engleski

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

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.

HE4 ; analytical performance ; verification ; precision ; linearity

nije evidentirano