C3b Complement Assay Report

Test Code
11371


CPT Codes
83520<br>This test is not available for New York patient testing<br>Restricted Client Code

Preferred Specimen
2 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
2 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 lbs 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 lbs) 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
-Patients 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 • Serum separator tube


Methodology
Enzyme-Linked Immunosorbent Assay (ELISA)

Setup Schedule
Set up: Mon-Fri; Report available: 4 weeks


Reference Range
Negative


Clinical Significance
Thrombotic microangiopathy (TMA) describes a group of life-threatening multi-systemic diseases characterized by microvascular thrombosis, consumptive thrombocytopenia and microangiopathic hemolytic anemia, often leading to renal failure, cerebral ischemia and end-organ damage. While TMAs are often caused by infections, cancers, pregnancy, drugs, trauma, malignant hypertension and cobalamin deficiency, complement-mediated TMAs, such as atypical hemolytic uremic syndrome (aHUS) are triggered by over-activity of the complement alternative pathway on the cell surface. We have developed a simple, reliable and quick method to detect C3b deposition secondary to fluid-phase complement dysregulation. Images are numerically scored (normal, 1+, 2+, 3+, 4+) using predesignated images.

Indications for screening: Screening is appropriate only 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.