The new Coronavirus pandemic challenged laboratories to introduce new routines for Covid-19 testing in a short period of time. Even with little knowledge about the disease and with the recent arrival of diagnostic kits on the market, validation protocols are necessary for this stage.
In addition to meeting regulatory requirements, the entire laboratory must perform the verification and validation of its analytical system before inserting it into its routine. These practices must also be carried out periodically in order to: measure the present errors and determine with certainty whether they affect the results or not; identify significant changes in its processes and obtain objective evidence that the system or method adequately produces a result that meets predetermined requirements.
Those responsible must manage the tests, analyze the results obtained, prepare the report and decide whether the performance of the system or method has been approved. In support of these routines, Controllab provides services that optimize time and add more confidence to the evaluation of the analytical quality cycle.
For laboratories that search for Covid-19 antibodies through automation serology tests and/or Rapid Diagnostic Test (TLR), the Performance Panel and batch-to-batch Validation are available.
These are solutions that help laboratories, suppliers and manufacturers of diagnostic kits. See the functions:
Performance Panel: used to evaluate and validate new test methods and equipment, the service demonstrates the reliability of the systems. Composed of positive and negative items, with varied concentrations and heterologous items obtained from different donors from the regions of Brazil, this panel is previously assessed by different analysis methodologies. The use of little relative control materials allows to obtain valuable information regarding the analytical capacity of the laboratory and the variations between reagent batches.
Batch-to-batch Validation/Shipment: Verifies the proximity of the results obtained with the new lot and the current lot to detect any significant deviation in reagent performance, and then defines whether the reagent lot needs to be replaced.