Testing of kits
We test kits for detection of a wide variety of papillomaviruses (skin, mucosal and animal) on the manufacturer’s or distributor’s written request.
Anyone interested has to submit the manufacturer’s instructions provided with the kit (in both Czech and English) and then NRL will let him know how many kits are needed for the tests. An adequate number of kits is to be supplied free of charge. If any extra equipment unavailable in NRL is needed for testing the kits, the interested person has to lend such equipment to NRL free of charge for the period of time required to carry out the respective tests.
The kits are tested for suitability for use in the Czech Republic (the range of detectable PV types), assay feasibility (needs for equipment that is not part of the kit, space demands, skills required for performing the assay, kit packaging, package insert), sensitivity, specificity, reproducibility (only if two kits with different serial numbers are provided).
The kits submitted will be compared with those previously tested by FDA and/or those CE certified.
NRL will have 1 month to produce the report and to send it to the manufacturer (distributor).
NRL reserves the right to report on the kit quality in the event that the manufacturer/distributor is marketing the kit in the Czech Republic, e.g. on Consulting days, in Newsletters of the Centre of Epidemiology and Microbiology and on other working forums.