C4NeF Report

Test Code
11375


CPT Codes
86161<br /> This test is not available for New York patient testing<br /> Restricted Client Code

Preferred Specimen
1 mL serum collected in a red-top tube (no gel)


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

Minimum Volume
1 mL


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

Sample type must be clearly labeled "serum" 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 a red-top vacutainer tube. Note: Serum separators with "clot activators" should not be used for the serum samples.
2.) Allow the blood in the red-top 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 "Serum" or "Red-top" 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.
Note: Do not transfer cells with serum. If necessary centrifuge a second time.

Serum 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 either serum.
-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)

Setup Schedule
Set up: Mon-Fri; Report available: 28 day


Reference Range
Negative


Clinical Significance
C4 Nephritic Factors
Dense Deposit Disease and C3 Glomerulonephritis

Testing is appropriate for patients with C3 glomerulopathy (DDD and C3GN). C4 nephritic factor (C4Nef) is an autoantibody to the classical pathway C3 convertase (C4b2a). By stabilizing C4b2a, it prolongs the half-life of this convertase and protects C4b2a against decay dissociation by C4 binding protein (C4BP). C4Nef has been associated with several diseases including post-infectious glomerulonephritis (Halbwachs et al, 1980), systemic lupus erythematosus (Daha and van Es, 1980), membranoproliferative glomerulonephritis (Tanuma, et al. 1989) and meningococcal disease (Miller, et al. 2012).

Indications for screening: Screening is appropriate for patients with DDD and C3GN




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.