To ensure control of laboratory equipment, and to ensure the accuracy of the results, there must be a plan for calibration, verification, and maintenance of equipment.
The quality of the reagents that have been used for each PCR run may be affected by small differences in thermal stability, and may substantially influence PCR yields and results.
In the presence of a failed assay, the most common solution is adding more enzyme to the reaction. This is not only an extremely costly action, it also greatly increases the likelihood of inhibition of the enzyme in the first test cycles.
Laboratories accredited under ISO 17025 and ISO 15189 must apply appropriate methods and procedures for all calibrations. But they are not the only laboratories that must guarantee the reliability of the results.
By definition of the International Metrology Vocabulary (IMV), the calibration is an operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication.”; and we can add: with corresponding values traceable by an international reference standard.
Traceability is guaranteed by the use of traceable international reference standards and the expression of calibration values in International System units, but also by the calculated uncertainty of a calibration that should be as small as is technically possible.
Only when the requirements of a calibration are met is it considered to be fully traceable to the ITS-90 (International Temperature Scale). Any PCR testing laboratory that is accredited under ISO 17025 or ISO 15189 or any manufacturer CE-IVD PCR kit that is certified under ISO 13485 must, according to these international standards, calibrate its thermocyclers in a traceable way and in accordance with ISO 17025.
Lab Compass offers the service of calibration of thermocyclers that allows a true report of the measured value and allows the comparison of the specifications defined by both the laboratory and the manufacturer of the thermal cycler.
The calibration certificate and report are very detailed and contain a wealth of information.
Calibration certificates contain the thermal performance categories that categorize a thermal cycler to operate within or outside the manufacturer and market specifications.
The reports contain a summary table of data, average graph and uniformity chart that are highly informative and give a good overview of the performance of the thermal cycler. In addition to the graphs, reports contain static data tables with detailed information of all probes at time-defined times.
To evaluate the performance of the thermocycler it is advisable not only to review the certificate but also the complete data in the report, especially the summary graphs.
If you are interested in the service, do not hesitate to request information.