Analytical Performance of a Novel Latex Turbidimetric Immunoassay, “Nanopia TARC”, for TARC/CCL17 Measurement: A Retrospective Observational Study

Author:

Yamashita Keita1ORCID,Takebayashi Shiori1,Murata Wataru1,Hirai Nao1,Ito Yui1,Mitsui Mayuka1,Saito Mina1,Sato Kei1,Terada Miyuki1,Niizeki Noriyasu1,Suzuki Akira1ORCID,Ogitani Kenya1,Fujikawa Toshihiko2,Komori Marie2ORCID,Inoue Nozomi2,Arai Norimitsu2,Maekawa Masato1ORCID

Affiliation:

1. Department of Laboratory Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3192, Japan

2. Diagnostic Products Development, Department Research & Development, Sekisui Medical Co., Ltd., Tokyo 103-0027, Japan

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.

Funder

Sekisui Medical Co., Ltd.

Department of Laboratory Medicine, Hamamatsu University School of Medicine

Publisher

MDPI AG

Subject

Clinical Biochemistry

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