Test ID: ANAPR

Not recommended as a first-line screening test. However, it may be appropriate when there is a strong clinical suspicion of systemic autoimmune rheumatic disease (ANA-associated rheumatic diseases or connective tissue diseases) and a need to evaluate for specific auto antibodies, regardless of ANA screening results. Useful in cases where patients present with signs and symptoms consistent with systemic lupus erythematosus, Sjögren syndrome, systemic sclerosis, or mixed connective tissue disease, especially if ANA results are negative or unavailable.

Note: ANA testing will include ANA titer and fluorescence pattern; dsDNA and ENA testing will be performed regardless of ANA results.

• EPIC Code: LAB3463
• Exsera Order Code: ANAPR
• CPT Code: 86038 (IFA), 86039 (Titer), 86255 (Cent), 86225 (dsDNA), 86235 (SM), 86235 (RNP), 86235 (SSA), 86235 (SSB)

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

ANAPR, ANA Profile with Titer

ANA Profile with Titer (only titer if positive) includes: dsDNA, SM, RNP, SSA & SSB regardless of IFA result