Test Catalog

Test Id : PINP

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Procollagen I Intact N-Terminal, Serum

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Overview

Test Catalog

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.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Procollagen I Intact N-Terminal, S

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

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

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.

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 of age.

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 bisphosphonates 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.

 

PINP 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

No

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.

2 to 6 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

2 weeks

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

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.

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

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
Test Status - Test Delay 2024-11-12
Test Status - Test Resumed 2024-11-01
Test Status - Test Delay 2024-10-23
Test Status - Test Resumed 2024-07-01
Test Status - Test Delay 2024-06-21
Test Status - Test Resumed 2024-02-14
Test Status - Test Delay 2024-02-08
Test Status - Test Resumed 2023-09-07
Test Status - Test Down 2023-07-19
Test Status - Test Delay 2023-07-14