Services


Chemistry / Immunology

Human Epididymal Protein

(HE4)

 

TEST: HE- Protein 4(Ovarian CA)

OTHER TEST REQUEST NAME:
• Human Epididymal Protein 4
• HE-4

TEST COMPOSITION:
Not applicable

INTENDED USE:
Used in monitoring recurrence of progressive disease in patients with epithelial ovarian cancer. Used in conjunction with the CA 125 II assay as an aid in estimating the risk of epithelial ovarian cancer in premenopausal and postmenopausal women presenting with pelvic mass.

METHODOLOGY:
Electrochemiluminescence Immunoassay (ECLIA)

LABORATORY SECTION:
Immunology

SPECIAL INSTRUCTIONS / PATIENT PREPARATIONS:
Samples should not be taken from patients receiving therapy with high biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin administration.

COLLECTION/SAMPLE CONTAINER:
Red or Gold tube

SPECIMEN AND VOLUME REQUIREMENT
Note: Follow tube manufacturer recommendation.  :    1-3 mL Serum

ALTERNATIVE SPECIMEN AND VOLUME REQUIREMENT:
1-3 mL Plasma (Li-heparin, K2-, K3-EDTA)

SPECIMEN STABILITY        
•   ROOM TEMPERATURE (15-25°C)    :     5 Hours
•   REFRIGERATED TEMPERATURE (2-8°C)    :     48 Hours
•   FREEZER TEMPERATURE (-20°C)    :    12 Weeks (Sample may be frozen twice)

TRANSPORT TEMPERATURE:
Transport specimen at 2°C – 8 °C (with cold packs)

REJECTION CRITERIA:
• Hemolyzed specimen
• Markedly lipemic sample
• Exceeded sample stability requirement
• Quantity not sufficient
• Improperly labeled specimen
• Improper collection tube used

RUNNING DAY:
Wednesday, Saturday

CUT OFF TIME:
12:00 Midnight

TAT/RELEASING OF RESULTS:

ROUTINE (on running days)
•  4 hours after receipt of specimen/ arrival of messenger
STAT (on running days only)
•  2½ hours from extraction/messenger arrival

REFERENCE INTERVAL/RESULT INTERPRETATION:
•  <40Y: <60.50 pmol/L
•  40Y & 1 Day – 49Y: <76.20 pmol/L
•  49Y & 1 Day– 59Y: <74.30 pmol/L
•  59Y & 1 Day – 69Y: <82.90 pmol/L
•  69Y & 1 Day - 999Y: <104.00 pmol/L


LIMITATIONS / INTERFERENCES:    
•         Samples should not be taken from patients receiving therapy with high biotin doses (i.e. > 5mg/day) until at least 8 hours following the last biotin administration.

•         In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.

 

 

@2017 Hi-Precision Diagnostics. All Rights Reserved