Antinuclear Antibody Screen

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ANA Screening

  • First step in diagnosing connective tissue disorders, which affect over a million people per year in the U.S.1
  • ANA ELISA assays perform comparably to IFA.2, 3
  • Antigens derived from HEp-2 whole cell lysate.
  • Assay specifically detects antibodies to dsDNA, SSA (Ro60 & Ro52), SSB (La), Sm, Sm/RNP, Scl-70, Jo-1, Ribosomal P, and Centromere proteins.
  • 100% correlation with reference sera from CDC and AMLI.*

*CDC #6 excluded because test does not contain antigens directed toward it

Benefits of ANA Screening by ELISA

  • High clinical specificity (>95%) and sensitivity (>80%)
  • Reduced false positive results
  • Qualitative results
  • Faster and simpler procedures – No special training required
  • Common 30/30/30 procedure allows for simultaneously running other assays

ASSAY DETAILS

Catalog Number:
GSD01-1300
Controls:
3
Specificity:
96.7%
Incubation:
30/30/30
Format:
96 Well MTP
Specimen Type/Volume:
Serum/25 uL
Total Analysis Time:
<3 hours
Methodology:
ELISA
Sensitivity:
83.5%
Reading Wavelength:
450nm

INTERFERING SUBSTANCES

Substance Concentration Mean Percent Inhibition
Hemoglobin 2 g/L -2.1%
Bilirubin 20 mg/dL -3.0%
Rheumatoid Factor 100 IU/mL 8.8%
Triglycerides 3000 mg/dL -1.4%
Heterophile 65 μg/mL 5.4%
Heterophile 32.5 μg/mL 2.2%
Heterophile 16.25 μg/mL -0.6%

Assay Protocol

Screening Algorithm

+ OVERVIEW

ANA Screening

  • First step in diagnosing connective tissue disorders, which affect over a million people per year in the U.S.1
  • ANA ELISA assays perform comparably to IFA.2, 3
  • Antigens derived from HEp-2 whole cell lysate.
  • Assay specifically detects antibodies to dsDNA, SSA (Ro60 & Ro52), SSB (La), Sm, Sm/RNP, Scl-70, Jo-1, Ribosomal P, and Centromere proteins.
  • 100% correlation with reference sera from CDC and AMLI.*

*CDC #6 excluded because test does not contain antigens directed toward it

Benefits of ANA Screening by ELISA

  • High clinical specificity (>95%) and sensitivity (>80%)
  • Reduced false positive results
  • Qualitative results
  • Faster and simpler procedures – No special training required
  • Common 30/30/30 procedure allows for simultaneously running other assays
+ DETAILS

ASSAY DETAILS

Catalog Number:
GSD01-1300
Controls:
3
Specificity:
96.7%
Incubation:
30/30/30
Format:
96 Well MTP
Specimen Type/Volume:
Serum/25 uL
Total Analysis Time:
<3 hours
Methodology:
ELISA
Sensitivity:
83.5%
Reading Wavelength:
450nm

INTERFERING SUBSTANCES

Substance Concentration Mean Percent Inhibition
Hemoglobin 2 g/L -2.1%
Bilirubin 20 mg/dL -3.0%
Rheumatoid Factor 100 IU/mL 8.8%
Triglycerides 3000 mg/dL -1.4%
Heterophile 65 μg/mL 5.4%
Heterophile 32.5 μg/mL 2.2%
Heterophile 16.25 μg/mL -0.6%

Assay Protocol

Screening Algorithm