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HbA1c – En jämförelse mellan två nya analysmetoder gentemot en befintlig
Kristianstad University, School of Education and Environment.
2018 (Swedish)Independent thesis Basic level (university diploma), 10 credits / 15 HE creditsStudent thesis
Abstract [sv]

Glykerat hemoglobin, HbA1c, är en indikation på genomsnittligt glukosvärde. HbA1c används vid diagnostisering av diabetes men också uppföljning av diagnostiserade diabetiker. Uppföljningen visar hur väl diabetiker förhåller sig till kost men också medicinering. Informationen av patientens HbA1c värde spelar en stor roll i vidare behandlingar. Analysmetoden HbA1c är inte helt standardiserad vilket har medfört att flera analysmetoder utvecklats för HbA1c.

Syftet med denna studie var att undersöka om en enzymatisk, Direct enzymatic HbA1c eller immunologisk analysmetod, Hemoglobin A1c kan lösa problemet med hemoglobin-variationer vid analys av HbA1c som idag analyseras med HPLC som rutin på klinisk kemi-laboratorium i Västerås.

Genomförandet gjordes på två instrument, TOSOH G7 och AU 680. TOSOH:s värden (HPLC) användes vid jämförelse av de två analysmetoderna på AU680. Förberedelse och behandling, såsom hemolysering, skedde innan proven sattes i instrumentet AU680.

Resultatet (n=134) visade att analysmetoden Hemoglobin A1c förhöll sig väl till HPLC analysmetod (R

2=0,98) jämfört med vad analysmetoden Direct enzymatic HbA1c gjorde (R2=0,86). Likartade resultat kunde observeras för Hemoglobin A1c (R2=0,98) och Direct enzymatic Hba1c (R2=0,95) då bara patientprov med hemoglobin-varianter analyserades (n=10). Mann-Whitney’s U-test vid analys av hemoglobin varianter med Hemoglobin A1c visade en tendens till signifikant skillnad gentemot HPLC analysen (p=0,051; n=34).

Fel reagens erhölls från reagenstillverkaren gällande Direct enzymatic, Detta kan förklara det erhållna resultatet och kräver fler analyser med korrekta reagens. Hemoglobin A1c bör även undersökas vidare med mer omfattande provmaterial för möjlig standardisering i rutin hos KKTM i Västerås.

Abstract [en]

Glycated hemoglobin, HbA1c, is an indication of average long-term glucose. HbA1c is used as a diagnostic method for diabetes but also as a follow-up for diagnosed diabetics. Follow-ups shows how well a diabetic relates to diet but also medication. The information of the patient's HbA1c value plays an important factor in further treatments. The analysis method for HbA1c is not standardized, which has resulted in several analysis methods developed for HbA1c.

The purposes of this study were to investigate whether an enzymatic, Direct enzymatic HbA1c or immunological assay method, Hemoglobin A1c, can solve the problem of hemoglobin variations in the analysis of HbA1c, which is currently analyzed by HPLC as a routine at the clinical chemistry laboratory in Västerås

The implementation was performed on two instruments, TOSOH G7 and AU 680. The values from TOSOH (HPLC) were used for comparison of the two analysis methods applied on the AU680. Preparation and treatment, such as hemolysis, occurred before putting the samples into the AU680 instrument.

The result showed that the Hemoglobin A1c assay method was well-matched with HPLC assay (R2 = 0.98) in comparison to that of the Direct enzymatic HbA1c assay method (R2 = 0.86). Similar results could be observed for Hemoglobin A1c (R2 = 0.98) and Direct Enzyme HbA1c (R2 = 0.95) when only samples from patients with hemoglobin variants were analyzed (n=10). Solely analysis of hemoglobin variants with Hemoglobin A1c showed a boundary case for a significant difference compared to HPLC analysis (P = 0.051; n=134).

Incorrect reagents were obtained from the reagent manufacturer in the case of Direct enzymatic. This can explain the results obtained. Hemoglobin A1c should also be investigated with more extensive test materials for possible standardization in the routine of KKTM in Västerås.

Place, publisher, year, edition, pages
2018. , p. 23
Keywords [en]
HbA1c, enzymatic assay method, immunological assay method, diabetes Mellitus, HPLC assay method
Keywords [sv]
HbA1c, enzymatisk analysmetod, immunologisk analysmetod, diabetes Mellitus, HPLC analysmetod
National Category
Biomedical Laboratory Science/Technology
Identifiers
URN: urn:nbn:se:hkr:diva-17858OAI: oai:DiVA.org:hkr-17858DiVA, id: diva2:1181144
Educational program
Bachelor of Science in Biomedical Laboratory Science
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Examiners
Available from: 2018-02-08 Created: 2018-02-07 Last updated: 2018-02-08Bibliographically approved

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