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测试ID：288PD

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程序性死亡配体1（PD-L1）（28-8），半定量免疫组织化学，手册

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overview

必威安全吗betway必威集团

对...有用
suggests clinical disorders or settings where the test may be helpful

我dentification of neoplasms expressing programmed cell death 1-ligand 1

方法名称
一种short description of the method used to perform the test

免疫组织化学（IHC）

纽约州可用
我ndicates the status of NY State approval and if the test is orderable for NY State clients.

是的

报告名称
列出了测试的已发布名称的缩写或缩写版本

pd-L1 (28-8), SemiQuant IHC, Manual

别名
lists additional common names for a test, as an aid in searching

28-8

GpPDL1288

我sPDL1288IHC

PDL1

specimen Type
描述了测试验证的样品类型

special

ordering Guidance

shipping Instructions

将套件中包含的绿色病理地址标签连接到运输容器的外部。

necessary Information

需要病理/诊断报告和简短的病史，包括肿瘤的主要部位。

specimen Required
defines the optimal specimen required to perform the test and the preferred volume to complete testing

样品类型：组织

supplies:病理packaging Kit (T554)

收集说明：Formalin-fixed, paraffin-embedded tissue block; or 3 unstained glass, "positively charged" slides with 4-microns formalin-fixed, paraffin-embedded tissue

一种dditional Information:一张幻灯片将用苏木精和曙红染色并返回。

形式

如果不以电子方式订购，请完成，打印并发送以下样品中的1个：

我mmunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request（T763）

肿瘤学test Request （T729）

拒绝due To
标识可能导致样品被拒绝的样品类型和条件

湿/冷冻组织
Cytology smears
nonformalin fixed tissue
nonparaffin embedded tissue
非充电幻灯片
probeOn slides		 拒绝

specimen Stability Information
provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

specimen Type temperature 时间 特殊容器
special 一种mbient (preferred)
refrigerated

对...有用
suggests clinical disorders or settings where the test may be helpful

我dentification of neoplasms expressing programmed cell death 1-ligand 1

Clinical Information
discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

程序性细胞死亡1-RIGAND 1（PD-L1），也称为B7同源物1（B7-H1）或CD274，是一种跨膜蛋白，参与通过与受体程序性死亡蛋白的相互作用来调节细胞介导的免疫反应1（PD-1）。PD-L1已被确定为多种肿瘤中的预后和疗法标记。在膀胱，肺，胃和胃食管连接，结肠，卵巢，乳房，肾脏和黑色素瘤的癌中已经观察到PD-L1的过表达。

解释
provides information to assist in interpretation of the test results

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
讨论可能导致诊断混乱的条件，包括不正确的标本收集和处理，不适当的测试选择以及干扰物质

临床前研究表明，肿瘤细胞中的阳性程序性细胞死亡1-凸出1凸（PD-L1）免疫组织化学可能预测免疫检查点抑制剂对治疗的肿瘤反应。该结果不应用作确定治疗的唯一因素，因为还研究了其他因素（例如，肿瘤突变负担和微卫星不稳定性）作为预测标记。

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.

一种ge 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
recommendations for in-depth reading of a clinical nature

1。Garcia A, Recondo G, Greco M et al: Correlation between PD-L1 expression (clones 28-8 and SP263) and histopathology in lung adenocarcinoma. Heliyon. 2020 Jun;6(6):e04117

2. Kintslera S，Cassataroa MA，Drosch M，Holenya P，Knuechel R，Braunschweig T：不同肿瘤中编程死亡配体（PD-L1）的表达。比较几个当前可用的抗体克隆和抗体分析的比较。Ann Diagn Pathol。2019年8月; 41：24-37

3。O'Malley DP，Yang Y，Boisot S等：参考实验室中多种人类肿瘤中PD-L1的免疫组织化学检测：基于62,896例的观察结果。mod pathol。2019年7月; 32（7）：929-942

4。Koppel C，Schwellenbach H，Zielinski D等：使用不同染色平台上的抗体克隆28-8对PD-L1免疫组织化学染色方案的优化和验证。mod pathol。2018年11月; 31（11）：1630-1644

5. Phillips T, Simmons P, Inzunza HD, et al: Development of an automated PD-L1 immunohistochemistry (IHC) assay for non-small cell lung cancer. Appl Immunohistochem Mol Morphol. 2015 Sep;23(8):541-549

方法描述
describes how the test is performed and provides a method-specific reference

我mmunohistochemistry on sections of paraffin-embedded tissue using程序性细胞死亡1 rigand 1（PD-L1）克隆28-8。（未发表的Mayo方法）

pdFreport
指示该报告是否包含带有图表，图像或其他丰富信息的其他文档

no

day(s) Performed
概述了进行测试的日子。该领域反映了样品必须在测试实验室中才能开始测试过程的一天，并包括进行测试之前的任何标本准备和处理时间。一些测试被列为连续执行的，这意味着测定在白天多次执行。

从星期一到星期五

report Available
the interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

5 to 7 days

specimen Retention Time
outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

直到报道

performing Laboratory Location
指示执行测试的实验室的位置

罗切斯特

Fees
several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • 一种uthorized users can sign in totest Prices有关详细的费用信息。
  • Clients without access to Test Prices can contact必威平台官网24 hours a day, seven days a week.
  • prospective clients should contact their Regional Manager. For assistance, contact必威平台官网。

test Classification
provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

this test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT代码信息
为确定每个测试或配置文件的适当当前程序术语（CPT）代码提供指导。列出的CPT代码反映了Mayo Clinic实验室对CPTbetway中国版编码要求的解释。每个实验室的责任是确定用于计费的正确CPT代码。

CPT代码由表演实验室提供。

88360

lo我nC® Information
provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

test Id 测试订单名称 订单loinc值
288PD pd-L1 (28-8), SemiQuant IHC, Manual 85148-5
result Id test Result Name result LOINC Value
一种pplies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
609995 解释 83056-2
609996 participated in the Interpretation no LOINC Needed
609997 报告以电子方式签名 19139-5
609998 material Received 81178-6
609999 disclaimer 62364-5
610000 Case Number 80398-1

测试设置资源

setup Files
test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel|pdf

样本报告
normal and Abnormal sample reports are provided as references for report appearance.

normal Reports|异常报告

SI样本报告
我nternational System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

s我normal Reports|s我异常报告

test Update Resources

Change Type effective Date
new Test 2021-10-05