UC DA VIS MEDICAL CENTER:
DEPARTMENT OF PATHOLOGY AND LABORATORY MEDICINE
DATE:
September 20, 2007
TO:
Housestaff and PCN Physicians, Faculty, and Nursing Personnel
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FROM:
Sridevi Devaraj, Ph.D., DABCC, FACB
Director of Toxicology and Special Chemistr
RE:
SIROLIMUS (Rapamune, Rapamycin) TESTING
Effective October 3, 2007, the Sirolimus (Rapamycin) testing will be performed in the Clinical
Laboratory, Toxicology. The new Sirolimus assay is based on Microparticle Enzyme Immunoassay
(MEIA) technology. This method compares well to the current LC MS/MS method, although some
individual variation may be seen. Due to the potential variation, for three months we will save a split
sample that could be sent out for LC MS/MS testing. A physician request for a repeat LC MS/MS test
at no charge can be made by calling Toxicology, 734-2741. It should also be noted that Sirolimus
concentrations can vary according to the methodology used and results from different methodologies
. cannot be used interchangeably due to difference in reference ranges and cross-reactivity with
metabolites.
•
Sample Requirement:
One whole blood EDTA (purple-top) tube
•
Routine Testing:
Performed Monday, Wednesday, and Friday - at 0800
•
Reference Interval:
7-29 ng/mL (trough level, includes Sirolimus alone as well as in
combination with CsA)
The Reference Interval of 7-29 ng/mL is based on studies of kidney transplant patients 4-12 months post
transplant in maintenance phase, and encompasses Sirolimus alone and in conjunction with Cyclosporin
treatment. Optimal ranges depend upon the patient's clinical state, individual differences in sensitivity to
immunosuppressive and adverse effects of Sirolimus, co-administration of other immunosuppressants, and
time post-transplant.
~
•
If you have any questions or need additional information, please contact, Dr. Sridevi Devaraj (734­
6594), Kathy On1and, (734-3049) or John Tsushima (734-2741)
APPROVED BY:
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Ralph Green, MD
Professor and Chair
Departn1ent of Pathology and Laboratory Medicine
cc:
Allan Siefkin, MD
Carol Robinson, RN
Richard Pollard, MD
Bettye Andreos
Darrell O'Sullivan
Robert Taylor
Phillip Raimondi, MD
UNIVERSITY OF CALIFORNIA-(Letterhead for interdepartmental use)
D3189 (6/92)M
Analyte: Sirolimus
METHOD EVALUATION PROTOCOL
MethodlInstrument: Abbott IMx 12407-96, 26083-96
Cost Center:
9694
Please include the following items with approvals in the validation packet.
Approval:
Dept.
Date
ITEM
PLAN
Approved Validation Plan
INSTRUMENT
Installation Qualification for test Equipment
Operational Qualification for test Equipment
In-house Preventive Maintenance Schedule
Set up QC, limits, ranges, dilutions, calibration intervals, etc.
VALIDATION TESTING RESULTS AND PARAMETERS
Accuracy - Comparison Study
Accuracy - Other Study
Precision
Linearity
Sensitivity
Specificity
Hook effect
Carryover
Reference Interval (if indicated)
Operating Parameters (if indicated)
List of Reagent & Calibrator Lots Used
SOPs used during validation testing
Product inserts used dtuing validation
Raw Data
WRITTEN PROTOCOL
Final SOP
QUALITY CONTROL
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Establish Reporting method
Define ranges
As appropriate, enter ranges into instrument, LIS, PC, QC book
PROFICIENCY TESTING
List Program subscribed to: ~1JfJ CS
TRAINING PLAN
Initial training and competence
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COSTS & BILLING
Cost analysis
Supply agreements
Service contract
Billing code
COMPUTER UPDATES & REPORTS
LIS changes
Copy of LIS report from 18t live test
Copy of EMR report from I 8t live test
NOTIFICATIONS
Memo to Faculty & Housestaff
Notification to Laboratory Staff
Lab User Guide Update
Section Director Sign Off:
Laboratory Director Sign Off:
Test Implementation Date:
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