Test Id : P1NP
Intact Procollagen I N-Terminal, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
Aiding in monitoring antiresorptive and anabolic therapy in patients with osteoporosis
This test should not be used as a screening test for osteoporosis in the general population.
Method Name
A short description of the method used to perform the test
Chemiluminescence
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Intact PINP
PINP
Procollagen I Intact N-Terminal
Specimen Type
Describes the specimen type validated for testing
Serum
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Patient Preparation: For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL Serum
Collection Instructions: Centrifuge and aliquot serum into a plastic vial.
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
Serum: 0.5 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
| Gross lipemia | OK |
| Gross icterus | OK |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 14 days | |
| Ambient | 7 days | ||
| Frozen | 90 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Aiding in monitoring antiresorptive and anabolic therapy in patients with osteoporosis
This test should not be used as a screening test for osteoporosis in the general population.
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Procollagen type I propeptides are derived from collagen type I, the most common collagen in mineralized bone. In bone, collagen is synthesized by osteoblasts in the form of procollagen, a precursor that contains a short signal sequence and terminal extension peptides: amino-terminal propeptide (PINP) and carboxy-terminal propeptide. These propeptide extensions are removed by specific proteinases before the collagen molecules form. Both propeptides circulate in blood, and their concentrations reflect the rate of collagen type I synthesis. Although collagen type I propeptides may also originate from other tissues, including skin, vessels, fibrocartilage, and tendons, most nonskeletal tissues exhibit a slower turnover than bone and contribute very little to the circulating pool of PINP. PINP is considered the most sensitive marker of bone formation and is particularly useful for monitoring bone formation and antiresorptive therapies. Testing is recommended at baseline before osteoporosis therapy begins and again 3 to 6 months later.
Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Adult male: 26-108 ng/mL
Adult female premenopausal: 22-103 ng/mL
Adult female postmenopausal: 18-119 ng/mL
Reference values have not been established for patients who are younger than 18 years.
Interpretation
Provides information to assist in interpretation of the test results
This assay is specific for the intact trimeric form of procollagen type I N-terminal propeptide (PINP). When monitoring response to osteoporosis treatment, the reference change value (RCV) has been estimated to be ?-19.9% for decreases and?+24.8% for increases from baseline PINP levels (ie, prior to the start of therapy), 3 to 6 months after initiation of therapy indicates an adequate therapeutic response.
The direction of the change in PINP levels (decrease or increase) will depend on the type of osteoporosis treatment. In patients taking bisphosphonates, PINP levels have been shown to decrease up to 70% from baseline after 6 months of therapy. Treatment with hormone replacement therapy also shows a decrease in PINP levels but to a lesser degree than bisphosphonate therapy.
In patients treated with teriparatide (recombinant human parathyroid hormone 1-34), PINP levels increase from baseline, reflecting the stimulatory effect of teriparatide on osteoblasts and bone formation. PINP levels have been shown to significantly increase as early as 1 month after teriparatide treatment, peaking at 6 months following treatment. Increases greater than 10 mcg/L have been reported in 77% to 79% of teriparatide-treated patients after 3 months of therapy and are considered a successful response.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Intact procollagen type I N-terminal propeptide (PINP) is metabolized in the liver. In individuals with severe liver disease, clearance from the circulation might be affected resulting in elevated PINP levels.
The use of biotin-containing supplements may lead to inaccurately reduced PINP measurements.
In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human anti-mouse antibodies [HAMA] or heterophile antibodies), which may cause interference in some immunoassays. Caution should be used in interpretation of results, and the laboratory should be alerted if the result does not correlate with the clinical presentation.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Naylor KE, Jacques RM, Paggiosi M, et al. Response of bone turnover markers to three oral bisphosphonate therapies in postmenopausal osteoporosis: the TRIO study. Osteoporosis Int. 2016;27(1):21-31. doi:10.1007/s00198-015-3145-7
2. McClung MR, San Martin J, Miller PD, et al. Opposite bone remodeling effects of teriparatide and alendronate in increasing bone mass. Arch Intern Med. 2005;165(15):1762-1768
3. Eastell R, Krege JH, Chen P, et al. Development of an algorithm for using PINP to monitor treatment of patients with teriparatide. Curr Med Res Opin. 2006;22(1):61-66
4. Brown JP, Don-Wauchope A, Douville P, Albert C, Vasikaran SD. Current use of bone turnover markers in the management of osteoporosis. Clin Biochem. 2022;109-110:1-10. doi:10.1016/j.clinbiochem.2022.09.002
5. Bhattoa HP, Vasikaran S, Trifonidi I, et al. Update on the role of bone turnover markers in the diagnosis and management of osteoporosis: a consensus paper from The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO), International Osteoporosis Foundation (IOF), and International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Osteoporos Int. 2025;36(4):579-608. doi:10.1007/s00198-025-07422-3
6. Morovat A, Catchpole A, Meurisse A, et al. IDS iSYS automated intact procollagen-1-N-terminus pro-peptide assay: method evaluation and reference intervals in adults and children. Clin Chem Lab Med. 2013;51(10):2009-2018. doi:10.1515/cclm-2012-0531
Method Description
Describes how the test is performed and provides a method-specific reference
The assay is based on chemiluminescence technology. Twenty microliters of patient sample or calibrator are added to a diluent, and a portion incubated with a biotinylated anti-procollagen type I N-terminal propeptide (PINP) monoclonal antibody, an acridinium labelled monoclonal antibody, streptavidin labelled magnetic particles and an assay buffer. The magnetic particles are captured using a magnet, and a wash step is performed to remove any unbound analyte. Trigger reagents are added; the resulting light emitted by the acridinium label is directly proportional to the concentration of intact PINP in the original sample.(Unpublished Mayo method)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday through Friday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
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Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.
CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
83520
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| P1NP | Intact Procollagen I N-Terminal, S | 77370-5 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| P1NP | Intact Procollagen I N-Terminal, S | 77370-5 |