HE- Protein 4(Ovarian CA)

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. > 5 mg/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.

FREQUENTLY ASKED QUESTIONS (FAQS) :

Not applicable

RELATED WORDS/TEST :

Tumor Markers, BRCA-1 and BRCA-2, CA 125

 

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