LeuTech(R) is a Tc-99(m) labelled, anti-CD15, IgM, murine monoclonal antibo
dy shown to have high affinity (K-d = 10(-11) M) for CD15 receptors (5.1 x
10(5)/cell) expressed on human neutrophils. LeuTech(R) was injected directl
y, intravenously, and its efficacy in imaging infection in 46 consecutive p
atients was determined. Human anti-mouse antibody (HAMA) response was exami
ned in 30 normal volunteers using a standard LeuTech(R) dose reconstituted
with decayed Tc-99(m) solution. There were 38 true positive, six true negat
ive, and two false negative scans. Of the 38 positive images, 33 (92%) were
positive within 10 min after injection of LeuTech(R). LeuTech(R) accuracy
in this group of patients was 96%, sensitivity 95%, specificity 100%, posit
ive predictive value (PPV) 100%, and negative predictive value (NPV) 75%. N
o elevation of the HAMA titre was observed in any of the 30 normal voluntee
rs and no adverse reaction was noted in any patient. LeuTech(R) is a highly
promising agent for rapid imaging of infectious foci. ((C) 2001 Lippincott
Williams & Wilkins).