Analytical Performance of a Novel Latex Turbidimetric Immunoassay, "Nanopia TARC", for TARC/CCL17 Measurement: A Retrospective Observational Study.
Title: | Analytical Performance of a Novel Latex Turbidimetric Immunoassay, "Nanopia TARC", for TARC/CCL17 Measurement: A Retrospective Observational Study. |
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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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Sep2023, Vol. 13 Issue 18, p2935. 13p. – Name: Subject Label: Subject Terms Group: Su Data: *<searchLink fieldCode="DE" term="%22IMMUNOASSAY%22">IMMUNOASSAY</searchLink><br />*<searchLink fieldCode="DE" term="%22ENZYME-linked+immunosorbent+assay%22">ENZYME-linked immunosorbent assay</searchLink><br />*<searchLink fieldCode="DE" term="%22LATEX%22">LATEX</searchLink><br />*<searchLink fieldCode="DE" term="%22ATOPIC+dermatitis%22">ATOPIC dermatitis</searchLink><br />*<searchLink fieldCode="DE" term="%22ALLERGIES%22">ALLERGIES</searchLink> – Name: Abstract Label: Abstract Group: Ab 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 Label: Group: Ab 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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RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.3390/diagnostics13182935 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 13 StartPage: 2935 Subjects: – SubjectFull: IMMUNOASSAY Type: general – SubjectFull: ENZYME-linked immunosorbent assay Type: general – SubjectFull: LATEX Type: general – SubjectFull: ATOPIC dermatitis Type: general – SubjectFull: ALLERGIES Type: general Titles: – TitleFull: Analytical Performance of a Novel Latex Turbidimetric Immunoassay, "Nanopia TARC", for TARC/CCL17 Measurement: A Retrospective Observational Study. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Yamashita, Keita – PersonEntity: Name: NameFull: Takebayashi, Shiori – PersonEntity: Name: NameFull: Murata, Wataru – PersonEntity: Name: NameFull: Hirai, Nao – PersonEntity: Name: NameFull: Ito, Yui – PersonEntity: Name: NameFull: Mitsui, Mayuka – PersonEntity: Name: NameFull: Saito, Mina – PersonEntity: Name: NameFull: Sato, Kei – PersonEntity: Name: NameFull: Terada, Miyuki – PersonEntity: Name: NameFull: Niizeki, Noriyasu – PersonEntity: Name: NameFull: Suzuki, Akira – PersonEntity: Name: NameFull: Ogitani, Kenya – PersonEntity: Name: NameFull: Fujikawa, Toshihiko – PersonEntity: Name: NameFull: Komori, Marie – PersonEntity: Name: NameFull: Inoue, Nozomi – PersonEntity: Name: NameFull: Arai, Norimitsu – PersonEntity: Name: NameFull: Maekawa, Masato IsPartOfRelationships: – BibEntity: Dates: – D: 15 M: 09 Text: Sep2023 Type: published Y: 2023 Identifiers: – Type: issn-print Value: 20754418 Numbering: – Type: volume Value: 13 – Type: issue Value: 18 Titles: – TitleFull: Diagnostics (2075-4418) Type: main |
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