VARIABILITY OF REPORTING AND LACK OF ADHERENCE TO CONSENSUS GUIDELINES IN HUMAN T-LYMPHOCYTE IMMUNOPHENOTYPING REPORTS - RESULTS OF A CASE SERIES

Percentages and absolute counts of CD4- lymphocytes, as determined by T-lymphocyte immunophenotyping (TLI), are prognostic, as well as diagn ostic, of the course of human immunodeficiency virus type 1 infections and are important indicators for initiating Pneumocystis carinii pneu monia prophylaxis and antiretroviral therapy. In December 1990, we req uested that a nonrandom sample of 17 laboratories provide us with typi cal reports of their TLI results from an immunodeficient patient and f rom a patient whose TLI results were within the laboratory's normal re ference ranges. We also searched published literature and documents pr oposed by professional organizations for recommendations regarding T-l ymphocyte testing and reporting. This article compares guidelines for reporting TLI results, as proposed by the National Committee for Clini cal Laboratory Standards in Document H42-P, with samples of reports ob tained in our case series. Most reports follow some, but not all, of t he proposed guidelines. A majority of the laboratories provided interp retations of the results in their reports. We found considerable varia tion in normal reference ranges. We describe this variation in detail for the CD4+ T-lymphocyte counts and CD4+ T-lymphocyte percentages. Th is article describes some of the TLI result report forms currently bei ng used and identifies important quality issues in this rapidly expand ing area of clinical laboratory testing.