We have utilized this resource in order to evaluate the sensitivity, specificity and overall performance of commercial assays and have selected only those kits which have proven to be consistently reliable over time. The serum bank has enabled RDL to define clinically relevant cutoff levels of assays in order to optimize the value of the results. Furthermore, RDL has collaborated with several biotechnology companies interested in developing high quality assays, utilizing our serum bank.

An important example of the significance of our serum bank is the role that our laboratory played in identifying anti-cyclic citrullinated peptide antibody (anti-CCP) as an important new assay in the diagnostics of Rheumatoid Arthritis (RA). RDL was the first lab in the country to offer this new and highly promising test specific for Rheumatoid Arthritis. Extensive in-house testing of the only commercial kits available were performed with serum from our serum bank as a method to define sensitivity and specificity. Thus, it has been determined that anti-CCP antibody assay has an 80% sensitivity and 96% specificity for Rheumatoid Arthritis. This represents a substantial improvement compared to rheumatoid factor. This much needed assay assists in diagnosing unequivocal diagnoses of RA, particularly in seronegative disease. In addition, it facilitates diagnosis in early RA synovitis in that approximately 70% of patients are Anti-CCP positive in contrast to Rheumatoid Factor (RF) which is more frequently absent in this setting.

Importantly, there were seven external trial sites in addition to RDL, testing the sensitivity and specificity of the new FDA approved Axis Shield Anti-CCP kit by EIA. All of the trial sites tested serum which contained a variety of rheumatic diseases in addition to both seropositive and seronegative RA. All these sites independently had sensitivities and specificities that were statistically quite similar. This helps to validate the value of our serum bank as a resource for testing future assays in RA diagnosis.

Below are a sampling of our in-house and research studies.

You can review the latest In-House and Research Studies here: Studies

1) In-house study of anti-cyclic citrullinated (CCP) peptide that determined that anti-CCP antibody assay has an 80% sensitivity and 96% specificity for Rheumatoid Arthritis; poster presentation at the 2003 National ACR meeting.

2) In-house study comparing specificity and sensitivity of autoimmune diagnostic kits from three commercial vendors; #410 sera evaluated from our serum bank which comprises a wide variety of autoimmune diseases and controls.

3) INOVA study to determine false negative and false positive rates for cardiolipin screen and ENA screen.

4) Study of #5000 sera analyzed on Hep-2000 substrate to determine false positive and false negative rates for anti-Ro (for Immunovision).

5) Study to evaluate use of HLA-DRB1 alleles in management of patients with Rheumatoid Arthritis.

6) Michelle Petrie (UCSF), “Antinuclear Antibody, Lupus Anticoagulant and Anti-cardiolipin Antibody in Women with Idiopathic Habitual Abortion”. Each specimen was tested for anti-RNP, Anti-dsDNA, C3 and C4 Complements, Anti-centromere, Anti-Ro, Anti-La.

7) Serologic evaluation of presumed lupus patients exposed to environmental toxins in Arizona. Drs. Daniel Wallace, Quismorio, Tessar. Each specimen was tested for reflex protein electrophoresis, rheumatoid factor (by nephelometry), Anti-nuclear antibody, Anti-ds DNA, Anti-SM, Anti-RNR Anti-Ro, Anti-La, C3 and C4 Complements, Anti-thyroid microsomal antibody, Anti-centromere, Anti-Scl 70 antibody.

8) For Dr. E. Chalom. Multi-center study. "Idiopathic Neonatal Hepatitis can be the sole manifestation of Neonatal Lupus.” Testing on each specimen included Anti-nuclear antibody, Anti-dsDNA, Anti-Ro, Anti-La, Anti-SM, Anti-RNP.

9) Multi-center NIH granted study of 800-1000 patients over a five-year period, for Dr. Bevra Hahn, Chief of Rheumatology at UCLA School of Medicine. “Genetic Aspects of Autoimmune Disease.” Tests to be performed on each specimen include: Anti-nuclear antibody, Anti-ds DNA (Farr Assay), Anti-SM, Anti-RNP, Anti-Ro, Anti-La, Anti-centromere, Anticardiolipin, C3 and C4 Complements.

10) Dr. Stuart Silverman, first author of immunological study of the differences between breast implant related and idiopathic Fibromyalgia. Tests included: Anti-nuclear antibody, Anti-ds DNA, Anti-SM, Anti-RNP, C3 and C4 Complements, Anti-centromere, Anticardiolipin, Anti-Scl 70, Anti-Ro, Anti-La, Anti-thyroid microsomal.

11) Collaborative study with Pharmacia-Upjohn comparing four different methods of double-stranded DNA antibodies.

12) In-house study to evaluate the clinical sensitivity and specificity of anti-telomere antibodies for systemic lupus erythematosus.

13) Research study with UCLA performing the following tests: anti-Cyclic Citrullinated Peptide antibody (anti-CCP), Rheumatoid Factor (nephelometry) and C –Reactive Protein (CRP).

14) Robinson, W., et al, “Autoantigen Microarrays for Multiplex Characterization of Autoantibody Responses,” Nature Medicine, Vol. 8, No. 3, 295-301, 2002.

15) Schoenfeld, Y., Wu, R., et al, “Are Anti-Oxidized Low-Density Lipoprotein Antibodies Pathogenic or Protective?” Circulation, October 26, 2004; 2552-2558

16) Shen, G., “Anti-C1q Specific IgG Antibodies in SLE Patients and Other Disease Groups”; poster presentation at the 2004 National ACR Meeting.

17) Dr. Douglas Lienesch, University of Cincinnati College of Medicine. Study to examine autoimmune activity in patients with hepatitis C infection. Tests performed: anti-CCP, Rheumatoid Factor Isotypes, and anti-C1q.

For more information regarding the possibility of a collaboration contact
John Sama at 800 338-1918