ems point of care saliva testing for cardiac injury markers
Post on 14-Jan-2017
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Salivary Diagnostics
Craig Manifold, DO
Medical Director, San Antonio Fire Department
Original Presentations by:
Spencer Redding, DDS
David Wampler, PhD
Salivary Diagnostics
• Preliminary
Information
– Not yet ready for
Prime Time
• Three Major
Concepts
– Salivary Diagnostics
– Point of Care Testing
– Lab on a Chip
Salivary Diagnostics
• Is it comparable to blood?
• Biological fluid that contains many analytes
• Non-invasive collection– Easily done at
multiple outpatient settings
Salivary Diagnostics
• Utilized in other
disease processes
– Cancer
– Infectious disease
– Diabetes mellitus
– Potential for virtually
any disease
Point of Care Testing
• Gurney/bedside vs. Centralized lab
• Cost of equipment greatly reduced
• Results in 10-15 minutes vs 1-6 hours
Point of Care Testing
• Samples placed on individual card for the
appropriate test
• Card placed in common analyzer where
result is reported
QuickTime™ and aDV/DVCPRO - NTSC decompressor
are needed to see this picture.
Lab on a Chip
Lab on a Chip
• Sample placed on card
• Card placed in analyzer
QuickTime™ and aDV/DVCPRO - NTSC decompressor
are needed to see this picture.
Cardiac Diagnostics
Acute Coronary Syndrome
(IMA,D-dimer, Troponin I,
Troponin T, CKMB, Myoglobin
and Digoxin)
At Risk Testing
(CRP, TNF
Alpha, IL1-data,
WBC)
Congestive Heart
Failure Prognosis
(BNP, Pro BNP,
Urotensin)
Time Course of Established AMI Biomarkers in
Serum
Biomarkers of ACS
Ratio of median concentration for the ACS (NSTEMI
&STEMI) over median concentration for the controls
Biomarkers
of ACS in
saliva
Biomarkers
of ACS in
serum
**
*
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
0 0.5 11 - Specificity (false positives)
Se
ns
itiv
ity
(tr
ue
po
sit
ive
s)
No discrimination
all serum
Top 5 serum
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
0 0.5 11 - Specificity (false positives)
Se
ns
itiv
ity
(tr
ue
po
sit
ive
s)
No discrimination
all saliva
Top 5 saliva
SALIVA (UK & UL)SERUM (UK & UL)
43 Controls, 23 NSTEMI, 25 STEMI
ROC Curves for 21 and Top-5 Biomarkers
for AMI Diagnosis
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
0 0.5 1
1 - Specificity (false positives)
Se
ns
itiv
ity
(tr
ue
po
sit
ive
s)
No discrimination
Triage BMs
Triage & EKG
EKG
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
0 0.5 11 - Specificity (false positives)
Se
ns
itiv
ity
(tr
ue
po
sit
ive
s)
No discrimination
CRP & MPO
EKG
CRP MPO & EKG
SALIVA (UK & UL)SERUM (UK & UL)
ROC Curves for Combination EKG and Saliva
Biomarker Panel
43 Controls, 23 NSTEMI, 25 STEMI
g15, off0, 0.25”exp 10/14/08
CRP
0.2 ng/mL
IL1b
0.2 ng/mL
MPO
5 ng/mL
MYO
0.2 ng/mL
CRP
2 ng/mL
IL1b
2 ng/mL
MPO
50 ng/mL
MYO
2 ng/mL
CRP
20 ng/mL
IL1b
20 ng/mL
MPO
500 ng/mL
MYO
20 ng/mL
CAL CALCALNEGATIVE NEGATIVENEGATIVE
Dose Response
Curves
MYOMPO
IL1bCRP
CRPCAOI (0.25”)
MPOCAOI (0.25”)
EMS-21.2 ng/mL
EMS-330.5 ng/mL
UT0024.0 ng/mL
EMS-275.5 ng/mL
EMS-377.5 ng/mL
UT002<0.2 ng/mL
Ambulance Patient - EMS2
NEGATIVE CAL
CRP IL1b MPO MYO
NEGATIVE CAL
CRP IL1b MPO MYOHealthy Donor – UT002
NEGATIVE CAL
CRP IL1b MPO MYO
Ambulance Patient- EMS3
g15/off0/0.25”
Healthy Donor – UT002
g15/off0/0.75”
Ambulance Patient - EMS2
NEGATIVE CAL
CRP IL1b MPO MYO
NEGATIVE CAL
CRP IL1b MPO MYO
NEGATIVE CAL
CRP IL1b MPO MYO
Ambulance Patient- EMS3Healthy Donor – UT002
IL1b Standard
Curve
EMS Study
• Is there a role for salivary markers in
the pre-hospital setting?
• Can they replace blood tests for
definitive diagnosis by reducing time
from diagnosis to treatment?
EMS Study
• Collect saliva
samples from
patients with ACS
symptoms
• Evaluate for
markers found in
University of Kentucky MI
study
• Correlate with
diagnosis of
STEMI/NSTEMI
EMS Study
• Faculty from UTHSCSA
School of Health Professions
Coordinate:
– patient recruitment
– patient history
– collection of samples
– Geoff Smith, LP
– David Wampler, PhD, LP
SAFD Paramedics
• Danny Zamora
• Timothy Worley
• Christopher Velasquez
• Trenton Thames
• Greg Tetsch
• Hank Schott
• Robert Payne
• Mark Olson
• James Murray
• Michael Mumme
• Juan Morin
• Donald Merecka
• Jeremy McElroy
• Ray Mays
• Terrence D Lowe
• Mark Lerma
• Jonathan Hosek
• Alberto Garcia
• Joel Fox
• Marti Flores
• Robert Dugie
• Kenneth Dugger
• Michael Dixon
• Eli Dierkhising
• Kevin Cryus
• Kristy Crenshaw
• Kelvin Broadnax
• Peter Baron
•
Requirements for Study
Enrollment• IRB Training 1 Hour
• Study Training 1 Hour
• Review/Updates 1 hour,
Group mtg
• Research Assistant– Bi-
Weekly phone reminder
• Cooler issued
• Swab obtained
• Sampled delivered to
VA
• Verbal consent by
paramedic followed by
formal consent post-
event
EMS Study
• Cardiologist will confirm patient diagnosis
• Salivary diagnostics lab will process samples for delivery to Rice University
EMS Study
• Markers will be
analyzed using lab
on a chip technology
EMS Study
• Potential Findings:
– Increase accuracy of
diagnosis in
combination with
ECG
– Reduce diagnosis
time
– Alter treatment
12 lead EKG used by paramedics
to transmit initial findings to
emergency room physicians.
EKG does not diagnose NSTEMI
cases.
Saliva ACS biomarker testing in ambulance
User: paramedics, highly trained
Environment: EMS vehicle, battery power, significant vibrations, compact
Accessories: used in connection with EKG, radio communications with hospital
Saliva testing allows for
identification of
NSTEMI patients
Results
• Recruited 29/ 120
patients
• 7 Confirmed
STEMI/NSTEMI
• 3 Heart Failure
• Acute Coronary
Syndrome/ Chest
Pain
• Is this important?
• Will it alter
therapy?
• Does it improve
outcomes?
Acknowledgements:
• San Antonio Fire Department
• Dr. Spencer Redding
• David Wampler, PhD
• Geoff Smith
• Chih-Ko Yeh
• Alan Lin
• Terry Baucher
• John McDevitt
• Funded Grant NIH “Development of a lab on
a chip system for saliva based diagnostics””
Salivary Diagnostics
Projects
• Four funded Groups
– UT Austin-UTHSCSA-UK-UL
• Cardiac disease
– NYU
• Tuberculosis
– UCLA
• Oral cancer
– Tufts
Future
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