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FH Complement Assay Report
Test Code11380
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)
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
Factor H Autoantibodies
Dense Deposit Disease (DDD, aka Membranoproliferative Glomerulonephritis Type II, MPGNII) Factor H autoantibodies have been associated with DDD (Meri, et al., 1992). In patients with DDD, these autoantibodies bind to and block the N-terminal region of the Factor H protein, which compromises its fluid-phase regulatory function.
Atypical Hemolytic-Uremic Syndrome Factor H autoantibodies are identified in ~10% patients with aHUS (Dragon-Durey, et al., 2005, Moore, et al., 2010). Most but not all patients with aHUS who develop Factor H autoantibodies are homozygous for a known polymorphism, del(CFHR3-CFHR1). Homozygosity for this deletion is seen in 15% of patients with aHUS as compared to 5% of controls of northern European ancestry (Zipfel, et al., 2007, Skerka, et al., 2009). The Factor H autoantibodies in aHUS patients bind to and block the C-terminal region of the Factor H protein, which interferes with its surface regulatory function (Józsi, et al., 2007).
Indications for screening: Screening is appropriate for patients with aHUS and biopsy-proven DDD
Dense Deposit Disease (DDD, aka Membranoproliferative Glomerulonephritis Type II, MPGNII) Factor H autoantibodies have been associated with DDD (Meri, et al., 1992). In patients with DDD, these autoantibodies bind to and block the N-terminal region of the Factor H protein, which compromises its fluid-phase regulatory function.
Atypical Hemolytic-Uremic Syndrome Factor H autoantibodies are identified in ~10% patients with aHUS (Dragon-Durey, et al., 2005, Moore, et al., 2010). Most but not all patients with aHUS who develop Factor H autoantibodies are homozygous for a known polymorphism, del(CFHR3-CFHR1). Homozygosity for this deletion is seen in 15% of patients with aHUS as compared to 5% of controls of northern European ancestry (Zipfel, et al., 2007, Skerka, et al., 2009). The Factor H autoantibodies in aHUS patients bind to and block the C-terminal region of the Factor H protein, which interferes with its surface regulatory function (Józsi, et al., 2007).
Indications for screening: Screening is appropriate for patients with aHUS and biopsy-proven DDD
