Assay Validation of the Updated Elecsys FT3 III Assay.
Objectives: In April 2022, Roche informed SCL's Southland Hospital laboratory of the launch of an updated Elecsys FT3 III assay. To ensure that the new assay could be implemented without significantly changing the results obtained, assay validation was required. Methods: Forty-five samples were anal...
| Publicado en: | New Zealand Journal of Medical Laboratory Science Vol. 77; no. 2; pp. 95 - 97 |
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| Autores principales: | , |
| Formato: | abstract research Journal Article |
| Publicado: |
New Zealand Institute of Medical Laboratory Science
Jul2023
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=164790083&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 164790083 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 11710195 H2G jtl: New Zealand Journal of Medical Laboratory Science issn: 11710195 maglogo: N pubinfo: dt: Jul2023 vid: 77 iid: 2 pid: 12822 pub: New Zealand Institute of Medical Laboratory Science artinfo: ui: 164790083 164790083 164790083 164790083 ppf: 95 ppct: 2 formats: fmt: @attributes: type: P tig: atl: Assay Validation of the Updated Elecsys FT3 III Assay. aug: au: Gill, Olyvia Elizabeth, Karen affil: University of Otago, Dunedin sug: subj: Biological Assay Diagnosis, Laboratory Autoanalyzers Retrospective Design Record Review Data Analysis Software ab: Objectives: In April 2022, Roche informed SCL's Southland Hospital laboratory of the launch of an updated Elecsys FT3 III assay. To ensure that the new assay could be implemented without significantly changing the results obtained, assay validation was required. Methods: Forty-five samples were analysed; 18 were collected from the Royal College of Pathologists of Australasia (RCPA) Quality Assurance program, and 27 were retrospectively collected from past patient samples. The samples were analysed on the Cobas Pro e801 analyser, first using the reference assay and then analysed again using the updated assay. The two sets of results were compared and analysed using XLSTAT and Analyse-It software to measure the degree of method agreement and the presence of any significant differences between the assays. RCPA Analytical Performance Specifications were used to determine whether the difference between the assays was considered significant. Results: Analysis revealed that the results obtained from the new FT3 assay did not vary significantly from the results from the reference FT3 assay. Passing-Bablok analysis revealed no systemic bias and small levels of proportional bias. The Bland Altman graph identified that, on average, the reference assay produced FT3 results that are 0.151 pmol/L higher than the new assay. The difference between the results from the new FT3 assay compared to the reference assay were below the limits set by the RCPA Analytical Performance Specifications, meaning the differences were insignificant. Conclusion: This assay validation assures us that when SCL's Southland Hospital laboratory starts using the updated Elecsys FT3 III assay, there will be no significant change in the results or how free T3 levels are reported. pubtype: Academic Journal doctype: abstract research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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