This activity originally released as IHC: Test Validation (SAM eligible) and was available between November 24, 2014 and November 22, 2017. The contents were reviewed in November 2017. If you completed the previous version, you are NOT eligible to claim CME/SAM credit(s) for completing this version.
This activity introduces the CAP Immunohistochemistry (IHC) Test Validation Guidelines from the point of view of the IHC Laboratory Director. After a brief introduction to how the assay selection can impact the rigor of the test validation, you will be presented with the considerations and parameters for developing an IHC test validation plan and validation set. You will also learn about adapting the validation methodology based on variations in tissue handling versus the need to revalidate an assay and the conditions under which revalidation is required.
As a result of participating in this SAM eligible activity and post-test, you should be able to:
- Distinguish between laboratory developed tests (LDTs) and FDA-approved assays in order to determine how validation should proceed.
- Decide on the appropriate ‘comparator’, the appropriate number of cases in the validation set, the composition of the validation set, and planned number of runs for validation.
- Identify the appropriate level of concordance for the validation.
- Recognize the variations in validation methodology required for predictive markers.
- List typical causes and solutions for validation failure.
- Adapt the validation methodology based on variations in tissue handling which may include: decalcified tissues, cytology specimens, or non-formalin fixed tissues.
- Identify and react to changes in assay conditions that merit assay revalidation.
- Determine the extent of required revalidation based on the assay change.
Accreditation: The College of American Pathologists (CAP) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
CME Category 1: The College of American Pathologists designates this internet enduring material educational activity for a maximum of 2.5 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
This activity meets the American Board of Pathology’s (ABP) Maintenance of Certification (MOC) requirements for Self-Assessment Modules (SAMs).
Continuing Professional Development (CPD), Section 3 Credit
Accreditation in Canada: This event is an Accredited Self Assessment Program (Section 3) as defined by the Maintenance of Certification Program of the Royal College of Physicians and Surgeons of Canada, approved by the Canadian Association of Pathologists - Association Canadienne des Pathologistes. You may claim a maximum of 2.5 hours equivalent to 7.5 credits.
You have a total of three opportunities to take and pass the post-test. If you correctly answer 70% or more of the post-test items, you may claim credit. CME/SAM credit can be applied to the American Board of Pathology (ABP) Self-Assessment Module (SAM) requirements. You must pass the post-test to claim credit; therefore, if you do not pass, you cannot claim any credit.
Attention Canadian Participants: You have three opportunities to take and pass the post-test. If you do not pass the post-test after three attempts, you may still claim CPD credit (self-assessment program credits) for this activity. Please contact a representative of the CAP Learning Division at 800-323-4040 option 1 or firstname.lastname@example.org with the name of this activity and the date completed to request a letter of participation.
To pay with a check, print a copy of this page and send it with your check to the address below. You will be notified when your payment has been processed and you have been registered into the activity.
College of American Pathologists
325 Waukegan Road
Northfield, IL 60093-2750
Refunds will be handled on an exception basis. Please submit your request to the CAP in writing via email at
email@example.com or fax at 847-832-8006.
Pop-up blockers must be turned off.
CAP Learning has recognized that some Veteran’s Administration, US Government, and military participants may have difficulty accessing the online assessment portion of this activity. If you experience difficulty or have any questions, please contact a representative of the CAP Learning Division at 800-323-4040 option 1 or firstname.lastname@example.org.
This activity and evaluation is available March 1, 2018, and will expire on February 26, 2021, at 12:00 AM (ET). You MUST claim credit by this date and time.