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AP Activity Report
Test Code11370
CPT Codes
86162<br>This test is not available for New York patient testing<br>Limited Access Code
Preferred Specimen
1 mL frozen serum collected in a red-top tube (no gel)
Patient Preparation
PLEX treatments will affect serum tests, please wait 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
-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
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
-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
Refrigerated: Unacceptable
Frozen (-80° C): Indefinitely
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Unlabeled samples • Serum separator tubes (SST)
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
Normal
Clinical Significance
The Alternative Pathway Functional Assay (APFA) measures activity of the alternative pathway (AP) of complement. Specific initiators are used to stimulate the AP on patient-derived sera; neoantigens of C9 produced as a result of terminal complement complex (C5b-9) activation are measured. Consumption or depleted of AP complement proteins will result in a low (abnormal) APFA.
Dense Deposit Disease, C3 Glomerulonephritis and atypical Hemolytic Uremic Syndrome
Dense deposit disease (DDD) and C3 glomerulonephritis (C3GN) are two ultra-rare renal diseases. Both diseases are characterized by fluid-phase dysregulation of the AP that often leads to partial or complete consumption of circulating complement components, including complement C3, factor B, properdin and C5 (see Zhang et al. Defining the complement biomarker profile of C3 glomerulopathy, CJASN 2014). As a consequence, APFA can be low.
Indications for screening: Screening is appropriate for patients with dysregulated AP activity
Dense Deposit Disease, C3 Glomerulonephritis and atypical Hemolytic Uremic Syndrome
Dense deposit disease (DDD) and C3 glomerulonephritis (C3GN) are two ultra-rare renal diseases. Both diseases are characterized by fluid-phase dysregulation of the AP that often leads to partial or complete consumption of circulating complement components, including complement C3, factor B, properdin and C5 (see Zhang et al. Defining the complement biomarker profile of C3 glomerulopathy, CJASN 2014). As a consequence, APFA can be low.
Indications for screening: Screening is appropriate for patients with dysregulated AP activity
