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NeF Activity Assay (IFE) Report
Test Code11386
CPT Codes
86334<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: 28 days
Reference Range
Negative
Clinical Significance
C3 Nephritic Factor/C5 Nephritic Factor/Nef Activity Assay
Dense Deposit Disease (DDD, aka Membranoproliferative Glomerulonephritis Type II, MPGNII)
C3 nephritic factors (C3Nefs), C5 nephritic factors (C5Nefs) and nephritic factor activity (nef activity) are defined as IgG autoantibodies to C3 convertase (C3bBb) that were first described by Spitzer and colleagues in 1969 as a substance in patient serum that constantly activated the alternative pathway cascade (Spitzer, 1969). They can be detected in ~80% of DDD patients and interfere with innate mechanisms that would otherwise control C3 convertase activity. Nephritic factors can also be detected in patients with partial lipodystrophy, meningococcal meningitis and post-streptococcal acute glomerulonephritis (Savage et al., 2009; Fremeaux-Bacchi, et al., 1994; Hulton, et al., 1992).
Indications for screening: Screening is appropriate for patients with biopsy-proven DDD
Dense Deposit Disease (DDD, aka Membranoproliferative Glomerulonephritis Type II, MPGNII)
C3 nephritic factors (C3Nefs), C5 nephritic factors (C5Nefs) and nephritic factor activity (nef activity) are defined as IgG autoantibodies to C3 convertase (C3bBb) that were first described by Spitzer and colleagues in 1969 as a substance in patient serum that constantly activated the alternative pathway cascade (Spitzer, 1969). They can be detected in ~80% of DDD patients and interfere with innate mechanisms that would otherwise control C3 convertase activity. Nephritic factors can also be detected in patients with partial lipodystrophy, meningococcal meningitis and post-streptococcal acute glomerulonephritis (Savage et al., 2009; Fremeaux-Bacchi, et al., 1994; Hulton, et al., 1992).
Indications for screening: Screening is appropriate for patients with biopsy-proven DDD
