Aperio GT 450 Improves Throughput by 64% and Reduces QC Tech Time by 94% in Workflow Study

Lance Mikus MBA

Ashley Troutman MBA, HT(ASCP), QIHC, CLSSBB.

Julie Broccardo HTL, QIHC, Director of Anatomic Pathology Operations, NeoGenomics Laboratories, Inc.

Vladislav Chizhevsky MD SSBBP

James Wells

Thomas Lee MD, PhD, Director of Surgical Pathology Services, NeoGenomics Laboratories, Inc.

Sally Agersborg MD, PhD, Medical Director, NeoGenomics Laboratories, Inc.

NeoGenomics is a large research and reference laboratory located in California and has experienced significant increases in annual slide volumes. The NeoGenomics senior management team was tasked with evaluating ways to scale up digital pathology operations to keep up with increasing demand. Consequently, the laboratory director desired to perform a comparative research study to assess the performance of the Aperio GT 450 versus Aperio AT2. Throughput, QC tech time and other performance metrics were measured.

Methodology

Samples

A total of 155 slides, that were representative samples from the high volume reference laboratory, were part of this study. Samples included:

35 individual H&E stained slides
36 breast IHC slides evaluated for key biomarkers along with 10 associated breast H&E slides
26 colon IHC stained slides for key biomarkers along with 8 associated colon H&E slides
33 squamous mucosa CISH stained slides for HPV biomarkers (RNA ISH) along with 7 associated H&E slides

H&E stained slides

35 Individual H&E stained slides included in the study

Organ	Method	# of slides
Brain	H&E	1
Cervix	H&E	2
Gall bladder	H&E	1
Lung	H&E	4
Prostate	H&E	20
Right iliac bone	H&E	1
Soft palate	H&E	1
Stomach	H&E	3
Tongue	H&E	1
Uterus	H&E	1
Total		35

IHC breast biomarkers

36 breast IHC slides evaluated for key biomarkers along with 10 associated breast H&E slides were included in the study.

Organ	Method	Stain	# of slides	Case #
Breast	IHC/H&E	HER2, ER, PR, Ki67, H&E	5	1
Breast	IHC/H&E	HER2, ER, PR, Ki67, p53, H&E	5	2
Breast	IHC/H&E	ER, PR, Ki67, p53, H&E	5	3
Breast	IHC/H&E	ER, PR, Ki67, p53, H&	5	4
Breast	IHC/H&E	ER, PR, Ki67, p53, H&E	5	5
Breast	IHC/H&E	HER2, ER, PR, Ki67, H&E	5	6
Breast	IHC/H&E	HER2, PR, KI67, H&E	4	7
Breast	IHC/H&E	HER2, Ki67, p53, H&E	4	8
Breast	IHC/H&E	HER2, Ki67, p53, H&E	4	9
Breast	IHC/H&E	HER2, Ki67, p53, H&E	4	10
		Total slides	46

Colon biomarkers

26 colon IHC stained slides evaluated for key biomarkers along with 8 associated colon H&E slides were included in the study.

Organ	Method	Stain	# of slides	Case #
Colon	IHC/H&E	MLH-1, MSH-2, MSH-6, PMS-2, H&E	5	1
Colon	IHC/H&E	MLH-1, MSH-2, MSH-6, PMS-2, H&E	5	2
Colon	IHC/H&E	MLH-1, MSH-2, MSH-6, PMS-2, H&E	5	3
Colon	IHC/H&E	MLH-1, MSH-2, MSH-6, PMS-2, H&E	5	4
Colon	IHC/H&E	MLH-1, MSH-2, MSH-6, PMS-2, H&E	5	5
Colon	IHC/H&E	MSH-2, MSH-6, H&E	3	6
Colon	IHC/H&E	MLH-1, PMS-2, H&E	3	7
Colon	IHC/H&E	MLH-1, PMS-2, H&E	3	8
		Total slides	34

Squamous mucosa RNA ISH biomarkers

33 squamous mucosa CISH stained slides evaluated for HPV biomarkers (RNA ISH) along with 7 associated H&E slides were included in the study.

Organ	Method	Stain	# of slides	Case #
Squamous Mucosa	CISH/H&E	HPV 16/18, HR 18, HPV LR10, HPV RNA-, HPV RNA+, HPV H&E	6	1
Squamous Mucosa	CISH/H&E	HPV 16/18, HR 18, HPV LR10, HPV RNA-, HPV RNA+, HPV H&E	6	2
Squamous Mucosa	CISH/H&E	HPV 16/18, HR 18, HPV LR10, HPV RNA-, HPV RNA+, HPV H&E	6	3
Squamous Mucosa	CISH/H&E	HPV 16/18, HR 18, HPV LR10, HPV RNA-, HPV RNA+, HPV H&E	6	4
Squamous Mucosa	CISH/H&E	HPV 16/18, HR 18, HPV LR10, HPV RNA-, HPV RNA+, HPV H&E	6	5
Squamous Mucosa	CISH/H&E	HPV 16/18, HR 18, HPV LR10, HPV RNA-, HPV RNA+, HPV H&E	5	6
Squamous Mucosa	CISH/H&E	HPV 16/18, HR 18, HPV LR10, HPV RNA-, HPV RNA+, HPV H&E	5	7
		Total slides	40

Equipment

Equipment Type / Description	Identification / Serial Number
Aperio GT 450 next generation scanner	Serial number 12001 with hardware version 1.0.1 and controller version 1.0.0.5055
Dell R740XL DSR server loaded with Aperio eSlide Manager and Aperio ImageScope Version 12.4.	Aperio eSlide Manager Version 12.4.2.5010
Dell 5820 workstation with ImageScope version 12.4, Win 10 operating system and ICC calibration file loaded on workstation, Dell 24 inch calibrated monitor model.	Aperio ImageScope Version 12.4.2.5010 ICC calibration file version Aperio GT 450
Scanner Admin Manager (SAM) server Dell R640	Serial number SAMBAR2
Scanner Admin Manager (SAM) client software	Version 1.0.0.5052
Aperio AT2 scanner	Serial number 7553 with hardware version 102.0.7.5 and controller version 102.0.4.201

Workflow Steps Start and End Points

Starting point: flats loaded with the 155 slides with ethanol

Step	Workflow Steps	Timing Category
1	Clean all slides	Hands-on time
2	Insert all slides into Aperio AT2 racks per user manual instructions	Hands-on time
3	Load all racks into Aperio AT2	Hands-on time
4	Pre-snaps	Scan time
5	Manually adjust scan area (green box)	Hands-on time/ QC Tech time
6	Manually adjust or add focus points	Hands-on time/ QC Tech time
7	Scan all slides at 20x	Scan time
8	Review image quality in 5 image points for each image created	Hands-on time/ QC Tech time
9	Remove racks and place on lab bench	Hands-on time
10	Put slides back in flats	Hands-on time

Step	Workflow Steps	Timing Category
1	Clean all slides	Hands-on time
2	Insert all slides into Aperio GT 450 racks per user manual instructions	Hands-on time
3	Continuously load all racks into Aperio GT 450 while automatic scanning occurs	Hands-on time/ Scan time
4	Review tissue finder results via macro image	Hands-on time/ QC Tech time
5	Remove racks and place on lab bench	Hands-on time
6	Put slides back in flats	Hands-on time

Study Endpoint Measurements

Definitions:

1.QC tech time

Aggregate time the operator spent with the instrument that was required for slide quality or slide inspection purposes, measured in hours, minutes and seconds.

2.Hands on time

Aggregate time a tech spent performing the workflow steps from beginning to end. This included steps 1, 2, 3, 4, 5, 6, 8, 9 and 10 for the Aperio AT2 (see table of workflow steps below) and steps 1, 2, 4, 5 and 6 for the Aperio GT 450 (see table of workflow steps below). Each measured in hours, minutes and seconds.

3.Turnaround time (TAT)

Total amount of time to perform the workflow steps from beginning to end measured in hours, minutes and seconds.

4.Slide throughput

Number of slides processed for all workflow steps beginning to end measured in slides per hour.

Image Quality

Each of the three participating pathologists viewed and scored image quality for 155 images from the sample set generated with the Aperio AT2, and 155 images from the sample set generated with the Aperio GT 450. Images were viewed on the Aperio Viewing Station running Aperio eSlide Manager 12.4 Image Management Software, and Aperio ImageScope 12.4 Viewing Software.

There was a minimum of a 2 week wash out period between the reads on images generated from Aperio AT2 and Aperio GT 450. Image quality was assessed by each participating Pathologist using a quadrant-based scoring criteria, as shown in Figure 1. For example, a score of 4 was recorded by the pathologist if he or she assessed that the image quality fit with the description in quadrant 4.

Results

Total tech QC time

94% reduction.

QC tech time is defined as the aggregate time the operator spent with the instrument. This is the time that was required for slide quality or slide inspection purposes and is a subset of the total hands-on time.

Table 1 (below): Average Tech QC time was reduced from about 1 hour and 25 minutes to only 5 minutes with Aperio GT 450. This is a 94% reduction in Tech QC time.

AT2	Run 1	Run 2	Run 3	Avg
Tech QC Time (h:mm:ss)	1:22:38	1:45:41	1:06:46	1:25:02

GT 450	Run 4	Run 5	Run 6	Avg
Tech QC Time (h:mm:ss)	0:04:54	0:04:38	0:06:43	0:05:25

View the Full Case Study Now

For Research Use Only. Not For Use In Diagnostic Procedures.

발표자 소개

Lance Mikus , MBA

Lance Mikus earned his bachelor’s degree from UCLA. He worked as a scientist and lab manager at the UW-Madison Medical School, resulting in several publications, and went on to earn an MBA focused on Entrepreneurship and Marketing from the UW-Madison School of Business. Mr. Mikus has 20 years of commercial operations experience in the healthcare industry. He also holds a green belt in six sigma quality practices, is a certified practitioner in launch excellence and has been awarded 5 patents.

Ashley Troutman , MBA, HT(ASCP), QIHC, CLSSBB.

Ashley Troutman has been involved in Laboratory Medicine for more than 20 years in clinical, research and administrative capacities. He has worked in facilities of all sizes, from small community hospitals and private labs to large academic medical centers and corporate reference labs. He has extensive experience in laboratory science and management, specifically in anatomic pathology and immunohistochemistry. He has managed routine histology operations and has been part of the team to aid researchers in designing experiments using histologic techniques. These roles have allowed Ashley to lead work process implementation teams that saw success in scientific innovation as well as improving laboratory efficiency through areas of waste/cost reduction, process improvement and safety.

Julie Broccardo , HTL, QIHC, Director of Anatomic Pathology Operations, NeoGenomics Laboratories, Inc.

Julie Broccardo is the Director of Pathology Operations for NeoGenomics Laboratories, Inc. She is responsible for managing multi-site operations, including the Ft. Meyers, Houston, Carlsbad, and Aliso Viejo laboratories. Julie is passionate about developing her staff and working on initiatives to build and develop a more efficient lab.

Vladislav Chizhevsky , MD SSBBP

Dr. Chizhevsky is the Senior Hematopathologist and Medical Director, Flow Cytometry, NeoGenomics Laboratories, Inc. He is a member of the College of American Pathologists, American Society for Clinical Pathology and International Clinical Cytometry Society. Dr.Chizhevsky has authored many publications in medical journals.

James Wells

Thomas Lee , MD, PhD, Director of Surgical Pathology Services, NeoGenomics Laboratories, Inc.

Sally Agersborg , MD, PhD, Medical Director, NeoGenomics Laboratories, Inc.

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