아래는 최근 Antylia사와 합병된 ZeptoMetrix에서 제공하는 웨비나로 올바른 Quality Control Material의 선택과 사용의 중요성에 대해 설명하고 있습니다.
The role QC materials play in laboratory testing
The advantages of using third-party QC and the risks associated with a lack of QC
How to get more confidence in your test results
How to ensure consistency of SARS-CoV-2 test results
Molecular diagnostics has rapidly become one of the leading technologies for infectious disease testing around the world. These technologies allow for rapid detection, greater sensitivity, and more accurate diagnoses. For these reasons, it is imperative that laboratories administer a well-defined quality assessment of their tests to ensure the best possible patient outcomes. Implementation of full-process, external quality controls (QC) can assess the integrity of the entire test system to ensure the consistency of the produced and reported results by the molecular laboratory.
Whether you are using an In-Vitro Diagnostic (IVD) or laboratory developed test, you need a quality control that will provide consistent, correct results every time. ZeptoMetrix offers a wide range of QC materials that, when used on a regular basis, help monitor testing performance and provide additional confidence in the quality and reliability of molecular and clinical laboratory operations.
This webinar will help you to better understand QC for infectious disease testing. We will discuss the basic principles and practices of using QC materials in laboratories. From there, we will explore the types of molecular tests you might be using and delve into the benefits of using third-party quality controls. You will also get a glimpse into ZeptoMetrix NATtrol™ molecular quality control development and how the company is leading efforts on QC for SARS-CoV-2 testing.
PhD, Lead Technical Support Specialist, ZeptoMetrix®
Jessica holds a Bachelor of Science in Chemistry from Nazareth College and a PhD in Biochemistry from the University of Rochester. She joined ZeptoMetrix’s molecular department in 2012 as a Senior Molecular Biologist, then became the manager of QC for the department. In these roles, she focused on all aspects of NATtrol™ molecular quality control development including manufacturing, working with assay developers to design and develop new products, data collection and analysis, and QC testing and stability testing. More recently, she has taken a role in the sales and marketing department as the lead technical support specialist, incorporating her experience and expertise to better serve customers around the world.
Questions & Answers from the live event
Yes, typically calibrators are solutions with a defined, specific concentration that are used to set or calibrate an instrument or system before testing is started. Most times, they are provided by an assay or instrument manufacturer. The purpose of a control is to validate the reliability of the test system and evaluate outside factors such as operator performance and environmental conditions that could influence results. Like we talked about in the presentation, controls should mimic patient samples to challenge the full process of the assay in question.
In many instances, there is no clear guidance on how often controls should be run. You should follow the Internal Quality Control Program (IQCP) as established in your laboratory. IQCP permits the laboratory to customize its QC plan according to test method and use, environment and personnel competency while providing for equivalent quality testing. You can also reference the manufacturer’s instructions for the assay or platform you are using. It may offer guidance specific to the instrument/test.
How do I know what kind of controls I need for my lab? That is, qualitative vs quantitated, panel vs controls.
The kind of controls you need obviously depends on the tests that you are running in your lab. The technical experts at ZeptoMetrix would be happy to work with you in determining which products that we offer will align with your laboratory’s quality control plan.
Yes, those terms are used interchangeably.
ISO said we should try to consider using a QC close to our test sample matrix. We analyze urine with a microarray but cannot find any external QC or proficiency supplier to do this. Any recommendations what we can do, as we are wanting to get UKAS accredited?
We are not aware of any control suppliers who use urine as a matrix. At ZeptoMetrix, our matrix is intended to be a mimic for clinical specimens in general and is not restricted to one type necessarily. We use this diluent in a variety of panels and controls that work with various assays and platforms with different sample types. How do you establish ‘expiration’ or storage requirements for QC material? For our controls specifically, real-time and/or retrospective stability testing has been performed to verify the expiration dating of our materials at the recommended storage temperature.
It’s possible that it indicates a difference in approach. It likely comes down to a variety of things: cost, ease of use, ease of manufacture, turnaround time, availability of tests already on the market, etc. It will be interesting to see the trend play out over the next year or so as routine testing will likely continue to ramp up.
That’s very specific to both the kind of internal control being used and the actual test/assay that it is being used for. Internal controls or built-in controls for some kits, for example, may only do so much as to indicate that all the reagents included in the device are active and working properly, while built-in controls for another kit may simply indicate that a sample was added, and the test device ran correctly. The manufacturer’s instructions should detail what their specific internal controls monitor thus helping you determine whether additional controls may be needed. Many laboratories incorporate unbiased, third-party controls as part of their IQCP protocol to provide a full-process control option that monitors the integrity of the entire test system.
Many labs use patient-known samples as external controls. Is this OK? What challenges might they face?
You’d have to check with specific federal or local guidelines as well as any specific accreditation bodies to determine if patient samples are an acceptable source for external controls. While they certainly would function as full-process controls, it may be more time-consuming and costly to maintain cultures and stocks of these materials in the long run. There should also be some method to periodically check for purity as well as monitor performance over time to ensure stability and material consistency.