Guideline Guidelines Regarding Genotypic False Detections From Blood Culture Bottles
Jan. 14, 2020
Recently, there have been several Class 2 recalls issued by the U.S. Food and Drug Administration (FDA) because of increased risk for false-positive detections with these assays due the presence of DNA from non-viable organisms present in certain blood culture media. Such analytical performance problems put the clinical laboratories in the difficult situation of reporting potentially inaccurate results for positive blood cultures. Here, we will describe this issue in more detail, including optional strategies for the clinical laboratory to address these issues.