He Ruiqing, Sun Xiaobing, Su Ling, Zhu Ting, Wu Jiong, Hou Qi
Department of Clinical Laboratory, Shanghai Jiahui International Hospital, Shanghai, China.
Front Med (Lausanne). 2025 Jun 17;12:1487557. doi: 10.3389/fmed.2025.1487557. eCollection 2025.
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 B⋅R⋅A⋅H⋅M⋅S PCT sensitive KRYPTOR assay (PCT-KR). Analytical 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.
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.
降钙素原（PCT）在临床实验室中的应用越来越广泛，导致商业化PCT检测方法激增。然而，并非所有这些检测方法都可溯源至B⋅R⋅A⋅H⋅M⋅S PCT标准，而该标准是既定PCT临床算法不可或缺的一部分。本研究评估了三种非B⋅R⋅A⋅H⋅M⋅S PCT检测方法在这些算法应用中的适用性。
该研究评估了万孚（PCT-W）、基蛋（PCT-G）和新波（PCT-S）的PCT检测方法，并将它们与B⋅R⋅A⋅H⋅M⋅S PCT敏感型KRYPTOR检测方法（PCT-KR）进行比较。评估了包括线性、不精密度和回收率在内的分析性能。此外，进行了一项涉及350份常规血清样本的方法比较研究，以评估与KRYPTOR检测方法的一致性、偏差和相关性。
KRYPTOR检测方法的最大不精密度为4.65%，而万孚、基蛋和新波分别显示出更高的不精密度，为8.38%、10.25%和15.67%。万孚和基蛋检测方法超出了线性的最大允许偏差，新波检测方法未通过回收率评估。低浓度样本的Passing-Bablok回归表明，万孚（PCT-W = 0.663 PCT-KR + 0.076）和基蛋（PCT-G = 0.838 PCT-KR - 0.06）存在显著偏差。万孚和基蛋与KRYPTOR检测方法的一致性分别为Kc = 0.83和Kc = 0.87，在下呼吸道感染（LRTI）中一致性较高，分别为Kc = 0.78和Kc = 0.65。新波检测方法显示出更好的总体一致性（PCT-S = 1.002 PCT-KR - 0.069），在脓毒症中Kc = 0.92，在LRTI中Kc = 0.76。
尽管与KRYPTOR检测方法总体一致性较高，但所评估的检测方法（万孚、基蛋和新波）在低PCT浓度下分析性能不足，这可能会限制它们在脓毒症和LRTI诊断及管理中的可靠性。
