The diagnostic accuracy of infection scintigraphy with 99mTc-labelled monoclonal antibody Fab' fragments (sulesomab) was studied in patients with suspected total knee arthroplasty (TKA) infection. Images from 26 patients were evaluated by two independent readers and compared with a quantitative interpretation of time-activity courses. Microbiological examinations and joint aspiration results were used as reference standards. Histologically, aseptic TKA loosening occurred in two patients and severe, moderate or mild septic loosening in four, nine and 11 patients, respectively. Diagnostic accuracy for severe infection was 100% for both readers, whereas for moderate infection accuracy decreased by 12% and 12% for readers one and two, respectively. For mild infection a further decrease of approximately 61% and 52% occurred for readers one and two, respectively. Quantitative evaluation gave significantly better results over visual interpretation with a diagnostic accuracy of 100% for severe infection and decreased by only 10% and 15% in patients with moderate and mild infection, respectively. Quantitative evaluation of 99mTc-Fab' fragments is highly sensitive and specific for diagnostic imaging of infection in patients with septically-loosened TKA.
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