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--- mdhpdl1nonreportable [2026/04/08 04:26] – gilbert
+++ mdhpdl1nonreportable [2026/04/08 04:31] (current) – gilbert
@@ Line 1: / Line 1: @@
-PD-L1 IHC BIOMARKER – NON-REPORTABLE
+<WRAP group>
-Comment: PD-L1 has been requested on this case; however, the result cannot be reported for one of the following reasons:
+<WRAP center width-90%>
-    • PD-L1 immunohistochemistry testing has been validated only for tissue fixed in 10% neutral buffered formalin (NBF) for 12 to 72 hours.
+===== PD-L1 IHC BIOMARKER – NON-REPORTABLE =====
-    • The sample lacks the minimum of 100 cells.
-    • Tissue samples fixed for shorter or longer times in NBF, other fixatives, with extended ischemic time, or treated with microwaves or decalcification, cannot be used for this testing.
-    • PD-L1 assays (such as 22-C3, 28-8, and SP263) are not interchangeable and cannot be substituted for each other.
-    • PD-L1 tests cannot be reported for malignancies of unknown primary since the location of the primary dictates whether the testing is indicated and which scoring system is used to report the result.
-    • PD-L1 tests cannot be reported for cancer types for which the testing is not yet approved in Alberta. For more information on which drugs require the testing, please visit the following links:
-        ◦ https://www.albertahealthservices.ca/assets/programs/ps-1025651-drug-benefit-list.pdf
-        ◦ https://www.pdl1alberta.com
-Test ID: MDHPDL1NONREPORTABLE
+**Comment:** PD-L1 was requested; however, the result is **Non-Reportable** for the following reason(s):
+  * **Fixation Requirements:** Validated only for tissue fixed in 10% NBF for 12–72 hours.
+  * **Cellularity:** Sample lacks the minimum requirement of **100 viable tumor cells**.
+  * **Pre-analytical Interference:** Incompatible with:
+    * Non-NBF fixatives or sub-optimal fixation times.
+    * Extended ischemic time.
+    * Decalcification or microwave treatment.
+  * **Assay Specificity:** PD-L1 assays (22C3, 28-8, SP263) are **not interchangeable** and cannot be substituted.
+  * **Clinical Indications:**
+    * **Unknown Primary:** Primary site must be known to determine the appropriate scoring system.
+    * **Provincial Approval:** Testing is restricted to cancer types approved for funding in Alberta.
+**Resources:**
+  * [[https://www.albertahealthservices.ca/assets/programs/ps-1025651-drug-benefit-list.pdf|AHS Drug Benefit List]]
+  * [[https://www.pdl1alberta.com|PD-L1 Alberta Portal]]
+----
+**Test ID:** %%MDHPDL1NONREPORTABLE%%
+</WRAP>
+</WRAP>
+{{:MDHPDL1NONREPORTABLE.docx|MDHPDL1NONREPORTABLE}}