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EntericBio Dx GI Panel

The EntericBio® Dx test is performed on Cary-Blair preserved diarrheal specimens collected from symptomatic patients with suspected acute gastroenteritis, enteritis or colitis of bacterial or parasitic origin. The test is performed directly on the specimen, utilizing the ABI 7500 Fast Dx Real-Time instrument, for the amplification of Salmonella enterica spp., Shigella spp./Enteroinvasive E. coli (EIEC), Campylobacter spp. (jejuni, coli and lari), STEC (Shiga-like toxin-producing E. coli), stx1/ stx2 genes, Vibrio spp. (cholerae and parahaemolyticus), Giardia lamblia (also known as G. intestinalis and G. duodenalis), and Entamoeba histolytica.

The Cary-Blair preserved specimen is collected with the FLOQSwabTM, then re-suspended in the EntericBio Stool Preparation Solution (SPS). The SPS tube is closed with a pierceable cap, and the sample is placed in the corresponding position on the EntericBio SPS rack(s). Once the batch of samples is ready to be processed, the EntericBio SPS racks are closed and transferred to the EntericBio Heatstation for lysis at 103°C for 30 minutes. The heat-treated samples are then placed on the EntericBio Workstation for fully automated transfer of the processed samples directly to the lyophilized PCR reaction wells using the EntericBio Dx program. The wells are capped, vortexed, centrifuged and transferred to the ABI 7500 Fast Dx Real-Time PCR instrument for amplification with the EntericBio Dx template and automated analysis with the UgenTec FastFinder EntericBio Dx plugin.

Features & Benefits

FeatureBenefit

Focused bacterial and parasite multiplex assay

The EntericBio Dx Enteric GI Panel 7 detects the following bacteria and parasitic causing infectious gastroenteritis, including Salmonella enterica spp., Shigella spp./ Enteroinvasive E. coli (EIEC), Campylobacter spp. (jejuni, coli and lari), STEC (Shiga-like toxin-producing E. coli), stx1/ stx2 genes, Vibrio spp. (cholerae and parahaemolyticus), Giardia lamblia (also known as G. intestinalis and G. duodenalis), and Entamoeba histolytica

The EntericBio Dx Enteric GI Panel 5 detects the following bacteria and parasitic causing infectious gastroenteritis, including Salmonella enterica spp., Shigella spp./ Enteroinvasive E. coli (EIEC), Campylobacter spp. (jejuni, coli and lari), STEC (Shiga-like toxin-producing E. coli), stx1/ stx2 genes, Vibrio spp. (cholerae and parahaemolyticus).

(Cryptosporidium and Yersinia are in development)

Operational Outcomes

Faster reporting of negative and positive stool sample results in under 3 hours, allowing laboratories to reallocate technologist time to other priorities within the lab.

Time to result: 1-30 tests in less than 3 hours with consecutive runs of 30 tests every hour.

Process efficiency increased by 94% compared to conventional microbiology methods.

Robust and Reliable with < 2% Inhibition

Clinical Outcomes

Accurate: Stool culture and ELISA methods are less sensitive than molecular methods

Focused molecular GI Panel can improve patient management decision making - minimizing use of inappropriate or unnecessary drugs.

Public Health: Quicker Results can trigger outbreak investigations in a timely manner.

Diagnostic: Results can mitigate further unnecessary downstream testing.

Economical Outcomes

The focused GI Panel of 5 or 7 targets – lower cost per positive stool result with molecular comparedto conventional method.

Lower cost from reduced use of inappropriate or unnecessary antimicrobial or antiviral drugs.

Potential reduction in length of stay and length of isolation for patients in the hospital.

Reduced cost of sample send-out to reference laboratories.

Reallocation of technician time.

Environment: 88% reduction in clinical waste & up to 85% reduction in consumable storage compared to conventional microbiology methods.

Product Specifications

Product Spec NameProduct Spec Data
Sample type

Cary-Blair preserved diarrheal specimens

Time to results

1-30 samples in less than 3 hours with consecutive runs every hour.

Reagent storage

All kit components should be stored at 2°C to 8°C

Shelf life

24 months

Sensitivity*
Fresh Prospective Specimens
Salmonella 92.3%
Campylobacter 98.0%
Shigella/EIEC 100%
STEC 100%
Giardia lamblia 85.7%
Simulated Specimens Vibrio 100%
Entamoeba histolytica 98.6%
Specificity*
Fresh Prospective Specimens
Salmonella 100%
Campylobacter 99.8%
Shigella/EIEC 100%
STEC 99.9%
Giardia lamblia 99.9%
Simulated Specimens Vibrio 100%
Entamoeba histolytica 100%

*Refer to Package Insert for additional performance claims.

Ordering Information

Catalog NumberDescriptionKit Size / Case Size
EBGPDx-US

EntericBio Dx Panel (PCR Strips, EntericBio Resuspension Solution, EntericBio Positive Control, and EntericBio Reconstitution Solution)

240
EBSPSA-V2

EntericBio Stool Preparation Solution (SPS) tubes

240
502CS01

Copan disposable FLOQSwabs

100
5070000450

EntericBio Workstation with EntericBio SPS racks with UgenTec FastFinder software

1
EBQPD4 SEROSEP US

EntericBio Heatstation with EntericBio Block Inserts

1
4406984 / 4406985

ABI 7500 Dx Fast Cycler with SDS Dx software

1

Product Documentation

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