Due to a lack of accurate, independent, dynamic, and multi-channel temperature monitoring and validation systems for thermal cyclers, GENO-tronics and CYCLERtest developed a temperature measurement system for end-users optimized for this application, namely DRIFTCON. The system consists of special designed hardware and temperature probes for performing extremely accurate, sensitive and dynamic multi-channel temperature measurements. The temperature sensors used with the DRIFTCON are precisely designed and manufactured with the same cone angle and shaped as the sample wells. This means that for every sample block type there is an individually designed temperature probe. High thermal conductive cement with special parameters is used for molding the sensor in the precise shape. The bare sensors are not commercially available and are specially customized to suit the highly sophisticated DRIFTCON applications. The sensors have a high accuracy and sensitivity, as well as an extremely low drift and variation over time. Important parameters and specifications of the measurement system are the accuracy and the repeatability of the system. It is generally acknowledged that, if one wants to verify the quality and performance of a certain instrument, the accuracy and the resolution of the measurement system used has to be at least three times better than the instrument to be verified. The repeatability, reproducibility and drift of the complete measurement system are also considered important parameters. The DRIFTCON is designed to match all of these challenging parameters (see the paragraph “system specifications” for the technical details).

As mentioned in the previous paragraph, GENO-tronics and CYCLERtest (both located in The Netherlands), have developed a highly sophisticated temperature measurement and validation system for capturing and analyzing the temperature performance of thermal cycling equipment, especially instruments used for PCR® reactions, cycle sequencing instruments, incubators etc. The DRIFTCON has unique features and capabilities and is suitable for personal temperature validation monitoring as well as temperature drift monitoring of all kind and brands of instruments in the market e.g. thermal cyclers manufactured by MJ Research Inc, Applied Biosystems (PE), Eppendorf, Biometra, MWG, Thermo Hybaid, etc. The system has been calibrated against the ITS-90 temperature scale (NIST standard) and verified by an independent institute, which is accredited by the Dutch “Council of Accreditation”.

Another striking feature of the DRIFTCON is its mobility. It’s a “mobile”, “out of the box” and “ready to use” temperature-monitoring system. Users of thermal cyclers can now benefit from the convenience of frequent validation and accurate temperature drift monitoring on site, without having the necessity to send out the thermal cycler to a utilized test-site for validation.

DRIFTCON test results are analyzed and reported through an automated process, thereby minimizing user input operations and prohibiting any alteration of the acquired sample data.

Every temperature measurement, regardless of which type of thermal cycling instrument is tested, is performed using a standardized and prescribed temperature protocol. This enables the comparison of the results of every measurement performed and shows if the results of tested instrument deviate from the protocol standards. This standard protocol is designed to support all relevant temperatures related to instrument specifications and the PCR® processes. Data and results from the measurements are collected in a central database and the instrument specific “field ” performance is calculated. The “field” performance can differ from the cycler manufacturer specifications. DRIFTCON users can also participate in a global database network generated by CYCLERtest. Particularly, users can determine how their instrument behaves in accuracy, uniformity as well as drift-in time in comparison to the other global users of the same “cycler type and brand” which also participate in the database and are also users of DRIFTCON.

Besides the use of the personal DRIFTCON System (16 temperature channels), it is strongly recommended to use the external ”CYCLERtest Temperature Validation Service” (MTAS-16, MTAS-32, MTAS-48) once a year or after every 250 “runs”. The measurements and results of this unique service use even more channels (up to 48 simultaneously) and assure temperature validation of the highest standards and accuracy currently available. This validation comes with a detailed 16 pages of report which includes full dynamic accuracy, spread, uniformities, heating /cooling rates, graphs, gradient testing, load testing, recommendations and comparisons between same instruments etc.

The DRIFTCON System consists of two parts, 1) a hardware module with the temperature probe fixture and 2) the DRIFTCON monitor and analysis software. The DRIFTCON software controls the DRIFTCON hardware module and captures and processes the temperature data from the hardware module. The temperature data of each individual channel is acquired, plotted in real-time to a graph and stored to hard disk. The software indicates the actual temperature of each channel (up to 16) and calculates the average temperature and the temperature spread. The data in the log file is encrypted and can only be read and decrypted by the DRIFTCON software. The DRIFTCON-Card provides measurement credits; for each measurement a credit is deducted from the card. The software also analyses the captured data, calculates main instrument parameters such as accuracy, spread, ramp speeds and other relevant data.

The DRIFTCON software application is designed to provide easy operation and functionality. A graphical menu gains access to the main functions and features of the DRIFTCON software.

Some key-features of the software are:

DRIFTCON results are presented in detailed and partly selectable reports and relevant information is displayed and generated automatically. DRIFTCON offers several types of reports including retrospective overview of accuracy, uniformity, instrument and complete run trace-ability of all the variables used during the test. Participation in the global instrument database enables the user to compare the accuracy and spread against identical instruments used by other participants in the DRIFTCON market database. The thresholds for different users are not displayed in the database but may be available in specific user groups, which is a subpart of the database set-up. Privacy is assured since only the results will be available in the database and no other traceable personal information. CYCLERtest’s and GENO-tronics’ policy is to have uniformity and recognizability in the layout of the reports so that it cannot be changed or modified