AMS Reference Lab:

2003 New Test Information Index

Electrophoresis Will Be Performed at AMS Laboratory October 6th

PAP Screens Will Be Performed at AMS Laboratory September 7th

ELECTROPHORESIS WILL BE PERFORMED AT AMS LABORATORY OCTOBER 6, 2003

AMS Laboratory has acquired equipment and will perform electrophoresis testing in-house. Protein electrophoresis on serum, urine, and spinal fluid as well as immunofixation and hemoglobin electrophoresis will be offered. This should be a seamless change for our clients. Specimen requirements, order information, prices, and CPT codes will not change.

| Top of Page |

PAP SCREENS WILL BE PERFORMED AT AMS LABORATORY SEPTEMBER 7, 2003

The in-house test menu for AMS Laboratory now includes Cytology. This change should also be a seamless change for our clients. All ordering, coding, and pricing will remain the same. We hope this expansion will enable us to be more efficient and will improve service.

| Top of Page |

CPT CODES FOR NEW ANAs

ANA screen only - 86038

ANA Screen: If positive, reflex to autoantibodies dsDNA, SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, and Histones

ANA screen - 86038
ANA Quantitative - 86039
dsDNA - 86225
SSA - 86235
SSB - 86235
SM - 86235
RNP - 86235
Scl-70 - 86235
Jo-1 - 86235
Centromere - 86235
Histone - 86235

| Top of Page |

AMS LABORATORY: NEW ANA TECHNOLOGY

AMS Laboratory has implemented a new technology, the AtheNA Multilyte, for autoimmune testing. The new technology utilizes a patented microbead technology with a specialized flow cytometer. This is a significant improvement over the ANA IFA, which is subjective in interpretation, non-standardized, and may lack SSA/SSB sensitivity.

Traditional autoimmune testing often involved performing an ANA screen, performing IFA, and performing individual autoantibody testing based on the patterns and titers.

The new technology performs the ANA screen and nine additional autoantibodies:

SSA	Scl-70	RNP
SSB	Jo-1	Histones
Sm	Centromere	DsDNA

Numeric results are available for a specific antibody (or antibodies) at the same time the ANA screen result is available, because all the assays are performed simultaneously. This technology offers significant benefits in turn around time and interpretation. The presence of characterized autoantibodies in conjunction with a positive ANA result and symptomatology can have far greater clinical significance than an uncharacterized ANA result alone.

A recent paper submitted at the AACC meeting in Orlando compared this test system, the AtheNA Multilyte, to consensus outcome of multiple IFA and ELISA testing systems. Concordance of the individual markers of the AtheNA Multilyte compared to the consensus of the reference methods was:

SSA: 97%	Scl-70: 99.5%	RNP: 97.4%
SSB: 99.2%	Jo-1: 99.7%	Histones: 99.3%
Sm: 98.8%	Centromere: 99.3%	DsDNA: 96.6%

It is well known that the AMA and HCFA are averse to automatic reflex testing. This is do to concerns that stem from eliminating the doctor’s intervention in determining the tests performed. Future forms will address this issue by offering the physician two boxes.

To check:

[ ] ANA:Screen only

[ ] ANA Screen: If positive, reflex to autoantibodies dsDNA, SSA, SSB, Sm, RNP, Scl-70,Jo-1, Centromere B, and Histones.

A special form will be required for the new ANA reflex test until new requisitions are printed.

Traditional cut points for ANA titers are usually a 1:40 titer is not significant, while a 1:80 titer is significant. The new technology will report numerical results with a cut point of 100. Values below 100 are not significant and values greater than 100 are positive. The reporting format will list negative and positive results in different columns, so results will be easy to interpret.

For positive patients, you will receive screen results plus the individual autoantibodies that are positive. Results will be available overnight.

AMS Laboratory will begin using the AtheNA Multilyte ANA test system October 6, 2003. If you have any questions or concerns please feel free to contact Bill Combs at 316-858-8804.

| Top of Page |