| Title: |
Analytical Performance of a Novel Latex Turbidimetric Immunoassay, "Nanopia TARC", for TARC/CCL17 Measurement: A Retrospective Observational Study. |
| Authors: |
Yamashita, Keita1 (AUTHOR) keitay@hama-med.ac.jp, Takebayashi, Shiori1 (AUTHOR) w.murata@hama-med.ac.jp, Murata, Wataru1 (AUTHOR) hirai-n@hama-med.ac.jp, Hirai, Nao1 (AUTHOR) itoyui@hama-med.ac.jp, Ito, Yui1 (AUTHOR) mayuka@hama-med.ac.jp, Mitsui, Mayuka1 (AUTHOR) mina.s@hama-med.ac.jp, Saito, Mina1 (AUTHOR) keis2@hama-med.ac.jp, Sato, Kei1 (AUTHOR) tmyk17@hama-med.ac.jp, Terada, Miyuki1 (AUTHOR) niizeki@hama-med.ac.jp, Niizeki, Noriyasu1 (AUTHOR) suzukia@hama-med.ac.jp, Suzuki, Akira1 (AUTHOR) k.ogi@hama-med.ac.jp, Ogitani, Kenya1 (AUTHOR), Fujikawa, Toshihiko2 (AUTHOR) fujikawa@sekisui.com, Komori, Marie2 (AUTHOR) marie.komori@sekisui.com, Inoue, Nozomi2 (AUTHOR) nozomi.inoue@sekisui.com, Arai, Norimitsu2 (AUTHOR) n.arai@sekisui.com, Maekawa, Masato1 (AUTHOR) keitay@hama-med.ac.jp |
| Source: |
Diagnostics (2075-4418). Sep2023, Vol. 13 Issue 18, p2935. 13p. |
| Subject Terms: |
*IMMUNOASSAY, *ENZYME-linked immunosorbent assay, *LATEX, *ATOPIC dermatitis, *ALLERGIES |
| Abstract: |
Thymus- and activation-regulated chemokine (TARC, also known as CCL17) is used as a biomarker for atopic dermatitis. The methods currently used for its measurement are complex, time-consuming, and require large machinery, warranting the need for a method that is simple, has a quick turnaround time, and requires less complex machinery. We evaluated the analytical performance of a novel latex turbidimetric immunoassay method, "Nanopia TARC", on 174 residual serum samples from patients with skin or allergic diseases. This evaluation included the assessment of the limit of blank/detection/quantification (LOB/D/Q), precision, accuracy, linearity, interference, and commutability between Nanopia TARC and "HISCL TARC", based on the chemiluminescent enzyme immunoassay (CLEIA) method. The LOB/D/Q values were 13, 57, and 141 pg/mL, respectively. The coefficient of variation of the repeatability was 0.9–3.8%, and that of the intermediate precision was 2.1–5.4%. The total error of the accuracy was 1.9–13.4%. The linearity was 141 and 19,804 pg/mL for TARC. The correlation coefficient between Nanopia TARC and HISCL TARC determined using the Passing–Bablok regression analysis was 0.999. Furthermore, the concordance of diagnostic criteria with AD was 92%. Nanopia TARC was confirmed to have the same analytical performance for TARC measurement as the existing CLEIA method. [ABSTRACT FROM AUTHOR] |
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