Chen Kai, Wu Dan, Gao Mengdan, Yan Yongfeng, Li Huiqiang
Department of Clinical Laboratory, Tianjin Beichen Hospital, Tianjin, China.
Department of Clinical Immunology, School of Medical Laboratory, Tianjin Medical University, Tianjin, China.
Ann Transl Med. 2021 Sep;9(18):1411. doi: 10.21037/atm-21-3119.
To study the performance of quantitative determination of progesterone by light-initiated chemiluminescent assay (LICA).
Clinical samples of serum were used for detection of progesterone by LICA. The precision study was performed according to Clinical and Laboratory Standards Institute (CLSI) EP15-A3, the linear range validation was performed according to CLSI EP06-A, accuracy was evaluated according to CLSI EP9-A3, and the performance of detection capability was confirmed according to CLSI EP17-A2. All data were analyzed using SPSS software. Function regression analysis was performed by OriginPro software.
The LICA-800 system exhibited low coefficients of variation (CVs) and high reproducibility, and the calculated synthetic CV was 2.16%. The access progesterone assay showed excellent linearity in the assay measuring range (0.37-40 ng/mL) using the polynomial regression method in accordance with CLSI EP06-A. Bias assessment was used to verify accuracy, and the percentage deviation met the quality requirements of the laboratory's allowable deviation of 10.00%. In terms of the detection capability of LICA, the calculated limit of blank (LoB) was 0.046 ng/mL, limit of detection (LoD) was 0.057 ng/mL, and the limit of quantitation (LoQ) value was 0.161 ng/mL.
The competitive LICA provided a highly sensitive, accurate and precise method for measuring serum progesterone level.
研究光启动化学发光分析法（LICA）定量测定孕酮的性能。
采用临床血清样本通过LICA检测孕酮。按照临床和实验室标准协会（CLSI）EP15-A3进行精密度研究，按照CLSI EP06-A进行线性范围验证，按照CLSI EP9-A3评估准确度，按照CLSI EP17-A2确认检测能力性能。所有数据使用SPSS软件进行分析。通过OriginPro软件进行函数回归分析。
LICA-800系统显示出低变异系数（CVs）和高重现性，计算得出的综合CV为2.16%。在分析测量范围（0.37 - 40 ng/mL）内，使用符合CLSI EP06-A的多项式回归方法，孕酮检测显示出良好的线性。采用偏差评估来验证准确度，百分比偏差符合实验室允许偏差10.00%的质量要求。就LICA的检测能力而言，计算得出的空白限（LoB）为0.046 ng/mL，检测限（LoD）为0.057 ng/mL，定量限（LoQ）值为0.161 ng/mL。
竞争性LICA为测量血清孕酮水平提供了一种高度灵敏、准确和精密的方法。
