Post on 09-Jun-2020
Liquid Based Microbiology (LBM) Simplify Sample Collection and Transport Improve Patient Care
August 29,2018 Presented By: Susan E. Sharp, PhD, (D)ABMM, (F)AAM, MS, MT(ASCP)
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Industry consolidation
Journey to value
Return on technology and innovation investments Big data and advancement of precision medicine Millennials will change healthcare delivery Health systems of the future
Key: Health systems should develop market-specific health delivery services that enhance
personalization.
https://www.huronconsultinggroup.com/resources/healthcare/trends-shape-future-healthcare?gclid=EAIaIQobChMItfuP44XK3AIVyCSGCh2a3QvkEAAYAiAAEgIUjvD_BwE
Huron is a global consultancy that
helps our clients drive growth, enhance performance and sustain leadership in the markets they serve.
Health Care is Facing Big Challenges
Clinical Microbiology is Facing Big Challenges
Increasing Workload • Hospital-Associated Infections (HAI)
• Emerging antibiotic resistance bacteria
• Laboratory consolidations
• Pressure for shorter patient LOS
• Need for more rapid results
Decreasing Resources • Less reimbursement
• Laboratory consolidations
• Aging workforce / retirements
• Lack of personnel entering the profession
2005: American Society for Microbiology Benchmarking Study, Survey of Clinical Microbiology Laboratory Workloads, Productivity Rates and Staffing Vacancies
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Things are Improving 5
But What Does the Future Hold? 6
What Does this have to do with Specimen Collection?
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Let’s Take a Look Microbiology Samples
Swabs:
• Throat
• Wound
• Vaginal
Containers:
• Urine
• Respiratory samples
• Stool
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Let’s Take a Look Microbiology Samples
Swabs:
• Throat
• Wound
• Vaginal
Containers:
• Urine
• Respiratory samples
• Stool
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1940s State of the Art
2003:
First international published standards for transport swabs was established in the NCCLS M40-A document. (second edition published in 2014)
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Traditional Swabs
3% of sample is retrieved from the swab
Flocked Swab
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Flocked Swabs
Liquid Based Microbiology Swabs Flocked swab + 1mL Liquid Amies Collection and transport device for aerobic, anaerobic, and fastidious bacteria for up to 48 hours *The exception is Neisseria gonorrhoeae which is stable for up to 24 hours.
• Simplify and Streamline • Better Gram Slides • Better Growth and Recovery • Open Platform
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LBM: Better Sample –
Better Patient Care Collects and releases more specimen
Detects up to 20% more S.aureus nasal colonization.
Chapin, K.C. et. al. Solutions for implementation of the automated PREVI Isola plating instrument in the clinical laboratory, July 2012
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18ul Flocked swab 47.7% 30ul Flocked swab 86.7%
Beck, E.T. et. al. Sensitivity of the BD MAX group B Streptococcus assay increases with direct testing of specimens collected in Copan ESwab collection devices vs. enriched culture specimens, June 2010
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LBM: Better Sample –
Better Patient Care Collects and releases more specimen
Demonstrates higher sensitivity than current systems for recovery of Group B Strep from pregnancy screens.
2016 study comparing
traditional collection and
transport system with LBM
product for maintenance of
fastidious anaerobic bacteria
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Organisms
and
Sources
studied
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Study
Design
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1. 0.5 McFarland subcultures were made for each test organism.
2. Each swab system tested at room temperature and 4°C.
3. Each temperature had subcultures performed at time = 0, 24 and 48h.
4. At each sampling time a suspension was plated, incubated, and colony counts determined.
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Flocked swab = eSwab Classic ana. swab = ATM
Conclusions
The flocked swab was shown
to provide equal or superior
results as compared to routine
agar swab collections.
The flocked swab can be used
in automated specimen
plating devices.
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2017 study evaluating
LBM Swab product for
use with fungi
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Let’s Take a Look Microbiology Samples
Swabs:
• Throat
• Wound
• Vaginal
Containers:
• Stool
• Respiratory samples
• Urine
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Managing Fecal Samples, Traditionally 25
• Easy to Use
• Standardize and Simplify
• Can be Used as Rectal Swab or Directly
from Stool
Liquid Based Microbiology Stool Samples
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2016 study evaluating
use of rectal swabs with
molecular testing in the
pediatric emergency
department
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2016 study evaluating
use of rectal swabs with
molecular testing in the
pediatric emergency
department
Let’s Take a Look Microbiology Samples
Swabs:
• Throat
• Wound
• Vaginal
Containers:
• Stool
• Respiratory samples
• Urine
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Sputum specimens
• Single Use Product - Less Waste, Cost Savings
• More Consistent Planting & Streaking
• Does not Affect Cell Morphology or Growth
of Organisms
• Room Temperature Stable
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Liquid Based Microbiology Sputum
Let’s Take a Look Microbiology Samples
Swabs:
• Throat
• Wound
• Vaginal
Containers:
• Stool
• Respiratory samples
• Urine
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Liquid Based Microbiology Urine
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Comparison of urine
preservation devices for uropathogens.
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Comparison of urine preservation devices for uropathogens.
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UriSponge™ maintained significantly more urinary pathogens than the urine culture paddle with fewer mixed or contaminated cultures. UriSponge™ was comparable to BD preservative tubes for maintenance of viability of the pathogens, with fewer mixed cultures when samples were collected with UriSponge™.
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Liquid Based Microbiology
Better Patient Care, Streamline Collection
Fontana, et al, 2013.
Demonstrates how LBM has
positively affected their
laboratory and hospital and
helped to improve patient
care.
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Researchers completed 3 assays and 5 culture plates with one Liquid Based Microbiology collection system • 1 Rapid Point-of-Care Strep A test
• 1 Reflex plate culture for Strep A, C/G
• 4 culture plates for F.necrophorum
• 1 PCR test for Strep A, C/G
• 1 PCR for F.necrophorum
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8 multi-center study - evaluated rayon swabs vs LBM Swab system for new assay
• Positive predictive value of rayon
swabs was 78.7% vs 83.5% for LBM
• Negative predictive value of rayon swabs was 98.9% vs 99.1% for LBM
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The Specimen Challenge
Microbiology is Unique Unlike Chemistry and Hematology, Microbiology receives various sample viscosities, and container types.
Liquid Based Microbiology handles this diversity of specimens by liquefying all samples in uniform containers making them easy to automate.
Flocked Swabs Opened the Door for Liquid Based Microbiology
Liquid Based Microbiology Opens the Door for Automated Specimen Processing
Comparison of Recovery Rates of Enteropathogens From Stool Cultures for a One and Two Year Period Before and After Introduction of Inoculation Using Automation
Mischnik A., et al. Annals of Laboratory Medicine, 2015
Comparison of Recovery Rates of Enteropathogens From Stool Cultures for a One and Two Year Period Before and After Introduction of Inoculation Using Automation
Mischnik A., et al. Annals of Laboratory Medicine, 2015
Automated steaking by the
is superior to manual
streaking and results in
single colonies yielded
Comparison of Sensitivities and Specificities of Manual/Rayon Swab to Automated Processor/LBM Swab for the recovery of S.agalactiae
No. with indicated test result
Total no. Sensitivity
(%) Specificity
(%) True
positive False
positive True
negative False
negative
Direct plating
Manual/ rayon swab
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0
65
4
97
87.5
100.0
Automated/ flocked swab
30
0
65
2
97
93.8
100.0
Enrichment culture
Manual/ rayon swab
29
0
65
3
97
90.6
100.0
Automated/ flocked swab
31
0
65
1
97
96.9
100.0
Buchan B et al. 2014. JCM
Comparison of Sensitivities and Specificities of Manual/Rayon Swab to Automated Processor/LBM Swab for the recovery of S.agalactiae
No. with indicated test result
Total no. Sensitivity
(%) Specificity
(%) True
positive False
positive True
negative False
negative
Direct plating
Manual/ rayon swab
28
0
65
4
97
87.5
100.0
Automated/ flocked swab
30
0
65
2
97
93.8
100.0
Enrichment culture
Manual/ rayon swab
29
0
65
3
97
90.6
100.0
Automated/ flocked swab
31
0
65
1
97
96.9
100.0
Buchan B et al. 2014. JCM
Comparison of Sensitivities and Specificities of Manual/Rayon Swab to Automated Processor/LBM Swab for the recovery of S.agalactiae
No. with indicated test result
Total no. Sensitivity
(%) Specificity
(%) True
positive False
positive True
negative False
negative
Direct plating
Manual/ rayon swab
28
0
65
4
97
87.5
100.0
Automated/ flocked swab
30
0
65
2
97
93.8
100.0
Enrichment culture
Manual/ rayon swab
29
0
65
3
97
90.6
100.0
Automated/ flocked swab
31
0
65
1
97
96.9
100.0
Buchan B et al. 2014. JCM
6%
Comparison of Sensitivities and Specificities of Manual/Rayon Swab to Automated Processor/LBM Swab for the recovery of S.agalactiae
No. with indicated test result
Total no. Sensitivity
(%) Specificity
(%) True
positive False
positive True
negative False
negative
Direct plating
Manual/ rayon swab
28
0
65
4
97
87.5
100.0
Automated/ flocked swab
30
0
65
2
97
93.8
100.0
Enrichment culture
Manual/ rayon swab
29
0
65
3
97
90.6
100.0
Automated/ flocked swab
31
0
65
1
97
96.9
100.0
Buchan B et al. 2014. JCM
6%
6%
Benefits of Automated Specimen Processing in
Microbiology
• Improved quality/accuracy of specimen inoculation • Better detection of pathogens Improved Patient Care
• Specimen traceability • Improved ergonomics - decrease repetitive motion injuries Increased efficiency and productivity
Liquid Based Microbiology Has made Automated Specimen Processing possible
Automated Specimen Processing Open yet Another Door to Total Laboratory Automation (TLA) in clinical microbiology.
Plates on bench – not incubating
Slower growth of colonies
TLA: Plates always incubating
More rapid growth of colonies
Unique Location for Each Plate • Homogenous atmospheric
conditions • Excellent thermal conductivity
Earlier Plate Reading • Results in improved TAT
• Delivery of actionable results
sooner
Smart Incubators
Imaging times are set by the user
Examples:
urine = 12, 14, 16 hours
sputum = 24 and 48 hours
Imaging for Microbiology
• Plates are displayed on the screen
• Colonies digitally selected and
instructions for each colony entered
• Plates can be sent for other automated
processes
• Or users get plates at the bench
Digital Imaging
LBM / Total Laboratory Automation
Shaping the Future of Microbiology
Flocked Swabs Open the Door for Liquid Based Microbiology