Orderable EAP code:

LAB102560

Billable EAP Codes:

80005300 x 1

CPT Codes:

85130 x 1

Lab Section:

Hemostasis and Thrombosis

Turnaround Time:

1 to 3 Days 

Test Schedule:

Monday, Wednesday, Friday 

Units:

%

Interpretation:

This test was performed using the chromogenic method of detecting Factor VIII activity. There may be a discrepancy in Factor VIII activity when compared to the one stage (i.e. clot-based) detection method potentially resulting in a missed diagnosis (or misclassification of severity) of mild/moderate hemophilia A. Heparin and/or EDTA contamination will falsely lower FVIII levels.

Critical Values:

< 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: 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:

*This lab is not recommended to be tested on patients <2 years of age. You may proceed with ordering, but results should be          interpreted with caution.

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: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:

43.2% - 159.3%

Comments:

Rivaroxaban and dabigatran interfered with the quantification of FVIII activity. 
The performance of this device has not been established in individuals with von Willebrand disease Type 2M

RECOVERY OF FVIII REPLACEMENT PRODUCTS 
1.    CRYOcheck Chromogenic Factor VIII accurately evaluated the potency of FVIII replacement products including ADVATE, ADYNOVATE, AFSTYLA, ALTUVIIO, ESPEROCT, HUMATE-P, JIVI, KOVALTRY, Novoeight, Nuwiq, and wilate at concentrations ranging from 0.05 to 1.0 IU/mL. 
2.    It also accurately evaluated the potency of ELOCTATE, and XYNTHA from 0.05 to 0.6 IU/mL, with an over recovery observed at 0.8 and 1.0 IU/mL. 
3.    There was an underestimation of OBIZUR.
4.    Per the manufacturer’s recommendations, chromogenic assays overestimate Altuviiio approximately 2.5-fold. Mean percent recovery value includes dividing by a correction factor of 2.5.

Synonyms:

CHF8
Hemophilia Chromogenic FVIII
Hemophilia A EHL
Chromogenic
Chromogenic FVIII