Primerjava različnih analiznih kriterijev za sprejemljivost rezultatov notranje kontrole pri izbranih imunokemijskih metodah

Triplat, Katjuša (author), Jerin, Aleš (mentor)

Za varno in kakovostno obravnavo je izrednega pomena kakovost medicinskega laboratorija. Z vzpostavitvijo celovitega sistema kakovosti, ki omogoča spremljanje in obvladovanje vseh faz procesa, zagotavljamo kakovostne laboratorijske storitve. Vzpostaviti moramo sistem, ki bo v skladu z našimi zmožnostmi in bo odkril klinično pomembne napake. Doseganje predvidene kakovosti preverjamo z vpeljavo in vodenjem kontrol kakovosti, a si moramo pri tem postaviti jasne cilje. Eno izmed priporočil pri postavitvi ciljev je izbira ustreznih pravil notranje kontrole kakovosti, ki temelji na izbiri ustreznega kontrolnega materiala, postavitvi ciljnih vrednosti in intervala sprejemljivosti, izbiri izvajanja časovnega okvira, uporabi ustreznih statističnih pravil ter postopku ukrepanja ob odstopanju kontrol kakovosti. Namen magistrske naloge je bil narediti primerjavo različnih analitskih kriterijev za sprejemljivost rezultatov notranje kontrole kakovosti pri imunokemijskih metodah za tumorske označevalce CYFRA21-1, CA72 – 4, AFP, TESTO in fßHCG. Zanimalo nas je, ali se pri kontrolnem materialu za notranjo kontrolo kakovosti proizvajalčeve povprečne vrednosti razlikujejo od naših lastnih vrednosti in ali je delež zavrnjenih rezultatov notranje kontrole kakovosti višji pri uporabi lastnih mej za sprejemljivost rezultatov. Zbrane podatke smo statistično obdelali v programu Acusera 24-7. Primerjali smo rezultate proizvajalčevih povprečnih vrednosti in mej s proizvajalčevimi povprečnimi vrednostmi in lastnimi mejami, lastnimi povprečnimi vrednostmi in proizvajalčevimi mejami, lastnimi povprečnimi vrednostmi in mejami, lastnimi povprečnimi vrednostmi, mejami in pravili ter kumulativnimi povprečnimi vrednostmi in mejami ter ocenili porazdelitev kontrolnih rezultatov. S primerjavo rezultatov z uporabo enega pravila 13s z rezultati, kjer smo uporabili več dodatnih pravil hkrati, smo ocenili delež zavrnitve kontrolnih rezultatov. Ugotovili smo, da se povprečne vrednosti proizvajalca le malo razlikujejo od lastnih povprečnih vrednosti, razlike so bile statistično značilne ter delež zavrnjenih rezultatov notranje kontrole kakovosti je bil višji pri uporabi lastnih mej. Proizvajalčeve meje so bile postavljene širše. Lastne meje so pridobljene znotraj laboratorija, določene so za vsak koncentracijski nivo posebej, prikažejo dejansko učinkovitost metode. Uporaba dodatnih pravil kontrole kakovosti je povečala stopnjo zavrnitve podatkov ob uporabi proizvajalčevih vrednosti.

• Language: Slovenian
• Keywords: notranja kontrola kakovosti, Westgardova pravila, imunokemijske metode, tumorski označevalci.
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2021
• PID: 20.500.12556/RUL-126277
• Publication date in RUL: 14.04.2021

Secondary language

• Language: English
• Title: Comparison of different analytical criteria for acceptability of internal control results obtained with selected immunochemical methods

Abstract

To ensure that work is performed safely and at a high level of quality, a medical laboratory must be of the highest possible calibre. By establishing a comprehensive quality control system that enables the monitoring and control of all phases of a process, we can provide high-quality laboratory services. A system must be established that is in line with our capacities and that can detect clinically significant errors. To verify whether the envisaged level of quality has been achieved, quality control processes are introduced and managed, whereby clear objectives must be set. One of the recommendations for setting objectives is the selection of suitable internal quality control rules based on selecting the appropriate control material, setting target values and acceptance intervals, selecting an implementation timeframe, using suitable statistical models and intervention techniques for quality control deviations. The purpose of the master's thesis was to compare a variety of analytical criteria for the acceptability of internal quality control results in immunochemical methods for tumour markers CYFRA21-1, CA72–4, AFP, TESTO and fßHCG. We aimed to determine whether the control material used for the internal quality control of the manufacturer's average values differed from our values, and whether the number of rejected internal quality control results was higher when applying our limits for acceptable results. The data collected was statistically processed using the Acusera 24-7 program. We compared the results of the manufacturer’s average values and limits with the manufacturer’s average values and our limits, our average values and the manufacturer’s limits, our average values and limits, our average values, limits and rules, and the cumulative average values and limits, and assessed the distribution of the control results. By comparing the results using a single rule (13s) with the results where we used several additional rules simultaneously, we assessed the number of rejected control results. We found that the manufacturer's average values differed only slightly from our own average values, but the differences were statistically significant and the number of rejected internal quality control results was higher when applying our own limits. The manufacturer's limits were set wider. Our limits are obtained within the laboratory, are defined for each individual concentration level and show the actual effectiveness of the method. Applying additional quality control rules increased the data rejection rate when using the manufacturer's values.

• Keywords: internal quality control, Westgard rules, immunochemical methods, tumour markers.