Investigation: a potential false positive c.Tropicalis result on the biofire bcid2 panel was reported after testing a patient blood culture sample on an unknown date.The patient impact due to the biofire bcid2 result is unknown.No serious injury or death occurred.Conclusion: the investigation determined that the most likely cause of the discrepant c.Tropicalis result was the presence of non-viable organism/nucleic acid in the blood culture media bottle.Similar events were recently observed in the field with the combination of the biofire bcid2 panel and bd bactec¿ blood culture bottles.A field safety corrective action (fsca) was issued in the u.S.On january 26, 2024, and countries outside u.S.On january 30, 2024, via (b)(4) for this issue.While blood culture vials are autoclaved and routinely quality controlled for sterility, non-viable organisms or nucleic acids can remain in the blood culture media after the sterilization process.The presence of non-viable organisms and nucleic acid does not compromise the intended use of blood culture media, culturing viable microorganisms; however, the biofire bcid2 panel does not distinguish between nucleic acid from viable or non-viable organisms.The biofire bcid2 panel is working as intended.The "laboratory precaution" and "limitation" sections of the biofire bcid2 panel instructions for use (ifu) (www.Online-ifu.Com/iti0048) outlines the potential for false positive detections during molecular testing with sterile blood culture media containing detectable levels of non-viable organisms and/or nucleic acid.Importantly, results from the biofire bcid2 panel are intended to be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient.All identification results provided by the biofire bcid2 panel are intended to be interpreted in conjunction with gram stain results.Clinical performance: according to table 38.Biofire bcid2 panel clinical performance summary, candida spp.Of the biofire bcid2 panel ifu, the performance claim for the c.Tropicalis assay compared to standard of care identification for genus level followed by pcr & sequencing of isolates for species identification showed an overall sensitivity of 100% (95% ci 93.5-100%) and an overall specificity of 99.9% (95% ci 99.7-100%).The single false positive specimen was identified as a cross-reactivity between the biofire bcid2 panel c.Tropicalis assay and high titer candida parapsilosis.This cross-reactivity is a known limitation of the biofire bcid2 panel.
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