Test Catalog

Test Id : CH8BI

Chromogenic Factor VIII Inhibitor Bethesda Profile Interpretation

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

Interpretation of CHF8P / Chromogenic Factor VIII Inhibitor Bethesda Profile, Plasma

 

Detecting the presence and titer of a specific factor inhibitor directed against coagulation factor VIII

 

This test is not useful for detecting the presence of inhibitors directed against other clotting factors and will not detect the presence of lupus anticoagulants.

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

Only orderable as part of a profile. For more information see CHF8P / Chromogenic Factor VIII Inhibitor Bethesda Profile, Plasma.

 

Medical Interpretation

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

Chromogenic FVIII Inhibitor Interp

Specimen Type
Describes the specimen type validated for testing

Plasma Na Cit

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

 

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 14 days

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

Interpretation of CHF8P / Chromogenic Factor VIII Inhibitor Bethesda Profile, Plasma

 

Detecting the presence and titer of a specific factor inhibitor directed against coagulation factor VIII

 

This test is not useful for detecting the presence of inhibitors directed against other clotting factors and will not detect the presence of lupus anticoagulants.

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

Factor VIII (FVIII) inhibitors are IgG antibodies directed against coagulation FVIII that typically result in development of potentially life-threatening hemorrhage. These antibodies may be alloimmune: developing in patients with congenital FVIII deficiency (hemophilia A) in response to therapeutic infusions of factor VIII concentrate or autoimmune: occurring in patients without hemophilia (not previously factor VIII deficient) either spontaneously or during pregnancy or in association with autoimmune diseases.

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.

Only orderable as part of a profile. For more information see CHF8P / Chromogenic Factor VIII Inhibitor Bethesda Profile, Plasma.

 

An interpretive report will be provided.

Interpretation
Provides information to assist in interpretation of the test results

The interpretive report will include assay information, background information, and conclusions based on the test results.

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

Contamination with excess heparin and hemodilution due to improper specimen collection through an intravenous access device or collection above a running intravenous fluid line may cause spurious results.

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

1. Peyvandi F, Oldenburg J, Friedman KD. A critical appraisal of one-stage and chromogenic assays of factor VIII activity. J Thromb Haemost. 2016;14(2):248-261

2. Verbruggen B, van Heerde WL, Laros-van Gorkom BA. Improvements in factor VIII inhibitor detection: From Bethesda to Nijmegen. Semin Thromb Hemost. 2009;35(8):752-759

3. Miller C, Platt S, Rice A, Kelly F, Soucie JM, Hemophilia Inhibitor Research Study Investigators. Validation of Nijmegen-Bethesda assay modifications to allow inhibitor measurement during replacement therapy and facilitate inhibitor surveillance. J Thromb Haemost. 2012;10:1055-1061

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

A coagulation expert (clinician or hematopathologist) reviews the laboratory data, and an interpretive report is issued.

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 Friday

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.

2 days

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 account representative. 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.

Not Applicable

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.

85390

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
CH8BI Chromogenic FVIII Inhibitor Interp 95122-8
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.
606844 Chromogenic FVIII Inhibitor Interp 95122-8
606865 Reviewed by 18771-6

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 | PHP Pdf | CMS 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