


Please note that other than the protozoan parasites listed above, this assay does not detect other enteric parasites, e.g. helminthic ova/larvae, microsporidia etc.


Please note that this assay may not be able to detect certain strain variants of Campylobacter coli.


Rare isolates of non - Vibrio cholerae Vibrio species that have acquired a homolog of the toxR gene have been reported and may show cross-reactivity with the V.cholerae analyte.

Change History Notes

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