IHC抗原修复

提到全球实验室质量体系中难以实现的丢失环节时,需要迫切填补此空白。

有了我公司研发的创新性染色记录玻片(PRS),我们能够通过非常精确和严格的方式实现此需求。

IHC抗原修复

WHO的质量控制要求

从历史观点上说,当提到活检组织的免疫组织化学(IHC)染色过程时,全球几乎没有一个实验室能够按照世界卫生组织(WHO)严格要求在单一载玻片上处理共存控制材料与患者样本。除每次测试的质量控制材料缺失之外,还不能获取用以追踪与改进IHC流程的校正系统。

然而,现在可引入PRS产品,其将提供一个具有成本竞争力的解决方案以及获取只与IHC兼容的粘附涂层玻片。

Why PRS?

Our product, the Process Record Slide (PRS) came about due to a book published by the World Health Organization (WHO). If you Google “Laboratory Quality Control”, you will find a copy of a book entitled “Laboratory Quality Control System” . This book provides details of the universal quality control rules for health related laboratories.

In chapter 7.2, WHO provides a clear definition of control materials and calibrators:

Defining control materials

7-2: Control materials

Controls are substances that contain an established amount of the substance being tested -the analyse. Controls are tested at the same time and in the same way as patient samples. The purpose of the sample is to validate the reliability of the test system and evaluate the operator’s performance and environmental conditions that might impact results.

Differentiating controls and calibrators
It is important not to confuse calibrators and control materials. Calibrators are solutions with a specified concentration that are used to set or calibrate an instrument, kit, or system before testing is begun. Calibrators are often provided by the manufacturer of an instrument. They should not be used as controls since they are used to set the instrument. Calibrators are sometimes called standards, but the term calibrator is preferred. They usually do not have the same consistency as patients’ samples.

The solution

With this in mind, we have developed the PRS product as a must-have essential device for combining the functions of control material and calibration in strict accordance with the WHO requirements:

Role in quality management system

7-1: Overview

Quality Control (QC) is a component of process control, and is an essential element of the quality management system. It monitors the process related to the examination phase of testing and allows for detecting errors in the testing system. These errors may be due to test system failure, adverse environmental conditions or operator performance. QC gives the laboratory confidence that test results are accurate and reliable before patient results are reported.

How the PRS helps laboratories

We strongly recommend that all laboratories consider using PRS for their IHC biopsy staining process particularly in view of the fact that WHO states this quality control component is an essential element. By including this, the laboratory can confirm the efficacy of reagents used, tissue handling, and process control of the patient sample through the IHC processing. Thus, the laboratory can document that its processing of the biopsy sample is valid prior to the diagnostic interpretation being performed. Of course, the biopsy may not contain any of the sought for conditions and the outcome would be a true negative result.

WHO also goes on to stress that if QC is missing from the process, then laboratories should not consider reporting the patient results at all:

If QC results are not what are expected, do not report patient results.

If you are a laboratory that wishes to comply with the WHO guidelines, then the Process Record Slide (PRS) product is for you. Contact us now for full details and get your laboratory fully QC compliant and your patient reports fully controlled and recorded.