Table 1.
Select US Food and Drug Administration–Approved Rapid Diagnostic Assays Used in Clinical Practice
| Technology | Manufacturer(s) | Specimen Origin | Organisms Detected | Resistance Target(s) | Approximate Time Required (hours) | Notesa |
|---|---|---|---|---|---|---|
| MALDI-TOF MS [58, 59, 90–93] | Bruker Daltonics, Inc.; bioMérieux, Inc. | All body sites | Large numbers of bacteria and yeast | None | 0.2 | Reduces costs, high sensitivity and specificity except for polymicrobial cultures; decreases LOS and costs |
| PNA FISH [94–99] | AdvanDx, Inc. | Blood |
Staphylococcus aureus/coagulase-negative staphylococci, Enterococcus faecalis/other Enterococcus spp, Escherichia coli/Klebsiella pneumoniae/Pseudomonas aeruginosa, Candida albicans/C parapsilosis/C tropicalis/C glabrata/C krusei |
mecA | <2 | Reduces LOS, costs, time to effective therapy, and mortality rate |
| Nucleic acid microarray BC-GP [53–55] |
Nanosphere, Inc. | Blood |
Staphylococcus spp (S aureus, S epidermidis, S lugdunensis), Streptococcus spp (S pneumoniae, S pyogenes, S agalactiae, S anginosus group), E faecalis, Enterococcus faecium, Listeria spp |
mecA, vanA, vanB | <3 | Reduces time to effective therapy, LOS, and costs |
| Nucleic acid microarray BC-GN [100, 101] |
Nanosphere, Inc. | Blood |
E coli/Shigella spp, K pneumonia, K oxytoca, P aeruginosa, S marcescens, Acinetobacter spp, Proteus spp, Citrobacter spp, Enterobacter spp |
bla KPC, blaNDM, blaCTX-M, blaVIM, blaIMP, blaOXA | <3 | Reduces time to effective therapy, costs, and mortality rate |
| FilmArray [60, 102, 103] | BioFire, Inc. | Blood, cerebrospinal fluid, stool | E coli, K oxytoca, K pneumoniae, Enterobacter cloacae, Serratia spp, Proteus spp, Acinetobacter baumannii, Haemophilus influenzae, Neisseria meningitidis, P aeruginosa, Staphylococcus spp (S aureus), Streptococcus spp (S agalactiae, S pyogenes, S pneumoniae), Enterococcus spp, Listeria monocytogenes, Clostridium difficile, C albicans, C glabrata, C parapsilosis, C krusei, C tropicalis, Cryptococcus neoformans; CMV, HSV, HHV6, enterovirus, parechovirus, norovirus, adenovirus | mecA, vanA, vanB, blaKPC | <2 | Reduces treatment of contaminated blood cultures, broad-spectrum antibiotic use, and time to appropriate antibiotic escalation and deescalationb |
| qPCR [56, 57, 61] | BD GeneOhm, Inc., Cepheid | Blood, wounds | S aureus, coagulase-negative Staphylococcus spp | mecA, SCCmec | <2 | Reduces time to appropriate therapy, LOS, and costs |
| FilmArray [104] | BioFire, Inc. | Respiratory secretions | Adenovirus, coronavirus, human metapneumovirus, influenza A, influenza B, parainfluenza, rhinovirus/enterovirus, RSV, Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae | None | <2 | Reduces antibiotic use among patients with influenza |
Abbreviations: BC-GN, Gram-negative blood culture test; BC-GP, Gram-positive blood culture test; CMV, cytomegalovirus; HHV6, human herpesvirus 6; HSV, herpes simplex virus; LOS, length of stay; MALDI-TOF, matrix-assisted laser desorption ionization–time-of-flight mass spectrometry; PNA FISH, fluorescence in situ hybridization using peptide nucleic acid probes; qPCR, quantitative polymerase chain reaction; RSV, respiratory syncytial virus.
aSuccessful outcomes described in this column often involved active assistance from an antimicrobial stewardship program.
bRandomized controlled trial–level data.