The Clinical Chemistry Laboratory is making changes to viral hepatitis testing to be instituted Monday, April 5, 2010. The main changes are to move testing to automated Roche Diagnostics analyzers capable of providing faster turnaround time and fewer false positives.

(1) "HEPATITIS B SURFACE ANTIBODY" [LAB619]: Currently there are separate qualitative and quantitative tests available for ordering ("HEPATITIS B SURFACE ANTIBODY-QUALITATIVE" and "HEPATITIS B SURFACE ANTIBODY-QUANT").

We are combining the separate qualitative and quantitative tests into a single test. This will give three results:
     (a) Reactivity - "REACTIVE", "NON REAC", or "INDETERM"
     (b) Immune status "IMMUNE", "NON IMM", OR "INDETERM"
          ("INDETERM" is used for rare repeatedly minimally reactive specimens)
     (c) Quantitative result in mIU/mL

There is a single CPT codes that applies to hepatitis B surface antibody testing so there will be no change in charges for the new single test that provides both qualitative and quantitative results.

(2) "HEPATITIS B SURFACE ANTIGEN" [LAB625]: A limitation of the current Abbott Diagnostics assay is false positives seen most frequently in patients with autoimmune disease such as rheumatoid arthritis. These patients often get additional laboratory workup. From our validation data and other available information, the new Roche assay appears to have a much lower rate of false positives in patients with autoimmune disease or who have received therapeutic antibodies.

(3) "HEPATITIS A ANTIBODY (G & M)" [LAB620] has become a mail-out test. This assay is not yet FDA-approved for the newer analyzers in the Clinical Chemistry laboratory. It is anticipated that an FDA-approved assay for Hepatitis A total antibodies will be available by summer 2011, at which time this test should again be performed in-house. The laboratory will continue to perform "HEPATITIS A ANTIBODY-IGM" [LAB621] in-house.

HCIS staff will update all existing Epic Smart sets and preference lists with the new tests and codes.

For questions regarding these changes, contact Matthew Krasowski, MD, PhD, Medical Director of Clinical Chemistry (ext. 4-9380 or pager 1171).