Hemostasis and Thrombosis

Orderable EAP code:

LAB103280

Billable EAP Codes:

80001087 x 1 85576.3 x 1 (Profee)

CPT Codes:

85576 x 1 85576 x 1 (Profee)

Lab Section:

Hemostasis and Thrombosis

Turnaround Time:

1 day

Test Schedule:

Specimen must be collected at OHSU PPV or DCH by appointment only. Schedule with Lab Client Services 503-494-7383. Schedule appointments Tuesday only from 9:00 to 12:00, at least 1 hour apart and no more than 3 per day.

Specimen Requirements:

Patients should refrain from non-steroidal anti-inflammatory drugs, aspirin and aspirin containing products, (unless the patient is being checked for aspirin resistance) or dietary supplements known to affect platelet function 10-14 days prior to testing.

Two FULL 2.7 mL whole blood LIGHT BLUE (3.2% sodium citrate) tubes and one 3 mL whole blood LAVENDER (EDTA). Do NOT send in pneumatic tube system. Do NOT spin.

Stability is 3 hours at Room Temperature.

Sample must be received in SIC Lab within 1 hour of the draw.

Pediatric Specimen Requirements:

Two FULL 2.7 mL whole blood LIGHT BLUE (3.2% sodium citrate) tubes and one 3 mL whole blood LAVENDER (EDTA). Do NOT send in pneumatic tube system. Do NOT spin.

Stability is 3 hours at Room Temperature.

Sample must be received in SIC Lab within 1 hour of the draw.

For pediatric patients requiring multiple coagulation tests, please call 503-494-7383 regarding draw volumes.

Reference Range:

Ristocetin Aggregation (0.25mg/mL) less than 5 Ohms

Ristocetin Aggregation (1.0mg/mL) greater than 5 Ohms

Comments:

Used for the detection of Von Willebrand Disease, Bernard Soulier, and Type 2B or Platelet-type vW disease.

Synonyms:

RIPA

Orderable EAP code:

LAB00266

Billable EAP Codes:

80001094 x 1 (Factor VIII Coag) 80001090 x 1 (Factor VIII: VWF AG) 80001088 x 1 (Von Will/RAF)

CPT Codes:

85240 x 1 (Factor VIII Coag) 85246 x 1 (Factor VIII: VWF AG) 85397 x 1 (Von Will/RAF)

Lab Section:

Hemostasis and Thrombosis

Includes:

Factor VIII Activity, Von Willebrand Factor Activity, Von Willebrand Antigen

Turnaround Time:

1 to 3 days

Test Schedule:

Factor VIII Activity = 7 days a week, performed at Core Lab.

Von Willebrand Factor Activity, Von Willebrand Antigen = Monday, Wednesday, Friday.

Critical Values:

See individual tests.

Specimen Requirements:

Four full 2.7 mL LIGHT BLUE top tubes, 3.2% sodium citrate. Specimens must be processed and frozen within 2 hours of specimen collection.

Send 4- 1ml aliquots of platelet poor plasma, samples must remain frozen during storage and shipment.

Stability is 14 days at -20°C or at -70°C for up to 12 months.

Detailed specimen collection and processing instructions are located under Lab Sections and then the Hemostasis and Thrombosis (Opens in a new window) section.

Pediatric Specimen Requirements:

Two full pediatric 1.3 mL LIGHT BLUE top tubes, 3.2% sodium citrate. Specimens must be processed and frozen within 2 hours of specimen collection.

Send 2- 600 uL aliquot of platelet poor plasma, samples must remain frozen during storage and shipment.

Stability is 14 days at -20°C or at -70°C for up to 12 months.

For pediatric patients requiring multiple coagulation tests, please call 503-494-7383 regarding draw volumes.

Reference Range:

See individual tests.

For children less than 6 months, see link to published reference ranges (Opens in a new window).

Comments:

This test is used in the diagnosis and classification of von Willebrand disease.

The von Willebrand factor (vWF) is absent or decreased in individuals with von Willebrand disease (vWD). vWF activity is the functional measure of the factor VIII molecule that is necessary for the agglutination of platelets observed in the presence of ristocetin. Since many variants of vWD exist, the yield of identifying patients with this disease is enhanced if all three of the following are assayed: factor VIII activity, von Willebrand factor antigen (vWF:Ag), and vWF-RCT activity. Because many patients with vWD have mild disease, repeated testing may be necessary to diagnose this disorder. Normal values do not exclude vWD. Female patients with vWD on oral contraceptives or who are pregnant may have normal values. Von Willebrand factor is also an acute-phase reactant and is elevated with stress or exercise.

Methodology: Refer to specific assays.

High doses of standard heparin (greater than 1.0 U/mL) may interfere with a PT mixing study. Anti-Xa agents such as Rivaroxaban may also interfere with PT mixing studies. Clinical correlation is advised.

Synonyms:

Von Willebrand

Orderable EAP code:

LAB00238

Billable EAP Codes:

80001090 x 1

CPT Codes:

85246 x 1

Lab Section:

Hemostasis and Thrombosis

Includes:

This assay is included in Von Willebrand Panel.

Turnaround Time:

1 to 3 days

Test Schedule:

Monday, Wednesday, Friday

Units:

Critical Values:

Less than 19%

Specimen Requirements:

Two full 2.7 mL LIGHT BLUE top tube, 3.2% sodium citrate. Specimens must be processed and frozen within 2 hours of specimen collection.

Send 2- 1 mL aliquots of platelet poor plasma, samples must remain frozen during storage and shipment.

Stability is 14 days at -20°C or at -70°C for up to 12 months.

Detailed specimen collection and processing instructions are located under Lab Sections and then the Hemostasis and Thrombosis (Opens in a new window) section.

Pediatric Specimen Requirements:

One full pediatric 1.3 mL LIGHT BLUE top tube, 3.2% sodium citrate. Specimens must be processed and frozen within 2 hours of specimen collection.

Send 1 600uL aliquot of platelet poor plasma, samples must remain frozen during storage and shipment.

Stability is 14 days at -20°C or at -70°C for up to 12 months.

For pediatric patients requiring multiple coagulation tests, please call 503-494-7383 regarding draw volumes.

Reference Range:

42% to 176%

Comments:

This test is used in the diagnosis, classification, and treatment of von Willebrand disease.

Von Willebrand disease is characterized by easy bruising or prolonged bleeding from mucosal surfaces due to reduced vWF concentration (Type I), qualitative dysfunction (Type II) or complete loss of production (Type III). Both quantitative and qualitative (functional) assays are required for the diagnosis and appropriate therapeutic intervention. Because many patients with vWD have mild disease, repeated testing may be necessary to diagnose this disorder. Normal values do not exclude vWD. Female patients with vWD on oral contraceptives or who are pregnant may have normal values. Von Willebrand factor is also an acute-phase reactant and is elevated with stress or exercise.

Methodology: Immunoturbidometric assay.

Synonyms:

VWF AG

Orderable EAP code:

LAB00232

Billable EAP Codes:

80001088 x 1

CPT Codes:

85397 x 1

Lab Section:

Hemostasis and Thrombosis

Includes:

This assay is included in Von Willebrand Panel.

Turnaround Time:

1 to 3 days

Test Schedule:

Monday, Wednesday, Friday

Units:

Critical Values:

Less than 19%

Specimen Requirements:

Two full 2.7 mL LIGHT BLUE top tube, 3.2% sodium citrate. Specimens must be processed and frozen within 2 hours of specimen collection.

Send 2- 1mL aliquots of platelet poor plasma, samples must remain frozen during storage and shipment.

Stability is 14 days at -20°C or at –70°C for up to 12 months.

Detailed specimen collection and processing instructions are located under Lab Sections and then the Hemostasis and Thrombosis (Opens in a new window) section.

Pediatric Specimen Requirements:

One full pediatric 1.3 mL LIGHT BLUE top tube, 3.2% sodium citrate. Specimens must be processed and frozen within 2 hours of specimen collection.

Send 1 600 uL aliquot of platelet poor plasma, samples must remain frozen during storage and shipment.

Stability is 14 days at -20°C or at –70°C for up to 12 months.

For pediatric patients requiring multiple coagulation tests, please call 503-494-7383 regarding draw volumes.

Reference Range:

40% to 130%

For children less than 6 months, see link to published reference ranges (Opens in a new window).

Comments:

This test aids in diagnosis of von Willebrand disease.

Von Willebrand disease is characterized by easy bruising or prolonged bleeding from mucosal surfaces due to quantitative (Type I) or qualitative (Type II) vWF deficiency. Both quantitative and qualitative (functional) assays are required for the diagnosis and appropriate therapeutic intervention. Because many patients with vWD have mild disease, repeated testing may be necessary to diagnose this disorder. Normal values do not exclude vWD. Female patients with vWD on oral contraceptives or who are pregnant may have normal values. Von Willebrand factor is also an acute-phase reactant and is elevated with stress or exercise.

Methodology: Turbidometric Enzymeimmunoassay.

This test was developed and its performance characteristics determined by OHSU.The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

The clinical significance of vWF activity levels between 0.3 to 0.5 U/mL is unclear and clinical correlation is required. See NHLBI von Willebrand Disease Expert Panel Guidelines:

https://www.nhlbi.nih.gov/health-pro/guidelines/current/von-willebrand-guidelines/full-report/1-intro.htm (Opens in a new window)

Orderable EAP code:

LAB00699

Billable EAP Codes:

80001127 x 1

CPT Codes:

85303 x 1

Lab Section:

Hemostasis and Thrombosis

Includes:

INR is reflexed on patients with a low Protein C level.

Turnaround Time:

1 - 3 days

Test Schedule:

Monday, Wednesday, and Friday.

Units:

Interpretation:

Non-coumadin anticoagulants may falsely elevate Protein C values, even when the concurrent PTT is normal.

Specimen Requirements:

Two full 2.7 mL LIGHT BLUE top tubes, 3.2% sodium citrate.

Specimens must be processed and frozen within 2 hours of specimen collection.

Send 2- 1mL aliquots of platelet poor plasma, samples must remain frozen during storage and shipment.

Stability is 14 days at -20 C or at -70 C for up to 12 months.

Detailed instructions are included in this manual under Specialized Lab Services, Hemostasis & Thrombosis (Opens in a new window) section.

Pediatric Specimen Requirements:

One full pediatric 1.3 mL LIGHT BLUE top tubes, 3.2% sodium citrate.

Specimens must be processed and frozen within 2 hours of specimen collection.

Send 1- 600 uL aliquot of platelet poor plasma, samples must remain frozen during storage and shipment.

Stability is 14 days at -20 C or at -70 C for up to 12 months.

For pediatric patients requiring multiple coagulation tests, please call 503-494-7383 regarding draw volumes.

Reference Range:

70% to 140%

For children less than 6 months, see link to published reference ranges (Opens in a new window).

Comments:

This test aids in the diagnosis of patients at risk of venous thromboembolic disease.

Normal, full-term newborn infants or healthy premature infants may have decreased levels of protein C activity (15% to 50%), which may not reach adult levels until later in childhood or early adolescence.

Discontinue Coumadin therapy 1 month prior to testing. Heparin greater than 1.0 U/mL, coumadin, and fibrinolytic agents interfere with this assay. Coumadin decreases Protein C.

Methodology: Clot-based on prolongation of APTT assay.

Synonyms:

Protein C

PTC

Orderable EAP code:

LAB00231

Billable EAP Codes:

80001087 x 6 85576.3 x 6 (Profee)

CPT Codes:

85576 x 6 85576 x 6 (Profee)

Lab Section:

Hemostasis and Thrombosis

Turnaround Time:

1 day

Test Schedule:

Specimen must be collected at OHSU PPV or DCH by appointment only. Schedule with Lab Client Services 503-494-7383. Schedule appointments Tuesdays, 9:00 to 12:00, at least 1 hour apart and no more than 3 per day.

Specimen Requirements:

Four FULL 2.7 mL whole blood LIGHT BLUE (3.2% sodium citrate) tubes and one 3 mL whole blood LAVENDER (EDTA). Do NOT send in pneumatic tube system. Do NOT spin.

Stability is 3 hours at Room Temperature.

Sample must be received in SIC Lab within 1 hour of the draw.

Pediatric Specimen Requirements:

Three FULL 2.7 mL whole blood LIGHT BLUE (3.2% sodium citrate) tubes and one 3 mL whole blood LAVENDER (EDTA). Do NOT send in pneumatic tube system. Do NOT spin.

Stability is 3 hours at Room Temperature.

Sample must be received in SIC Lab within 1 hour of the draw.

For pediatric patients requiring multiple coagulation tests, please call 503-494-7383 regarding draw volumes.

Reference Range:

Thrombin ATP Release (1 Unit/mL) greater than 0.5 nmole

Ristocetin Aggregation (0.25mg/mL) less than 5 Ohms

Ristocetin Aggregation (1.0mg/mL) greater than 5 Ohms

Collagen Aggregation (1ug/mL) 12 to 33 Ohms

Collagen ATP Release (1ug/mL) 0.5 to 1.7 nmole

Collagen Aggregation (5ug/mL) 17 to 42 Ohms

Collagen ATP Release (5ug/mL) 0.7 to 2.4 nmole

ADP Aggregation (10uM) 10 to 31 Ohms

ADP ATP Release (10uM) 0.35 to 1.4 nmole

Arachidonic Acid Aggregation (0.5mM) 10 to 32 Ohms

Arachidonic Acid ATP Release (0.5mM) 0.44 to 2.0 nmole

Comments:

This test is to screen for specific hereditary and acquired platelet functional abnormalities such as rare congenital disorders (Glanzmann's thrombasthenia and Bernard-Soulier syndrome).

Synonyms:

Aggregation

Plt Agg

Orderable EAP code:

LAB00323

Billable EAP Codes:

85390.3 x 1 (Profee) 80001119 x 1 80001121 x 1 Reflexes create additional charges

CPT Codes:

85390 x 1 (Profee) 85613 x 1 85598 x 1 Reflexes create additional charges

Lab Section:

Hemostasis and Thrombosis

Includes:

DRVV Confirm Normalized Ratio; SCT Confirm Normalized Ratio, if indicated: SCT Mix, DRVVT Mix.

To exclude anticoagulant effects, a reflex Heparin, Thrombin Time, and INR will be performed when the lupus panel screens or normalized ratios are prolonged. Additional Charges will apply.

Turnaround Time:

5 days

Test Schedule:

Tuesday and Thusday

Specimen Requirements:

Three full 2.7 mL LIGHT BLUE top tubes, 3.2% sodium citrate. Specimens must be processed and frozen within 2 hours of specimen collection.

Send 3- 1.5ml aliquots of platelet poor plasma, samples must remain frozen during storage and shipment.

Stability is 14 days at -20 C.

Detailed specimen collection and processing instructions are located under Lab Sections and then the Hemostasis and Thrombosis (Opens in a new window) section.

Pediatric Specimen Requirements:

Three full pediatric 1.3 mL LIGHT BLUE top tubes, 3.2% sodium citrate. Specimens must be processed and frozen within 2 hours of specimen collection.

Send 2- 1.5ml aliquots of platelet poor plasma, samples must remain frozen during storage and shipment.

Stability is 14 days at -20 C.

For pediatric patients requiring multiple coagulation tests, please call 503-494-7383 regarding draw volumes.

Reference Range:

dRVVConfirm Normalized Ratio: less than or equal to 1.20

SCT Confirm Normalized Ratio: less than or equal to 1.23

Comments:

Testing for lupus inhibitors is not recommended while a patient is on anticoagulation therapy because heparins, direct Xa inhibitors, warfarin, and direct thrombin inhibitors variably confound the parent test systems (SCT, dRVVT, and mixing studies).

The Lupus Inhibitor panel does not include serologic studies (anti-cardiolipin and anti-beta 2 glycoprotein 1) which are also useful in evaluating anti-phospholipid syndrome (APS). For comprehensive APS evaluation follow ISTH guidelines.

Synonyms:

Dilute Viper Venom Time (DVVT) with Reflex to DVV Confirm Ratio

Lupus Anticoagulant

Lupus Panel

Orderable EAP code:

LAB00259

Billable EAP Codes:

80001097 x 1

CPT Codes:

85270 x 1

Lab Section:

Hemostasis and Thrombosis

Turnaround Time:

1 to 3 days

Test Schedule:

Monday, Wednesday, and Friday

Units:

Critical Values:

Less than 5%.

Specimen Requirements:

Two full 2.7 mL LIGHT BLUE top tubes, 3.2% sodium citrate. Specimens must be processed and frozen within 2 hours of specimen collection.

Send 2- 1 ml aliquots of platelet poor plasma, samples must remain frozen during storage and shipment.

Stability is 14 days at -20° C or at –70°C for up to 12 months.

Detailed specimen collection and processing instructions are located under Lab Sections and then the Hemostasis and Thrombosis (Opens in a new window) section.

Pediatric Specimen Requirements:

1 full pediatric 1.3 mL LIGHT BLUE top tube, 3.2% sodium citrate. Specimens must be processed and frozen within 2 hours of specimen collection.

Send 1 600 uL aliquot of platelet poor plasma, samples must remain frozen during storage and shipment.

Stability is 14 days at -20°C or at –70°C for up to 12 months.

For pediatric patients requiring multiple coagulation tests, please call 503-494-7383 regarding draw volumes.

Reference Range:

65% to 150%

For children less than 6 months, see link to published reference ranges (Opens in a new window).

Comments:

Refer to FACTOR XI (11) ACTIVITY W/REFLEX TO INHIBITOR [LAB101691] if inhibitor testing is desired.

Synonyms:

Factor 11

Factor 11A

Factor XI

FXIA

Orderable EAP code:

LAB00684

Billable EAP Codes:

80001122 x 1

CPT Codes:

85260 x 1

Lab Section:

Hemostasis and Thrombosis

Turnaround Time:

1 to 3 days

Test Schedule:

Monday, Wednesday, Friday

Units:

Interpretation:

Oral anticoagulant therapeutic range: 20% to 40%.

Critical Values:

≤ 10%

Specimen Requirements:

Two full 2.7 mL LIGHT BLUE top tubes, 3.2% sodium citrate. Specimens must be processed and frozen within 2 hours of specimen collection.

Send 2- 1mL aliquots of platelet poor plasma, samples must remain frozen during storage and shipment.

Stability is 14 days at -20 C or at –70°C for up to 12 months.

Detailed specimen collection and processing instructions are located under Lab Sections and then the Hemostasis and Thrombosis (Opens in a new window) section.

Pediatric Specimen Requirements:

One full pediatric 1.3 mL LIGHT BLUE top tube, 3.2% sodium citrate. Specimens must be processed and frozen within 2 hours of specimen collection.

Send 1 600 uL aliquot of platelet poor plasma, samples must remain frozen during storage and shipment.

Stability is 14 days at -20 C or at –70°C for up to 12 months.

For pediatric patients requiring multiple coagulation tests, please call 503-494-7383 regarding draw volumes.

Reference Range:

59% to 130%

Therapeutic range: Patient on warfarin anticoagulant therapy: 20-40%

INR of 2.0 - 3.5 correlates with a Factor X activity of 20-40%.

Comments:

Diagnostic Criteria: Factor X, Chromogenic Assay is indicated to monitor oral anticoagulation therapy in patients with a lupus inhibitor or thrombin inhibitor (argatroban, ect) + coumadin. This method is not affected by the lupus inhibitor or by therapeutic heparin levels.

Assay performed to document congenital and acquired factor deficiency. (Order Factor X, chromogenic if patient on argatroban, lepirudin or other thrombin inhibitors).

Acquired deficiencies occur with significant hepatic dysfunction and with oral anticoagulant (coumarin) therapy. Factor X levels are most frequently used to monitor oral anticoagulant therapy in patients with lupus inhibitors. Factor X deficiency may be associated with primary systemic amyloidosis. The rare clinical condition (X deficiency) is inherited as autosomal, incompletely recessive. About 25 cases of hereditary factor X deficiency have been reported.

High doses of standard heparin (greater than 1.0 U/mL) may interfere with PT mixing study. Anti-Xa agents such as Rivaroxaban may also interfere with PT mixing studies. Clinical correlation is advised.

Methodology: Chromogenic

This test was developed and its performance characteristics determined by OHSU laboratories. Although the testing kit has been approved by the US Food and Drug Administration (FDA), the use of this kit on the testing platform used at OHSU has not been approved by the FDA. However, the FDA does not require this process to go through FDA review. This test is used for clinical purposes. It should not be regarded as investigational or for research. The laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing.

Synonyms:

Activity

Chromogenic Factor 10

Chromogenic Factor X

Orderable EAP code:

LAB00260

Billable EAP Codes:

80001098 x 1

CPT Codes:

85230 x 1

Lab Section:

Hemostasis and Thrombosis

Turnaround Time:

1 to 3 days

Test Schedule:

Monday, Wednesday, and Friday

Units:

Critical Values:

Less than 5%

Specimen Requirements:

Two full 2.7 mL LIGHT BLUE top tubes, 3.2% sodium citrate. Specimens must be processed and frozen within 2 hours of specimen collection.

Send 2- 1mL aliquots of platelet poor plasma, samples must remain frozen during storage and shipment.

Stability is 14 days at -20 °C or at -70 °C for up to 12 months.

Detailed specimen collection and processing instructions are located under Lab Sections and then the Hemostasis and Thrombosis (Opens in a new window) section.

Pediatric Specimen Requirements:

1 full pediatric 1.3 mL LIGHT BLUE top tube, 3.2% sodium citrate. Specimens must be processed and frozen within 2 hours of specimen collection.

Send 1 600 uL aliquot of platelet poor plasma, samples must remain frozen during storage and shipment,

Stability is 14 days at -20 °C or at -70 °C for up to 12 months.

For pediatric patients requiring multiple coagulation tests, please call 503-494-7383 regarding draw volumes.

Reference Range:

50% to 129%

For children less than 6 months, see link to published reference ranges (Opens in a new window).

Comments:

Avoid warfarin (Coumadin) therapy for 2 weeks and heparin therapy for 2 days prior to the test.

Assay to document factor VII deficiency. Deficiency of factor VII should be considered in patients with a prolonged prothrombin time but a normal APTT. While isolated deficiency is rare, two forms exist. Both are autosomal recessive and affect both sexes. In one form the VII molecules are decreased while In the second group an abnormally formed molecule is produced. Bleeding symptoms may be severe in homozygotes and include epistaxis, ecchymoses, GI bleeding, hemarthroses, menorrhagia, and umbilical cord hemorrhage. Fatal cerebral hemorrhage may occur. Heterozygotes are usually asymptomatic. Homozygotes have prolonged prothrombin time (corrected by adding normal plasma) but normal APTT, cephalin activated clotting time, and thrombin time.

Methodology: PT based clotting method.

Synonyms:

F7A

Factor 7

FVII A

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