Most Fast-track diagnostics kits are CE labelled. Reliability is assured through rigorous on-going quality checks and controls, and with a limit of detection as low as 102 copies/ml, sensitivity is comparable with singleplex testing. Sensitivity is tested using both plasmid dilution series and clinical samples obtained from collaboration partners around the world and our kits are not approved until there is less than one dilution step difference between singleplex and multiplex.
Every assay is tested with 66 clinical samples containing 11 gram positive bacteria, 26 gram negative bacteria, 3 parasites, 17 RNA viruses and 9 DNA viruses, so our assays only detect the specific pathogens they target.
Our kits are regularly tested using QCMD and Instand external quality assessment panels. For example over 65 external assessments during 2013-2014, 100% of core samples were detected accurately by our respiratory kits. Occasional missed samples were "infrequently detected" or of "educational value” only:
Results from on-going assessments for a wide range of panels can be supplied on request and viewed by our distributors in the distributor only area.
Our kits are reliable, consistent and precise. Intra- and inter- assay comparisons are regularly made and are shown to be accurate over separate replication tests on different days. As illustrated by these examples for influenza A panels:
Different reagent batches are also tested to ensure consistent PCR run results. For example the parameters illustrated in the table below were tested over three seperate runs and showed consistent results:
Stability and robustness
Finally every assay is tested for stability and robustness for up to 24 months with no significant differences noted:
Every Fast-track diagnositics kit has a Validation file with further detailed information about the above specific to each assay. Validation files are made available to all our customers.