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Test Code EculizPhrm Eculizumab Pharmacokinetic Assay

Clinical System Name

Eculizumab Pharmacokinetic Assay

Sample Requirements

Specimen: Whole Blood

Container(s): Red

Preferred Vol: 4.0 mL

Minimum Vol: 2.0 mL

 

Note: Draw blood between 06:00 AM - 10:00 AM. Deliver to the Main Lab within 30 minutes of collection.

Processing Instructions

Reject due to: Gold/SST, > 2 freeze/thaw cycles or refrigerated

Spin: Y

Aliquot: Y

Temp: -20 C

Storage Location: Separate serum from cells within TWO hours of collection. Place sample in the CPA freezer Send Outs rack.

 

Off-site Collection: Separate serum from cells within TWO hours of collection and freeze.

Stability

Specimen Type Temperature Time
Serum Room temp

N

  Refrigerated N
  Frozen

> 1 y

 

Availability

STAT Performed TAT
N Drawn daily, performed biweekly 7 - 14 d

 

Performing Laboratory

Cincinnati Children’s Hospital

Thrombotic Microangiopathy Laboratory

3333 Burnet Avenue

ATTN: Lab Processing B-4

Cincinnati, OH 45229

 

Phone: (513) 636-4530

Department

Department: Send Outs

Phone Number: (206) 987-2563

 

Reference Range

Eculizumab Level >500 mcg/mL
CH50 CCH 101-300 CH50 Units

 

Eculizumab is considered to be present in a therapeutic level in aHUS if the trough serum concentration is >99 μg/mL, and in PNH if the serum concentration is >35 μg/mL.

 

 

Methodology

Method: ELISA

Analytical Volume: None specified

Limitations:

CPT Codes

80299, 86162

Send Out Instructions

Reference Test Name: Eculizumab Pharmakokinetic Assay
Reference Test Number:  
Instructions: Ship frozen on dry ice overnight via FedEx Priority Overnight to Cincinnati Children's Hospital.