Evaluation of the FilmArray Blood Culture Identification Panel: Results of a Multicenter Controlled Trial

Abstract

Sepsis is a major cause of morbidity, mortality, and increased medical expense. Rapid diagnosis improves outcomes and reduces costs. The FilmArray blood culture identification panel (BioFire Diagnostics LLC, Salt Lake City, UT), a highly multiplexed PCR assay, can identify 24 etiologic agents of sepsis (8 Gram-positive, 11 Gram-negative, and 5 yeast species) and three antimicrobial resistance genes (mecA, vanA/B, and blaKPC) from positive blood culture bottles. It provides results in about 1 h with 2 min for assay setup. We present the results of an eight-center trial comparing the sensitivity and specificity of the panel with those of the laboratories' standard phenotypic identification techniques, as well as with molecular methods used to distinguish Acinetobacter baumannii from other members of the A. calcoaceticus-A. baumannii complex and to detect antimicrobial resistance genes. Testing included 2,207 positive aerobic blood culture samples, 1,568 clinical and 639 seeded. Samples were tested fresh or were frozen for later testing within 8 h after the bottles were flagged as positive by an automated blood culture system. At least one organism was detected by the panel in 1,382 (88.1%) of the positive clinical specimens. The others contained primarily off-panel organisms. The panel reported multiple organisms in 81 (5.86%) positive clinical specimens. The unresolved blood culture identification sensitivity for all target detections exceeded 96%, except for Klebsiella oxytoca (92.2%), which achieved 98.3% sensitivity after resolution of an unavoidable phenotypic error. The sensitivity and specificity for vanA/B and blaKPC were 100%; those for mecA were 98.4 and 98.3%, respectively.

Benefits of Adding a Rapid PCR-Based Blood Culture Identification Panel to an Established Antimicrobial Stewardship Program

“…Note that the clinical implications of early antimicrobial de-escalation, such as limiting selective pressure, are likely of societal benefit but cannot easily be quantified and that such assessments were beyond the scope of this study design. Several previous studies documented the excellent sensitivity and specificity of the BCID (9,16,17). The multiplexed BCID provided results in 76.9% of positive blood cultures, and those results were concordant with results of conventional methods in 93.1% of positive cultures.…”

Efficiency of BD MAXTM CRE Method on Detection of Carbapenemase-Producing Enterobacteriaceae spp. from Rectal Swab Samples

“…BD MAX TM CRE sistemi sürüntü örnekleri ve bakteri süspansiyonları ile çalışabilmektedir. Günümüzde kan kültürü sistemlerinden ya da solunum örneklerinden doğrudan karbapenemaz genlerini belirleyen moleküler temelli sistemler de bulunmaktadır (18,19) . Rektal sürüntü örnekle-rinden direkt olarak karbapenemaz genlerini tanımlayan sistemlerden, GeneXpert Carba-R (Cepheid) sistemi Amerika Birleşik Devletleri'nde kullanımı FDA onayı almış bir sistem olup, bunun dışında Check-Direkt CPE, RenDx Carbaplex assay ve Amplidiag CarbaR+VRE gibi sistemler de bulunmaktadır.…”

Clinical and laboratory considerations for the rapid detection of carbapenem-resistant Enterobacteriaceae

“…An additional 33/33 KPC-producing organisms seeded into blood were detected by the system. 20 No false-positive bla KPC results were observed. 20 Some investigators have applied this technology to specimens other than blood (i.e., normally sterile body fluids and respiratory secretions), performing the test directly from the specimen without the benefit of pre-culture.…”

“…20 No false-positive bla KPC results were observed. 20 Some investigators have applied this technology to specimens other than blood (i.e., normally sterile body fluids and respiratory secretions), performing the test directly from the specimen without the benefit of pre-culture. As might be expected, the sensitivity for the detection of bacteria in these specimens was lower than what is observed for blood cultures (i.e., 71-89% sensitivity of the BCID as compared to conventional cultures).…”