Test Catalog

Test Id : CHF8P

Chromogenic Factor VIII Inhibitor Bethesda Profile, Plasma

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

Detecting the presence and titer of a specific factor inhibitor directed against coagulation factor VIII for patients on emicizumab (Hemlibra)

 

Detecting the presence and titer of an inhibitor directed against 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.

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test Id Reporting Name Available Separately Always Performed
CH8BI Chromogenic FVIII Inhibitor Interp No Yes
CHF8 Chromogenic FVIII, P Yes Yes
CH8B Chromogenic FVIII Inhibitor Titer,P No Yes

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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

Chromogenic

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 Profile

Specimen Type
Describes the specimen type validated for testing

Plasma Na Cit

Ordering Guidance

This test is indicated for testing for FVIII inhibitors in patients being treated with the specific antibody emicizumab (Hemlibra).

 

This test is for detection of presence of specific inhibitors against factor VIII (FVIII). If the presence or type of inhibitor is unknown, APROL / Prolonged Clot Time Profile, Plasma or ALUPP / Lupus Anticoagulant Profile, Plasma should be ordered first.

 

Multiple coagulation profile tests are available. See Coagulation Profile Comparison in Special Instructions for testing that is performed with each profile.

Shipping Instructions

Send all vials in the same shipping container.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Specimen Type: Platelet-poor plasma

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

Submission Container/Tube: Plastic vials

Specimen Volume: 2 mL in 2 plastic vials, each containing 1 mL

Collection Instructions:

1. Specimen must be collected prior to factor replacement therapy.

2. If collecting sample through a port/line, be sure to waste the appropriate amount prior to collection.

3. For complete instructions, see Coagulation Guidelines for Specimen Handling and Processing in Special Instructions.

4. Centrifuge, transfer all plasma into a plastic vial, and centrifuge plasma again.

5. Aliquot plasma (1 mL per aliquot) into 2 separate plastic vials leaving 0.25 mL in the bottom of centrifuged vial.

6. Freeze plasma immediately (no longer than 4 hours after collection) at -20 degrees C or, ideally, < or =-40 degrees C.

Additional Information:

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

2. Each coagulation assay requested should have its own vial.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

Coagulation Patient Information (T675) in Special Instructions. 

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

See Specimen Required

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

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject
IV heparin contamination Reject

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

Detecting the presence and titer of a specific factor inhibitor directed against coagulation factor VIII for patients on emicizumab (Hemlibra)

 

Detecting the presence and titer of an inhibitor directed against 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, 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.

CHROMOGENIC Factor VIII Activity Assay

Adults: 55.0-200.0%

Normal, full-term newborn infants or healthy premature infants usually have normal or elevated factor VIII.*

*See Pediatric Hemostasis References section in Coagulation Guidelines for Specimen Handling and Processing in Special Instructions.

 

BETHESDA TITER

< or =0.5 Bethesda Units

Interpretation
Provides information to assist in interpretation of the test results

An interpretive report will be provided.

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 Feb;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 Nov;35(8):752-759

3. Miller CH, Platt SJ, Rice AS, 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 Jun;10(6):1055-1061

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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

The Chromogenic Factor VIII assay is performed on the Instrumentation Laboratory ACL TOP 700 using the CRYOcheck Chromogenic Factor VIII kit. In this 2-stage assay, patient plasma is diluted and combined with reagents containing bovine factor X, human factors IXa and IIa, calcium chloride, and phospholipids. The factor VIII in the patient's plasma aids in the activation of factor X to factor Xa. After a specified incubation period, chromogenic substrate is added at which time, the factor Xa, present from the previous step, hydrolyzes the substrate into peptide and p-nitroaniline (pNA). The color produced by the release of pNA is measured photometrically at 405 nm and is proportional to the factor VIII in the sample.(Package insert: CRYOcheck Chromogenic Factor VIII. Precision BioLogic Inc; Rev V04 06/2020)

 

In the Bethesda procedure, patient plasma is heat inactivated (HI) at 56 degrees C for 30 minutes. Next using the HI patient plasma, serial dilutions are prepared and mixed in equal volumes with normal pooled plasma. The mixture is incubated 2 hours at 37 degrees C. At the end of the incubation, chromogenic factor VIII (CHF8) activity is measured and compared to a control performed at the same time. The difference between the CHF8 activity of the patient's incubation mixture and that of the control is used to calculate the titer. The residual CHF8 activity is converted to Bethesda units: 50% residual CHF8 is equal to 1 Bethesda unit. Assays using the same basic principle as the Bethesda assay are used to quantitate the inhibitors of the other coagulation factors.(Kasper CK, Aldedort LM, Counts RB, et al: A more uniform measurement of factor VIII inhibitors. Thromb Diath Haemorrh. 1975;34:869-872; Miller C: Laboratory testing for factor VIII and IX inhibitors in haemophilia: A review. Haemophilia. 2018;00:1-12)

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 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 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 Regional Manager. 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.

See Individual Test IDs

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.

CHF8-85130

CH8B-85335

CH8BI-85390-26

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
CHF8P Chromogenic FVIII Inhibitor Profile 95121-0
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.
CH8B Chromogenic FVIII Inhibitor Titer,P 93450-5
606844 Chromogenic FVIII Inhibitor Interp 95122-8
606865 Reviewed by 18771-6
CHF8 Chromogenic FVIII, P 49865-9

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 | 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

Test Update Resources

Change Type Effective Date
New Test 2021-06-08