transferring a test from sending out to in your lab.

1. Immunological Basic of Diseases
presentation
Presented by:
Nadia Alanzi
Marwa Alshanqity
Cellular and Molecular Pathology
MSc Clinical Laboratory Sciences

2. In your lab, IHC staining is always
sent out. Your manager asked you if it
is possible to do the test in house.
Discuss the rational for transferring a
test from send out to in house?

3. Introduction
• Immunohistochemistry (IHC) is used in histology to detect
the presence of specific protein marker that can assist with
accurate tumor classification and diagnosis also important
application of monoclonal as well as polyclonal antibodies.
• Using specific antigen-antibody reaction.
• The purpose of IHC is to perform most IHC staining by
causing least damage on the cell or tissue, and by using
least amount of antibody, it finds a way in the tumor
typing and tumor markers.

4. Applications of IHC
• Prognostic Markers in Cancer
• Tumors of Uncertain Histogenesis
• Prediction of Response to Therapy
• Infections
• Genetics
• Neurodegenerative Disorders
• Brain Trauma
• Muscle Diseases
• Research Application

5. the strategic plan
1- Tests order and
budget
4- Decision
2- Test research
5- Special
requirements
3- Interacting with
Vendors
6- Documentation
7- Training,
competency, and
proficiency testing

6. 1- Tests order and budget
1- The laboratory must first decide if demand
is present.
2- compared between the test cost and how
many tests order.
3- It may not be costly for low tests ordered
done in house based on the test cost, setup,
controls and proficiency testing.

7. 2- Test research
A research team could consist of a laboratory manager,
section supervisor, technologist, medical billing specialist,
and an information technology (IT) representative.
Important issues addressed by this research team on a test
include:
• laboratory space available.
• Service/support of vendors.
• physical requirements, such as temperature, humidity
and lighting.
• costs (including cost per reportable test)/
reimbursement/ billing codes.
• staffing requirements/training required.

8. 3- Interacting with vendors
• Vendors are essential for implementing a new test.
• Vendors can supply a list of laboratories that use the
particular product so these laboratories can be visited
during heavy testing times, which can yield beneficial
information.
• With recognition of demand, research, and vendor
interaction concluded, a decision can be made on the test
that will be brought in-house.

9. 4- Decision
• It is best to have a consensus decision with the research
team and the laboratory director, allowing examination of
contrasting views. The laboratory director must be fully
committed to the test because he or she is ultimately
responsible for the test’s performance.
• When attempting to get approval by management, all
relevant information, such as demand, cost/benefit
analysis, literature reviews, and patient impact, must be
presented.
• After the laboratory director finalizes a decision on a
particular test, special requirements for that test must be
addressed before proceeding.

10. 5- Special requirements
• New tests implemented by the clinical laboratory will
usually have common requirements along with some
unique requirements. It is important to be aware of these
requirements and plan accordingly:
1. Knowledge of personnel performing test.
2. training and experience of personnel performing test.
3. reagent and material preparation.
4. characteristics of operational steps.
5. calibration, quality control (QC), and proficiency testing
materials.
6. test system troubleshooting.
7. interpretation and judgment.

11. 6- Documentation
• This documentation is a continuous process because any
alteration in testing must be documented as stated in the
CLIA regulations.
• Specification sheets should be updated when a new batch
of antibody is purchased.
• The literature documents optimal conditions for tissue
fixation, processing and sectioning to ensure morphology
and antigenicity are maintained.

12. 7- Training, competency, and
proficiency testing
• The laboratory director determines which personnel will be
trained to perform this new test
• Staff must establish and maintain competency in
performing the new test procedure initially, after six
months, after one year, and annually thereafter.
• The laboratory director, or personnel in charge of
implementing this new test, must be aware of special
requirements of their accreditation agency

13. Guidelines for Test Validation
• Use manufacturer’s instructions.
• Use high-quality test materials with known target values.
• Test materials should be of similar type as patient samples.
• Complete documentation, including procedure and results.
• Lab director review/approve results.

14. ASCO/CAP Guidelines HER2
• Initial validation must be performed before test is
offered.
• 25-100 samples tested by validated method in same
or different laboratory.
• 95% concordance in (+) and (-) categories required.
• Ongoing validation should be done biannually.

15. IHC testing is widely accessible on
VENTANA BenchMark XT
instruments.

16. References
• Laboratory Accreditation Test Validation: A Brave New World for Anatomic
Pathology, Francis E. Sharkey, MD, FCAP University of Texas Health Science Center,
San Antonio, TX Richard W. Brown, MD, FCAP Memorial Hermann Healthcare
System, Houston, TX. 2010 College of American Pathologists. Materials are used
with the permission of the faculty.
• Enhancing Roche’s position as the world’s leading fully-integrated personalised
healthcare company. Ventana Acquisition: Conference call to analysts & investors.
26 June 2007.
• Michael A. Lazzari, Developing a Standard Protocol for the Introduction of New
Testing Into a Clinical Laboratory, Laboratory Medicine, Volume 40, Issue 7, July
2009, Pages 389–393.
• Duraiyan J, Govindarajan R, Kaliyappan K, Palanisamy M. Applications of
immunohistochemistry. J Pharm Bioallied Sci. 2012;4(Suppl 2):S307–S309.
doi:10.4103/0975-7406.100281

17. Remember…
Safety First!
(thank you)