Plasma Factor I Level Report

Test Code
11383


CPT Codes
86160<br /> This test is not available for New York patient testing<br /> Restricted Client Code

Preferred Specimen
1 mL plasma collected in EDTA (lavender-top) tube


Patient Preparation
PLEX treatments will affect tests, please wait approximately 14 days after PLEX to draw samples.

Minimum Volume
1 mL


Instructions
All plasma samples MUST be processed and frozen down to -80° C immediately after collection (please see instructions).

Sample type must be clearly labeled (plasma) and shipped out overnight on at least 5 lb dry ice (Monday-Thursday).

1.) Follow standard phlebotomy techniques to collect at least 6 cc of whole blood drawn in an EDTA or Citrate vacutainer tube.
2.) Allow the blood in the EDTA or Citrate tube to clot at room temperature for 30 minutes.
3.) Centrifuge the clotted blood at room temperature (1000 x g for 10 minutes).
4.) Label "EDTA" or "Citrate" on clean screw top-tube(s).
5.) Pipette cell-free supernatant (at least 2 mL) to each labeled tube(s).
6.) Place the tube immediately at -80°C (or on dry ice). Sample must remain deep frozen.

Plasma must be frozen and U.S. samples must be shipped OVERNIGHT with a minimum of 3 kg (or 6 lb) dry ice.
-Cryovials should be put in zip lock bags and completely covered in dry ice to keep the sample frozen until it arrives in the lab.
-Delivery: Monday-Friday. NO WEEKEND DELIVERIES

ALL requested information must be provided or testing will not be performed

Patient information:
-Patient date of birth and gender
-Patient ethnicity and race
-Patient's clinical information and family history of kidney disease

Specimen information:
-Patient identifiers (full name, date of birth, sex and medical record number)
-Date of collection
-Sample type-frozen samples must be CLEARLY LABELED as plasma (and type, EDTA or Citrate)
-Ordering physician


Transport Temperature
Frozen (-80° C)


Specimen Stability
Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen (-80° C): Indefinitely


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Thawed OR unlabeled samples will be REJECTED for testing


Methodology
Enzyme-Linked Immunosorbent Assay (ELISA)

FDA Status
This test was developed and its performance characteristics determined by the Clinical Diagnostics Division of the Molecular Otolaryngology & Renal Research Laboratories. It has not been cleared or approved by the US Food and Drug Administration.

Setup Schedule
Set up: Mon-Fri; Report available: 14 days


Reference Range
Negative


Clinical Significance
Plasma Complement Factor I Level
Atypical Hemolytic Uremic Syndrome
Complement Factor I (FI; MW: 88 kDa) is an important regulator of complement activity triggered through the classical and alternative pathways. FI limits complement activation by cleaving surface-bound and fluid-phase C3b and C4b, preventing the assembly of the C3 and C5 convertases. Patients with FI mutations may have reduced plasma FI levels and/or function, and are at-risk to develop atypical hemolytic uremic syndrome or C3 glomerulopathy.

Indications for screening: Testing is appropriate for patients with aHUS.




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.