Extended in-use stability of Krebs von den Lungen-6 (KL-6) reagents, quality controls, and calibrators under refrigerated conditions
DOI:
https://doi.org/10.63719/imrj.2026.12.02.003Keywords:
KL-6, Krebs von den Lungen-6, Nanopia, stability, extendedAbstract
Reliable diagnostic testing depends on the stability of assay compo-nents, including reagents, quality controls (QCs), and calibrators. For the Nanopia KL-6 assay used in interstitial lung disease (ILD) assessment, the manufacturer states that in-use stability is limited to 1 month for reagents and QCs and approximately 2.5 months for calibrators at 2–8°C. This study evaluated the extended in-use stability of Nanopia KL-6 reagents, QCs, and calibrators for up to four months under refrigerated conditions. Extended stability testing was performed at seven prede-fined time points (T0–T6) over 132 days. Reagent stability was assessed using in-use QC materials at two concentration levels. QC stability was evaluated by aliquoting and testing stored QC material over time. Cali-brators stability was assessed across four concentration levels using bias analyses. Reagents and QCs demonstrated acceptable analytical stability for up to 132 days, with increasing bias observed beyond Day 90. All calibrator levels remained stable for up to 132 days with minimal bias (<10%). Nanopia KL-6 reagents, QCs and all calibrator levels remain sta-ble for up to 132 days when stored at 2–8°C, provided appropriate qual-ity monitoring is implemented.
References
Clinical and Laboratory Standards Institute. Evaluation of stability of in vitro medical laboratory test reagents. 2nd ed. CLSI guideline EP25. Clinical and Laboratory Standards Institute; 2023 [cit-ed 2024, January 26]. Available from: https://clsi.org/shop/standards/ep25/.
Ikeda K, Ichihara K, Hashiguchi T, Hidaka Y, Kang D, Maekawa M, et al. Evaluation of the short-term stability of specimens for clinical laboratory testing. Biopreserv Biobank. 2015;13(2):135–143. doi:10.1089/bio.2014.0072.
Sakai M, Kubota T, Ohnishi H, Yokoyama A. A novel lung injury animal model using KL-6-measurable human MUC1-expressing mice. Biochem Biophys Res Commun. 2013;432(3):460–465. doi:10.1016/j.bbrc.2013.01.123.
Zhou A, Tang H, Peng W, Wang Y, Tang X, Yang H, et al. KL-6 levels in the connective tissue disease population: typical values and potential confounders—a retrospective, real-world study. Front Immunol. 2023;14:1098602. doi:10.3389/fimmu.2023.1098602.
Sekisui Medical Co., Ltd. Nanopia KL-6 reagent [package insert]. Tokyo: Sekisui Medical Co., Ltd.; 2019 [cited 2024 Jan 26]. Available from: https://www.sekisuimedical.jp/english/business/diagnostics/immunology/n_kl/pdf/202138- 005_Nanopia_KL-6.pdf
Zander J, Bruegel M, Kleinhempel A, Becker S, Petros S, Kortz L, et al. Effect of biobanking condi-tions on short-term stability of biomarkers in human serum and plasma. Clin Chem Lab Med. 2014;52(5):629–639. doi:10.1515/cclm-2013-0705.
Pum JKW. Evaluating sample stability in the clinical laboratory with the help of linear and non-linear regression analysis. Clin Chem Lab Med. 2020;58(2):188–196. doi:10.1515/cclm-2019-0596.
Dakappagari N, Zhang H, Stephen L, Amaravadi L, Khan MU. Recommendations for clinical bi-omarker specimen preservation and stability assessments. Bioanalysis. 2017;9(8):643–653. doi:10.4155/bio-2017-0009.
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Copyright (c) 2026 Noor Hafizah Hassan, Ili Karmila Norazli, Siti Nurwani Ahmad Ridzuan, Muhammad Nursyazwan Zamre, Nurul Izzati Hamzan, Hamadah Mohammad Shariff, Fadzlyasraf Shaari, Hanna Nadhirah Mohd Radzi, Anasufiza Habib (Author)
This work is licensed under a Creative Commons Attribution 4.0 International License.
