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Test ID PT Prothrombin Time, Plasma

Useful For

Monitoring intensity of oral anticoagulant therapy when combined with INR reporting

 

Screening assay to detect deficiencies of 1 or more coagulation factors (factors I, II, V, VII, X) due to:

-Hereditary or acquired deficiency states

-Vitamin K deficiency

-Liver disease

-Specific coagulation factor inhibitors

 

Screening assay to detect coagulation inhibition ("circulating anticoagulants") associated with:

-Specific coagulation factor inhibitors

-Lupuslike anticoagulant inhibitors (antiphospholipid antibodies)

-Nonspecific prothrombin time inhibitors (eg, monoclonal immunoglobulins, elevated fibrin degradation products)

Method Name

Electromagnetic Viscosity Detection System

Reporting Name

Prothrombin Time, P

Specimen Type

Plasma Na Cit

Platelet-Poor Plasma

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

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Specimen Stability Information: Frozen

Collection Instructions: Spin down, remove plasma and spin plasma again

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

 

Whole Blood (Available to local accounts only)

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

Specimen Volume: 4.5 mL

Specimen Stability Information: Ambient

Collection Instructions: Protime must be completed within 24 hours of draw time.

Specimen Minimum Volume

Whole blood: 1.8 mL/Plasma: 0.5 mL

Specimen Stability Information

Specimen Type Temperature Time
Plasma Na Cit Frozen (preferred) 30 days
  Ambient  24 hours

Clinical Information

The prothrombin time (PT) represents the time elapsed between:

1) addition of a standardized mixture of tissue thromboplastin and calcium to citrate anticoagulated plasma and;

2) detection of clot formation, representing fibrin polymerization resulting from the generation of thrombin, which proteolytically transforms fibrinogen to fibrin.

 

Tissue thromboplastin is a mixture of phospholipid vesicles and tissue factor (TF), a protein cofactor.

 

Tissue thromboplastins have traditionally been prepared from animal tissue extracts (brain, placenta, lung) however, the recent availability of recombinantly derived human TF combined with purified phospholipid mixtures allows preparation of well-defined tissue thromboplastin with several potential advantages.

 

Together with phospholipid, TF forms a complex with coagulation factor VII/VIIa (activated factor VII), providing an enzyme-cofactor complex which, in the presence of ionic calcium, activates proenzyme coagulation factor X to the enzyme factor Xa.

 

Factor Xa, in turn, forms a complex with phospholipid, calcium, and activated factor V (Va, a protein cofactor) to form prothrombinase, which hydrolyzes factor II substrate (prothrombin) to the active coagulant enzyme thrombin.

 

Thrombin hydrolyzes fibrinogen (factor I) by cleaving specific peptides (fibrinopeptides A and B), to form fibrin monomer, which assembles into fibrin polymers (a clot).

 

The PT is not sensitive to deficiencies of coagulation factors VIII, IX, XI, XII ("intrinsic pathway" factors), or factor XIII, although the TF/VIIa complex can activate factor IX (in addition to factor X). A prolonged PT indicates deficiency of 1 or more coagulation factors (I, II, V, VII, or X) or the presence of a coagulation inhibitor.

 

The PT is the most common test used for monitoring oral anticoagulant therapy (warfarin or Coumadin, and congeners).Oral anticoagulants reduce the activities of the 4 vitamin K-dependent procoagulant factors (factors II, VII, IX, and X), and the PT is sensitive to 3 of them.

 

The PT requires standardization because there are numerous thromboplastins and coagulation testing instruments, and they all vary in their responsiveness to the concentrations or activities of coagulation proteins. The international normalized ratio (INR) is a method of standardizing PT reporting for monitoring the intensity of oral anticoagulant therapy. The INR is the ratio of the patient's PT to the laboratory’s mean normal (reference) PT. 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

 

Recommended INR therapeutic ranges for orally administered drugs are as follows:

-Anticoagulation intensity: INR

-Standard intensity: 2.0 to 3.0

-Higher intensity: 3.0 to 4.5

 

The INR is used only for patients on stable oral anticoagulant therapy. It makes no significant contribution to the diagnosis or treatment of patients whose PT is prolonged for other reasons.

 

At Mayo Clinic and for Mayo Medical Laboratories clients, the PT test is performed with a sensitive thromboplastin (ISI 1.0 ± 0.05), containing phospholipid and recombinantly derived TF.

Reference Values

PROTHROMBIN TIME

9.5-13.8 seconds

 

INTERNATIONAL NORMALIZED RATIO (INR)

0.8-1.2

The INR is used only for patients on stable oral anticoagulant therapy. It makes no significant contribution to the diagnosis or treatment of patients whose PT is prolonged for other reasons.

Cautions

Not useful for detecting deficiencies of coagulation factors that have no influence on the prothrombin time (PT) test (eg, factors VIII, IX, XI, XII, XIII). International normalized ratio (INR) reporting of the PT is useful only for monitoring intensity of stable oral anticoagulant therapy. 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 an occasional individual, a more marked decrease of factor V activity may occur with freeze-thaw of plasma. Hence, the PT of frozen-thawed plasma potentially may be slightly more prolonged than would be observed in testing of fresh specimen. Frozen plasma kept on dry ice (solid carbon dioxide) in closed shipping containers may have spurious prolongation of PT, due to acidification of plasma by absorbed carbon dioxide. Exposure of thawed plasma to a normal atmosphere for a few minutes usually eliminates this spurious effect.

 

The PT is much less sensitive to heparin effect than is the activated partial thromboplastin time (APTT), and therapeutic concentrations of heparin usually cause only slight prolongation of the PT (≤1 sec with normal plasma, thromboplastin ISI 1.0, heparin ≤1 microgram/mL).

Day(s) Performed

Monday through Sunday; Continuously

Report Available

1 day

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test has been cleared or approved by the U.S. 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

85610

NY State Approved

Yes