PROPRIETARY INFORMATIONCONFIDENTIAL MATERIALAssays/Reagents Not for Customer Distribution90 AEROSET ® System Troubleshooting Guide94816-107—November 2004Frequently Asked Questions (FAQ)Question ResponseWhy are Phenytoin precision data from onlytwo instruments included in the packageinsert?Because of instrument issues, data from onlytwo instruments will be included in thepackage insert but additional studies are beingperformed for inclusion at a later date.Why are AEROSET precision data differentthan the c 8000® precision data presented?Precision was performed for all four TDMassays at the same time on both the c 8000and AEROSET Systems. Testing was repeatedon the AEROSET for all four assays because ofadditional requirements for a daily blankcalibration and calibration with each newwedge.Why is it now necessary to calibrate with eachnew reagent cartridge?It is necessary to recalibrate with each newcartridge to optimize performance, and toachieve 28 days reagent onboard stability and14 days calibration stability. Also, thiseliminates the need to recap reagentcartridges and place them back in therefrigerator, which is necessary with othervendor products, such as Olympus.How is Abbott’s precision claim determined? Abbott’s package insert claim for totalprecision is CV < 7% for Carbamazepine andPhenobarbital, and CV < 8% for Phenytoinand Theophylline. These are based on initialproduct requirements used in productdevelopment. The validation and verificationtesting demonstrated total precision of lessthan 7%. Representative data are included inthe package insert.What is the benefit of running a blankcalibration (using CAL 1) once each day ofassay use?It provides an additional level of robustness toassay performance.Why was the method comparison datachanged from the previous package insert?Slope, correlation coefficient, and Y-interceptwere recalculated using least squaresregression; this aligns with the method usedto calculate c 8000 data.Was there a change to the TDM onboardstability?Yes, changes were made to provide anadditional level of robustness to onboardstability.
