The metabolic product of type I collagen synthesis, intact procollagen type I N propeptide (intact PINP), is a potential marker of bone formation and osteoporosis, which is not affected by kidney function. We sought to establish a chemiluminescent immunoassay method for the detection of serum intact PINP with previously prepared paired monoclonal antibodies and to evaluate the diagnostic value of the assay in osteoporosis. Using the capture molecule and monoclonal antibody as detection molecule, a diagnostic reagent was developed to detect intact PINP in serum with magnetic nanosphere carriers by the chemiluminescence method, and its analytical performance in the laboratory was evaluated. Serum intact PINP was measured in 142 healthy people and 115 osteoporosis patients. Results were matched with results of a similar test kit, Roche total PINP Elecsys Chemiluminescent Immunoassay Assay. Compared with the performance of the Roche PINP assay product, our method had higher sensitivity (0.02 ng/mL), wider linear range (0.02-1500 ng/mL), and anti-interference. Serum intact PINP values in osteoporosis patients were significantly higher than in healthy subjects (p < 0.001). Our method had good consistency compared with the Roche PINP assay (r = 0.9794). This chemiluminescence method for detecting serum intact PINP (CLIA-intact PINP) with magnetic nanosphere carrier technology meets the requirements of a clinical testing reagent and is expected to have clinical application after further evaluation and can compete with expensive imported kits on the market.

中文翻译：

---

使用磁性纳米球载体技术开发用于检测完整前胶原蛋白 IN 型前肽的夹心化学发光免疫测定法。

I 型胶原合成的代谢产物，完整的前胶原 IN 型前肽（完整的 PINP），是骨形成和骨质疏松症的潜在标志物，不受肾功能影响。我们试图建立一种化学发光免疫测定方法，用于使用先前制备的配对单克隆抗体检测血清完整的 PINP，并评估该测定在骨质疏松症中的诊断价值。以捕获分子和单克隆抗体为检测分子，研制了一种以磁性纳米球载体为载体的血清中完整PINP的化学发光检测诊断试剂，并对其在实验室中的分析性能进行了评价。在 142 名健康人和 115 名骨质疏松症患者中测量了血清完整的 PINP。结果与类似检测试剂盒的结果相匹配，罗氏总 PINP Elecsys 化学发光免疫分析。与罗氏 PINP 检测产品的性能相比，我们的方法具有更高的灵敏度 (0.02 ng/mL)、更宽的线性范围 (0.02-1500 ng/mL) 和抗干扰性。骨质疏松症患者的血清完整 PINP 值显着高于健康受试者（p < 0.001）。与 Roche PINP 检测相比，我们的方法具有良好的一致性（r = 0.9794）。这种利用磁性纳米球载体技术检测血清完整PINP（CLIA-intact PINP）的化学发光方法符合临床检测试剂的要求，经进一步评估有望在临床上应用，可与市场上昂贵的进口试剂盒竞争。