C1q Antibody (IgG)

Test Code
34303


CPT Codes
83516

Preferred Specimen
0.5 mL serum collected in a red-top tube (no gel)


Minimum Volume
0.3 mL


Other Acceptable Specimens
Plasma collected in: Sodium heparin (green-top) tube or EDTA (lavender-top) tube


Transport Container
Transport tube


Transport Temperature
Room temperature


Specimen Stability
Room temperature: 7 days
Refrigerated: 14 days
Frozen: 42 days


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Serum separator tube (SST)


Methodology
Enzyme Linked Immunosorbent Assay (ELISA)

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Sun, Thurs


Report Available
2-5 days


Reference Range
<26 RU/mL


Clinical Significance
This assay serves as a non-invasive aid for the diagnosis of active proliferative lupus nephritis (LN) and for monitoring disease activity. Autoantibodies to C1q (C1q Ab; IgG isotype) are detected in a number of autoimmune and infectious diseases but are best described in patients with systemic lupus erythematosus (SLE). Several studies suggest that C1q Ab plays a pathogenic role in the development of LN and that serum levels correlate with disease activity [1]. Moreover, C1q Ab results demonstrate fair sensitivity and specificity for active proliferative LN [2]. In addition, C1q Ab levels may begin to rise in advance of a renal flare and absence of C1q Ab suggests that a flare is unlikely [3].

References 
1. Bock M, Heijnen I, Trendelenburg M. Anti-C1q antibodies as a follow-up marker in SLE patients. PLoS One. 2015;10(4):e0123572. doi:10.1371/journal.pone.0123572
2. Yin Y, Wu X, Shan G, et al. Diagnostic value of serum anti-C1q antibodies in patients with lupus nephritis: a meta-analysis. Lupus. 2012;21(10):1088-1097. doi:10.1177/0961203312451202
3. Fatemi A, Samadi G, Sayedbonakdar Z, et al. Anti-C1q antibody in patients with lupus nephritic flare: 18-month follow-up and a nested case-control study. Mod Rheumatol. 2016;26(2):233-239. doi:10.3109/14397595.2015.1074649


Performing Laboratory
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042



Last Updated: November 6, 2024


The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.