title: Assessing relative risks of infection and rejection: a meta-analysis using an immune function assay.
abstract: BACKGROUND
  Long-term use of immunosuppressants is associated with significant morbidity and mortality in transplant recipients. A simple whole blood assay that has U.S. Food and Drug Administration clearance directly assesses the net state of immune function of allograft recipients for better individualization of therapy. A meta-analysis of 504 solid organ transplant recipients (heart, kidney, kidney-pancreas, liver and small bowel) from 10 U.S. centers was performed using the Cylex ImmuKnow assay.
  
  
  METHODS
  Blood samples were taken from recipients at various times posttransplant and compared with clinical course (stable, rejection, infection). In this analysis, 39 biopsy-proven cellular rejections and 66 diagnosed infections occurred. Odds ratios of infection or rejection were calculated based on measured immune response values.
  
  
  RESULTS
  A recipient with an immune response value of 25 ng/ml adenosine triphosphate (ATP) was 12 times (95% confidence of 4 to 36) more likely to develop an infection than a recipient with a stronger immune response. Similarly, a recipient with an immune response of 700 ng/ml ATP was 30 times (95% confidence of 8 to 112) more likely to develop a cellular rejection than a recipient with a lower immune response value. Of note is the intersection of odds ratio curves for infection and rejection in the moderate immune response zone (280 ng/ml ATP). This intersection of risk curves provides an immunological target of immune function for solid organ recipients.
  
  
  CONCLUSIONS
  These data show that the Cylex ImmuKnow assay has a high negative predictive value and provides a target immunological response zone for minimizing risk and managing patients to stability.
authors.affiliation: Cylex Incorporated, Columbia, MD 21045, USA. rkowalski@cylex.net
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Kowalski
authors.forename: Diane R
authors.initials: DR
authors.lastname: Post
authors.forename: Roslyn B
authors.initials: RB
authors.lastname: Mannon
authors.forename: Anthony
authors.initials: A
authors.lastname: Sebastian
authors.forename: Harlan I
authors.initials: HI
authors.lastname: Wright
authors.forename: Gary
authors.initials: G
authors.lastname: Sigle
authors.forename: James
authors.initials: J
authors.lastname: Burdick
authors.forename: Kareem Abu
authors.initials: KA
authors.lastname: Elmagd
authors.forename: Adriana
authors.initials: A
authors.lastname: Zeevi
authors.forename: Mayra
authors.initials: M
authors.lastname: Lopez-Cepero
authors.forename: John A
authors.initials: JA
authors.lastname: Daller
authors.forename: H Albin
authors.initials: HA
authors.lastname: Gritsch
authors.forename: Elaine F
authors.initials: EF
authors.lastname: Reed
authors.forename: Johann
authors.initials: J
authors.lastname: Jonsson
authors.forename: Douglas
authors.initials: D
authors.lastname: Hawkins
authors.forename: Judith A
authors.initials: JA
authors.lastname: Britz
mesh_terms: D006084:Graft Rejection / Q000453:epidemiology* / Q000276:immunology; D006801:Humans; D007239:Infections / Q000453:epidemiology* / Q000276:immunology; D016017:Odds Ratio; D016377:Organ Transplantation / Q000009:adverse effects*; D011183:Postoperative Complications / Q000453:epidemiology* / Q000276:immunology; D012189:Retrospective Studies; D012306:Risk