NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Detecting increased or decreased fibrinogen (factor I) concentration of acquired or congenital origin
Monitoring severity and treatment of disseminated intravascular coagulation and fibrinolysis
Electromagnetic End point Detection: STA-R Evolution
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Specimen Type Describes the specimen type needed for testing
Plasma Na Cit
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Specimen Type: Platelet-poor plasma
Preferred: Light-blue top (3.2% sodium citrate at 9:1 ratio)
Acceptable: Light-blue top (3.8% sodium citrate at 9:1 ratio)
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Plasma Na Cit||Frozen (preferred)||30 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Fibrinogen, also known as factor I, is a plasma protein that can be transformed by thrombin into a fibrin gel ("the clot").
Fibrinogen is synthesized in the liver and circulates in the plasma as a disulfide-bonded dimer of 3 subunit chains.
The biological half-life of plasma fibrinogen is 3 to 5 days.
An isolated deficiency of fibrinogen may be inherited as an autosomal recessive trait (afibrinogenemia or hypofibrinogenemia) and is 1 of the rarest of the inherited coagulation factor deficiencies.
Acquired causes of decreased fibrinogen levels include: acute or decompensated intravascular coagulation and fibrinolysis (disseminated intravascular coagulation [DIC]), advanced liver disease, L-asparaginase therapy, and therapy with fibrinolytic agents (eg, streptokinase, urokinase, tissue plasminogen activator).
Fibrinogen function abnormalities, dysfibrinogenemias, may be inherited (congenital) or acquired. Patients with dysfibrinogenemia are generally asymptomatic. However, the congenital dysfibrinogenemias are more likely than the acquired to be associated with bleeding or thrombotic disorders. While the dysfibrinogenemias are generally not associated with clinically significant hemostasis problems, they characteristically produce a prolonged thrombin time clotting test. Congenital dysfibrinogenemias usually are inherited as autosomal codominant traits.
Acquired dysfibrinogenemias mainly occur in association with liver disease (eg, chronic hepatitis, hepatoma) or renal diseases (eg, chronic glomerulonephritis, hypernephroma) and usually are associated with elevated fibrinogen levels.
Fibrinogen is an acute phase reactant, so a number of acquired conditions can result in an increase in its plasma level:
-Acute or chronic inflammatory illnesses
-Liver disease and cirrhosis
-Pregnancy or estrogen therapy
-Compensated intravascular coagulation
The finding of an increased level of fibrinogen in a patient with obscure symptoms suggests an organic rather than a functional condition. Chronically increased fibrinogen has been recognized as a risk factor for development of arterial thromboembolism.
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.
Males: 200-375 mg/dL
Females: 200-430 mg/dL
In normal, full-term newborns and in healthy, premature infants (30-36 week gestation), fibrinogen is near adult levels and reaches adult levels by < or =21 days postnatal.
This kinetic assay assesses levels of functional (clottable) fibrinogen (see Cautions).
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
In patients with dysfibrinogenemias, kinetic fibrinogen assays may give spuriously-low values.
In patients with markedly elevated plasma levels of fibrin degradation products (eg, thrombolytic therapy or disseminated intravascular coagulation and fibrinolysis), clottable fibrinogen determined by kinetic (rate) technique may be lower than when measured by an end-point method (eg, nephelometric assay.
Patients with antibodies to bovine thrombin (which can arise in association with surgical application of topical bovine thrombin) may have spuriously-decreased fibrinogen when assayed by kinetic technique.
In each of the above cases, end-point determinations of clottable fibrinogen (eg, nephelometric assay) may be helpful or diagnostic. The nephelometric assay is available as part of a Coagulation Consultation.
The presence of large amounts of heparin (>5-10 U/mL) may cause erroneously-low kinetic estimates of fibrinogen or make it impossible to measure fibrinogen by the nephelometric end-point technique.
In these cases, end-point determinations of clottable fibrinogen by a gravimetric/spectrophotometric (biuret) technique or fibrinogen immunoassay may be helpful.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Dang CV, Bell WR, Shuman M: The normal and morbid biology of fibrinogen. Am J Med 1989;87:567-576
2. Bowie EJW, Owen CA Jr: Clinical and laboratory diagnosis of hemorrhagic disorders. In Disorders of Hemostasis. Edited by OD Ratnoff, CD Forbes. Philadelphia, WB Saunders Company, 1991, pp 68-69
3. Martinez J: Quantitative and qualitative disorders of fibrinogen. In Hematology: Basic Principles and Practice. Edited by R Hoffman, EJ Benz Jr, SJ Shattil, et al. New York, Churchill Livingstone, 1991, pp 1342-1354
4. Mackie IJ, Kitchen S, Machin SJ, Lowe GD: Haemostais and Thrombosis Task Force of the British Committee for standards in Haematology. Guidelines for fibrinogen assays. Br J Haemotol 2003;121:396-304
Method Description Describes how the test is performed and provides a method-specific reference
The STA Fibrinogen Kit is intended for the quantitative determination of fibrinogen in plasma by the Clauss clotting method. In the presence of an excess of thrombin, the clotting time of diluted plasma is inversely proportional to the level of plasma fibrinogen. The clot is detected by the STA-R Evolution. The STA-R Evolution is a fully automated coagulation instrument that uses an electromagnetic viscosity detection system. The oscillation of a steel ball within the cuvette with the thrombin and diluted plasma is monitored by the STA-R Evolution. At the constant viscosity; constant pendular swings of the ball are obtained within an electromagneticfield. As the viscosity increases as a result of the coagulation, the oscillation amplitude of the ball swing decreases. An algorithm uses these variations in oscillation amplitude to determine the clotting time. The time is read from a stored curve on the STA-R Evolution. An increase of the fibrinogen level is observed in cases of diabetes, inflammatory syndromes, and obesity. A decrease of the fibrinogen level is observed in DIC, fibrinolysis and hereditary diseases. (Package insert: STA Fibrinogen, Diagnostica Stago, Inc.)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Sunday Continuously
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|