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"Cell-mediated immunity, as measured with Cylex's ImmuKnow test, mayindicate the effectiveness of augmented immunosuppression and the risk ofviral infections," said Brad Stewart, president of Cylex. "By contrast, levelsof anti-HLA antibodies may determine the risk for antibody-mediated rejection.In renal transplant patients who are being weaned from immunosuppression, itseems that both assays may contribute independently to characterize thesepatients."
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Researchers at the University of Pittsburgh Medical Center haveindependently shown that immune function, assessed using the ImmuKnow assayfor cell-mediated immunity, may correlate with decreased immunosuppression ina cohort of renal transplant recipients enrolled in a protocol ofimmunosuppression minimization using depletion induction and monotherapy.(1)They have also determined humoral sensitization by assessing the circulatinganti-HLA antibodies.(2) The current study ("Relationship between immunefunction and humoral sensitization in renal transplant recipients;" seeabstract no. 974) was designed to assess the relationship between immunefunction and the level of humoral sensitization in serially matched samples.
The ImmuKnow assay of cell-mediated immunity is used to measure the degreeof immune activation of CD4+ T-cell function. Circulating anti-HLA antibodieswere determined by ELISA and expressed as percent ELISA-PRA for anti-HLA classI and II antibodies. Immune function was determined by using the ImmuKnowassay and ELISA-PRA in 290 samples from 39 patients receiving renaltransplantation. Samples were collected pre-treatment through 2,160 dayspost-treatment (mean 289 +/- 428 SD). For 33 patients, sequential analysis (ofbetween 4 and 14 samples per patient) also correlated with clinical outcomesand responses to various therapies.
There was no correlation between the cell-mediated immunity (measured innanograms of ATP per milliliter) and percent ELISA-PRA for class I or class II(R2 <0.1). However, the median ATP concentration of samples that exhibitedELISA-PRA class II < 20% (n = 203) was significantly higher than the medianATP concentration of samples (n = 87) with ELISA-PRA >20% (216 vs. 138;p = 0.0002). A similar pattern, but less significant (p = 0.07) was observedfor ELISA-PRA class I.
About ImmuKnow(R)
ImmuKnow is an immune cell function assay that can detect cell-mediatedimmunity (CMI) in adult patient populations undergoing immunosuppressivetherapy for organ transplantation, by measuring the concentration of adenosinetriphosphate (ATP) released from CD4 cells following cell stimulation.
The ImmuKnow test is a qualitative assay and does not directly quantifythe level of immunosuppression. Results of ImmuKnow assays should be used inconjunction with clinical presentation, medical history, and other clinicalindicators when assessing the immune status of any individual patient. The useof the ImmuKnow assay as described in this study has not been approved orcleared by the FDA. The company may use data from this or similar studies tosupport a future FDA marketing application for a similar indication.
About Cylex, Incorporated
Cylex(TM) is a privately held global life sciences company that is theleader in the development and manufacture of in vitro diagnostic productsintended to illuminate immunity. ImmuKnow is the in vitro diagnostic utilizedto detect cell-mediated immunity (CMI) in patient populations undergoingimmunosuppressive therapy, and is increasingly being adopted at organtr
