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FB Complement Assay Report
Test Code11377
CPT Codes
⁠⁠⁠⁠⁠⁠⁠86160<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
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
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 days
Reference Range
Negative
Clinical Significance
Factor B Autoantibodies
Dense Deposit Disease (DDD, aka Membranoproliferative Glomerulonephritis Type II, MPGNII)
C3 Glomerulonephritis (C3GN)
Atypical Hemolytic Uremic Syndrome (aHUS)
Factor B autoantibodies (FBAAs) have been associated with DDD (Strobel, et al. 2010; Chen, et al. 2011). FBAA binds to factor B and/or the individual component Bb part of C3 convertase. More importantly, FBAA enhances C3 convertase activity, which often leads to increased complement breakdown products. FBAA represents an additional acquired driver of disease in DDD, C3GN and aHUS. Although rare, FBAAs should be considered in the comprehensive evaluation of patients with DDD, C3GN and aHUS.
Indications for screening: Screening is appropriate in patients with aHUS and biopsy-proven DDD and C3GN
Dense Deposit Disease (DDD, aka Membranoproliferative Glomerulonephritis Type II, MPGNII)
C3 Glomerulonephritis (C3GN)
Atypical Hemolytic Uremic Syndrome (aHUS)
Factor B autoantibodies (FBAAs) have been associated with DDD (Strobel, et al. 2010; Chen, et al. 2011). FBAA binds to factor B and/or the individual component Bb part of C3 convertase. More importantly, FBAA enhances C3 convertase activity, which often leads to increased complement breakdown products. FBAA represents an additional acquired driver of disease in DDD, C3GN and aHUS. Although rare, FBAAs should be considered in the comprehensive evaluation of patients with DDD, C3GN and aHUS.
Indications for screening: Screening is appropriate in patients with aHUS and biopsy-proven DDD and C3GN
