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Review article

One method – two instruments. Analytical performance of electrochemiluminescent assay for he4 in serum

Sanja Dobrijević ; Department of Medical Biochemistry in Oncology, University Hospital for Tumors, Sestre milosrdnice University Hospital Center, Zagreb, Croatia
Zvjezdana Špacir Prskoalo   ORCID icon orcid.org/0000-0002-4519-8183 ; Department of Medical Biochemistry in Oncology, University Hospital for Tumors, Sestre milosrdnice University Hospital Center, Zagreb, Croatia
Mihaela Gaće ; Department of Medical Biochemistry in Oncology, University Hospital for Tumors, Sestre milosrdnice University Hospital Center, Zagreb, Croatia
Ljiljana Mayer

Fulltext: english, pdf (248 KB) pages 15-21 downloads: 111* cite
APA 6th Edition
Dobrijević, S., Špacir Prskoalo, Z., Gaće, M. & Mayer, Lj. (2015). One method – two instruments. Analytical performance of electrochemiluminescent assay for he4 in serum. Libri Oncologici, 43 (1-3), 15-21. Retrieved from https://hrcak.srce.hr/189800
MLA 8th Edition
Dobrijević, Sanja, et al. "One method – two instruments. Analytical performance of electrochemiluminescent assay for he4 in serum." Libri Oncologici, vol. 43, no. 1-3, 2015, pp. 15-21. https://hrcak.srce.hr/189800. Accessed 20 Sep. 2019.
Chicago 17th Edition
Dobrijević, Sanja, Zvjezdana Špacir Prskoalo, Mihaela Gaće and Ljiljana Mayer. "One method – two instruments. Analytical performance of electrochemiluminescent assay for he4 in serum." Libri Oncologici 43, no. 1-3 (2015): 15-21. https://hrcak.srce.hr/189800
Harvard
Dobrijević, S., et al. (2015). 'One method – two instruments. Analytical performance of electrochemiluminescent assay for he4 in serum', Libri Oncologici, 43(1-3), pp. 15-21. Available at: https://hrcak.srce.hr/189800 (Accessed 20 September 2019)
Vancouver
Dobrijević S, Špacir Prskoalo Z, Gaće M, Mayer Lj. One method – two instruments. Analytical performance of electrochemiluminescent assay for he4 in serum. Libri Oncologici [Internet]. 2015 [cited 2019 September 20];43(1-3):15-21. Available from: https://hrcak.srce.hr/189800
IEEE
S. Dobrijević, Z. Špacir Prskoalo, M. Gaće and Lj. Mayer, "One method – two instruments. Analytical performance of electrochemiluminescent assay for he4 in serum", Libri Oncologici, vol.43, no. 1-3, pp. 15-21, 2015. [Online]. Available: https://hrcak.srce.hr/189800. [Accessed: 20 September 2019]

Abstracts
Human epididymis protein 4 (HE4) is a tumor marker approved by authority organizations in clinical chemistry for the detection and monitoring recurrence of ovarian cancer. Before the assay becomes part of standard laboratory practice, every laboratory has to confi rm the analytical performance of the assay, declared by its manufacturers. The verifi cation of the analytical performance of the electrochemiluminescent assay was performed on 2 analytical platforms produced by the same manufacturer. Within-run (reapeatability) and within-laboratory precision were determined in accordance with the
CLSI EP15 protocol on both analyzers. The linearity study was determined in accordance with the CLSI EP6 protocol. The
Roche HE4 assays showed excellent within-run and within-laboratory precision (CV< 4%). Within-run precision at 2 concentration
levels is the same on both analyzers (2.1% CV and 1.2% CV). Within-laboratory precision was CV3.3 %, and 2.8% on Elecsys, respectively, 2.8% and 3.4 % on Cobas e411. The HE4 assay on Elecsys showed good linearity (r2=0,99), within the range of 53 to 982 pmol/L. Completely automated analytical systems for determining HE4 in serum, Elecsys and Cobase411 that were verifi ed in this research have shown remarkable analytical characteristics and they meet all the analytical
goals necessary for their introduction to laboratory practice.

Keywords
HE4; analytical performance; verification; precision; linearity

Hrčak ID: 189800

URI
https://hrcak.srce.hr/189800

[croatian]

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