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

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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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  Data: Analytical Performance of a Novel Latex Turbidimetric Immunoassay, "Nanopia TARC", for TARC/CCL17 Measurement: A Retrospective Observational Study.
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  Data: <searchLink fieldCode="AR" term="%22Yamashita%2C+Keita%22">Yamashita, Keita</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> keitay@hama-med.ac.jp</i><br /><searchLink fieldCode="AR" term="%22Takebayashi%2C+Shiori%22">Takebayashi, Shiori</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> w.murata@hama-med.ac.jp</i><br /><searchLink fieldCode="AR" term="%22Murata%2C+Wataru%22">Murata, Wataru</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> hirai-n@hama-med.ac.jp</i><br /><searchLink fieldCode="AR" term="%22Hirai%2C+Nao%22">Hirai, Nao</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> itoyui@hama-med.ac.jp</i><br /><searchLink fieldCode="AR" term="%22Ito%2C+Yui%22">Ito, Yui</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> mayuka@hama-med.ac.jp</i><br /><searchLink fieldCode="AR" term="%22Mitsui%2C+Mayuka%22">Mitsui, Mayuka</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> mina.s@hama-med.ac.jp</i><br /><searchLink fieldCode="AR" term="%22Saito%2C+Mina%22">Saito, Mina</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> keis2@hama-med.ac.jp</i><br /><searchLink fieldCode="AR" term="%22Sato%2C+Kei%22">Sato, Kei</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> tmyk17@hama-med.ac.jp</i><br /><searchLink fieldCode="AR" term="%22Terada%2C+Miyuki%22">Terada, Miyuki</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> niizeki@hama-med.ac.jp</i><br /><searchLink fieldCode="AR" term="%22Niizeki%2C+Noriyasu%22">Niizeki, Noriyasu</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> suzukia@hama-med.ac.jp</i><br /><searchLink fieldCode="AR" term="%22Suzuki%2C+Akira%22">Suzuki, Akira</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> k.ogi@hama-med.ac.jp</i><br /><searchLink fieldCode="AR" term="%22Ogitani%2C+Kenya%22">Ogitani, Kenya</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Fujikawa%2C+Toshihiko%22">Fujikawa, Toshihiko</searchLink><relatesTo>2</relatesTo> (AUTHOR)<i> fujikawa@sekisui.com</i><br /><searchLink fieldCode="AR" term="%22Komori%2C+Marie%22">Komori, Marie</searchLink><relatesTo>2</relatesTo> (AUTHOR)<i> marie.komori@sekisui.com</i><br /><searchLink fieldCode="AR" term="%22Inoue%2C+Nozomi%22">Inoue, Nozomi</searchLink><relatesTo>2</relatesTo> (AUTHOR)<i> nozomi.inoue@sekisui.com</i><br /><searchLink fieldCode="AR" term="%22Arai%2C+Norimitsu%22">Arai, Norimitsu</searchLink><relatesTo>2</relatesTo> (AUTHOR)<i> n.arai@sekisui.com</i><br /><searchLink fieldCode="AR" term="%22Maekawa%2C+Masato%22">Maekawa, Masato</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> keitay@hama-med.ac.jp</i>
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– Name: Abstract
  Label: Abstract
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  Data: 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]
– Name: AbstractSuppliedCopyright
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  Data: <i>Copyright of Diagnostics (2075-4418) is the property of MDPI and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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