GI Panel CIM Pamphlet ASPAC PDF

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How Do You

Help Diagnose
Guidelines
22 Fast and Manage
Gastrointestinal
A. 2017 Infectious Diseases Society of America Clinical Practice Guidelines
for the Diagnosis and Management of Infectious Diarrhea. https:// TARGETS Accurate
1hr
www.idsociety.org/globalassets/idsa/practice-guidelines/2017-
infectiousdiseases-society-of-america-clinical-practice-guidelines-for-
thediagnosis-and-management-of-infectious-diarrhea.pdf.
B. IDSA 2018 A Guide to Utilization of the Microbiology Laboratory for
Comprehensive Infections?
Diagnosis of Infectious Diseases: 2018 Update by the Infectious Diseases BACTERIA VIRUSES
Society of America and the American Society for Microbiology, Miller et al, Campylobacter (jejuni, coli, and upsaliensis) Adenovirus F 40/41
2018.
C. Practice guidelines for the management of infectious diarrhea. Guerrant
Clostridium difficile (toxin A/B)
Plesiomonas shigelloides
Astrovirus
Norovirus GI/GII
Don’t Guess. Know.
et al. Clin Infect Dis. 2001; 32:331-351. Salmonella Rotavirus A
D. European Society for Pediatric Gastroenterology, Hepatology and Nutrition/ Vibrio (parahaemolyticus, vulnificus, and cholerae) Sapovirus (I, II, IV, and V)
European Society for Pediatric Infectious Diseases Evidence-Based Vibrio cholerae
Guidelines for the Management of Acute Gastroenteritis in Children in Yersinia enterocolitica PARASITES
Europe: Update 2014, Guarino et al, JPGN, July 2014. Diarrheagenic E.coli/Shigella Cryptosporidium
Enteroaggregative E.coli (EAEC) Cyclospora cayetanensis
“ We conclude that multiplex screening can
optimize the yield from stool examinations,
Enteropathogenic E.coli (EPEC)
Enterotoxigenic E.coli (ETEC) lt/st
Entamoeba histolytica
Giardia lamblia
[and] can dramatically improve the timeliness Shiga-like toxin-producing E.coli (STEC) stx1/stx2
of diagnosis...

(Spina et al, 2015)
E.coli O157
Shigella/Enteroinvasive E.coli (EIEC)

“ Due to the extensive panel of targeted


pathogens and the rapid turnaround time,
Pathogens Under Surveillance5
• Campylobacter • Salmonella
the [BioFire] Panel has the potential to direct • Cryptosporidium • Shigella
appropriate therapy and infection control • Giardia lamblia • Vibrio cholerae
precautions.
” (Buss et al, 2015)
• Enterohaemorrhagic E. coli
Shiga-like toxin-producing
E.coli (STEC), E.coli 0157
• Yersinia

References
Where to Order This Test?
1. Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and
territories, 1980–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet 2018;
392: 1736–88.
2. Estimates of global, regional, and national morbidity, mortality, and aetiologies of diarrhoeal diseases: a
systematic analysis for the Global Burden of Disease Study 2015. Lancet Infect Dis 2017; 17: 909–48.
3. Riddle et al, ACG Clinical Guideline: Diagnosis, Treatment, and Prevention of Acute Diarrheal Infections in

BFDX-MKT-0343-01
Adults. 2016.
4. Spina et al. Spectrum of enteropathogens detected by the FilmArray GI Panel in a multicentre study of
community-acquired gastroenteritis. Clin Microbiol Infect. 2015;21:719-728.
5. European Centre for Disease Prevention and Control Surveillance and disease data https://ecdc.europa.eu/
en/surveillance-and-disease-data.
6. Buss et al, Multicenter Evaluation of the BioFire FilmArray® Gastrointestinal Panel for the Etiologic Diagnosis
of Infectious Gastroenteritis, Journal Of Clinical Microbiology. March 2015, 53(3):915-25. The information in this booklet is given as a guideline only and is not intended to be exhaustive. It in no way
binds bioMérieux or BioFire Diagnostics, LLC to the diagnosis established or the treatment prescribed by the
7. Data on file, BioFire Diagnostics. The stated performance is the overall aggregate performance of the physician. If you have any questions please contact your bioMérieux representative. BioFire is wholly owned
prospective clinical study data presented in the IFU. by bioMérieux.
8. Rand et al, Multiplex gastrointestinal pathogen panels: implications for infection control. Diagn Microbiol
Infect Dis. 2015;82(2):154-157. bioMérieux S.A. Manufactured by:
69280 Marcy I’Etoile BioFire Diagnostics, LLC
9. Yang et al, Diagnostic determination of Norovirus infection as one of the major causes of infectious diarrhea France 515 Colorow Drive
in HIV patients using a multiplex polymerase chain reaction assay. International Journal of STD & AIDS2018.
Tel.: +33 (0) 4 78 87 20 00 Salt Lake City, UT 84108
10. Stockmann et al, How well does physician selection of microbiologic tests identify Clostridium difficile and Fax: +33 (0) 4 78 87 20 90 USA
other pathogens in paediatric diarrhoea? Insights using multiplex PCR-based detection, Clinical Microbiology
and Infection 2014 European Society of Clinical Microbiology and Infectious Diseases. www.biomerieux.com www.biofiredx.com
What’s the Problem? The Right Test, The First Time. Quickly Ruling In or Out Enteric
Diarrheal disease is a global burden. One of the leading Syndromic testing is a symptom-driven broad Pathogens Can Improve Patient
causes of mortality, it caused about 1.6 million deaths in grouping of probable pathogens into one, rapid test
20171. An estimated amount of 525,000 diarrheal deaths that maximizes the chance of getting the right answer Care.
occur among children less than 5 years of age every year, in a clinically relevant timeframe. Standard Testing vs. Syndromic Testing for Infectious
with the majority of deaths occurring in southern Asia and Gastroenteritis
sub-Saharan Africa.2 Syndromic Testing
Standard Testing Syndromic Testing
Conventional testing methods to determine the cause of
gastroenteritis traditionally have long turnaround times, Low Yield Improve Diagnostic Yield4, 6
coupled with complicated ordering practices and work Multiple Tests Needed 1 Comprehensive Test
flows. Often, stool culture is not sensitive enough to detect
the causative etiology, due to the fastidious nature of some Results in Days Results in About an Hour
One One Results take Multiple Improves
bacteria, or the presence of viral or parasitic pathogens.10 sample comprehensive about an hour results patient Pathogen Positivity 4

When necessary, culture-independent assays are test in one report management 60.0%
recommended as adjunct methods.3
vs.
50.0% 54.2%
40.0%
In any laboratory setting, the BioFire FilmArray
® ®
30.0%
Gastrointestinal (GI) Panel offers improved performance 20.0%
parameters, an extensive menu of pathogens, and a Traditional Testing 10.0% 18.1%
turnaround time of about an hour.7 0%
Tested according to BioFire
local protocol GI Panel

1 Test. 22 Pathogens. 1 Hour. “Rotavirus and Salmonella are no longer the leading
This results in approximately a 3-fold increase in diagnostic One Multiple tests Results take Individual Less viral and bacterial GI pathogens in Europe”4
yield over traditional diagnostic methods.4,6 sample ordered hours to days results in efficient
separate patient
reports management BioFire GI Panel
Diagnostic Yield The BioFire GI Panel facilitates timely and appropriate Tested according
interventions that can alleviate symptoms and prevent to local protocol
secondary transmissions.8

Who Should Get Tested?

EPEC
Campylobacter
Clostridium difficile
EAEC
Norovirus
ETEC
Salmonella
Rotavirus
Yersinia enterolitica
STEC
Sapovirus
Giardia
Adenovirus
Cryptosporidium
Astrovirus
EIEC
Plesiomonas shigelloides
Vibrio
Cyclospora cayetanensis
Syndromic Testing Traditional Testing
VS
54% 18% Young Elderly
infants patients
Overall Performance of
the BioFire GI Panel.7
Pathogens Detected Pathogens Not Detected Immuno-compromised
Travelers
patients9

98.5% Sensitivity 99.3% Specificity


Sample Type.
200 µL stool collected in Cary Blair transport medium.

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