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Protein C Antigen/Factor VII Antigen

CPT 85230; 85302

Test Details

Methodology

Enzyme-linked immunosorbent assay (ELISA)

Result Turnaround Time

3 - 6 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.

Related Documents

Test Includes

Protein C antigen; factor VII antigen; protein C:factor VII ratio

Use

This assay is used to obtain a presumptive diagnosis of protein C deficiency while a patient is receiving antivitamin K therapy. Use of this assay is discouraged.

Limitations

The extremely rare presence of antirabbit antibodies in certain subjects leads to aberrant results.

This procedure may be considered by Medicare and other carriers as an investigational and, therefore, may not be payable as a covered benefit for patients.

Custom Additional Information

Protein C (PrC) and factor VII (F VII) are vitamin K-dependent factors and may be decreased in patients on stable antivitamin K (warfarin) therapy. By calculating a PrC:VII ratio, a tentative diagnosis of PrC deficiency can be made in those patients receiving stable antivitamin K therapy. A decreased PrC:VII antigen ratio is indicative of a protein C deficiency; however, a final diagnosis of protein C deficiency should not be made until and individual has been removed from warfarin therapy for a minimum of two weeks and then testing repeated. The kindred of protein C deficient individuals should be screened for deficiency both to confirm its hereditary nature and to assess thrombotic risk to family members.

Specimen Requirements

Specimen

Plasma, frozen

Volume

1 mL

Container

Blue-top (sodium citrate) tube

Collection Instructions

Citrated plasma samples should be collected by double centrifugation. 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.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 alternate 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. Centrifuge for 10 minutes and carefully remove 2/3 of the plasma using a plastic transfer pipette, being careful not to disturb the cells. Deliver to a plastic transport tube, cap, and recentrifuge for 10 minutes. Use a second plastic pipette to remove the plasma, staying clear of the platelets at the bottom of the tube. Transfer the plasma into a LabCorp PP transpak frozen purple tube with screw cap (LabCorp N° 49482). Freeze immediately and maintain frozen until tested. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.

Please print and use the Volume Guide for Coagulation Testing to ensure proper draw volume.

Reference Range

0.5:2.2 ratio

Storage Instructions

Freeze.

Causes for Rejection

Hemolysis; clotted specimen; specimen contaminated with heparin (ie, drawn with blood gases); samples containing fibrin clots; specimens received thawed for more than 24 hours

Footnotes

1. Adcock DM, Kressin DC, Marlar RA. Effect of 3.2% vs 3.8% sodium citrate concentration on routine coagulation testing. Am J Clin Pathol. 1997Jan; 107(1):105-110. 8980376
2. Reneke J, Etzell J, Leslie S, Ng VL, Gottfried EL. Prolonged prothrombin time and activated partial thromboplastin time due to underfilled specimen tubes with 109 mmol/L (3.2%) citrate anticoagulant. Am J Clin Pathol. 1998 Jun; 109(6):754-757. 9620035
3. National Committee for Clinical Laboratory Standardization. Collection, Transport, and Processing of Blood Specimens for Coagulation Testing and General Performance of Coagulation Assays; Approved Guideline. 5th ed. Villanova, Pa: NCCLS; 2008. Document H21-A5:28(5).
4. Gottfried EL, Adachi MM. Prothrombin time and activated partial thromboplastin time can be performed on the first tube. Am J Clin Pathol. 1997 Jun; 107(6):681-683. 9169665
5. McGlasson DL, More L, Best HA, Norris WL, Doe RH, Ray H. Drawing specimens for coagulation testing: Is a second tube necessary? Clin Lab Sci. 1999 May-Jun; 12(3):137-139. 10539100

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
500534 Protein C Ag/FVII Antigen 500535 Protein C Antigen % 27820-0
500534 Protein C Ag/FVII Antigen 500532 Factor VII Antigen** % 49870-9
500534 Protein C Ag/FVII Antigen 500536 Protein C Ag/FVII Ag Ratio** ratio 27438-1
Order Code500534
Order Code NameProtein C Ag/FVII Antigen
Order Loinc
Result Code500535
Result Code NameProtein C Antigen
UofM%
Result LOINC27820-0
Order Code500534
Order Code NameProtein C Ag/FVII Antigen
Order Loinc
Result Code500532
Result Code NameFactor VII Antigen**
UofM%
Result LOINC49870-9
Order Code500534
Order Code NameProtein C Ag/FVII Antigen
Order Loinc
Result Code500536
Result Code NameProtein C Ag/FVII Ag Ratio**
UofMratio
Result LOINC27438-1