Fluorescence in situ hybridization BCR/ABL fusion signal rate in interphase nuclei of healthy volunteer donors: a test study for establishing false positive rate.
Fluorescence in situ hybridization (FISH) using chromosome-specific DNA probes is rapidly becoming a part of clinical laboratory practice. However, as a relatively new clinical test, it is not yet standardized and for practical reasons each laboratory must establish its own criteria. For this purpose we have evaluated the specificity of a dual-color BCR/ABL translocation probe by establishing the range of BCR/ABL fusion-positive scores in a healthy donor group. The false positive rate (FPR), determined by the percent of FISH BCR/ABL fusion-positive cells found in the specimens of healthy donors, was estimated at 2.3% (mean = 1%-4%). Thus the cut-off value for false positive nuclei was set at 5%.
Kowalczyk
Jerzy R
JR
Department of Pediatric Hematology and Oncology, Cytogenetic Laboratory, Children's University Hospital, Chodzki Strasse 2, 20-093 Lublin, Poland.
Gaworczyk
Anna
A
Winnicka
Dorota
D
Lejman
Monika
M
Babicz
Mariusz
M
D000293:Adolescent; D002467:Cell Nucleus / Q000235:genetics; D002648:Child; D002675:Child, Preschool; D005189:False Positive Reactions; D005260:Female; D016044:Fusion Proteins, bcr-abl / Q000235:genetics*; D006801:Humans; D017404:In Situ Hybridization, Fluorescence / Q000379:methods* / Q000592:standards; D007399:Interphase / Q000235:genetics; D008297:Male; D012016:Reference Values; D012680:Sensitivity and Specificity
D016044:Fusion Proteins, bcr-abl