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2025 Cleveland Clinic Laboratories Soft Tissue Pathology Course – Save the Date!

Comprehensive & Immersive Soft Tissue Pathology Course

May 15-18, 2025

InterContinental Hotel at Cleveland Clinic Main Campus | Cleveland, OH

Join us for an Interactive, Immersive, and Comprehensive Soft Tissue Pathology Course

This four-day course is a one-of-a-kind experience set in the heart of one of the country’s busiest soft tissue pathology consultation practices.

Participants will have the opportunity to digitally preview a wide variety of soft tissue cases spanning from benign lesions and reactive mimics to high grade sarcomas, followed by interactive case-based discussions with world-renown faculty. Interspersed lectures focusing on a practical approach to common diagnostic scenarios will complement these case sessions.

During this course, pathologists will develop skills and tools to work-up and triage mesenchymal lesions encountered in every-day practice.

Registration Information

Symposium Director

Karen Fritchie, MD
Director, Soft Tissue Pathology

Course Objectives

Comprehend the utility of immunohistochemical, molecular techniques, and radiology studies in the work-up of soft tissue tumors
Develop a work-up strategy for the diagnosis of mesenchymal neoplasms
Identify common and uncommon soft tissue tumors
Recognize pitfalls commonly encountered in soft tissue pathology

Who Should Attend?

Pathologists, Pathology Residents & Fellows

CME Credits

This live activity is approved for continuing medical education credits. Read more.

Faculty Presenters

John Goldblum, MD
Chair, Division of Pathology

John Reith, MD
Staff Pathologist, Orthopaedic Pathology

Steven D. Billings, MD
Staff Pathologist, Dermatopathology & Soft Tissue Pathology

Scott Kilpatrick, MD
Director, Orthopaedic Pathology
Medical Director, CCL Anatomic Pathology Services

Brian Rubin, MD, PhD
Chief, Diagnostics Institute
Chair, Department of Pathology & Laboratory Medicine

Josephine Dermawan, MD, PhD
Director, AP Molecular Pathology
Staff Pathologist, Soft Tissue & Orthopaedic Pathology

Susan Armstrong, MD
Staff Pathologist, Pulmonary Pathology

Registration

Online registration will be available soon.

In-person fee includes:
Continental breakfasts, refreshment breaks, Saturday reception (in-person only), and online access to faculty PowerPoint presentations in PDF format pre and post-course.

Virtual option fee includes:
Access to view lectures and online access to faculty PowerPoint presentations.

Early Bird
on or before April 1, 2025

After
April 1, 2025

Physician (MD, Scientist, PhD)

$699

$749

Resident* / Fellow*

$349

$399

Non-Physician

$349

$399

*A letter from the program director is required to receive the discounted fee. If the letter is not received two weeks prior to the activity, the full physician fee will be charged.

Group Discount Available
Groups of three or more from the same office/institution will receive a $100 discount on the full registration fee. Registrants must call 216.444.9990 to receive a promotional code for special pricing.

Registration and Cancellation
Preregistrations are accepted until 11:59 p.m. ET on Wednesday, May 14, 2025. Register onsite after this date. Contactless registration on your own device will be required.
In case of cancellation, an email notification is required to process your refund. A full refund will be issued if canceled by May 3, 2025. After May 3, 2025, a $125 cancellation fee will be deducted from your refund. No refunds will be issued after May 7, 2025.

For questions about registration or cancellation, email cmeregistration@ccf.org or call 216.448.8710.

Cleveland Clinic Center for Continuing Education reserves the right to cancel or postpone an activity at our sole discretion. In the unlikely event that this occurs, any registration fee(s) paid will be refunded. Be advised that Cleveland Clinic is not responsible for related costs including airline tickets, hotel costs, or any similar fee penalties incurred as a result of any meeting cancellations or changes.

General Information

Location
InterContinental Cleveland
Cleveland Clinic Main Campus
9801 Carnegie Avenue
Cleveland, OH 44106
216.707.4100
iccleveland.com

Hotel Accommodations
A limited block of rooms will be reserved at the InterContinental Cleveland – more details will be available starting December 1, 2024.

Faculty Disclosure
The Cleveland Clinic Center for Continuing Education has implemented a policy to comply with the current Accreditation Council for Continuing Medical Education Standards for Integrity and Independence requiring mitigation of all faculty conflicts of interest. Faculty declaring a relevant financial relationship will be identified in the activity syllabus.

For further information about this activity, contact Karen Fritchie, MD, at fritchk@ccf.org.

Americans with Disabilities Act
Cleveland Clinic Center for Continuing Education fully intends to comply with the legal requirements of the Americans with Disabilities Act. If you need assistance, please notify us at least two weeks prior to the activity.

Accreditation
In support of improving patient care, Cleveland Clinic Center for Continuing Education is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

Credit Designation
American Medical Association (AMA)
Cleveland Clinic Center for Continuing Education designates this live activity for a maximum of 28.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Participants claiming CME credit from this activity may submit the credit hours to the American Osteopathic Association for Category 2 credit.

American Board of Pathology MOC (ABPath)
Successful completion of this CME activity, which includes participation in the evaluation component, earns 28.75 credits toward the Lifelong Learning requirement for the American Board of Pathology’s Continuing Certification program. It is the CME activity provider’s responsibility to submit learner completion information to ACCME for the purpose of granting credit. Credit will be reported within 30 days of claiming credit.

Certificate of Participation
A certificate of participation will be provided to other healthcare professionals for requesting credits in accordance with their professional boards and/or associations.

Study References
Faculty presentations will also be available online in PDF format pre and post-course. You will have access to download or print the slides.

Health and Safety
As participants are responsible for their own health choices, the use of masks by all participants at this event is optional. Additionally, attendees are not required to verify vaccination status nor to provide a negative COVID-19 test for entry. Please note this is subject to change based on the most recent status of CDC, local and/or state guidelines.

Agenda

Thursday

Thursday, May 15, 2025

7:00 am Continental Breakfast

7:45 am Course Introduction and Welcoming Remarks (in-person only) – Karen Fritchie, MD

8:00 am Slide Preview, Staff Q&A (in-person only) – Course Faculty

11:00 am Lunch – On Your Own

12:00 pm The Utility of MDM2 FISH in the Work-up of Lipomatous Lesions – Karen Fritchie, MD

1:00 pm Lipomatous tumors – John Goldblum, MD

2:30 pm Break

3:00 pm Spindle Cell Sarcomas with Herringbone/Fascicular Morphology – Brian Rubin, MD, PhD

4:00 pm “Pseudosarcomas” – Scott Kilpatrick, MD

5:00 pm Acral Soft Tissue Tumors: The Answer is at Your Fingertip – Karen Fritchie, MD

6:00 pm Adjourn

Friday

Friday, May 16, 2025

7:30 am Continental Breakfast

8:00 am Slide Preview, Staff Q&A (in-person only) – Course Faculty

11:00 am Lunch – On your own

12:00 pm Common Core Biopsy Scenarios in Soft Tissue Pathology – Karen Fritchie, MD

1:30 pm Pediatric Soft Tissue Pathology – Scott Kilpatrick, MD

2:30 pm Break

3:00 pm Periprosthetic Joint Infection – John Reith, MD

4:00 pm Myxoid Soft Tissue Tumors – Steven Billings, MD

5:30 pm Adjourn

Saturday

Saturday, May 17, 2025

7:30 am Continental Breakfast

8:00 am Slide Preview, Staff Q&A (in-person only) – Course Faculty

11:00 am Lunch – On your own

12:00 pm S100-Positive Mesenchymal Neoplasms – Karen Fritchie, MD

1:00 pm What’s New in Soft Tissue Pathology? – Karen Fritchie, MD and Josephine Dermawan, MD, PhD

2:00 pm Break

2:30 pm “Everyday” Cutaneous Soft Tissue Tumors – Steven Billings, MD

2:30 pm The Importance of Molecular Correlation in Mesenchymal Neoplasia – Josephine Dermawan, MD, PhD

6:00 pm Reception with Attendees & Cleveland Clinic Staff

Sunday

Sunday, May 18, 2025

7:30 am Continental Breakfast

8:00 am Slide Preview, Staff Q&A (in-person only) – Course Faculty

10:00 am Mesenchymal Tumors of the Thorax and Lung – Susan Armstrong, MD

11:00 am Myoepithelioma… or Not? – Karen Fritchie, MD

12:00 pm Course Conclusion & Adjourn

October 2024: Stool Testing Universal Laboratory (STUL) Kit for Microbiology

Special Communication

Stool Testing Universal Laboratory (STUL) Kit for Microbiology

Effective October 1, 2024.

The Stool Testing Universal Laboratory (STUL) Kit for Microbiology contains the collection and transport items necessary for most stool testing.

Place all (3) vials into the white STUL Kit bag or a large biohazard bag with Beaker labels attached externally.

All vials remain at Main Campus for add-on testing, stability permitting. Refer to the Microbiology Collection & Transport Guide: Stool Collection Devices for specific test and item information.

Order STUL Kits

September 2024: Test Update – Vasoactive Intestinal Polypeptide (VIP), Plasma

Special Communication

Test Update – Vasoactive Intestinal Polypeptide, Plasma (VIP)

Effective October 8, 2024.

Beginning October 8, 2024, Vasoactive Intestinal Polypeptide, Plasma (VIP) will return to the previous reference lab following the resolution of the reagent shortage.

Refer to the table below for an outline of testing changes.

Please contact Client Services with any questions or for assistance.

Test Change Overview

Vasoactive Intestinal Polypeptide, Plasma (VIP)

For specimens collected between 9/17/24 and 10/8/24, the VIP order will be canceled and replaced by a MISC1 test due to the test at Mayo being discontinued as of 9/17/24 with no advance notice. The specimen will be sent to ARUP and results will be uploaded as a PDF when they are received.

New Test

Old Test

Performing Laboratory

ARUP

Mayo Clinic Laboratories

Methodology

Enzyme-linked immunosorbent assay (ELISA)

Enzyme-linked immunosorbent assay (ELISA)

Specimen Collection

Plasma, 2 mL

Lavender K₂EDTA tube

Plasma, 1 mL

Lavender K₂EDTA tube

Minimum Volume

0.5 mL

0.5 mL

Transport Temperature

Critical frozen

Critical frozen

Reference Interval

0-89.1 pg/mL

0-36 pg/mL

Turnaround Time

4-8 days

6-10 days

Vendor Test Information

Test ID: 3018202

TEST ID : FVIP2

Sept 2024: Immediate Test Change – Testosterone, Free and Total

Immediate Test Change

Test Update – Testosterone, Free and Total (TFTEST)

Effective September 12, 2024.

Beginning September 12, 2024, Testosterone, Free and Total (TFTEST) will be sent to a different reference laboratory due to an emergency inactivation at the current reference laboratory because of reagent problems.

This follows an extended test delay since April of this year.

Please contact Client Services with any questions or for assistance.

For specimens ordered and collected before September 12, 2024, but not received by Mayo before September 12, 2024, Mayo will send them to LabCorp for testing. When available, those results will be uploaded as scanned documents to the lab order.

Test Change Overview

Testosterone, Free and Total (TFTEST)

As part of this change, the test’s name has been modified to clarify its contents and how it is performed. Test name changes for the other testosterone assays are planned for later this fall.

New Test

Old Test

Test Name

Testosterone, free and total, by equilibrium ultrafiltration mass spectrometry

Testosterone, Free and Total

Performing Laboratory

LabCorp

Mayo Clinic Laboratories

Methodology

Equilibrium ultrafiltration; Liquid chromatography/tandem mass spectrometry

Equilibrium dialysis; Liquid chromatography/tandem mass spectrometry

Specimen Collection

Serum, 2.2 mL

Red (No Additive) Tube

Serum, 2.5 mL

Red (No Additive) Tube

Minimum Volume

1.8 mL

1 mL

Transport Temperature

Ambient

Refrigerated

Turnaround Time

5-7 days

4-8 days (delay as of April 19, 2024)

Vendor Test Information

TEST: 070038

Test ID: TGRP

July 2024: Blood Culture Bottle Shortage

Clinical Update

Blood Culture Bottle Shortage: Make the most of every bottle

A global shortage of blood culture bottles is expected to last for months, so we need caregivers’ help to make the most of every bottle.

Blood cultures are commonly used in patients with symptoms of an infection. It is always important to culture with purpose, but even more so when supplies are constrained.

When placing blood culture orders, consider this high-level overview of some blood culture best practices:

Do’s

Blood cultures are recommended as part of the initial evaluation for:

Severe sepsis or septic shock
Neutropenia with fever and febrile illnesses in immunocompromised patients
High-acuity illnesses like meningitis, endocarditis, and vascular graft infections
Fever in a patient with central venous catheter
Fever in an infant

Don’ts

Blood cultures are not routinely helpful for general medical and surgical patients with these common conditions:

Isolated fever without shaking chills
Isolated leukocytosis
Uncomplicated cystitis and prostatitis, non-severe community-acquired pneumonia, and non-severe cellulitis
Asymptomatic patients with a central line
Post-operative fever within 48 hours of surgery

For follow-up testing:

Do’s

Blood cultures are needed:

To confirm clearance of Staphylococcus bacteremia and candidemia
To confirm bloodstream clearance when treating a catheter-related bloodstream infection when the catheter has been maintained

Don’ts

Blood cultures are not needed to confirm bloodstream clearance in these situations:

Bacteremia due to urinary tract infection
Most routine gram-negative bacteremias
Bacteremia due to pneumonia or soft tissue infection

When drawing blood for blood cultures, remember these best practices:

Once the decision is made to culture, draw two sets – a single set is not optimal.

Avoid false-positive results due to skin contamination by strictly adhering to antisepsis protocols before venipuncture.

Collect the recommended volume of blood to maximize test sensitivity (weight-based blood volume for children; 8-10 mL per bottle for adults).

No order = no draw. Do not draw blood cultures before an order is placed, which can result in discarded bottles.

Register Now! 2025 Cleveland Clinic Multispecialty Pathology Symposium

Clinical Updates

2025 Cleveland Clinic Multispecialty Pathology Symposium

January 24-26, 2025 | Encore at Wynn Las Vegas

Overview

This pathology symposium will focus on practical discussions of commonly encountered problems in surgical pathology. The goal is to provide useful tips that the speakers utilize in their own practice at the microscope. We aim to address and discuss common problems and avoid an undue focus on esoterica.

In this course, renowned subspecialists who are highly sought-after for their teaching skills will cover a broad spectrum of cases, including genitourinary pathology, thoracic pathology, gastrointestinal and hepatobiliary pathology, gynecologic cancer, and breast pathology.

Practicing pathologists, fellows, and residents who attend will maintain, develop, and increase their knowledge, competence, and professional performance, with the intent to improve diagnosis and positively impact patient care.

Target Audience: Pathologists, Pathology Residents & Fellows

This activity has been approved for AMA PRA Category 1 credit™.

Overview & Agenda (.pdf)

Symposium Co-Directors

Sanjay Mukhopadhyay, MD

Sean Williamson, MD

Faculty Presenters

Erica Savage, MD

Vincent Cracolici, MD

Erna Forgó, MD

Friday, 1/24

Friday, January 24, 2025

10:45 a.m.

Registration, Lunch, and Exhibits

11:45 a.m.

Welcoming Remarks
Sean Williamson, MD
Sanjay Mukhopadhyay, MD

Genitourinary Pathology

12:00 p.m.

Staging and Handling of Kidney Tumor Specimens
Sean Williamson, MD

12:45 p.m.

Common Consultation Challenges in Genitourinary Pathology
Sean Williamson, MD

1:30 p.m.

Question & Answer Period

1:45 p.m.

Refreshment Break and Exhibits

Gastrointestinal Pathology

2:30 p.m.

Updates in Colorectal Adenocarcinoma – What to Know and Include in Your Pathology Report
Erica Savage, MD

3:15 p.m.

MMR, HER2, and PD-L1, Oh My! – Biomarkers in Gastrointestinal Lesions
Erica Savage, MD

4:00 p.m.

Question & Answer Period

Pulmonary Pathology

4:15 p.m.

Thoracic Frozen Section Pitfalls: What to Say to Your Surgeon, and How to Stay Out of Trouble
Sanjay Mukhopadhyay, MD

5:00 p.m.

Not Your Grandpa’s Thoracic Pathology: Changes in Terminology, Ancillary Testing and Treatment In The Last 10 Years
Sanjay Mukhopadhyay, MD

5:45 p.m.

Question & Answer Period

6:00 p.m.

Adjourn

Saturday, 1/25

Saturday, January 25, 2025

7:00 a.m.

Continental Breakfast and Exhibits

Head & Neck Pathology

7:45 a.m.

Challenges in Frozen Section Pathology of the Head & Neck
Vincent Cracolici, MD

8:30 a.m.

Modern Considerations in Salivary Gland Tumors
Vincent Cracolici, MD

9:15 a.m.

Question & Answer Period

9:30 a.m.

Refreshment Break and Exhibits

Gynecologic Pathology

10:00 a.m.

2023 FIGO Staging of Endometrial Carcinoma: Spotting the Sheep in Wolf’s Clothing
Erna Forgó, MD

10:45 a.m.

Biomarkers in Gynecologic Pathology: Knowing When to Order What and How to Interpret the Results
Erna Forgó, MD

11:30 a.m.

Question & Answer Period

11:45 a.m.

Lunch Served at Encore Las Vegas

Pulmonary Pathology

1:00 p.m.

Discord in the Thorax: Discrepancies Between Clinical Impression, Imaging, and Pathology
Sanjay Mukhopadhyay, MD

1:45 p.m.

My Approach to Pulmonary Infections
Sanjay Mukhopadhyay, MD

2:30 p.m.

Question & Answer Period

2:45 p.m.

Refreshment Break and Exhibits

Genitourinary Pathology

3:30 p.m.

Updates in Male External Genital Pathology
Sean Williamson, MD

4:15 p.m.

Odds and Ends: Genitourinary Pathology No One Talks About
Sean Williamson, MD

5:00 p.m.

Question & Answer Period

5:15 p.m.

Adjourn

Sunday, 1/26

Sunday, January 25, 2025

7:00 a.m.

Continental Breakfast and Exhibits

Gastrointestinal Pathology

7:30 a.m.

Unintended Consequences – Iatrogenic/Medication Induced Gastrointestinal Injury
Erica Savage, MD

8:15 a.m.

Hepatocellular Lesions – From Adenoma to Carcinoma
Erica Savage, MD

9:00 a.m.

Question & Answer Period

9:15 a.m.

Refreshment Break and Exhibits

Head & Neck Pathology

9:30 a.m.

Follicular Patterned Thyroid Tumors
Vincent Cracolici, MD

10:30 a.m.

Aggressive Thyroid Malignancies
Vincent Cracolici, MD

11:15 a.m.

Question & Answer Period

Gynecologic Pathology

11:30 a.m.

Uterine Smooth Muscle Neoplasms: Defining the Blurry Lines
Erna Forgó, MD

12:15 p.m.

Mucinous Lesions of the Ovary: How to Recognize When Tumors Do Not Belong
Erna Forgó, MD

12:45 p.m.

Question & Answer Period

1:00 p.m.

Closing Remarks
Sean Williamson, MD
Sanjay Mukhopadhyay, MD

1:10 p.m.

Adjourn

June 2024: Test Update – Vasoactive Intestinal Polypeptide (VIP), Plasma

Immediate Test Change

Test Update – Vasoactive Intestinal Polypeptide, Plasma (VIP)

Effective June 27, 2024.

Beginning June 27, 2024, Vasoactive Intestinal Polypeptide, Plasma (VIP) will be sent to a different reference laboratory due to issues with the current reagent manufacturer.

Refer to the table below for an outline of testing changes.

Please contact Client Services with any questions or for assistance.

Test Change Overview

Vasoactive Intestinal Polypeptide, Plasma (VIP)

Additional patient preparation information for the new test:
Patients must fast for 10-12 hours and avoid antacid medications or medications that affect intestinal motility for at least 48 hours before collection.

New Test

Old Test

Performing Laboratory

Mayo Clinic Laboratories

ARUP

Methodology

Enzyme-linked immunosorbent assay (ELISA)

Radioimmunoassay (RIA)

Specimen Collection

Plasma, 1 mL

Lavender K₂EDTA tube

Plasma, 1 mL

PPACK tube

Minimum Volume

0.5 mL

0.5 mL

Transport Temperature

Critical frozen

Frozen

Reference Interval

0-36 pg/mL

0-60 pg/mL

Turnaround Time

6-10 days

4-8 days

Vendor Test Information

TEST ID : FVIP2

Test ID: 0099435

Test Discontinuation: Creatine Kinase-Myocardial Band

Clinical Updates

Test Discontinuation – Creatine Kinase-Myocardial Band (CKMB)

Beginning June 11, 2024, Creatine Kinase-Myocardial Band (CKMB) testing (CKCKMB, MBE) will no longer be orderable at Cleveland Clinic.

Recommended Alternative Test: High-Sensitivity Troponin T (HSTNT)

Background

CKMB is an antiquated cardiac marker due to its limited clinical utility. Current guidelines recommend cardiac troponin testing as the biomarker of choice for myocardial injury due to its superior specificity and sensitivity. Additionally, co-testing with CKMB and troponin adds no incremental value.

This is supported by the American College of Cardiology (ACC), European Society of Cardiology (ESC), Association for Diagnostics & Laboratory Medicine (formerly AACC), American Society for Clinical Pathology (ASCP), Cleveland Clinic’s Cardiovascular Medicine Division, Clinical Biochemistry Section, and Laboratory Stewardship Committee.

References

Fourth Universal Definition of Myocardial Infarction (PMID: 30571511)
Eliminating CKMB Testing in Suspected ACS: A Value-Based Quality Improvement (PMID: 28806444)
ESC Study Group on Cardiac Biomarkers of the Association for Acute CardioVascular Care: A Fond Farewell at the Retirement of CKMB (PMID: 33486520)

New Test: Alzheimer’s Disease Biomarker Panel, Cerebrospinal Fluid

Clinical Updates

New Test – Alzheimer’s Disease Biomarker Panel, Cerebrospinal Fluid

Alzheimer’s Disease Biomarker Panel, Cerebrospinal Fluid (ALZCSF) measures p-Tau181, Total-Tau, and β-Amyloid (1-42) (Abeta42).

Testing is performed on cerebrospinal fluid (CSF) from adult patients 55 years of age and older undergoing evaluation for Alzheimer’s disease and other causes of cognitive impairment to generate pTau181/Abeta42 and Total-Tau/Abeta42 ratios.

The new test requires a CSF Specimen Transport Tube and other modifications to the reporting format, which are detailed below.

Note: ADmark Phospho-Tau CSF (PHOTAU) testing, sent out to Athena, will be discontinued.

Test Overview

Test Name

Alzheimer’s Disease Biomarker Panel, Cerebrospinal Fluid

Test Code

ALZCSF

CPT Codes

83520 – QTY (3)

Methodology

Electro Chemiluminescence Immunoassay (ECLIA)

Specimen Requirements

Type:
Cerebrospinal fluid (CSF)

Volume:
2.5 mL

Container:
CSF Transport Tube, 2.5 mL (Sarstedt)

Collection Instructions

Confirm that the tube type is correct – only a specimen collected in the Sarstedt CSF Transport Tube [ref. 63614.625] is acceptable.
Perform a lumbar puncture using the gravity drip collection method (preferred). Do not use the first 2 mL of CSF.
Collect CSF directly into the tube up to the fill line.
Inspect the sample for the presence of blood. Do not use CSF samples that appear reddish. Instead, collect additional clear (non-hemolytic) CSF in a new CSF tube.
Do not process the sample before sending it to the laboratory (i.e., do not invert, transfer, or aliquot).

Rejection Criteria

CSF collected in polystyrene or glass tubes

Bloody or hemolyzed specimens.

Unfilled tubes.

Stability

Ambient:
5 days

Refrigerated (preferred):
14 days

Frozen:
8 weeks (-20⁰C)

Days Performed

Days Performed
Once a week

Reported
1-8 days

Reporting

Component

p-Tau181/Abeta42

Total-Tau/Abeta42

p-Tau181

Total-Tau

Abeta42

Reference Interval

≤0.0230

≤0.280

≤31.3 pg/mL

≤375.4 pg/mL

≥564.2 pg/mL

Clinical Information

A negative p-Tau181/Abeta42 ratio and/or Total-Tau/Abeta42 ratio is consistent with a negative amyloid positron emission tomography (PET) scan and reduces the likelihood that a patient’s cognitive impairment is due to Alzheimer’s disease.

A p-Tau181/Abeta42 ratio and/or Total-Tau/Abeta42 ratio elevated above the cut-off is consistent with biological changes associated with Alzheimer’s disease (AD) and a positive amyloid positron emission tomography (PET) scan. A positive result does not establish a diagnosis of AD or other cognitive disorders and should be interpreted as an adjunct to other clinical diagnostic information.

The ratios will not be calculated in samples with an Abeta42 concentration >2,500 pg/mL. This result is consistent with a negative amyloid positron emission tomography (PET) scan and reduces the likelihood that a patient’s cognitive impairment is due to Alzheimer’s disease.

The p-Tau181, Total-Tau, and Abeta42 tests are not intended to be used as a stand-alone test in spinal fluid. For interpretation of results, refer to the p-Tau181/Abeta42 and Total-Tau/Abeta42 ratios.

The test method is the Elecsys electrochemiluminescence immunoassay manufactured by Roche Diagnostics. Values determined by different assay methods cannot be used interchangeably.

The validity of this test interpretation requires strict adherence to the specimen collection and preparation instructions detailed in the Cleveland Clinic’s Test Directory.