Table 3.
Molecular panels performances |
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Pathogens | Time for results obtaining/hands-on time | Sn/Sp of evaluated tests (%) | Trade Name | Manufacturer | Preextraction required | Principle | Detection methodology | Reference | |
Blood multipathogen detection panels | C. albicans; C. glabrata; C. krusei; C. parapsilosis; C. tropicalis; Staphylococcus spp.; S. aureus; Streptococcus spp.; S. agalactiae; S. pyogenes; S. pneumonia; Enterococcus spp.; L. monocytogenes; Enterobacteriaceae; E. coli; Enterobacter cloacae complex; Klebsiella. Oxytoca; K. pneumoniae; Serratia marcescens; Proteus spp.; A. baumannii; H. influenzae; N. meningitidis; P. aeruginosa; antibiotic resistance markers mecA, vanA/vanB, KPC (27 pathogens) | 65 min/5 min | 99.5%/91.7% for fungi 98.5%/100% for Gram – bacteria 96.7%/93.7% for Gram+ bacteria |
FilmArray® BCID | BioFire Diagnostics, Salt Lake City, UT | No | Nested multiplex PCR | Endpoint melting curve analysis | [117] |
C. albicans; C. tropicalis; C. parapsilosis; C. krusei; C. glabrata; A. fumigatus; E. coli; Klebsiella pneumoniae/oxytoca; Serratia marcescens; Enterobacter cloacae/aerogenes; P. mirabilis; P. aeruginosa; A. baumannii; S. maltophilia; S. aureus; CoNS; Str. pneumoniae; Streptococcus spp.; E. faecium; E. faecalis; (25 pathogens) | 6–8 h/3 h | 69–90.5%/65–87%for newborns 75%/92% for adults |
LightCycler® SeptiFast Test MGRADE | Roche Diagnostics GmbH, Manheim, Germany | Yes | Multiplex Real Time PCR | Endpoint melting curve analysis | [118], [119] | |
13 fungal pathogens, over 60 bacterial pathogens, and three resistance genes (mecA, vanA, and vanB) in positive blood cultures | 3–3.5 h/90 min | 94.7%/98.8% 99%/98% for fungal targets |
Prove-it® Sepsis | Mobidiag, Helsinki, Finland | Yes | Multiplex PCR | Microarray Colorimetric Read-out |
[120], [121] | |
345 fungi and bacteria | 8 h/2.5 h | 87.0%/85.8% | SepsiTest® | Molzym, Bremen, Germany | Yes | Broad-range PCR | Sequencing | [122] | |
6 fungi, 73 Gram (+) bacteria, 3 Drug resistance markers, 12 Gram (−) bacteria (more than 90 pathogens), 27 pathogens can be identified to the species level | 5–7 h/No data available | 64%/96% | Magicplex™ Sepsis Real-time Test | Seegene, Seoul, Korea | Yes | Multiplex Real Time PCR based on READ™ technology | Multiple fluorophore detection | [122], [123] | |
A. fumigatus; C. albicans; C. dubliniensis; C. glabrata; C. tropicalis; C. krusei; C. parapsilosis; Gram-positive bacteria: S. pneumoniae; S. pyogenes; S. sanguinis; S. agalactiae; S. dysgalactiae; S. mutans; E. faecium; E. faecalis; C. perfringens; S. aureus; S. epidermidis; S. saprophyticus; S. haemolyticus; S. hominis Gram-negative bacteria: E. coli; P. aeruginosa; K. pneumonia; K. oxytoca; E. cloacae; E. aerogenes; N. meningitides; M. morganii; P. mirabilis; A. baumannii; B. fragilis; S. marcescens; B. cepacia; S. maltophilia; P. buccae; P. intermedia; P. melaninogenica; Five most common resistance markers: methicillin mecA, vancomycin vanA, vancomycin vanB, β-lactamase blaSHV, β-lactamase blaCTX-M (34 bacterial and 7 fungal pathogens) |
6–8 h/70 min | 60%/75% | Vyoo® | SIRS-Lab GmbH, Jena, Germany | Yes | Multiplex PCR | Gel-electrophoresis | [111], [124] | |
Cerebrospinal fluid multipathogen detection panels |
C. neoformans/gattii; E. coli K1; H. influenzae; L. monocytogenes; N. meningitidis; S. agalactiae; S. pneumoniae; CMV; EnV; HSV-1/2/3; HHV−6; hPEV; VZV (14 pathogens) | 1 h/2 min | 100% for 9 of 14 analytes/99.2% | FilmArray® ME Panel | BioFire Diagnostics, Salt Lake City, UT | No | Nested multiplex PCR | Endpoint melting curve analysis | [113], [125] |
Respiratory multipathogen detection panels |
Inf A; Inf B; Inf C; hRV; hCoV (NL63, 229E, OC43, HKU1); PIV 1–4; hMPV A/B; hBoV; hRSV A/B; AdV; EnV; EVs; hPEV; C. pneumonia; S. aureus; S. pneumonia; Haemophilus influenzae spp.; CMV; P. jirovecii; H. influenzae B; Bordetella spp. (except B. parapertussis); M. pneumoniae; M. catarrhalis; K. pneumoniae; Legionella spp.; Salmonella spp. (33 pathogens) | 4 h/No data available | 77.89–92.2%/94.37–99.5% |
FTD® Respiratory Pathogens 33 | Fast Track Diagnostics, Luxembourg | Yes | Multiplex Real-Time PCR based on TaqMan® technology | Multiple fluorophore detection | [126], [127] |
P. jirovecii; H. capsulatum; C. neoformans/C. gattii (4 fungal pathogens) | No data available | 90.7–100%/100% | Not registered | In-house | Yes | Multiplex Real-Time PCR | Multiple fluorophore detection | [128] |
Sn: sensitivity; Sp: specificity; Acinetobacter baumannii: A. baumannii; Aspergillus fumigatus: A. fumigatus; Escherichia coli: E. coli; Klebsiella pneumoniae: K. pneumoniae; Klebsiella oxytoca: K. oxytoca; Serratia marcescens: S. marcescens; Proteus mirabilis: P. mirabilis; Pseudomonas aeruginosa: P. aeruginosa; Stenotrophomonas maltophilia: S. maltophilia; Enterococcus faecium: E. faecium; Enterococcus faecalis: E. faecalis; Candida albicans: C. albicans; Candida tropicalis: C. tropicalis; Candida parapsilosis: C. parapsilosis; Candida krusei: C. krusei; Candida glabrata: C. glabrata; Candida dubliniensis: C. dubliniensis; Clostridum perfrigens: C. perfrigens; Cryptococcus neoformans/Cryptococcus gattii: C. neoformans/gattii; Enterococcus faecalis: E. faecalis; Enterococcus faecium: E. faecium; Escherichia coli: E. coli; Histoplasma capsulatum: H. capsulatum; Haemophilus influenzae: H. influenzae; Neisseria meningitidis: N. meningitidis; Pseudomonas aeruginosa: P. aeruginosa; Listeria monocytogenes: L. monocytogenes; Morganella morganii: M. morganii; Pneumocystis jiroveci: P. jirovecii; Prevotella buccae: P. buccae; Prevotella intermedia: P. intermedia; Prevotella melaninogenica: P. melaninogenica; Staphylococcus aureus: S. aureus; CoNS (Coagulase negative Staphylococci); Staphylococcus aureus: S. aureus; Staphylococcus epidermidis: S. epidermidis; Staphylococcus haemoliticus: S. haemoliticus; Staphylococcus hominis: S. hominis; Staphylococcus saprophyticus: S. saprophyticus; Streptococcus agalactiae: S. agalactiae; Streptococcus pyogenes: S. pyogenes; Streptococcus pneumoniae: S. pneumoniae; Streptococcus bovis: S. bovis; Streptococcus dysgalactiae: S. dysgalactiae; Streptococcus mutans: S. mutans; Streptococcus sanguinis: S. sanguinis; Cytomegalovirus: CMV; enterovirus: EnV; herpes simplex virus: HSV; human herpesvirus: HHV; human parechovirus: hPEV; varicella-zoster virus: VZV; Inf: influenza virus; hRV: human rhinovirus; hCoV: human coronavirus; PIV: parainfluenzavirus; hMPV: human metapneumovirus; hBoV: human bocavirus; hRSV: human respiratory syncytial virus; AdV: adenovirus; EVs: echovirus; hPEV: human parechovirus