QC upgrade and verification for HS-Lenti RT Activity Kit

Sammanfattning: The aim of this project was to present a cost-efficient quality control routine to ensure thefunctionality of HS-Lenti RT Activity Kit, an ELISA-based kit produced by Cavidi AB, thatscreens for lentiviruses such as HIV. Two main methods for quality control are presented inthis report; acceptance sampling and Statistical Process Control (SPC). Acceptance samplingis a process where only parts of a batch are tested in order to determine whether or not thewhole batch should be accepted or rejected. SPC centers around monitoring an ongoingprocess by using statistical measures and charts which visualize variations in these measuresover time. Initially, using an acceptance sampling plan is recommended as the primaryapproach. SPC charts can then be set up using the data generated from the acceptancesampling, and be used in parallel with the acceptance sampling for some time until they canbe implemented to a wider extent. This report also presents different options forimmunoassay data processing. Bayesian methods of estimating analyte concentrations inunknown samples are highlighted as promising candidates in improving the performance andusability of the kit. The report also includes a customer requirements analysis, based on aconducted survey, that investigates the demands researchers within Uppsala University placeon products similar to HS-Lenti RT Activity Kit. The data which the analysis is based on wasobtained from an online questionnaire and three interviews. An ethical analysis regarding thequality control approach and survey is included as well.