Serum P1NP, one of the important biomarkers for bone turnover, is commonly used for the prediction of bone fracture and the prognosis of osteoporosis after therapy. We developed a P1NP chemiluminescence assay and evaluated changes in bone metabolism markers in lung transplant patients. The screened 2 P1NP antibodies with constructed antigens and α-1 chain antigens expressed by the Corynebacterium glutamate expression system were applied into assay development. The assay performance was evaluated to examine the reliability. A normal Q-Q plot was used to establish male reference interval. Changes of bone metabolism markers before and after lung transplantation in 19 patients were evaluated. The linear factor R of P1NP reagent was greater than 0.99. The limit of detection was 3.32 ng/ml. The precision of the three batches of P1NP reagents was lower than 8%. Method comparison with Roche P1NP reagent showed that the correlation coefficient R² was 0.91. In the monitoring of bone mass in a short time, bone metabolism markers can better indicate the change of bone mass, while the traditional bone mineral density detection is lagging behind the bone metabolism markers. P1NP and β-CrossLap to bone mass change in patients after lung transplantation, and P1NP and β-CrossLap are very good clinical markers for bone mass monitoring.

中文翻译：

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I型胶原总N端前肽化学发光法的开发及其在肺移植中的评价

血清 P1NP 是骨转换的重要生物标志物之一，常用于预测骨折和治疗后骨质疏松症的预后。我们开发了一种 P1NP 化学发光测定法，并评估了肺移植患者骨代谢标志物的变化。筛选的2个P1NP抗体与构建的抗原和谷氨酸棒杆菌表达系统表达的α -1 链抗原被应用于检测开发。评估测定性能以检查可靠性。使用正态 QQ 图建立男性参考区间。评价19例患者肺移植前后骨代谢标志物的变化。线性因子RP1NP 试剂的浓度大于 0.99。检测限为 3.32 ng/ml。三批P1NP试剂的精密度均低于8%。与罗氏P1NP试剂的方法比较表明相关系数R ²为0.91。在短时间内对骨量的监测中，骨代谢标志物可以更好地指示骨量的变化，而传统的骨密度检测则落后于骨代谢标志物。P1NP和β -CrossLap对肺移植后患者骨量变化的影响，而P1NP和β -CrossLap是非常好的骨量监测临床标志物。