Intended for the evaluation of patients suspected of having systemic autoimmune rheumatic diseases (also known as ANA-associated rheumatic or connective tissue diseases), such as systemic lupus erythematosus (SLE), Sjögren syndrome, systemic sclerosis, and mixed connective tissue disease. Also applicable in the assessment of certain organ-specific autoimmune diseases, including autoimmune liver disorders (e.g., autoimmune hepatitis), where antinuclear and extractable nuclear antigen antibodies may be diagnostically relevant.
Note: ANA testing is performed by indirect immunofluorescence (IFA). If positive, the antibody titer and fluorescence pattern will be reported.
Specimen Type: Serum
Collection Tube: Serum separator tube (SST) or red top
Collection Instructions: Separate serum from cells ASAP or within 2 hours of collection. Then transfer available serum to a standard transport tube.
Volume Required: 1 mL with a minimum of 500 mcL
Storage/Transport Temperature: Refrigerated/Frozen
Stability: Ambient (up to 8 Hours), refrigerated (up to 2 weeks/14days), frozen (up to 30 days) and avoid freeze/thaw cycles with no more than 3 in total
Unacceptable Conditions: Contaminated, heat-inactivated, containing clots fibrin or gross red blood cells, or severely lipemic hemolyzed or icteric samples
Normal Human: <1:80
This test has been cleared by the US Food and Drug Administration and is used per manufacturer's instructions and per Exsera's SOPs. Performance characteristics were verified by Exsera in a manner consistent with CAP/CLIA requirements.
Indirect Immunofluorescence assay
5 Business Days
Days Performed: M-F
ANAPAT. ANA Pattern with titer
ANA Titer only if positive