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. 2024 Jan 25;4(1):e8. doi: 10.1017/ash.2024.10

Table 2.

Summary of FDA approved commercially available multiplex assays including targets, source, methodology, turnaround time, and clinical caveats

Blood
Name Manufacturer Organism targets Gene targets resistance genes (RGs) Specimen source Technique Turnaround time Clinical caveat Citation
Biofire Blood culture identification (BCID) 2 panel Biomerieux 7 yeast, 26 bacterial 10 RGs Positive blood culture bottle mPCR 1 hour Detects multiple targets in polymicrobial samples 95
ePlex BCID Gram-positive panel GenMarkDx 20 organisms, pan-Gram-negative and pan- Candida 4 RGs Positive blood culture bottle mPCR 1.5 hours Detects multiple targets in polymicrobial samples 96
ePlex BCID Gram-negative panel GenMarkDx 21 organisms, pan-Gram- positive and pan-Candida 7 RGs Positive blood culture bottle mPCR 1.5 hours Detects multiple targets in polymicrobial samples 96
ePlex BCID Fungal panel GenMarkDx 15 organisms None Positive blood culture bottle mPCR 1.5 hours Detects multiple targets in polymicrobial samples 96
Verigene Gram-positive panel Diasorin 13 organisms 3 RGs Positive blood culture bottle Nanoparticle probe 2.5 hours Unreliable for polymicrobial samples 97
Verigene Gram-negative Diasorin 9 organisms 6 RGs Positive blood culture bottle Nanoparticle probe 2.5 hours Unreliable for polymicrobial samples 97
T2Bacteria panel T2Biosystems 5 organisms None Direct from blood NMR 3-5 hours Lower limit of detection 98
T2Candida panel T2Biosystems 5 organisms None Direct from blood NMR 3-5 hours Lower limit of detection 99
Accelerate Pheno and blood culture panel Accelerate diagnostics 14 bacteria, 2 yeast Susceptibility to 17 agents Positive blood culture bottle PNA-FISH, morphokinetic cellular analysis 2-7 hours Unreliable if multiple organism morphologies or polymicrobial samples 100
Upper respiratory
Name Manu-facturer Organism Targets Gene targets Specimen source Turnaround time Cost
Biofire FilmArray respiratory pathogen panel Biomerieux 17 viruses, 3 bacteria None Nasopharyngeal (NP) swab mPCR 1 hour Requires pairing with ASP* to reduce antimicrobial utilization 101
Biofire Respiratory 2.1-EZ panel Biomerieux 15 viruses, 4 bacteria None NP swab mPCR 45 minutes Requires pairing with ASP to reduce antimicrobial utilization 102
Verigene Respiratory pathogens flex Luminex 13 viruses and 3 bacteria None NP swab mPCR 2 hours Requires pairing with ASP to reduce antimicrobial utilization 103
eSensor Respiratory virus panel GenMarkDx 14 viruses None NP swab mPCR 6 hours 104
ePlex Respiratory virus panel 2 GenMarkDx 16 viruses, 2 bacteria None NP swab mPCR 3 hours Requires pairing with ASP to reduce antimicrobial utilization 104
Lower respiratory
Biofire FilmArray pneumonia panel Biomerieux 8 viruses, 18 bacteria RGs Sputum or BAL mPCR 1 hour Requires pairing with ASP to reduce antimicrobial utilization 105
Gastrointestinal
Biofire FilmArray GI panel Biomerieux 5 viruses, 11 bacteria, 4 parasites None Stool mPCR 1 hour Cannot differentiate between live and dead organisms, high rates of colonization with unclear clinical significance 106
xTAG GI Pathogen panel Luminex 3 viruses, 8 bacteria, 1 bacterial toxin, 3 parasites None Stool mPCR 5 hours Cannot differentiate between live and dead organisms, high rates of colonization with unclear clinical significance 107
BDMax Enteric bacterial panel BD 4 bacteria None Stool mPCR 3.5 hours Cannot differentiate between live and dead organisms 108
BDMax Extended enteric bacterial panel BD 8 bacteria None Stool mPCR 3.5 hours Cannot differentiate between live and dead organisms 109
BDMax Enteric viral panel BD 5 viruses None Stool mPCR 3 hours Cannot differentiate between live and dead organisms 110
BDMax Enteric parasite panel BD 3 parasites None Stool mPCR 4.5 hours Lower sensitivity than conventional methods 111
Verigene Enteric pathogens panel Diasorin 2 viruses, 5 bacteria, 2 bacterial toxins None Stool mPCR 2 hours Cannot differentiate between live and dead organisms, high rates of colonization with unclear clinical significance 112
Joint
Biofire joint infection panel Biomerieux 15 Gram-positive, 14 Gram-negative, 2 yeast 20 RGs Synovial fluid mPCR 1 hour Missing many common causes of prosthetic joint infections 113
CNS
Biofire meningitis/Encephalitis panel Biomerieux 7 viruses, 6 bacteria, 1 yeast None Cerebrospinal fluid mPCR 1 hour Cannot fully replace traditional diagnostics 114

Note.

*

ASP: antibiotic stewardship program.