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National Center for Emerging and Zoonotic Infectious Diseases Culture-Independent Diagnostic Testing: Where Are We Now? Logan Ray, MPH Epidemiologist, FoodNet, Enteric Diseases Epidemiology Branch Division of Foodborne, Waterborne, and Environmental Diseases PulseNet/OutbreakNet Joint Midwest/Central Regional Meeting Omaha, NE March 8, 2019

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Page 1: Culture-Independent Diagnostic Testing: Where Are We Now?...1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 The findings and conclusions in this report are those of the authors and do

National Center for Emerging and Zoonotic Infectious Diseases

Culture-Independent Diagnostic Testing:Where Are We Now?

Logan Ray, MPHEpidemiologist, FoodNet, Enteric Diseases Epidemiology Branch

Division of Foodborne, Waterborne, and Environmental Diseases

PulseNet/OutbreakNet Joint Midwest/Central Regional Meeting

Omaha, NE

March 8, 2019

Page 2: Culture-Independent Diagnostic Testing: Where Are We Now?...1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 The findings and conclusions in this report are those of the authors and do

Foodborne Diseases Active Surveillance Network (FoodNet)

Collaboration among CDC, 10 state health departments, USDA-FSIS, and FDA

Determine the burden of foodborne illness

Monitor trends in the burden over time

Population-based active surveillance for 8 pathogens commonly transmitted through food– Campylobacter, Listeria, Salmonella, Shiga

toxin-producing E. coli (STEC), Shigella, Vibrio, Yersinia, and Cyclospora

Surveillance for culture-confirmed infections began in 1996, expanded to CIDT+ infections in 2012

Page 3: Culture-Independent Diagnostic Testing: Where Are We Now?...1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 The findings and conclusions in this report are those of the authors and do

Laboratory Surveys Objectives

– Supplement case data

– Assess changes in diagnostic testing practices over time

Biannual surveys of all clinical laboratories in FoodNet catchment

– 5 questions per pathogen

– Test methods, brand, reflex culture, specimen submission

Page 4: Culture-Independent Diagnostic Testing: Where Are We Now?...1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 The findings and conclusions in this report are those of the authors and do

Challenges

Surveillance

– Need to change case definitions?

– How do we interpret test results?

– Increased case load? Need to prioritize interviews?

– How do we interpret changes in incidence?

Laboratory

– Will clinical laboratories maintain culture? Will they reflex?

– Increased or decreased specimen submission? Need to change rules?

– Can SPHLs perform the reflex? How does that affect recovery?

– How do we track and interpret results?

Page 5: Culture-Independent Diagnostic Testing: Where Are We Now?...1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 The findings and conclusions in this report are those of the authors and do

How have CIDTs affected case reporting?

0

5000

10000

1996 2006 2016

Campylobacter

0

100

200

1996 2006 2016

Cyclospora

0

100

200

1996 2006 2016

Listeria

0

5000

10000

1996 2006 2016

Salmonella

0

2500

5000

1996 2006 2016

Shigella

0

1000

2000

1996 2006 2016

STEC

0

150

300

1996 2006 2016

Vibrio

0

200

400

1996 2006 2016

Yersinia

No

. cas

esN

o. c

ases

Page 6: Culture-Independent Diagnostic Testing: Where Are We Now?...1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 The findings and conclusions in this report are those of the authors and do

Increased case counts for all pathogens since 2012

0

5000

10000

1996 2006 2016

Campylobacter

0

100

200

1996 2006 2016

Cyclospora

0

100

200

1996 2006 2016

Listeria

0

5000

10000

1996 2006 2016

Salmonella

0

2500

5000

1996 2006 2016

Shigella

0

1000

2000

1996 2006 2016

STEC

0

150

300

1996 2006 2016

Vibrio

0

200

400

1996 2006 2016

Yersinia

No

. cas

esN

o. c

ases

CX+All Cases

Page 7: Culture-Independent Diagnostic Testing: Where Are We Now?...1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 The findings and conclusions in this report are those of the authors and do

CIDT adoption varied by pathogen

0

25

50

75

100

2012 2013 2014 2015 2016 2017

Campylobacter

0

25

50

75

100

2012 2013 2014 2015 2016 2017

Listeria

0

25

50

75

100

2012 2013 2014 2015 2016 2017

Salmonella

0

25

50

75

100

2012 2013 2014 2015 2016 2017

Shigella

0

25

50

75

100

2012 2013 2014 2015 2016 2017

Vibrio

0

25

50

75

100

2012 2013 2014 2015 2016 2017

Yersinia

%. c

ases

w/

CID

T+ r

esu

lts

%ca

ses

w/

CID

T+ r

esu

lts

Page 8: Culture-Independent Diagnostic Testing: Where Are We Now?...1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 The findings and conclusions in this report are those of the authors and do

CIDT use increasing among clinical laboratories

0

10

20

30

40

2012 2014 2015 2016 2017 2018

Pe

rce

nta

ge o

f la

bo

rato

rie

s

Year

Page 9: Culture-Independent Diagnostic Testing: Where Are We Now?...1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 The findings and conclusions in this report are those of the authors and do

Recent increases were driven by syndromic panelsAntigen-based test Locally-developed PCR test DNA-based syndrome panel test

0

4000

8000

2012 2013 2014 2015 2016 2017

Nu

mb

er

Campylobacter

0

1500

3000

2012 2013 2014 2015 2016 2017

Salmonella

0

600

1200

2012 2013 2014 2015 2016 2017

Shigella

0

2000

4000

2012 2013 2014 2015 2016 2017

Nu

mb

er

STEC

Year Year Year

0

100

200

2012 2013 2014 2015 2016 2017

Vibrio

0

250

500

2012 2013 2014 2015 2016 2017

YersiniaYear Year Year

Page 10: Culture-Independent Diagnostic Testing: Where Are We Now?...1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 The findings and conclusions in this report are those of the authors and do

Increased panel use mirrors increase in polymicrobial detections

0

0.2

0.4

0.6

0.8

1

2011 2012 2013 2014 2015 2016 2017

Inci

de

nce

of

Po

lym

icro

bia

l De

tect

ion

s(p

er

10

0,0

00

)

Year

CX+ only CX+ and CIDT+ CIDT+ only

*≥2 pathogens detected in <30 days†CT, GA, NM, MD, MN, TN and selected counties in CA and CO

Page 11: Culture-Independent Diagnostic Testing: Where Are We Now?...1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 The findings and conclusions in this report are those of the authors and do

Reflex CX done frequently, but not often positive

0

25

50

75

100

2012 2013 2014 2015 2016 2017

Campylobacter

0

25

50

75

100

2012 2013 2014 2015 2016 2017

Salmonella

0

25

50

75

100

2012 2013 2014 2015 2016 2017

Shigella

0

25

50

75

100

2012 2013 2014 2015 2016 2017

STEC

0

25

50

75

100

2012 2013 2014 2015 2016 2017

Vibrio

0

25

50

75

100

2012 2013 2014 2015 2016 2017

Yersinia

Reflex culture positive Reflex culture negative Reflex culture not performed

Per

cen

tage

Per

cen

tage

Page 12: Culture-Independent Diagnostic Testing: Where Are We Now?...1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 The findings and conclusions in this report are those of the authors and do

0

10

20

30

40

50

Pe

rce

nta

ge o

f la

bo

rato

rie

s

Stool

0

25

50

75

100

Pe

rce

nta

ge o

f la

bo

rato

rie

s

Isolates

2015 2016 2017 2018

Isolate submission decreasing and while stool increasing

2015 2016 2017 2018

Year Year

Page 13: Culture-Independent Diagnostic Testing: Where Are We Now?...1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 The findings and conclusions in this report are those of the authors and do

Surveillance Solutions

Adapt surveillance and revise case definitions to capture CIDT+ cases

– FoodNet revised definitions in 2012

– National case definitions updated

• Campylobacter, 2015

• Salmonella, Shigella, Vibrio, 2017

• STEC, 2018

• Listeria and Yersinia, 2019

Develop models to interpret incidence measures over time

– Monitor healthcare provider testing practices

– Estimate laboratory testing volume by test type

Page 14: Culture-Independent Diagnostic Testing: Where Are We Now?...1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 The findings and conclusions in this report are those of the authors and do

Laboratory Solutions

Consider best approaches for obtaining isolates for species, subtype, and antimicrobial sensitivity characterization

– Prioritize reflex culture

– Update specimen submission regulations

Survey clinical laboratories for testing practices

Page 15: Culture-Independent Diagnostic Testing: Where Are We Now?...1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 The findings and conclusions in this report are those of the authors and do

Unanswered questions require data & partnerships

Collect epidemiologic and clinical data to better understand

– Polymicrobial detections

– Exclusion criteria

Partner with industry to identify strategies to meet needs of both

– Anticipate upcoming changes

– Inform test interpretation

Page 16: Culture-Independent Diagnostic Testing: Where Are We Now?...1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 The findings and conclusions in this report are those of the authors and do

Acknowledgements

FoodNet Sites

California Emerging Infections Program

Connecticut Emerging Infections Program

Colorado Department of Public Health and Environment

Georgia Department of Public Health

Maryland Department of Health and Mental Hygiene

Minnesota Department of Health

New Mexico Emerging Infections Program

New York State Department of Health

Oregon Health Authority

Tennessee Department of Health

US Department of Agriculture Food Safety and Inspection Service

US Food and Drug Administration

US Centers for Disease Control and Prevention FoodNet Staff

Page 17: Culture-Independent Diagnostic Testing: Where Are We Now?...1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 The findings and conclusions in this report are those of the authors and do

For more information, contact CDC1-800-CDC-INFO (232-4636)TTY: 1-888-232-6348 www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.