Specimen Requirements:
6.0 mL Serum from a Red Top Tube in a Plastic Vial
Minimum Volume:
4.0 mL
Transport & Storage: Temperature/Stability:
48 hours Ambient
7 days Refrigerated
2 months Frozen
Reference Range:
ANA: <7.5 IU/mL
Complement C3: 82 - 235 mg/dL
Complement C4: 16 - 70 mg/dL
DNA (FARR): < 5.0 IU/ml
Not Detected: Less than 5.0 IU/mL
Indeterminate: 5.0 - 10.0 IU/mL
Detected: Greater than 10.0 IU/mL
Mitochondrial (M2) IgG: <20.1
Negative: Less than 20.1
Equivocal: 20.1 - 24.9
Positive: Greater than 24.9
Parietal Cell Total: < 1:40 Titer
Rheumatoid Factor: < 60 IU/mL
Scl-70 IgG: < 11
Negative: < 11 Units
Borderline: 11-20 Units
Positive: > 20 Units
Sm IgG: < 11
Negative: < 11 Units
Borderline: 11-20 Units
Positive: > 20 Units
Smooth Muscle Total: < 1:40 Titer
SS-A: < 11
Negative: < 11 Units
Borderline: 11-20 Units
Positive: > 20 Units
SS-B: <11
Negative: < 11 Units
Borderline: 11-20 Units
Positive: > 20 Units
Striational Total: < 1:40 Titer
Thyroid Peroxidase: < 60 U/mL
U1 RNP/snRNP IgG: < 11
Negative: < 11 Units
Borderline: 11-20 Units
Positive: > 20 Units
Methodology:
Multiple
Clinical Significance:
ANA: Screening test for the detection of antibodies to nuclear antigens. Over 96% of patients with systemic lupus erythematosus (SLE) have values above 7.5 IU/mL. Less than 3-4% of healthy patients display ANA concentrations of 7.5 IU/mL or higher. For specific antibodies associated with SLE and other autoimmune diseases, Specialty offers ANALyzer without ANA.
Complement C3: Quantitation of C3 is used to detect individuals with inborn deficiency of this factor or those with immunologic disease in whom complement is consumed at an increased rate. These diseases include lupus erythematosus, chronic active hepatitis, certain chronic infections, poststreptococcal and membranoproliferative glomerulonephritis, and others.
Complement C4: Quantitation of C4 is used to detect individuals with inborn deficiency of the factor or those with immunological disease in whom hypercatabolism of complement causes reduced levels. These diseases include lupus erythematosus, serum sickness, certain glomerulonephritides, chronic active hepatitis, and others. Low C4 with high dsDNA autoantibodies confirms the diagnosis of SLE and may help monitor activity. For patients with C4 concentrations below 22 mg/dL, complement C4 allotyping can be used to evaluate the possibility of C4 null alleles as a cause of decreased serum C4. For patients with very low C4, low CH50 and relatively normal C3, a genetic deficiency of C1 esterase inhibitor should be considered
DNA (FARR): The Farr method is the most sensitive method for detecting dsDNA autoantibodies. Significant elevations in dsDNA autoantibody concentrations confirm the diagnosis of systemic lupus erythematosus (SLE). Serial studies of elevated values of dsDNA autoantibodies are useful for predicting activity of SLE and for measurement of serum C3 or C4 concentrations. Absence of dsDNA autoantibodies does not exclude the diagnosis of SLE. Doubling of dsDNA autoantibody concentrations, or increases greater than 30.0 IU/mL in less than 10 weeks are reliably predictive of exacerbations of SLE. A simultaneous decrease in serum C4 complement enhances this predictive value
Mitochondrial (M2) IgG: Anti-Mitochondrial antibodies (AMA) have been reported in greater than 90% of patients with Primary Biliary Cirrhosis (PBC). AMA are also occasionally found in patients with chronic active hepatitis, cryptogenic cirrhosis and in patients with clinical but no biochemical evidence of liver disease. The M2 type of AMA is strongly associated with PBC
Parietal Cell Total: Detects autoantibodies useful in the differential diagnosis of pernicious anemia
Rheumatoid Factor: Rheumatoid factor is essentially an IgM antibody that is directed toward IgG. Although it is a non-specific marker, it is associated with autoimmunity and rheumatoid arthritis. IgG antibodies may be altered to be recognized as "foreign", resulting in an autoimmunity
Scl-70 IgG: Present in 20% to 40% of diffuse scleroderma patients
Sm IgG: Highly specific for systemic lupus erythematosus (SLE). Detect antibodies associated with SLE and mixed connective tissue disease. Sm autoantibodies are specific for systemic lupus erythematosus and do not correlate with any particular feature of SLE
Smooth Muscle Total: Useful in the diagnosis of liver disease. High titers of SMA of anti-active specificities are found in 97% of patients with autoimmune chronic active hepatitis. SMA (non-anti- active) are also found in virus induced liver disease. Absence of SMA and nuclear antibodies argues for non-autoimmune forms of chronic hepatitis
SS-A & SS-B IgG: This panel is used to aid the diagnosis of Sjogren's Syndrome. One or both of the autoantibodies are detected in 80-90% of Sjogren's Syndrome (SS) and 30 - 35% of patients with SLE. SSA and SSB antibodies detected in 96% of patients with primary (SS) and in all patients with SS secondary to RA. SSA and SSB are rarely detected in SS secondary to rheumatoid arthritis, progressive systemic sclerosis and primary biliary cirrhosis. Individual components are also available. Specialty offers Analyzer #1000 as a more comprehensive evaluation
Striational Total: Antibodies are used to diagnose myopathic disorders and are found in 80% to 100% of patients with myasthenia gravis and thymoma
Thyroid Peroxidase: Autoantibodies to thyroid peroxidase (TPO), which is the major antigen of thyroid microsomes, can be detected in the serum of patients with autoimmune thyroid disease (e.g., Hashimoto, Graves) and predict elevated serum TSH concentrations
U1 RNP/snRNP IgG: Autoantibodies to the protein components of the U1 variety of small nuclear ribonucleoproteins (U1 snRNP) are common in SLE-overlap syndromes (e.g., mixed connective tissue disease [MCTD]) and less so in SLE itself. High titers of autoantibody to U1 snRNP are a hallmark of MCTD
Custom Panel:
No
PRODUCTION SCHEDULE
Turn Around Time:
6 to 10 days
Days Performed:
Monday, Tuesday, Wednesday, Thursday, Friday, Saturday
Sites Performed:
Quest Valencia (SLI)
PHL Test Code:
LUPUS
Send Out Test Code:
P622OC
Alternate Test Names:
Comprehensive Lupus Panel; Extended ANA
Included Tests:
ANA with International Units and Pattern; Complement C3; Complement C4; DNA Autoantibodies, DNA Autoantibodies Double Stranded (FARR); Mitochondrial (M2) IgG Autoabs; Parietal Cell Total Autoantibodies; Rheumatoid Factor; Scl-70 IgG Autoantibodies; SM (Smith) IgG Autoantibodies; Smooth Muscle Total Autoantibodies; SS-A and SS-B IgG Autoantibodies; Striational Total Autoantibodies; Thyroid Peroxidase Autoantibodies; U1RNP/snRNP IgG Autoantibodies
CPT Coding:
86039, 86160 x 2, 86225, 86235 x 5, 83516, 86255 x 3, 86376, 86431