Standard Curve
Example of Human P1NP standard curve in Assay Diluent X1. Plotted are the background-subtracted data.
This standard curve is provided for demonstration only.
Product Details
Product Details
Product Specification
| Antigen | Human P1NP |
| Immunogen | Recombinant Protein |
| Antibody Type | Recombinant mAb |
| Reactivity | Hu |
| Purification | Protein A |
| Stability & Storage | 12 months from date of receipt / reconstitution, 2 to 8°C as supplied. |
Kit
| Precision | Intra-assay: 3.1%; Inter-assay: 3.9% |
| Sample type | EDTA Plasma, Cell Culture Supernatant |
| Assay type | Sandwich (quantitative) |
| Sensitivity | 18.75 pg/mL |
| Range | 54.7 pg/mL – 3500 pg/mL |
| Recovery | EDTA Plasma: 104% Cell Culture Supernatant: 95% |
| Assay time | 60 minutes |
| Species reactivity | Hu |
Background
Human P1NP (N-terminal propeptide of type I procollagen) is a 35-kDa peptide released during the extracellular processing of type I procollagen by osteoblasts. Structurally, it exists in circulation as both an intact trimeric form and smaller monomeric fragments, with the intact trimeric molecule being cleared by scavenger receptors in liver endothelial cells. Functionally, P1NP reflects the rate of type I collagen synthesis, making it the reference biomarker for bone formation. Clinically, serum P1NP is widely used to monitor osteoporosis treatment response (both antiresorptive and anabolic agents), assess Paget's disease, and evaluate bone turnover in conditions such as osteogenesis imperfecta and bone metastases.
Picture
Picture
ELISA
Spike Recovery
The recovery of Human P1NP was assessed by spiking a standard into plasma. Serial dilutions of the neat biological sample were prepared, and the percent recovery was calculated for each dilution relative to the expected concentration.
Spike Recovery
The recovery of Human P1NP was evaluated in medium spiked with concentrations spanning the entire assay range.
Spike-and-dilution Linearity
To evaluate assay linearity, samples were spiked with high levels of Human P1NP in matrices and serially diluted with the corresponding Calibrator Diluent to fall within the assay's dynamic range.
Intra-Assay Precision (Precision within an assay)
Three samples of known concentration were tested fifteen times on one plate to assess intra-assay precision.
Inter-Assay Precision (Precision between assays).
Three samples of known concentration were tested in separate assays to assess inter-assay precision. Assays were performed with at least three lots of components.
Determination of Minimum Detectable Dose (MDD)
The MDD was determined using three independent lots of assay components. For each lot, 19 replicate measurements of the diluent (zero calibrator) were performed. The mean (AVERAGE) and standard deviation (STDEV) of the 19 replicates were calculated. The MDD for each lot was then calculated according to the following formula:
MDD = 2 × STDEV + AVERAGE
HOOK Effect Threshold
The upper limit of the HOOK effect was established at 100× the highest calibrator concentration (equivalent to a 2-log10 increase). No HOOK effect was observed below this threshold, confirming that samples within this concentration range yield reliable quantitative results without signal depression.
Protocol Diagram
