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

• Published in: Diagnostics (Basel) Vol. 13; no. 18; p. 2935
• Main Authors: Yamashita, Keita, Takebayashi, Shiori, Murata, Wataru, Hirai, Nao, Ito, Yui, Mitsui, Mayuka, Saito, Mina, Sato, Kei, Terada, Miyuki, Niizeki, Noriyasu, Suzuki, Akira, Ogitani, Kenya, Fujikawa, Toshihiko, Komori, Marie, Inoue, Nozomi, Arai, Norimitsu, Maekawa, Masato
• Format: Journal Article
• Language: English
• Published: Basel MDPI AG 01.09.2023; MDPI
• Subjects: Accuracy; Antigens; Asthma; Atopic dermatitis; Automation; biomarker; Biomarkers; CCL17; Chemokines; Disease; Enzymes; Immunoassay; latex turbidimetric immunoassay; Measurement; Medical laboratories; Observational studies; Patient compliance; TARC; Japan; Israel
• ISSN: 2075-4418; 2075-4418
• DOI: 10.3390/diagnostics13182935

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.