MORL Screening Methodology
Modified enzyme linked immunosorbent assay (ELISA)
- 1ml frozen serum
- Serum samples must be frozen to below -80°C immediately after separation from cells and shipped on dry ice. These samples remain viable for at least six months when stored at -80°C.
- All serum samples MUST be processed and frozen down to -80°C immediately after collection
- Labeled with the sample type AND patient’s name, DOB, MRN and sex
- 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
- Shipped overnight on at least 5 lbs of dry ice
- Shipping and receiving dock closed on weekends and holidays
- Deliveries accepted Monday - Friday
If samples arrive thawed they will be REJECTED.
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.
Quick Facts
- CPT code: 86161
- Test code: 06APFA
- Turnaround time: 2 weeks
- Cost: $220
Background Knowledge
The Alternative Pathway Functional Assay (APFA) assesses the activity of the alternative pathway (AP) of complement. It utilizes specific initiators, such as LPS, to activate the AP in patient serum followed by the measurement of neoantigens of C9 produced upon generation of the terminal complement complex (C5b-9) as a consequence of alternative pathway activity. Reduced levels or depletion of any complement proteins in the alternative and terminal pathways will result in a decreased or reduced (abnormal) APFA outcome.
The Clinical Diagnostics Service of the Molecular Otolaryngology & Renal Research Laboratories is a CLIA-approved, Joint Commission-accredited diagnostic laboratory.