Bio-白念说明书.pdf

PLATELIA™ CANDIDA Ag 96 TESTS 62798 THE PLATELIA™ CANDIDA AG IS AN IMMUNOENZYMATIC SANDWICH MICROPLATE ASSAY FOR THE DETECTION OF CANDIDA MANNAN ANTIGEN IN SERUM 1- INTENDED USE The Platelia™ Candida Ag is an immunoenzymatic sandwich microplate assay for the detection of circulating Candida mannan antigen in serum samples. 2- INDICATIONS FOR USE The Platelia™ Candida Ag (cat. # 62798) is a test which, when used in combination with the Platelia™ Candida Ab/Ac/Ak (cat. # 62799) allows an earlier diagnosis and improves the sensitivity of the diagnosis of invasive candidiasis as part of a complete diagnostic approach integrating clinical 12 and mycological data and evaluation of intrinsic and iatrogenic risk factors . This combination is also an integral part of a clinical and laboratory patient monitoring system as an aid to treatment decisions. 3- SUMMARY AND EXPLANATION Candida infections are the most frequent form of nosocomial fungal infections 2 . Invasive forms represent the most serious infections with mortality rates ranging from 30 to 70% in immunodepressed subjects 10. The diagnosis of invasive Candida infections is difficult to establish due to the poor specificity of clinical symptoms and the low sensitivity of cultures, despite the considerable progress recently made in this field. The diagnosis of invasive candidiasis, leading to initiation of appropriate treatment, is usually based on a combination of clinical, mycological and risk-factor considerations 7 . In this context, the diagnosis of systemic candidiasis must always comprise serological techniques as well as direct mycological methods. The detection