ORIGINAL RESEARCH article
Front. Med.
Sec. Precision Medicine
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1487557
Analytical evaluation of the performances of point-of-care and benchtop procalcitonin assays in comparison with the B• R• A• H• M• S PCT sensitive KRYPTOR assay
Provisionally accepted
- Jiahui International Hospital, Shanghai, China
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Background: Procalcitonin (PCT) is increasingly utilized in clinical laboratories, leading to the proliferation of commercial PCT assays. However, not all of these assays are traceable to the B•R•A•H•M•S PCT standard, which is integral to established PCT clinical algorithms. This study evaluates the suitability of three non-B•R•A•H•M•S PCT assays for the application of these algorithms.The study assessed PCT assays from Wondfo (PCT-W), Getein (PCT-G), and Snibe (PCT-S), comparing them to the BAnalytical performance, including linearity, imprecision, and recovery, was evaluated. Additionally, a method comparison study involving 350 routine serum samples was conducted to assess agreement, bias, and correlation with the KRYPTOR assay.The KRYPTOR assay exhibited a maximum imprecision of 4.65%, while Wondfo, Getein, and Snibe showed higher imprecision at 8.38%, 10.25%, and 15.67%, respectively. Wondfo and Getein assays exceeded the maximum allowable deviation from linearity, and the Snibe assay failed the recovery assessment. Passing-Bablok regressions for low-range samples indicated significant bias for Wondfo (PCT-W = 0.663 PCT-KR + 0.076) and Getein (PCT-G = 0.838 PCT-KR -0.06). Agreement with the KRYPTOR assay was Kc=0.83 and Kc=0.87 for Wondfo and Getein, respectively, with substantial agreement in lower respiratory tract infections (LRTI) at Kc=0.78 and Kc=0.65. The Snibe assay showed better overall agreement (PCT-S = 1.002 PCT-KR -0.069), with Kc=0.92 for sepsis and Kc=0.76 for LRTI.Conclusions: Despite high overall agreement with the KRYPTOR assay, the evaluated assays (Wondfo, Getein, and Snibe) exhibit insufficient analytical performance at low PCT concentrations, which may limit their reliability in the diagnosis and management of sepsis and LRTI
Keywords: Procalcitonin1, Algorithms2, Respiratory tract infections3, sepsis4, Comparison5
Received: 03 Sep 2024; Accepted: 27 May 2025.
Copyright: © 2025 He, Sun, Su, Zhu, Wu and Hou. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Xiaobing Sun, Jiahui International Hospital, Shanghai, China
Jiong Wu, Jiahui International Hospital, Shanghai, China
Qi Hou, Jiahui International Hospital, Shanghai, China
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