Screen: Indirect immunofluorescence (IFA), HEp-2000 substrate. If positive reflex to multiplex immunobead and anti-ds-DNA (EIA) assays for both adult and pediatric patients along with tissue ANA for pediatric patients only where indicated.
Initial Screening test for wide variety of autoimmune diseases including SLE, scleroderma, mixed connective issue disease and others. HEp-2000 cell substrate indirect immunofluorescence pattern and titer will be reported on the positive screens.
A positive screen will reflex to an additional testing cascade which is designed to identify the specificity of antinuclear antibodies observed in the screening assay. See Test Methodology section.
A positive screen in a child with concordant clinical findings suggests the possibility of SLE or juvenile rheumatoid arthritis/juvenile chronic arthritis. A positive ANA HEp-2000 IFA screen will reflex to a tissue ANA in addition to the adult reflexive testing. See Test Methodology section.
ANA Screen: Negative, Titer: <1:80. See test specific handbook entries for reflexed testing (ADNA and ENA10) reference ranges.
24 - 48 hours
Collect specimen in SST tube. Centrifuge, aliquot serum into a plastic vial and refrigerate.
Initial testing includes Antinuclear Antibody by IFA, HEp-2000 Substrate (NAB). If the screen is positive, the following reflex testing will be performed at an additional charge: Antinuclear Antibody Titer & Pattern (NABTP), Antinuclear Antibody by Multiplexed Immunoassay (ANA), and DNA Antibody, Double-Stranded (ADNA), and for patients less than 18 years of age Antinuclear Antibody, Tissue Substrate (NABT) if clinically indicated. If the ANA is positive, an Extractable Nuclear Antibody panel (ENA10) will be performed at an additional charge. If the NABT is positive, a titer (NABTG) will be performed at an additional charge. Due to the known incidence of false positive SCL-70 results by the multiplex immunoassay method in patients without characteristic scleroderma symptoms, specimens positive for SCL-70 will be sent to RDL Reference Laboratories for more specific SCL-70 ELISA testing at an additional charge (RSCL). If the EIA test is positive, immunodiffusion testing will be performed for confirmation at an additional charge (RSCLR). By ordering this test the clinician acknowledges additional reflex testing will be performed and billed at a separate additional charge if indicated.