Published: ISO 20836:2021 - temperature performance testing of thermal cyclers

ISO 20836 specifies requirements for the installation, maintenance, temperature calibration and temperature performance testing of standard thermal cyclers and real-time thermal cyclers.
It enables laboratories to determine if a thermal cycler is suitable for intended use and if it meets the requirements as set by the laboratory.
The standard has been established for laboratories performing polymerase chain reactions (PCR) in for example the food, environmental, human health, animal health and forensic testing domains.
The CYCLERtest thermal cycler calibration method meets the ISO 20836.

On the 14^th of February 2022 the ISO 20836 was introduced by NEN via a webinar (in dutch).

Slides of the presentation are available in dutch and english.

Christmas Holidays 2022

The CYCLERtest team wishes everybody a Merry Christmas and a happy New Year!
We value your business and look forward to continue our relationship in the coming year.

Please note that our offices are closed between 24^th December 2022 and 1^st January 2023.
Your orders will be processed till 20^th December 2022 due to stock inventory.

Log4j Security Risk

Statement:
MTAS^® and DRIFTCON^® systems and software are not vulnerable to the Log4j security issue.

Christmas Holidays 2021

We will be closed between December 24.2021 and January 2.2022. Your 2021-orders will be processed till December 21 due to stock inventory.

Transition from ISO/IEC 17025:2005 to ISO/IEC 17025:2017 completed

CYCLERtest B.V. proudly announces that it has completed the transition to the ISO/IEC 17025 successfully. CYCLERtest has proven competence towards the Dutch accreditation body RvA and therefore been granted accreditation against the latest version of the ISO/IEC 17025.

This means that our excellent thermal cycler and dry heating block services continue and enable labs to comply to:
• international laboratory quality standards like ISO 15189, ISO 17025, ISO 13485, ISO 20836
• regulatory guidelines and standards like GMP, GLP, FDA, ASHI, EFI, NY State, CLIA, CAP
• quality standards for proper operation and validation of COVID-19 tests^*

Benefits of the service:
• Suitable for all thermal cycler brands
• Performed on-site in your laboratory
• Minimal instrument downtime
• Executed by qualified and experienced calibration engineers
• Published and international accepted calibration method
• Compliancy reporting, including uncertainty of measurement

Click here for our scope of calibrations and request your calibration here

For superior (q)PCR plastics visit CYCLERtest’s sister company www.bioplastics.com

* COVID-19 testing labs are required to calibrate (q)PCR instruments to traceable SI standards and perform validation of  those instruments.

Coronavirus and RT-PCR equipment

The latest coronavirus 2019-nCoV is diagnosed with RT-PCR which detects the amount of viral RNA in a patient’s blood, serum and/or sputum. It goes without saying that the used (q)PCR equipment has to function properly. To assure proper operation (q)PCR cyclers need to be calibrated regularly according to international standards.

ISO-norm
Even though the metrologically traceable temperature calibration is an ISO required norm for medical and test labs, not all of them adhere to the rules. But as a potential patient you don’t want to spend two weeks in isolation if you’re not sick and you don’t want to be send home when you’re seriously ill. We therefore advocate that all labs calibrate conform the norm and auditors assess accordingly. Better be safe than sorry.

Award for business excellence – Shanghai office

BPCT Incorporation Shanghai, the overseas office of BIOplastics and CYCLERtest in China, received the 2019 Trustworthy business enterprise award. This award is annually conferred by the Shanghai business district government to the company with the highest level of professionalism, workmanship and client satisfaction.

Companies are selected on the merits and strengths of criteria as product quality, reliability of the company through the years and customer service. The government also evaluates other areas of the business including - but not limited to - sales growth, tax payments, positive tax audits and business health picture.

‘It’s a great honor to receive this award’ says Tom Hendrikx, CEO and owner of BPCT Incorporation China. ‘It recognizes our engagement to offer high quality plastics and calibration services for PCR and qPCR thermocyclers and doing honest business. But above all it demonstrates the strengths of our extraordinary people and the Dutch and Chinese business ties. We will continue our efforts to provide top quality PCR and qPCR solutions in this way to strengthening our position in the Chinese market.’

The award was presented by the Shanghai business district government to office manager Wendy Gao.

Temperature calibration guide for (q)PCR thermocyclers

Most (q)PCR optimizations are performed on DNA, primers and template variables. Yet, very little attention is paid to the effect plastics and thermocyclers have on the (q)PCR result. They are incorrectly considered to be constants in the PCR process.
In this guide we illustrate different types of thermocycler variabilities and the impact they have on the (q)PCR results. We also give practical solutions on how to eliminate or control these variabilities.

Practical
You can easily use the data from the calibration certificates in practice. We give examples on how to align and program thermocyclers to mimic each other. You also learn how to use calibration results for validation purposes.

Complimentary guide
Do you want to explore the full potential of CYCLERtest thermocycler calibration data? Download your complimentary copy.

Supply chain (e)quality

We all want to enjoy a wonderful meal and drink a glass of tap water to quench our thirst without having to worry about safety. The same counts for the diagnosis we receive from a laboratory test.

Therefore our commitment to quality is not restricted to our products and services. The highest standards are achieved when the entire supply chain focuses on quality, from manufacturers of thermal cyclers through distributors to end-users. End-users play the most important roll to ensure reliable (q)PCR results. After all: any lack of attention to reliability can have negative implications.

All parties involved comply with certain regulations to combat problems, concentrating on preventing instead of curing them. By doing so, the highest quality level is met.

• Distributors control the quality of thermal cyclers with MTAS calibration tools to meet specifications
• End-users control the quality of their thermal cyclers annually - either with Driftcon calibration tools or with accredited on-site calibration service with MTAS system – to fully understand the performance of their cycler
• Calibration tools are calibrated in an accredited calibration laboratory to make sure that they perform according to international standards
• (q)PCR consumables are manufactured according to strict specifications for reproducible and reliable results. The characteristics:
  * Composition is always identical so consistent results
  * Low binding: all DNA is available for a reaction
  * (q)PCR is possible in volumes as low as 5µl
  * Pyrogyn, DNA(se) & RNA(se) free

We are extremely proud to have achieved this level of quality with our cooperation partners and are committed to further expand this method.
Better be safe than sorry!

REQUIRED TRACEABLE CALIBRATION (Q)PCR THERMAL CYCLERS

In accordance with the ISO 15189 standard for medical laboratories and ISO 17025 standard for testing laboratories any measurement equipment used for testing that has significant influence on the accuracy or validity of the test result needs to be calibrated to (inter)national standards (requirement 5.3.1.4 of ISO 15189: 2012 and requirement 6.4.5 & 6.4.6 of ISO 17025: 2017).

CYCLERtest offers a unique on-site calibration service.

The advantages:
•You meet the ISO 15189 or ISO 17205 quality requirements
•The temperature calibration is traceable to international quality standards
•You support reliable and reproducible (q)PCR results
•The service applies to all models of all brands of thermocyclers and dry heating block incubators
•Your equipment downtime is less than 40 minutes.

The only qualified calibration laboratory
Because we are independent of every thermal cycler manufacturer, CYCLERtest is the only qualified calibration laboratory in the world that can calibrate real-time PCR equipment under ISO 17025.
Thermocycler manufacturers are not able to perform metrologically traceable calibrations under ISO 17025, partly because they are not independent.

In-tube or in-well thermal cycler calibration method

During the 19th International Metrology Congress in Paris, CYCLERtest presented a comparison between an in-tube- and in-well thermal cycler calibration method. The study - performed with BIOplastics’ tubes - showed that it is feasible to develop an in-tube method with a low measurement uncertainty. However, due to the large impact of the tube-to-well fit on the measurement uncertainty and the large variability between tubes, it is not practical to use in-tube methods for metrology purposes. An in-well thermal cycler calibration method is therefore the preferred option. Read all about the research in the abstract Comparison of temperature dynamics of various thermal cycler methods.

Self service (q)PCR calibration

Calibrate your (q)PCR cycler or incubator yourself!

Suitable for all thermocyclers and incubators.

Now available in Europe.

Read more

CYCLERtest gained US Patent for Optical Calibration of qPCR cyclers

CYCLERtest is proud to announce that its patent for the optical calibration of qPCR cyclers is now also granted in the USA. The US patent complements similar patents held by CYCLERtest in Europe and Japan.

Breakthrough
The traceable Optical Calibration tool and service is ‘a major breakthrough for molecular diagnostics and life sciences’ according to CEO Tom Hendrikx. ‘With this advanced technique variables in qPCR are monitored, minimized and become controllable. This gives laboratories a better understanding of the qPCR process and enables them to expand its capabilities. This superior method with new developed hardware supersedes the, so far used, non traceable techniques as biological testing, crystal color changes and others!’

Combination
The innovative technique is based on the traceable calibration of temperature, optical detection and light of (q) PCR cyclers (excitation and emission). A truly unique method since these components are not only detected and generated separately but also in relationship to each other. By doing so, the performance of the real-time thermal cycler is monitored and calibrated like never before.

About CYCLERtest
CYCLERtest - a pioneer and global leader in ISO 17025 accredited (q)PCR cycler calibrations - is headquartered in The Netherlands and represented by qualified distributors worldwide. Its highly accurate calibration tools and services enable laboratories to monitor the performance of their thermo cyclers according to global quality requirements. All in order to generate reproducible, trustworthy and technical valid (q)PCR results.

Information
More information about CYCLERtest can be found on www.cyclertest.com.
Patent numbers: US 10,022,694 | Japan 6124903 | Europe 2 581 728

MTAS ® software 6.5.4

A new version of the MTAS software is released.

MTAS ® software 6.5.3

A new version of the MTAS software is released.

MTAS© Optical Calibration System

CYCLERtest introduces its new hard and software for Optical Calibration of qPCR cyclers and HRM modules.

qPCR thermocycler Optical Calibration & HRM (High Resolution Melt) modules

• Traceable
• Multichannel
• All Dyes ranging from 440 to 650 nm
• Cq detection and calibration
• Tm detection and calibration
• Tm validation (ratio Tm or RTm)
• Linear Sensitivity Factor (LSF)
• Channel Peak Height Consistency (CPHC)
• Identical Fragment Indicator
• Full Certificate Document
• Patented by CYCLERtest

Free Optical Calibration for Benelux customers up to December 15th, 2014 if combined with CYCLERtest's ISO17025 accredited Temperature thermocycler calibration services.

Download an example certificate here

For more information click here

Driftcon ® software release 2.1

The new software features:

• Updated database driver
• Added timeline to movieplayer
• Added 2 months and 6 months calibration intervals
• Added settings for ProbeControlSystem
• Show device note when starting a measurement

MTAS ® software 6.2.0 and MTAS PLATA 16-6 All well release

A new version of the MTAS software is released.
Further we have a new product available for MTAS : MTAS PLATA 16-6 All Well!

Driftcon ® software release 2.0

As a next step in the ongoing development of new innovative and state of the art products we are proud to introduce the NEW Driftcon ® software
The new software features:

• Measurement of heated lids (with PLATA probe-fixtures)
• Hardware box III support (Multi-point calibration and adjustment)
• Rotor Gene® Calibration (Driftcon® Rotor-Gene® Wireless Probe)
• Digital credits as well as credits on a card
• Measurement uncertainty (traceability) programmable/adjustable
• Improved device and user management
• Improved reporting format with graphical overview

ISO17025 accreditation extended!

In 2008 CYCLERtest BV was ISO17025 accreditated for the first time. Recently an external audit was performed and corrective and preventive actions were taken. The Dutch Accreditation Council (RvA) granted continued accreditation for the next period.

ISO17025 accredited Calibration now also for Rotor-Gene®

On site calibration for Qiagen® Rotor-Gene® systems models 6000 and Q Rotor-Genes under ISO17025 accreditation is added to our service portfolio. CYCLERtest, an ISO17025 accredited company calibrating (q)PCR cyclers, has designed and developed this new MTAS® hardware and software tool enabling Rotor-Gene® Calibration.

This new wireless system consists of a 12 sensor-equipped 72 Rotor with incorporated RF communication hardware. The system and the service are ISO17025 calibrated and accredited. Service is available from September 1st, 2013 and can be combined with other (q)PCR cycler calibrations, regardless of brand or model of the cycler.

All calibrations are under ISO17025 and comply to all regulations, including but not limited to GLP, GMP, ISO15189, ISO13485, CAP, EFI, CLIA, CPA, NY State, FDA, NFSCT, AAVLD, OECD, RiLiBAEK, Food Diagnostics and others.

Click here to request your on site Rotor-Gene® calibration
Click here to request a calibration quote
Download an example Calibration Certificate here
Download CYCLERtest ISO17025 certificate here
Download CYCLERtest ISO17025 calibration scope here

MTAS and Driftcon PLATA fixtures released

CYCLERtest BV has released the MTAS® PLATA 15 x 0.2ml, Driftcon® PLATA 96v-15 and Driftcon® PLATA 16-6 All-well. These robust PLATA products can be used in an even wider (q)PCR cycler range, measures heated lid temperatures and are available in Low (0.1ml Fast) and Regular Profile (0.2ml) formats. Plata products are designed to calibrate qPCR with lid closed.

ISO 17025 Accreditation

CYCLERtest is ISO 17025 accredited for on site thermocycler temperature calibrations and in house calibrations of DRIFTCON and MTAS systems since 2009.
In October 2012 the Accreditation Council has completed the fourth annual reassessment of CYCLERtest with a positive result. The accreditation is valid until April 2017 and CYCLERtest is authorized to perform calibrations under accreditation.

The accreditation is registered under number (RvA K145).

New CYCLERtest website

Welcome on the new CYCLERtest website. This site replaces the old CYCLERtest and Driftcon website.
All known features of both sites are now integrated within the new CYCLERtest website.

You can login on the website with your e-mail address and password.

If you experience sign-in issues please try again later or contact us.

Thermal cycler calibration service

CYCLERtest has elaborated its On-Site Thermal Cycler Calibration Service with Technical Expert Support in interpretation of the calibration data.

Thermal cycler calibration guide

This guide will allow PCR and qPCR users to explore the full potential of CYCLERtest thermocycler calibration data.

BIOzoom July 2009

BIOzoom newsletter is compelling news, developments and trends within the Dutch BIOzym Holding and its members BIOplastics, BIOzymTC, BPCTi Inc, CYCLERtest, GENO-tronics and Hendrikx Ltd. Headquarters, manufacturing and European sales, Landgraaf, The Netherlands,Sales Offices in Durham NC, USA and Shanghai, China. You can download the PDF in our download section

Normalizing SOPs

Many laboratories have SOP (Standard Operation Procedures) in place. Incorporation of new components in SOP’s are generally labor and time consuming. In the (q)PCR process, variables as cyclers, plastic disposables, kit components and work procedures are typically described and incorporated in SOP’s. Often different SOP’s in place for one application are used on several (different) cyclers. BIOplastics and CYCLERtest® have formulated a strategy which enables exclusion of the cycler as well as the used disposable variable. This strategy actually provides users the ability to normalyze their SOP. You can download the PDF in our download section

Driftcon 384 FFC fixtures released

Driftcon 384 FFC fixtures released

ISO 17025 Accreditation

ISO 17025 ACCREDITATION for (q)PCR Cycler Calibration