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Overview
ข้อมูลทั่วไป Specimen
ข้อมูลสิ่งส่งตรวจ Performance
ข้อมูลการทดสอบ Clinical & Interpretation
ข้อมูลทางคลินิก

Test Code (รหัสการทดสอบ):

094-21-0019

Order Name (ชื่อการทดสอบ):

PD-L1 (28-8), IHC, Tissue (FFPE) (Outside lab)

Specimen / Container (สิ่งส่งตรวจ/ภาชนะ):

Tissue/ Formalin-fixed paraffin-embedded (FFPE) block

Turnaround Time (ระยะเวลารอผล):

Receive specimen to report within 14 days

Useful For (ประโยชน์การทดสอบ):

Identification of neoplasms expressing programmed cell death 1-ligand 1 (clone 28-8)

Methodology (วิธีการทดสอบ):

Immunohistochemistry (IHC)

AliasesName (ชื่อเรียกอื่นๆ) :

Programmed Death-Ligand 1 (PD-L1) (28-8), Semi-Quantitative Immunohistochemistry, Manual
288PD
28-8
GPPDL1288
ISPDL1288IHC
PDL1

Test Code (รหัสการทดสอบ):

094-21-0019

Order Name (ชื่อการทดสอบ):

PD-L1 (28-8), IHC, Tissue (FFPE) (Outside lab)

Patient Preparation (การเตรียมตัวผู้ป่วย):

Necessary Information
A pathology/diagnostic report and a brief history, including primary site of neoplasm, are required.

Collection Specimen Or Container (สิ่งส่งตรวจ/ภาชนะ):

Tissue/ Formalin-fixed paraffin-embedded (FFPE) block

Specimen Testing Type (สิ่งส่งตรวจที่ใช้ในการทดสอบ):

Formalin-fixed, paraffin-embedded tissue block; or 3 unstained glass, "positively charged" slides with 4-microns formalin-fixed, paraffin-embedded tissue.
Additional Information: One slide will be stained with hematoxylin and eosin.

Sub Mission Container (ภาชนะส่งตรวจ):

1. Tissue in 10% neutral buffered formalin or
2. Paraffin embedded tissue block or
3. Unstained positively charged slides as least 3 slides with 4-microns formalin-fixed, paraffin-embedded tissue.

Rejection Criteria (เกณฑ์ปฏิเสธสิ่งส่งตรวจ):

Wet/frozen tissue
Cytology smears
Nonformalin fixed tissue
Nonparaffin embedded tissue
Noncharged slides
ProbeOn slides

Test Code (รหัสการทดสอบ):

094-21-0019

Order Name (ชื่อการทดสอบ):

PD-L1 (28-8), IHC, Tissue (FFPE) (Outside lab)

Method detail (วิธีการทดสอบ):

Immunohistochemistry (IHC)

Schedule (ตารางการทดสอบ):

N/A **Sent out to MAYO, USA

Turnaround Time (ระยะเวลารอผล):

Receive specimen to report within 14 days

Performing Location (หน่วยงานที่ทำการทดสอบ):

MAYO Laboratory
Referral Lab Services, Laboratory Department 14160-2

Test Code (รหัสการทดสอบ):

094-21-0019

Order Name (ชื่อการทดสอบ):

PD-L1 (28-8), IHC, Tissue (FFPE) (Outside lab)

Clinical Information (ข้อมูลทางคลินิก):

Programmed cell death 1-ligand 1 (PD-L1), also known as B7 homolog 1 (B7-H1) or CD274, is a transmembrane protein involved in the regulation of cell-mediated immune responses through interaction with the receptor programmed death protein-1 (PD-1). PD-L1 has been identified as both a prognostic and theranostic marker in a variety of neoplasms. Overexpression of PD-L1 has been observed in carcinomas of the bladder, lung, gastric and gastroesophageal junction, colon, ovary, breast, kidney, and melanoma.

Interpretation (การแปลผล):

The results of the test will be reported in form of scores. The scoring system is based on type and origin of tumor. If additional interpretation or analysis is needed, order PATHC / Pathology Consultation along with this test.

CAUTIONS

Preclinical studies suggest that positive programmed cell death 1-ligand 1 (PD-L1) immunohistochemistry in tumor cells may predict tumor response to therapy with immune checkpoint inhibitors. This result should not be used as the sole factor in determining treatment, as other factors (eg, tumor mutation burden and microsatellite instability) have also been studied as predictive markers.

This test has been validated for non-decalcified paraffin-embedded tissue specimens fixed in 10% neutral-buffered formalin. This assay has not been validated on tissues subjected to the decalcification process or the use of alternative fixatives for bone and bone marrow specimens or cell blocks.

Age of a cut paraffin section can affect immunoreactivity. Stability thresholds vary widely among published literature and are antigen dependent. Best practice is for paraffin sections to be cut within 6 weeks.

Clinical Reference (เอกสารอ้างอิง):