Analytical biochemistry · 2026
Establishment of a homogeneous immunoassay for quantitative detection of total procollagen type 1 N-terminal propeptide.
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Cheng Shanshan, Sun Yuanmin, Yang Xiaohui, Yang Hongwei, Cui Xiaoming, Li Xue, Li Huiqiang, Yu Yang
Аннотация
OBJECTIVE: To establish a homogeneous immunoassay for quantitative detection of total procollagen type 1 n-terminal propeptide (P1NP) in human serum.
METHODS: The assay was established after screening raw materials and optimizing the reaction conditions, and the performance of the assay was evaluated according to the clinical guidelines. Meanwhile, the detection results of the established assay were compared with those of the Roche electrochemiluminescence immunoassay.
RESULTS: The coefficient of variation was 4.20 % ∼9.37 %, and the intermediate precision was 6.20 % ∼9.80 %. The limit of blank (LoB) was 1.14 ng/mL, and the limit of quantification (LoQ) was 3.83 ng/mL. The linear range was 5.88 ng/mL ∼1447.65 ng/mL. The correlation coefficient (r) between the results of the established total P1NP-LiCA and the Roche ECLIA was 0.8969.
CONCLUSIONS: A homogeneous quantitative immunoassay for total P1NP was developed, which could be used as a practical and cost-effective alternative for routine clinical use in assessing bone formation markers.
METHODS: The assay was established after screening raw materials and optimizing the reaction conditions, and the performance of the assay was evaluated according to the clinical guidelines. Meanwhile, the detection results of the established assay were compared with those of the Roche electrochemiluminescence immunoassay.
RESULTS: The coefficient of variation was 4.20 % ∼9.37 %, and the intermediate precision was 6.20 % ∼9.80 %. The limit of blank (LoB) was 1.14 ng/mL, and the limit of quantification (LoQ) was 3.83 ng/mL. The linear range was 5.88 ng/mL ∼1447.65 ng/mL. The correlation coefficient (r) between the results of the established total P1NP-LiCA and the Roche ECLIA was 0.8969.
CONCLUSIONS: A homogeneous quantitative immunoassay for total P1NP was developed, which could be used as a practical and cost-effective alternative for routine clinical use in assessing bone formation markers.