Test Id : PINP
Procollagen I Intact 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
An adjunct in the assessment of conditions associated with increased bone turnover, such as Paget disease
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
Radioimmunoassay (RIA)
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
Specimen Type
Describes the specimen type validated for testing
Serum
Ordering Guidance
This test should not be requested in patients who have recently received radioisotopes, therapeutically or diagnostically, because of potential assay interference. A recommended time period before collection cannot be provided, as it depends on the isotope administered, the dose given, and the clearance rate in the individual patient. Specimens will be screened for radioactivity prior to analysis. Radioactive specimens received in the laboratory will be held and assayed after the radioactivity has sufficiently decayed. This will result in a test delay.
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
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: 0.25 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
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 | Frozen (preferred) | 180 days | |
| Ambient | 7 days | ||
| Refrigerated | 7 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
An adjunct in the assessment of conditions associated with increased bone turnover, such as Paget disease
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, which is the most common collagen type found in mineralized bone. In bone, collagen is synthesized by osteoblasts in the form of procollagen. This precursor 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 can be found in the circulation and their concentration reflects the synthesis rate of collagen type I. Although collagen type I propeptides may also arise from other tissues (such as the 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 it is particularly useful for monitoring bone formation therapies and antiresorptive therapies; it is recommended that the test be performed at baseline before starting osteoporosis therapy and performed 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: 22-87 mcg/L
Adult female premenopausal: 19-83 mcg/L
Adult female postmenopausal: 16-96 mcg/L
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, a change of greater or equal to 21% (least significant change) 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
There is diurnal variation of procollagen I intact N-terminal propeptide (PINP) levels, with the values being higher at night. When serial measurements of PINP are performed, specimens should be collected at the same time of the day.
Procollagen I intact N-terminal propeptide is metabolized in the liver. In individuals with severe liver disease, clearance from the circulation might be affected resulting in elevated PINP levels.
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. Osteoporos 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
Method Description
Describes how the test is performed and provides a method-specific reference
The procollagen I intact N-terminal (PINP) kit is based on the competitive radioimmunoassay technique. A known amount of labeled PINP and an unknown amount of unlabeled PINP in the sample compete for a limited number of high-affinity binding sites of the polyclonal rabbit anti-PINP antibody. A second antibody, directed against rabbit IgG and coated Kaolin particles, is used to separate the antibody-bound PINP from free PINP. The radioactivity of the bound tracer antigen is measured on a gamma counter. The amount of labeled PINP in the sample tube is inversely proportional to the amount of PINP in the sample. The concentrations in unknown samples are obtained from a calibration curve, which is based on the concurrent testing of PINP calibrators.(Package insert: UniQ PINP RIA, Intact N-terminal propeptide of type I procollagen. Orion Diagnostica; 03/2016)
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.
Tuesday, Thursday
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.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their account representative. For assistance, contact Customer Service.
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 has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.
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.
83519
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 |
|---|---|---|
| PINP | Procollagen I Intact N-Terminal, S | 47255-5 |
| 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.
|
|---|---|---|
| 61695 | Procollagen I Intact N-Terminal, S | 47255-5 |