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Characterization and metrological verification of thermocyclers

Satisfying regulatory requirements or completing an accreditation / certification process necessitates verifying the performance of your equipment. Your thermocyclers are metrologically verified at your facility and in accordance with your set of specifications.

Proposed services

Within the scope of performing metrological characterizations of your thermocycler, LNE is pleased to propose the following:

  • Advice and technical assistance,
  • Elaboration of a certification plan and set of specifications,
  • Execution of tests and measurements, i.e.:
    • Temperature differential relative to the guideline (accuracy)
    • Duration of temperature plateaus, as determined whenever temperatures lie within the MME(*), as defined by the client
    • Average plateau temperature (per both cycle and zone), as determined whenever temperatures lie within the MME
    • Transient temperature rises at the beginning of the plateau
    • Rate of temperature rise and fall
    • Temperature discrepancies between the various temperature sensor positions (homogeneity).

*MME: Maximum Margin of Error

The standard program, as outlined in the set of documentation referenced FD V 03 112, calls for a test covering 10 measurement cycles, able to be repeated n times (upon client request). The number of temperature sensors and their positions on the test block are predefined based on the number of thermocycler wells, in accordance with patent no. WO 2010/092137 A3 filed on August 19, 2010. The verified temperature plateaus are established by the client, with two plateaus for quantitative thermocyclers and three for qualitative thermocyclers.

These tests are all carried out with the hood closed.

Resources

In response to this challenge, we have at our disposal the following equipment:

  • Data acquisition stations linked to the temperature sensors
  • A set of micro-tubes.

Applicable regulations

FD V 03-112 documentation series - COFRAC accreditation no. 1-0606 between 0°C and +100°C, inclusive.

Scope of application available on www.cofrac.fr

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