Test Details
Methodology
The assay consists of the measurement of the clotting time in a system in which all the factors are present in excess except factor X, which is derived from the sample being tested. Testing coagulation factor activities requires that three dilutions be assayed and analyzed to produce a single result.9,10 The slope of the line created by plotting measured factor concentration against sample dilution is evaluated to discern the presence of inhibitors giving rise to nonparallelism.10 Moreover, samples producing results on initial dilution falling outside the analytic measurement range of the assay are tested at additional dilutions to produce reportable results.10
Result Turnaround Time
2 - 3 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
This test is used to evaluate an isolated, prolonged PT, evaluate prolongation of both the aPTT and PT, and to document factor X deficiency.6-8
Special Instructions
If the patient's hematocrit exceeds 55%, the volume of citrate in the collection tube must be adjusted. Refer to Coagulation Collection Procedures for directions.
Limitations
Direct Xa or thrombin inhibitor therapy may cause factitiously low results.
Custom Additional Information
This test is used to evaluate an isolated prolonged PT or to evaluate prolongation of both the APTT and PT and to document factor X deficiency.6-8 Factor X is a 54.8 kilodalton vitamin K-dependent glycoprotein coagulation factor that is produced by the liver.6 Normal factor X's plasma concentration is approximately 10 mg/mL and half-life is about 40 hours.6 Factor X activation occurs by both the extrinsic and intrinsic pathways. Factor X deficiency should be considered when a patient with bleeding history has both extended protime (PT) and activated partial thromboplastin time (aPTT). The dilute Russell viper venom (dRVVT) measures the activation of factor X and will be prolonged in patients with deficiency.7,8 Congenital factor X deficiency is rare and is inherited as an autosomal recessive trait.6 This condition affects both males and females.6 A few cases of combined congenital factor II, VII, IX and X factor deficiencies have been reported.6
Acquired deficiencies occur with significant hepatic dysfunction, with vitamin K antagonist (warfarin) therapy and in individuals with vitamin K deficiency.6,7 Factor X deficiency may be associated with primary systemic amyloidosis.6,8 Isolated factor X deficiency may also occur in patients with respiratory infections, acute myeloid leukemia, amyloidosis and with other malignancies.7 Acquired specific factor X inhibitors are rare in patients without congenital deficiency.6,7 Symptoms (homozygotes) include hematoma formation, postsurgical hemorrhage, menorrhagia, hematuria and umbilical cord hemorrhage.6,7 Factor X plasma activity <30% may result in excessive bleeding following a traumatic event.6 Spontaneous bleeding similar to that observed in severe hemophilia may occur when the activity is <1%.6,7
Specimen Requirements
Specimen
Plasma, frozen
Volume
1 mL
Container
Blue-top (sodium citrate) tube
Collection Instructions
Blood should be collected in a blue-top tube containing 3.2% buffered sodium citrate.1 Evacuated collection tubes must be filled to completion to ensure a proper blood-to-anticoagulant ratio.2,3 The sample should be mixed immediately by gentle inversion at least six times to ensure adequate mixing of the anticoagulant with the blood. A discard tube is not required prior to collection of coagulation samples unless the sample is collected using a winged (butterfly) collection system. With a winged blood collection set a discard tube should be drawn first to account for the dead space of the tubing and prevent under-filling of the evacuated tube.4,5 When noncitrate tubes are collected for other tests, collect sterile and nonadditive (red-top) tubes prior to citrate (blue-top) tubes. Any tube containing an alternative anticoagulant should be collected after the blue-top tube. Gel-barrier tubes and serum tubes with clot initiators should also be collected after the citrate tubes.
Please print and use the Volume Guide for Coagulation Testing to ensure proper draw volume.
Stability Requirements
| Temperature | Period |
|---|---|
| Frozen | 28 days |
| Freeze/thaw cycles | Stable x3 |
Reference Range
| Age | Range |
| 1 d | 46–67% |
| 3 d | 46–75% |
| 1 to 11 m | 77–122% |
| 1 to 5 y | 72–125% |
| 6 to 10 y | 68–125% |
| 11 to 16 y | 53–122% |
| >16 y | 69–131% |
Storage Instructions
Freeze.
Patient Preparation
Ideally, the patient should not be on anticoagulant therapy. Avoid warfarin (Coumadin®) therapy for two weeks prior to the test and heparin, direct Xa and thrombin inhibitor therapies for about three days prior to testing.
Causes for Rejection
Severe hemolysis; improper labeling; clotted specimen; specimen diluted with IV fluids; samples thawed in transit; improper sample type; sample out of stability
References
Iglay K, Aldridge ML, Calcinai M, Wolford E, Ashrani AA. The global epidemiology of acquired factor X deficiency. Hematology. 2025;30(1):2476254. PubMed 40151020
Mathews N, Hayward CPM. Vitamin K Deficiency: Diagnosis and Management. Ann Lab Med. 2025 Jul 1;45(4):358-366. PubMed 40269655
Napolitano M, Mariani G, Lapecorella M. Hereditary combined deficiency of the vitamin K-dependent clotting factors. Orphanet J Rare Dis. 2010 Jul 14;5:21. PubMed 20630065
STA® – Deficient X Instructions For Use (IFU) [package insert]. February 2024.
Footnotes
10. Riley PW, Gallea B, Valcour A. Development and Implementation of a Coagulation Factor Testing Method Utilizing Autoverification in a High-volume Clinical Reference Laboratory Environment. J Pathol Inform. 2017 Jun 19;8:25. PubMed 28706751
11. Monagle P, Barnes C, Ignjatovic V, et al. Developmental haemostasis. Impact for clinical haemostasis laboratories. Thromb Haemost. 2006 Feb;95(2):362-372. PubMed 16493500
12. Summerhayes R, et al. J Thromb Haemost. 2007;5(Supp 2):P-S-397.
13. Labcorp in-house development of adult reference ranges for factor X.
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 086306 | Factor X Activity | 3218-5 | 086306 | Factor X Activity | % | 3218-5 |
| Order Code | 086306 | |||||
| Order Code Name | Factor X Activity | |||||
| Order Loinc | 3218-5 | |||||
| Result Code | 086306 | |||||
| Result Code Name | Factor X Activity | |||||
| UofM | % | |||||
| Result LOINC | 3218-5 |