Test Catalog

Test Id : PTTP

Prothrombin Time, Plasma

Useful For
Suggests clinical disorders or settings where the test may be helpful

Screening assay to detect deficiencies of one or more coagulation factors (factors I, II, V, VII, X)

 

Screening assay to detect coagulation inhibition

 

Monitoring intensity of oral anticoagulant therapy when combined with INR reporting

Method Name
A short description of the method used to perform the test

Coagulometric (Turbidimetric)

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

Prothrombin Time, P

Aliases
Lists additional common names for a test, as an aid in searching

INR

Prothrombin Time, Plasma

Protime

PT

Specimen Type
Describes the specimen type validated for testing

Plasma Na Cit

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Specimen Type: Platelet-poor plasma

Collection Container/Tube: Light-blue top (3.2% sodium citrate)

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Centrifuge, remove plasma, and centrifuge plasma again.

2. Aliquot plasma into plastic vial leaving 0.25 mL in the bottom of centrifuged vial.

Additional Information: Double-centrifuged specimen is critical for accurate results as platelet contamination may cause spurious results.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

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
Plasma Na Cit Frozen (preferred) 30 days
Ambient 24 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

Screening assay to detect deficiencies of one or more coagulation factors (factors I, II, V, VII, X)

 

Screening assay to detect coagulation inhibition

 

Monitoring intensity of oral anticoagulant therapy when combined with INR reporting

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Prothrombin is a plasma protein with a molecular weight of 68,700 Da. It is an unstable protein that can split easily into smaller compounds, one of which is thrombin. Prothrombin is formed continually by the liver, and it is continually being used throughout the body for blood clotting. If the liver fails to produce prothrombin, in a day or so the prothrombin concentration in the plasma falls to levels too low to provide normal blood coagulation. Vitamin K is required by the liver for normal activation of prothrombin as well as other clotting factors. Therefore, either lack of vitamin K or the presence of liver disease that prevents normal prothrombin formation can decrease the prothrombin concentration so low that a bleeding tendency results.

 

Prothrombin time (PT) is used as a screening test to detect a deficiency of one or more of the clotting factors of the extrinsic coagulation system (I, II, V, VII, or X) due to a hereditary or acquired deficiency, liver disease, vitamin K deficiency, or presence of inhibitors. Inhibitors include specific coagulation factor inhibitors, Lupus-like anticoagulant inhibitors (eg, antiphospholipid antibodies), and nonspecific prothrombin time inhibitors (eg, monoclonal immunoglobulins, elevated fibrin degradation products). Mixing studies with normal plasma are useful in initial evaluation of prolonged PT when the cause is unknown (eg, not attributable to known oral anticoagulation or known coagulation factor deficiency). One of the following tests may be appropriate, depending on the clinical picture:

-ALUPP / Lupus Anticoagulant Profile, Plasma

-AATHR / Thrombophilia Profile, Plasma and Whole Blood

-ALBLD / Bleeding Diathesis Profile, Limited, Plasma

-APROL / Prolonged Clot Time Profile, Plasma

 

PT results produced by different assays may vary significantly as there are differences in activity of the tissue factor and the instrument used to perform the test. Tissue factor is isolated from a variety of sources by assay manufacturers, and different batches may have different activity. Calculation of the international normalized ratio (INR) addresses this problem by normalizing the PT result. For this reason, INR is used to monitor oral anticoagulant therapy (warfarin or Coumadin).

 

Warfarin inhibits the enzyme vitamin K epoxide reductase complex 1 (VKORC1), which is responsible for converting vitamin K to its active, reduced form. By inhibiting VKORC1, warfarin decreases the available active form of vitamin K in the tissues. Thus, when warfarin is given to a patient, the amounts of active prothrombin and factors VII, IX, and X, all formed by the liver degrade and are replaced by inactive factors. Although the coagulation factors continue to be produced, they have greatly decreased coagulant activity.

 

Bleeding is the primary adverse reaction associated with warfarin use, and warfarin is among the top 10 drugs with the largest number of serious adverse events reported to the FDA. For these reasons, monitoring therapy closely and adjusting dose accordingly is critical.

 

The international sensitivity index (ISI) is an experimentally derived measurement, usually provided by the thromboplastin manufacturer, reflecting thromboplastin (and PT) sensitivity to coagulation deficiencies. More sensitive thromboplastins have a low ISI (1.0-1.2), whereas less sensitive thromboplastins have a higher ISI (eg, 2.0-3.0). Calculation of the INR is as follows:

INR=(Patient's PT/mean PT of reference range) ISI where:

-INR=international normalized ratio

-ISI=international sensitivity index

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.

PROTHROMBIN TIME:

9.4-12.5 seconds

 

INTERNATIONAL NORMALIZED RATIO (INR):

0.9-1.1

 

Standard intensity warfarin therapeutic range: 2.0-3.0

High intensity warfarin therapeutic range: 2.5-3.5

Interpretation
Provides information to assist in interpretation of the test results

Prothrombin time (PT) may be prolonged due to deficiencies of factors X, VII, V, and II of the extrinsic pathway, presence of inhibitors, or oral anticoagulation therapy.

 

INR therapeutic ranges for orally administered drugs:

-Standard-intensity warfarin therapeutic range: 2.0 to 3.0

-High-intensity warfarin therapeutic range: 2.5 to 3.5

Note: The INR should only be used for patients on stable oral anticoagulant therapy, though it is reported for all patients despite whether they are receiving oral anticoagulants.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Prothrombin time (PT) is not useful for detecting deficiencies of coagulation factors that have no influence on the prothrombin time test (eg, factors VIII, IX, XI, XII, XIII).

 

The activity of coagulation factor V (labile factor) typically may be 10% to 20% lower in frozen-thawed plasma specimens than in fresh specimens, even under optimum conditions of processing and transportation, or may be even lower if these conditions are suboptimal, and may lead to a falsely prolonged PT.

 

In patients receiving heparin, PT is prolonged when heparin concentrations are above 1.0 IU/mL. Internal studies demonstrate plasma from subjects not taking warfarin have shown prolongation of approximately 10% (1-2 seconds) at heparin concentrations near 1.3 IU/mL. At concentrations between 1.5 and 2.0 IU/mL, prolongation of approximately 35% (3-5 seconds) was observed.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Hall JE: Hemostasis and blood coagulation. In: Guyton and Hall Textbook of Medical Physiology. 14th ed. Elsevier Sanders; 2021:447-488

2. Shin J, Kayser SR: Pharmacology of Vitamin K Antagonists. Fang MC, ed. Inpatient Anticoagulation. John Wiley-Blackwell; 2011:25-31

3. Clinical and Laboratory Standards institute (CLSI): One-stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin (APTT) Test. 2nd ed. CLSI document H47-A2, CLSI; 2008

Method Description
Describes how the test is performed and provides a method-specific reference

Coagulometric (turbidimetric) clot detection is based on the principle that light passing through a medium in which fibrinogen is converted to fibrin is absorbed by the fibrin strands. Light at 671 nm is transmitted through a sample onto a photodetector, which is positioned 180 degrees to the source. Light absorption increases as fibrin clot formation progresses. Consequently, light transmittance through the sample continuously decreases and is measured by the photodetector. The corresponding electrical signal output from the photodetector changes according to the detected light. The signal output is processed via software through a series of algorithms to determine the clot point.

 

In the prothrombin time (PT) test, the addition of the tissue thromboplastin (RecombiPlasTin 2G reagent) to the patient plasma in the presence of calcium ions initiates the activation of the extrinsic pathway. This results ultimately in the conversion of fibrinogen to fibrin, with formation of a solid gel. The time required for clot formation is measured. The thromboplastin reagent included in the RecombiPlasTin 2G kit, after reconstitution with the RecombiPlasTin 2G Diluent, is a liposomal preparation that contains human recombinant tissue factor (RTF) relipidated in a synthetic phospholipid blend and combined with calcium chloride, buffer, and a preservative.(Package insert: HemosIL RecombiPlasTin 2G. IL ACL TOP Operator's Manual. Instrument Laboratory; R10, 03/2019)

 

This PT test is performed with a sensitive thromboplastin (ISI 1.0 +/- 0.05), containing phospholipid and recombinant human tissue factor.

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.

Monday through Sunday

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.

Same day/1 day

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

1 day

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 Regional Manager. 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.

85610

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
PTTP Prothrombin Time, P 34528-0
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.
PTTTP Prothrombin Time, P 5902-2
INRTP INR 6301-6

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 | Create a 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