PCR Thermocycler Calibration and Validation using MTAS

Thermocycler Calibration and Validation is Essential to Conform to Regulatory Requirements, Improve PCR Yields and Control Reagent Usage

• need to calibrate their thermocycler before initial use, after moving from one lab to other and after return from repair to prove its performance (5.3.1, 5.5.7 and 5.6.1)
• the calibration needs to be done on the spot where the cycler is used, under guaranteed environmental conditions (5.3.1)
• the calibration results need to be reported in SI units and contain the calculated uncertainty of measurement. (5.6.2.1 and 5.6.2.2)
• the calibration method needs to be fully traceable to an international standard (ITS-90, not NIST!) (5.6.2.1 and 5.6.2.2)
• calibration needs to be performed by a party who has no commercial interest in the outcome of the calibration (4.1.5)
• need to prove the cycler is suitable for the PCR used (validate the test) (5.4.2, 5.4.5.2, 5.4.5.3 and 5.5.2)
• have the obligation to continuously improve (4.10)

Astral Scientific offers a NATA Accredited Temperature Calibration & Validation Testing Service using CYCLERtest’s MTAS (Mobile Temperature Acquisition System)

NATA Accreditation Number 18513

Features include:

• Calibration is fully traceable to the International Temperature Standard ITS-90
• MultiProbe Dynamic Measurements
• NATA Accredited
• Thermocycler Brand Independent
• On-site validation for minimal disturbance and downtime
• Everything you need to know: Uniformity, Accuracy, Ramp Speeds, Overshoots, Undershoots
• Calculated uncertainty

Most Sophisticated and Accurate Thermocycler Calibration Service

Astral Scientific Pty Ltd offers the most sophisticated and accurate temperature validation service for your PCR thermocycler with NATA accreditation. CYCLERtest’s MTAS provides assurance, with detailed information on how your PCR machine is performing throughout a reaction. Reporting on the real time performance of your PCR machines helps you better understand your results, adapt protocols for more efficient use of valuable reagents and conform to regulatory requirements.

Essential for Forensic and Diagnostic Applications

For forensic and diagnostic applications complete confidence in the procedure and data obtained is essential and can only be guaranteed with regular checking of the instrument used. NATA accreditation of this system ensures you are complying to the most stringent laboratory practices of ISO:17025, whether you work to these guidelines or not.

Biological Positive, Negative & Threshold Controls are Insufficient to Guarantee Reliable PCR Results

The use of biological positive, negative and threshold controls is insufficient to guarantee reliable PCR results but the unique method of CYCLERtest performs both static and dynamic testing on every commercially available PCR thermal cycler. CYCLERtest uses the MTAS® (Mobile Temperature Acquisition System) that has been calibrated by KEMA (recognised internationally and by NATA). It is verified by a “Council for Accreditation”.

Encrypted Test Results

Test results are analysed and reported through an automated process, prohibiting any alterations of the acquired sample data. The Data and layouts are encrypted and cannot be modified. A “Certificate of Thermal Validation” accompanies every test report. This certificate represents the results of the measured and calculated main parameters of the tested instrument.

Only Performed by Trained and Certified Technicians

Astral Scientifics’ ISO17025 accreditation ensures that only trained and certified technicians perform these validations and certifications. A Technician will come to your laboratory for maximum efficiency and convenience and test your thermocyclers, providing a full report on their functionality. A full understanding of your thermocycler’s performance will improve optimisation of PCR reactions

Independent Validation of All Makes & Models

Astral Scientific offers NATA accredited Calibration on virtually all makes & models of Thermocycler including Real-Time PCR Machines.(*)

• Applied Biosystems - (GeneAmp, Veriti, StepOne, 7300, 7500, 7900, Prism 7700 SDS)
• Roche – (Taqman, Lightcycler range)
• Bio-Rad – (iCycler, DNA Engine range)
• Corbett Research -(Palm Cycler, FTS range)
• Eppendorf - (Mastercycler range)
• Gene Technologies Ltd – (G-Storm range)
• MJ Research - (PTC-100 / 200, Dyad, Tetrad)
• Stratagene - (Mx3000P, Mx3005P, Mx4000)
• Techne
• Thermo Hybaid
• Whatman Biometra

(*) Dependant on availability of corresponding probe set

Thermal Cycler Calibration and Validation using Driftcon

DRIFTCON® – Your Personal Measurement System for Thermal Cycler Validation

The DRIFTCON system is a mobile, personal measurement device that you can use daily, weekly or monthly to monitor the performance and temperature drift of your thermal cyclers. No two thermal cyclers function identically but periodic and continuous validation with DRIFTCON offers a convenient and easy means to check if PCR tests are working within predetermined parameters. Detailed knowledge of your cycler’s true temperature performance can also enable adjustments for improved yields and use of less reagents – saving time and costs.

DRIFTCON measures temperature accuracy- deviation of the actual block temperature from the set temperature. It also monitors uniformity – the spread of the temperature between wells on the same block. It can also provide data on the speed, or ramp rate, at which the cycler changes temperature and report on any under or overshoots – all significant factors affecting the success of your PCR reactions.

Every temperature measurement systems regardless of the thermocycler model you have, or manufacturer, is performed using a standardized and prescribed temperature protocols, enabling the comparison of results and any deviation from protocol standards.

DRIFTCON temperature results are analysed and reported through an automated process, prohibiting any alterations of the acquired sample data, helping you keep a record of all your results.