The presence of the anti-C1q IgG antibody may be associated with increased risk of lupus nephritis or with systemic lupus erythematosus (SLE) global activity. Anti-C1q antibodies are not specific for SLE; strong clinical correlation with disease is recommended.
Compliance Statement A
: Analyte specific reagents (ASR) are used in many laboratory tests necessary for standard medical care and generally do not require U.S. Food and Drug Administration (FDA) approval or clearance. This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. This test should not be regarded as investigational or for research use.