U.S. flag An official website of the United States government.
Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

i

Analytical Performance of the AtheNA MultiLyte® ANA II Assay in Sera from Lupus Patients with Multiple Positive ANAs

Public Domain


Details

  • Personal Author:
  • Description:
    The purpose of this study was to evaluate the precision and accuracy of a commercial multiplexed kit for the measurement of 9 anti-nuclear antibodies (ANAs; anti-SS/A, anti-SS/B, anti-Sm, anti-RNP, anti-Jo-1, anti-Scl-70, anti-dsDNA, anti-Centromere B, and anti-Histone), and to compare these results to a subset of ANAs measured by enzyme-linked immunosorbent assays (ELISA) and immunodiffusion (ID). Sera were obtained from 22 systemic lupus erythematosus (SLE) patients, twelve controls and five others (commercial source) with various autoimmune diseases. ANA results from the AtheNA MultiLyte ANA II Assay (AtheNA) were compared to ELISA results (controls) and patients (ID). The AtheNA interassay coefficients of variation (CVs, N = 39, performed in duplicate; replicated 3×) ranged from 6.2% to 16.7% (mean = 9.8%), while the intra-assay CVs ranged from 5.8% to 14.3% (mean = 10.8%). Compared to results for SLE cases and controls, the sensitivity of AtheNA ranged from 85.7% to 100% (mean = 97.1%), while diagnostic specificity ranged from 16.7% to 100% (mean = 71.6%). There was significant agreement (P values ranging from 0.0001 to 0.03) when analytes coanalyzed by AtheNA and ELISA/ID were evaluated using Cohen's kappa (? values ranging from 0.376 to 1.000). No false positive ANA results were observed for either the control or commercial source autoimmune disease sera. These results indicate that the AtheNA assay is a precise and accurate alternative for performing multiple ELISAs or IDs in the diagnosis of autoimmune diseases, especially when the number of sera to be tested is large, such as in clinical screening or epidemiologic studies. It also appears that the AtheNA assay identifies positive ANA specificities which are missed by ID techniques, suggesting that it may have greater analytical sensitivity for some ANAs. [Description provided by NIOSH]
  • Subjects:
  • Keywords:
  • ISSN:
    1618-2642
  • Document Type:
    Text
  • Genre:
    Journal Article
  • Place as Subject:
  • CIO:
    National Institute for Occupational Safety and Health (NIOSH)
  • Division:
    DART - Division of Applied Research and Technology
  • Topic:
    Workplace Safety & Health
  • Location:
    North America
  • Volume:
    388
  • Issue:
    3
  • NIOSHTIC Number:
    nn:20032021
  • Citation:
    Anal Bioanal Chem 2007 Jun; 388(3):613-618
  • Contact Point Address:
    Biological Monitoring Research Team, Biomonitoring and Health Assessment Branch, DART, National Institute for Occupational Safety and Health (NIOSH), CDC, MS C26, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, OH 45226
  • Email:
    rbiagini@cdc.gov
  • Federal Fiscal Year:
    2007
  • Peer Reviewed:
    True
  • Source Full Name:
    Analytical and Bioanalytical Chemistry
  • Collection(s):
  • Main Document Checksum:
    urn:sha-512:376fc53a38512a0d441b5f0fb89668edfccba431fcc5f049a3b72be32fb4b315275f11c9f6066c671b6c3f57ec216f74a972e980499730a9ad6ebfb59d4e343d
  • Download URL:
  • File Type:
    Filetype[PDF - 136.15 KB ]
PREVIOUS
ON THIS PAGE
Details
CDC STACKS serves as an archival repository of CDC-published products including scientific findings, journal articles, guidelines, recommendations, or other public health information authored or co-authored by CDC or funded partners.

As a repository, CDC STACKS retains documents in their original published format to ensure public access to scientific information.
BACK TO TOP