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

CPT Codes

83520 – QTY (3)

Methodology

Electro Chemiluminescence Immunoassay (ECLIA)

Specimen Requirements

Type:
Cerebrospinal fluid (CSF)

Volume:
2.5 mL

Collection Instructions

  1. Confirm that the tube type is correct – only a specimen collected in the Sarstedt CSF Transport Tube [ref. 63614.625] is acceptable.
  2. Perform a lumbar puncture using the gravity drip collection method (preferred). Do not use the first 2 mL of CSF.
  3. Collect CSF directly into the tube up to the fill line.
  4. 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.
  5. 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.

January 2024: Send-Out Test Delays Caused by Weather

Immediate Test Notification

January 2024: Send-Out Test Delays Caused by Weather

Due to the recent winter weather, there are ongoing delays in the shipment of specimens from Cleveland Clinic Laboratories to reference laboratories, including ARUP, Mayo, LabCorp, Quest, National Jewish, Eurofins Viracor, and others.

Transportation vendors are working through operational backlogs, and we are communicating with vendors to ensure sample stability and perform testing as quickly as possible.

Please get in touch with your CCL Sales Manager or Client Services with any questions.

November 2023: Product Discontinuation – BD CultureSwab™

Immediate Test Change

Product Discontinuation: BD CultureSwab™ Liquid Amies Double Swab

Effective November 14, 2023.

Replacements: eSwab™ or Cepheid Collection Device

The eSwab™ (Copan Diagnostics) collection device—utilized by Cleveland Clinic for 8+ years—will now be the primary swab for bacteriology.

No change to the swabbing collection process is needed when using an eSwab™.

Although typically tissue or fluid is a superior quality sample for bacteriology, collecting a swab is often more feasible. The eSwab™ uses a patented flocked swab, which enables the elution of the primary sample into 1 mL of liquid contained within the collection tube. The bacteriology laboratory then uses this liquid for testing.

Swab discontinued by the manufacturer.

Choose the appropriate collection device: 

eSwab™

Use for:
Group A Strep PCR GASPCR

Fungal Screen for Candida FUNGSC

Bacteriology cultures:
• Abscess & Wound Culture WCUL
• Anaerobe Culture ANACUL
• Cystic Fibrosis Respiratory Culture CFRCUL
• Ear Culture & Stain EARCSM
• Eye Culture & Stain EYECSM
• MRSA culture screen MRSASC
• MRSA/S. aureus culture screen SANSAL
• Throat Culture THRCUL
• VRE Culture VRESC

Cepheid Collection Device

Use for:
Routine Prenatal Group B PCR GBPCR

S. aureus PCR SAPCR

November 2023: Test Update – Chromogranin A, New Assay

Immediate Test Change

Test Update – Chromogranin A (CHROMA), New Assay

Effective November 9, 2023.

Chromogranin A (CHROMAwill be updated to a new assay effective November 9, 2023.

The results of the current and new tests are not interchangeable. Due to a reagent shortage, the laboratory will not be able to undergo a rebaseline/parallel testing process.

Please contact Client Services for laboratory assistance with interpreting results in patients undergoing serial monitoring.

Test Change Overview

Chromogranin A (CHROMA)

Update?

Details

Methodology

Yes

New Assay:
Immunoassay, BRAHMS CGA II Kryptor Kit

Discontinued:
Cisbio CGA II, ELISA

The results in the new assay are, on average, 20% lower than the previous assay. The bias is more pronounced at concentrations below 200 ng/mL, where the observed bias is 30%.

Test Code

No

Specimen

No

Type
Serum

Container
Gold Serum Separator Tube, or
Red Plain (No Additive) Tube

Stability

Yes

Ambient:
48 hours

Refrigerated:
48 hours

Frozen:
3 months

Transport samples frozen.

Days Performed

Yes

Days Performed
Tuesday, Friday

Reported
1-4 days

Reporting

Yes

Reference Interval
<187 ng/mL

The results of the new and old assays will not trend together in the laboratory information system (e.g., Beaker/EPIC).

November 2023: Test Delay – Oxalate, Plasma and Oxalate, 24-hour Urine

Immediate Test Change

Test Delay – Oxalate, Plasma (OXLATE) and Oxalate, 24-hour Urine (UOXALD)

Effective November 6, 2023.

Oxalate, Plasma (OXLATE) and Oxalate, 24-hour Urine (UOXALD) will be delayed effective November 6, 2023, due to a global reagent shortage.

Currently, there are no alternative testing options available.

The vendor expects the reagent to be available in late November/December 2023.

For Existing Orders/Specimens
Specimens will be stored frozen, pending the arrival of the reagent. However, if specimens exceed validated stability (4 weeks for plasma specimens, 7 days for urine specimens), testing will be canceled.

Questions?
Please contact Client Services for assistance.

2024 Cleveland Clinic Laboratories Soft Tissue Pathology Course – Registration Now Open

Clinical Updates

Comprehensive & Immersive Soft Tissue Pathology Course

May 16-19, 2024

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.

Symposium Director

Karen Fritchie, MD

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

Course Includes:

• Access to over 100 digital soft tissue cases
• Opportunity to tour our CCF pathology department
• Designated time for questions and discussion with faculty
• After-hours reception with participants and staff

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

John Goldblum, MD
Chair, Department of Pathology

John Reith, MD
Staff Pathologist, Orthopaedic Pathology

Steven D. Billings, MD

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

Scott Kilpatrick, MD

Scott Kilpatrick, MD
Director, Orthopaedic Pathology
Medical Director, Cleveland Clinic Laboratories

Brian Rubin, MD, PhD

Brian Rubin, MD, PhD
Chair, Pathology & Laboratory Medicine Institute

Josephine Dermawan, MD, PhD

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

Jesse McKenney, MD

Jesse McKenney, MD
Staff Pathologist, Genitourinary & Gynecologic Pathology

Registration

Visit clevelandclinicmeded.com/live/courses/comprehensivesofttissue/ for complete registration information.

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, 2024

After
April 1, 2024

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 Monday, May 13, 2024. 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 2, 2024. After May 2, 2024, a $125 cancellation fee will be deducted from your refund. No refunds will be issued after May 6, 2024.

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

Visit clevelandclinicmeded.com/live/courses/comprehensivesofttissue/ for complete registration 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 has been reserved at the InterContinental Cleveland through April 16, 2024, at 5 p.m. EDT.

To make reservations, please call the Hotel Reservation Department at 855.765.8709 and reference the CCF Soft Tissue Pathology Program or reserve online at https://www.clevelandclinicmeded.com/live/courses/comprehensivesofttissue/ to receive the special rate of $209, plus tax.

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, May 16, 2024

7:30 am          Continental Breakfast

8:00 am          Course Introduction and Welcoming Remarks – Karen Fritchie, MD

8:15 am          Slide Preview, Staff Q&A

 

11:00 am        LunchOn Your Own

 

12:00 pm        When (and when not) to do MDM2 fluorescence in situ hybridization  Karen Fritchie, MD

1:00 pm          Adipocytic tumors (slide review) – John Goldblum, MD

 

2:30 pm          Break

 

3:00 pm          Smooth muscle/pericytic tumors and their mimics (slide review) – John Goldblum, MD

4:00 pm          Soft tissue tumors with skeletal muscle differentiation (slide review) – Scott Kilpatrick, MD

5:00 pm          Matrix-forming mesenchymal neoplasms (slide review) – Karen Fritchie, MD

 

6:00 pm          Adjourn

Friday, May 17, 2024

7:30 am          Continental Breakfast

8:00 am          Slide Preview, Staff Q&A

 

10:15 am         Tour of Cleveland Clinic’s Department of Pathology Optional (non-CME)

 

11:00 am         Lunch On your own

 

12:00 pm        Common myofibroblastic lesions (slide review) – Karen Fritchie, MD

1:30 pm          Practical approach to uterine mesenchymal neoplasms Jesse McKenney, MD

2:30 pm          Fibrohistiocytic tumors Steven Billings, MD

 

3:00 pm          Break

 

3:30 pm          Practical approach to synovial biopsies – John Reith, MD

4:30 pm          Tumors of uncertain histiogenesisSteven Billings, MD

 

6:00 pm          Adjourn

Saturday, May 18, 2024

7:30 am          Continental Breakfast

8:00 am          Slide Preview, Staff Q&A

 

11:00 am         Lunch On your own

 

12:00 pm        Vascular tumors – Steven Billings, MD

1:30 pm          Diagnosing soft tissue tumors with “NextGen” immunohistochemistry Scott Kilpatrick, MD

 

3:00 pm          Break

 

3:30 pm          The importance of morphologic correlation with molecular resultsJosephine Dermawan, MD, PhD

 

6:00 pm          Reception with Attendees & Cleveland Clinic Staff

Sunday, May 19, 2024

7:30 am          Continental Breakfast

8:00 am          Slide Preview, Staff Q&A

10:00 am        Peripheral nerve sheath tumors Brian Rubin, MD, PhD

11:00 am        How to work up a pleomorphic sarcoma Karen Fritchie, MD

12:00 pm        Course Conclusion & Adjourn

September 2023: Changes to Reference Ranges – Catecholamines, Fractionated, Plasma (PLCAT)

Special Communication

Changes to Reference Ranges – Catecholamines, Fractionated, Plasma (PLCAT)

Effective October 2, 2023.

Catecholamines, Fractionated, Plasma (PLCAT)

Epinephrine (18 years and older)
Seated (15 min): Less than or equal to 330 pmol/L
Supine (30 min): Less than or equal to 265 pmol/L

Norepinephrine (18 years and older)
Seated (15 min): 1050-4800 pmol/L
Supine (30 min): 680-3100 pmol/L

Dopamine (18 years and older)
Seated (15 min): Less than or equal to 240 pmol/L
Supine (30 min): Less than or equal to 240 pmol/L

August 2023: Test Discontinuation – HIV-1 Western Blot (HIV1CO)

Immediate Test Change

Test Discontinuation – HIV-1 Western Blot (HIV1CO)

Effective August 28, 2023.

HIV-1 Western Blot Antibody Confirmation (HIV1CO) has been discontinued by the performing reference laboratory.

As an alternative, Cleveland Clinic Laboratories recommends HIV-1 p24 Ag + HIV-1-2 Ab, with reflex to differentiation (HIV12C) testing.

This test, which is performed in-house, follows the CDC-recommended screening algorithm of reflex to differentiation.

HIV-1 p24 Ag +HIV-1-2 Ab, with reflex to differentiation (HIV12C)

CPT Code
87389

Performing Laboratory
Cleveland Clinic Laboratories

Methodology
Chemiluminescent microparticle immunoassay (CMIA)

Specimen Type
Serum: Gold Serum Separation Tube
Plasma: Sodium Heparin, Lithium Heparin (Green), or Lavender K2EDTA Tube

Volume
1 mL

Stability (after separation from cells)
Ambient: 72 hours
Refrigerated: 7 days
Frozen ≤ -20°C: 14 days

Clinical Information
HIV screening and diagnosis

Reference Range
Negative

Additional Information
The screening assay is an antigen-antibody combination; when reactive, an HIV confirmatory assay is automatically added and performed.

The confirmatory assay is FDA-approved and can differentiate HIV-1 from HIV-2, making it an integral part of the testing algorithm.

If a client performs a fourth-generation screen, HIV-1/2 Ab Confirmatory (HIV12M) testing may be ordered following a repeatedly positive screen.

July 2023: Updates to COMAP, DRGTOF, MECDRG, TAPENU, and UASFR

Special Communication

July 2023: Changes to COMAP, DRGTOF, MECDRG, TAPENU, and UASFR Testing

All changes effective August 21, 2023.

Changes to Specimen Requirements

Complement, Alternate Pathway (AH50), Functional (COMAP)

Specimen Type
Serum

Volume
1 mL

Minimum Volume
0.3 mL

Collection Container
Red Serum (Plain) Tube

Transport Temperature
Frozen, Critical (-70°C)

Specimen Instructions/Other Information
Locations without a -70°C freezer should not collect this test.

Do not use gel separator tubes.

Allow specimen to clot for 1 hour at room temperature. Centrifuge (at refrigerated temperature if possible) and separate serum from cells ASAP or within 2 hours of collection. Transfer into standard aliquot tube and freeze immediately in a -70°C freezer.

Separate specimens must be submitted when multiple tests are ordered.

Unacceptable conditions include specimen types other than serum, specimens left to clot at refrigerated temperature, specimens exposed to repeated freeze/thaw cycles, or specimens that are grossly hemolyzed, lipemic, or icteric.

Changes to Reference Ranges

Complement, Alternate Pathway (AH50), Functional (COMAP)

Reference Range
>= 31 % normal

Drug Detection Panel, TOF-MS, Umbilical Cord Tissue (DRGTOF)

Benzoylecgonine
Cutoff 1 ng/g

Cocaine
Cutoff 1 ng/g

Proinsulin, Intact (IPROIN)

18 Years to 99 Years:
<= 7.2 pmol/L

Changes to Test Build

Drug Detection Panel, Meconium, Qualitative (MECDRG)

New Component

Mitragynine (Kratom)
Cutoff 25 ng/g

Tapentadol Quant, Urine (TAPENU)

Remove Components

Tapentadol glucuronide, Urine
Tapentadol-O-sulfate, Urine
N-desmethyltapentadol, Urine

Arsenic, Fractionated Urine (UASFR)

New Component

Arsenic Fractionation Interpretation