End User Diagnostics

You are generating diagnostics results and support these results with appropriate evidence like biological controls, and assurance of full trace ability and quality of the used equipment. Depending on the internal validation schedule, as well as the type of investigations, and the impact and importance of the generated result, you typically use DRIFTCON on a daily, weekly or monthly base, and trace the drift of temperature performance of your cycler in time. Your kit manufacturer may strongly recommend the use of DRIFTCON. With DRIFTCON you are comparing if the cycler used to run your application, is suitable for this application.

Your kit manufacturer may recommend the regular use of a DRIFTCON system to exclude variations in results, generated by a lack of performance of the used cycler. A kit manufacturer may even require seeing the thermal DRIFTCON profile of the used cycler prior to the acceptance of kit claims.

Your instrument may be performing out of “instruments specs” provided by CYCLERtest. Please request latest specifications by synchronising to our general database.

Users of commercial kits may request kit manufacturers to provide prescribed threshold set(s) for temperature accuracy and block uniformity of the kit and/or cycler (see also “Application-based thresholds“). A kit manufacturer may be requested by governmental auditors and other regulatory bodies to provide the temperature threshold settings for the supplied kit as well as the actual validation of these data in time (DRIFTCON driven).

Threshold settings are used to compare the temperature performance of the cycler against (pre) defined thresholds. A kit manufacturer is capable of designing extremely detailed threshold settings. These threshold settings are used to check whether the tested instrument is within threshold (application) specifications or not. The kit manufacturer sets clear definitions whether if the threshold preference is based on application(s) or on the instrument.

Although the application thresholds are much more difficult and time consuming to design, they are superior to instrument thresholds. In other words: one is comparing if the cycler used to run an application is suitable for this application. If an end user is using a commercialised (diagnostic) kit (PCR, LCR, Real-Time PCR, RT-PCR etc) he or she may request the temperature profile thresholds from the kit manufacturer. If your kit manufacturer has not yet been able to provide you with temperature thresholds for your kit, you may consider using our discussion forum at the specific DRIFTCON website: www.driftcon.com or (if available) join one of the application threshold settings discussion groups.

Instruments thresholds settings (for a specific instrument and block type) are provided with the purchase of a DRIFTCON system. Other individual specific threshold settings may be purchased as software “ad on” (option). The provided specific instruments thresholds are extracted from the global database, which contains measurements from the same brand and type of machine. The provide threshold values are mean values plus or minus 2 x the standard deviation of the values (equals 95% of the population). You may adjust these by generating differently defined instrument threshold settings.