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

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

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