Rapid Microbiological Methods - Technologies

The RMM Product Matrix

The Product Matrix allows you to compare multiple rapid microbiological method technologies that are commercially available or in development. For information regarding instrument costs and cost per test (e.g., consumables, reagents, media), please contact the technology suppliers directly.

The information presented within the RMM Product Matrix is provided by technology suppliers and/or what is available in the public domain, and may change without notice.

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Qualitative Technologies


Company
•
Product
Name		 Scientific
Method
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Applications		 Time to Result Throughput Sample Size or Type Sensitivity Organism
Libraries		 Workflow
Applied Biosystems
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MycoSEQ		 PCR
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Mycoplasma detection		 < 5 hr Flexible 100 μl to 10 ml of cell culture sample < 10 CFU or copy equivalent/ml Detection of > 90 Mycoplasma species The sample is added to a centrifuge tube and Mycoplasma is concentrated in a pellet. The Mycoplasma is enzymatically lysed and purified using magnetic beads and washing steps. Real time PCR is performed and the Mycoplasma target sequence is detected via use of amplification plots and melt curve analysis. If a positive result fir Mycoplasma is obtained, the purified DNA can be used in the MicroSEQ for subsequent identification.
Bactest
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Speedy Breedy		 Respirometry, pressure sensing
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Detection of microbial growth; sterility testing; presence of specific organisms		 4-20 hr 2-4 per day Up to 50 mL 1 CFU after enrichment Aerobes, facultative anaerobes, anaerobes, and microaerophilic bacteria; yeast The sample is transferred into a disposable vessel containing a general or selective medium. The vessel is then placed into the portable respirometer and incubated to encourage microbial growth. Detection of metabolic activity is determined by pressure transients relating to gaseous exchanges within the closed culture vessel as a result of microbial respiration. Continuous data collected is analyzed in real time, and detection algorithms process the pressure transients to alert when significant changes have taken place. The instrument measures both positive and negative pressure meaning that monitoring can be performed on a range of microbial processes reacting to differing conditions within the culture chamber. The system is applicable for pharmaceuticals, raw materials, food and beverage, veterinary, household and hygiene products.
BD Diagnostic Systems
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BACTEC FX		 Growth-based; CO2 detection
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Detection of microbial growth; sterility testing		 8-48 hr 240-1200 per incubation period 1-10 mL or gm 1 CFU after enrichment Bacteria, yeast, mold Samples are added directly to bottles of liquid culture media and incubated in the system. During microbial growth, CO2 in the closed container accumulates and is detected by a fluorometric sensor. The system automatically monitors the sensor every 10 minutes, and the generation of CO2 indicates the presence of growing microorganisms.
BioLumix
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BioLumix System		 Growth-based; CO2 detection and selective growth
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Detection of specific organisms; detection of microbial growth		 8-48 hr 32 tests at a single temperature per instrument (3 instruments can be used with one computer) 0.1-1.0 mL 1 CFU after enrichment Total aerobic count, yeast & mold, coliforms, E. coli, lactic acid bacteria, Enterobacteriaceae, Salmonella, Pseudomonas, Staphylococcus The test sample is added to unique vials that contain a selective medium and a dye. Changes in color or fluorescence, expressed as light intensity units, are detected by the optical sensor and represent growing microorganisms. The total aerobic count and total yeast/mold vials detect microbial growth by monitoring the generation of CO2, and can be used to screen for an estimation of organisms in a test sample that are above or below a certain quantitative specification. Liquid and diluted solid samples can be assayed.
bioMérieux
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BacT/ALERT 3D Dual-T		 Growth-based; CO2 detection
•
Detection of microbial growth; sterility testing		 24-96 hr 480-1440 per incubation period 1-10 mL or gm 1 CFU after enrichment Bacteria, yeast, mold Samples are added directly to bottles of liquid culture media and incubated in the system (one of two temperatures). During microbial growth, CO2 in the closed container accumulates and diffuses into a colorimetric sensor at the base of the bottle. Hydrogen ions interact with the sensor resulting in a decrease in pH, causing the sensor to change to a yellow color. The system automatically monitors the sensor every 10 minutes, and the generation of CO2 indicates the presence of growing microorganisms.
BIOTECON
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Hygiene Screening System		 PCR
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Bacterial detection		 90 min 160 per day Cells from colony Corynebacterium, Staphylococcus, Macrococcus, Micrococcus, Kocuria, and Kytococcus Bacterial colonies growing on agar plates are suspended in buffer, and the suspension is placed in a reaction tube. Primers, fluorescence resonance energy transfer (FRET) probes and Taq polymerase are added to the reaction tube. PCR amplification and detection is carried out in a Roche Diagnostics LightCycler 2.0 Carousel-Based System. The amplification cycles are monitorined via fluorescence, and melting curves are used to determine what target sequences/organisms are present.
ceeram
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ceeramTools RT-PCR Real Time Detection Kits		 Real time RT-PCR
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Viral detection		 5 hrs Depends on thermocycler used 2 gr digestive tissue, 25 gr fruit or vegetable, 1 L water 5 genome copies Norovirus GI, GII; Hepatitis A, E; Enterovirus; Adenovirus; Sapovirus; Aichivirus; Rotavirus; Circovirus; Brachyspira; Giardia; Cryptosporidium Elution, concentration, extraction, purification, amplification, quantification and interpretation. Any matrix (food, environmental, health) may be assayed, including shellfish, vegetable, herbs and spices, water, sludge and surfaces. The detection kits can be used with most PCR instrumentation.
Charles River Laboratories
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Celsis Advance II™		 ATP bioluminescence
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Bioburden of water, raw materials, in-process samples, Microbial Limits		 <1-48 hr 120 assays per hour User selected 1 CFU in pre-enriched sample Bacteria, yeast, mold Sample in broth incubated according to assay type (e.g., MLT, sterility, aerobic, anaerobic, product neutralization). Aliquot of enrichment is placed into a cuvette and loaded into instrument. Luciferin/luciferase enzyme reagent catalyzes the conversion of microbial adenosine triphosphate (ATP) into ADP and light. The system provides full walkaway automation. If sufficient cells (and ATP) are present, direct assay can be performed within minutes without broth enrichment.
Charles River Laboratories
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Celsis Accel®		 Enzyme-amplification combined with ATP bioluminescence
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Sterility testing, bioburden of water, raw materials, in-process samples, Microbial Limits		 30 min (bioburden)

18-24 hr (MLT)

2-6 days (Sterility)		 30 assays per hour User selected 1 CFU in pre-enriched sample Bacteria, yeast, mold Sample in broth incubated according to assay type (e.g., MLT, sterility, aerobic, anaerobic, product neutralization). Aliquot of enrichment is placed into a cuvette and loaded into instrument. The presence of microbial adenylate kinase catalyzes the conversion of an ADP-containing reagent into ATP at significantly higher levels than microbial ATP alone. Amplified-ATP is then detected by a luciferin/luciferase-based bioluminescence assay resulting in a faster time-to-result and higher signal:noise ratio than traditional ATP bioluminescence. The system provides full walkaway automation.
Charles River Laboratories
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Endosafe® nexgen-PTS™ Glucan Assay		 LAL assay
•
Detection of glucan		 30 min 2 per hr 25 μL 10-1,000 pg/mL Glucans from yeast and mold Portable, handheld spectrophotometer that utilizes disposable cartridges. Rapid, in-process test designed for investigational purposes to detect (1,3)-ß-D glucans from the cell walls of most yeasts and molds.
Hygiena
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BAX System Q7		 PCR
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Detection of microorganisms		 1.5-2.5 hr; 48 hr for yeast/mold 96 per 1.5-2.5 hr 10-50 μL Salmonella, Listeria monocytogenes, Camplyobacter jejuni/coli, E. coli O157:H7, Enterobacter sakazakii, Staphylococcus aureus, yeast and mold, Vibrio Samples are enriched in media to provide enough DNA for analysis and to eliminate false positives from dead cells. The enriched samples are heated in a lysis solution to release DNA. PCR tablets, which contain all the reagents necessary for PCR plus fluorescent dye, are hydrated with lysed sample and processed in the cycler/detector. PCR amplifies a DNA fragment that is specific to a target organism. The amplified DNA generates a fluorescent signal, and results are displayed as positive or negative results. The system uses SYBR Green, Taqman and Scorpion probes, facilitating the detection of multiple species in a single sample.
Interscience
•
ScanStation		 Growth-based
•
Sterility testing, raw material or finished product quality control, bioburden, EM, challenge test		 Real-time: about 50% of incubation saving time 100, 200 or 300 Petri dish capacity From 55 to 90 mm Petri dish, contact plate or filtration membrane 1 CFU; 0.05 mm colony diameter Bacteria, yeasts and molds The ScanStation is a smart incubator that maintains an optimal temperature for microbial growth while analysing colony development in real time for enumeration. This real time growth monitoring allows more accurate enumerations and anticipated results. In addition, the ScanStation is 21 CFR part 11 certified, guaranteeing data protection and results traceability.
Greiner Bio-One
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CytoInspect		 PCR and microarray analysis
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Mycoplasma detection and identification		 5 hr 100 per day Detection of > 90 species of Mycoplasma and identification of 40 Mycoplasma species A microarray based test kit for the detection and identification of mycoplasma species in cell cultures and other biological materials. DNA is extracted and PCR performed using primers specific for conserved and species-specific regions of the 16S-23S rRNA intergenic transcribed spacer (ITS) of Mycoplasma DNA. The fluorescently labeled fragments are then hybridized to the microarray chip. The chip contains probes for both species-specific targets and a universal probe for all Mycoplasma.
Hyglos
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EndoLISA		 ELISA
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Detection of endotoxin		 3.5 hrs 96 samples every 3 hrs 100 μl 0.05-500 EU/mL Endotoxin Uses a microplate that is pre-coated with a phage-derived receptor protein which has a high affinity and specificity for the conserved core region of LPS (endotoxin). When the sample matrix is added to the microplate, the LPS is bound to the phage protein. Any sample matrix with potentially interfering components is then removed by a washing step. The subsequent detection by recombinant Factor C and a fluorescence substrate is left unaffected by inhibitors, facilitating a reliable quantification of endotoxin in the sample.
Innosieve Diagnostics
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Real-Time Q-PCR Detection Kits		 Q-PCR
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Bacterial detection		 3-5 hrs (15-25 cycles) Depends on thermocycler used 25 g < 1 cell / 25 g (after pre-enrichment)

< 10 cells / g or 10 non-degraded genomes (no enrichment)		 Campylobacter jejuni, Clostridium perfringens, Cronobacter sakazakii, E. coli, Listeria innocua, Legionella pneumophila, Legionella spp., Listeria monocytogenes, Salmonella sp., Staphylococcus aureus, Vibrio alginolyticus, Vibrio cholerae, V. cholerae tox, Vibrio parahaemolyticus, Vibrio vulnificus, MRSA Taqman-based Q-PCR detection kits. When necessary, use pre-enrichment of the sample in an appropriate (selective) medium (1:10 w/v: 25 g sample + 225 ml medium) for 20- 24 hours at appropriate temperature (the actual method is provided for each test kit). This is followed by filtration of 100 ml with an appropriate membrane system (e.g., 0.45 μm, cellulose nitrate filter). The detection kits can be used with most PCR instrumentation.
Lonza
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MycoAlert		 ATP bioluminescence
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Mycoplasma detection		 20 min 24 per 8 hr 100 µL of culture supernatant < 50 CFU/mL > 90 species of Mycoplasma Viable Mycoplasma are lysed and the organism's enzymes react with the MycoAlert® Substrate catalyzing the conversion of ADP to ATP. By measuring the level of ATP in a sample both before and after the addition of the MycoAlert® Substrate a ratio can be obtained which is indicative of the presence or absence of Mycoplasma. If these enzymes are not present, the second reading shows no increase over the first, while reaction of mycoplasmal enzymes with their specific substrates in the MycoAlert® Substrate, leads to elevated ATP levels.
LumiByte BV MuScan
•
Innosieve Diagnostics Test Kits		 Viability staining and solid phase cytometry; fluorescence microscopy
•
Bioburden of raw material and in-process samples, finished product, EM, water, sterility testing		 10-65 minutes 100 per 8 hours Filterable samples; 1 uL to 1L 1 - 105 cells Bacteria, yeast, fungal spores The test sample is filtered/concentrated through a 0.45um micro sieve. Microorganisms are retained on the membrane and subsequently labeled with a viability stain and/or a species-specific stain. Available are total viable count, total live-dead ratio, total species-specific count and total species-specific viable count. After staining a scanning period using MuScan digital fluorescent microscopy at specific excitation and emission wavelengths is performed. The image processing software analyzes fluorescent objects on size, shape and fluorescent signals of all microbes. The assay can be user-customized with different types of fluorescent stains, labeled antibodies, DNA-probes, etc., depending on the organism(s) to be detected. Examples of test kits for specific organisms include Legionella, Salmonella, Listeria, Chronobacter and E. coli. The method is non-destructive such that detected microbes can be subsequently cultured.
MAT Research
•
Monocyte Activation Test
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Qualitative and semi-quantitative results		 Activation of human monocytes, in vitro followed by ELISA
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Pyrogen testing (endotoxin & non-endotoxin pyrogens)		 28 hr 2 samples per plate Parenteral drugs (injected into body), biologics, pharmaceuticals and medical devices Cut-off for assay is <0.026 (tube concentration) N/A Samples are prepared at appropriate dilutions (defined by MVD), spiked with known concentrations of Reference Standard Endotoxin (RSE) or Non-endotoxin pyrogens alongside a 7-point concentration response curve for RSE and allowed to incubate for 18-22h. Supernatants are collected and analysed using IL-6 ELISA to establish presence of contamination in sample as according to the EU Pharmacopeia.
Micro Identification Technologies Light scattering
•
Detection of microorganisms		 10 min 48 per 8 hr Cells from colony 10-50 cells E. coli, Cryptosporidium, Giardia Cells from an isolated colony are suspended in filtered water in a sample vial and placed into the instrument. 35 photo detectors in five concentric arcs that surround the sample vial collect Mie scattering light intensities that are generated when a cell intersects a red laser beam. The shape, size and internal/external structures of microorganisms will provide a unique scattering signature, which are compared with an internal database.
Microtechnix
•
EMMA		 Automated, high resolution imaging of CFU with AI
•
Environmental monitoring; bioburden and sterility optional		 16 seconds following traditional enrichment 120 Petri dishes per hour per EMMA unit 55 or 90 mm Petri dish 1 CFU Bacteria, yeast, mold Petri dishes are loaded manually or with an optional robotic loader and identified via barcode for traceability. High-resolution images are captured, and AI algorithms analyze microbial growth, sorting plates into positive and negative stacks. All plates are recorded in the LIMS. Negatives can be discarded without review, while positive plates are flagged for supervisor review, allowing confirmation or adjustment of the AI-generated CFU count. All results, including images and their metadata, are securely stored and easily exported. Seamless LIMS integration ensures full workflow integration, human error reduction and enhancing data integrity.
Neogen Corporation
•
Soleris		 Growth-based, media based detection via CO2 or pH
•
Quality, spoilage and sterility microbial testing		 3 to 48 hours Up to 128 per unit; up to 4 units per computer 0.1-5.0 mL 1 CFU after enrichment Total aerobic count, sterility, yeast & mold, coliforms, E. coli, lactic acid bacteria, Enterobacteriaceae, Pseudomonas, Staphylococcus, aciduric organisms Samples are inoculated directly into a vial which contains ready to use media and a detection system. The optical assay measures microbial growth by monitoring pH or CO2 that generate a color change as microorganisms proliferate.
Neogen Corporation
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Listeria Right Now		 Isothermal replication of rRNA
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Environmental monitoring for Listeria spp.		 60 Minutes from point of sampling 48-96 per 8 hrs Swab 4 CFU per swab Listeria spp. Swab the surface, express the swab into lysis buffer and vortex. Transfer 5 mL solution to the cluster tube and incubate at 37oC for 10 minutes, followed by a second incubation at 80oC for 20 minutes. Transfer 50 uL to reaction tubes, vortex, place in the reader and hit "start." No enrichment is necessary.
Pall Corporation
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GeneDisc® Rapid Microbiology System		 qPCR
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Screening of pathogens (e.g. Specified Microorganisms, USP <62>)		 3 to 8 hours including sample filtration, nucleic acid prep, and PCR 96 per PCR run 1-300 mL. Protocol adapted for solids and non-filterable samples. 1 CFU after enrichment for 6 to 24 hours. >100 CFU without enrichment. E. coli, Salmonella, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Aspergillus brasiliensis, STEC and non-STEC, E. coli 0157, Listeria, Legionella, Enterococcus, Cyanobacteria Samples are filtered and microorganisms collected on the membrane are lysed by a combination of reagents, sonication and heating. The DNA and Master Mix (polymerase and deoxynucleotides) are added to the GeneDisc plate, pre-loaded with the primers and probes. The plate is transferred into the GeneDisc Cycler, and it rotates through four temperature zones during the PCR amplification process. When the target DNA sequence (from the microorganism of interest) is amplified, a fluorescent signal from the probe will increase and is measured in real time. Current plate comes pre-loaded with 6 probes for compendial specified microorganisms. The GeneDisc Cycler can measure fluorescent signal from each probe simultaneously in real time resulting in detection and positive identification of microorganisms in a single PCR run of less than 1 hour.
Promicol BV
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Promilite M4A		 ATP Bioluminescence
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Sterility testing of finished products and raw materials		 <1 - 72 hours Up to 500 samples per hour 50 µl of pre-enriched sample 1 cfu in pre-enriched sample Bacteria, yeasts and molds A sample of the pre-enriched product is added to a microplate and will be analyzed automatically in the Promilite M4A instrument. Specific reagents are added by the instrument according to the assay used and will turn microbial adenosine triphosphate (ATP) into light. Based on reference values implemented in the software measurement results will be interpreted using a color code. In this way a simple yes or no answer regarding sterility of the sample analyzed will be provided to the user. Up to 96 samples can be analyzed at once without any sample preparation step required.
Roche CustomBiotech
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MycoTOOL Real-Time PCR		 PCR
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Mycoplasma detection, in-process control, batch release, cell bank testing, raw material testing		 < 5 hr 40 biological samples/day 1 mL of cell culture < 10 CFU/mL > 150 Mollicutes species A 1 mL of sample of cell culture with a concentration of 5 × 106 cells/mL is used to purify Mycoplasma DNA fully automated (Roche MagNA Pure 96 Instrument) or manually. The Mycoplasma target DNA is amplified via Real-Time PCR (Roche LightCycler 480) and analyzed automatically by a dedicated software. Additional Comments: The PCR Kit is an in vitro nucleic acid amplification test optimized for the detection of Mycoplasma in cell culture and is validated according to EP chapter 2.6.7.
Sartorius Stedim Biotech GmbH
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Microsart® AMP Bacteria Kit		 qPCR; TaqMan® probe
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Detection of total bacterial contamination in cell culture; academic or R&D use only		 3 hr 3 hr for 1-10 samples; 4-5 hr up to 96 samples and controls 2 µL < 100 CFU > 95 % of all known gram-positive and gram-negative bacteria TaqMan® probe real-time qPCR is used for the detection of bacterial DNA (at the conserved region of 16S rRNA). If inhibitory effects are observed, DNA extraction may be necessary. The DNA is amplified in a qPCR cycler and the evaluation can be performed with the standard cycler software. The lyophilized master mix includes primers, nucleotides and polymerase. and can be supplemented by an internal amplification control. Measure 520 nm (bacteria) and 610 nm (control) at the same time.
Sartorius Stedim Biotech GmbH
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Microsart® AMP Mycoplasma Kit

Microsart® ATMP Mycoplasma Kit

Microsart® RESEARCH Mycoplasma Kit		 qPCR; TaqMan® probe
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AMP Kit: Regulated in-process and lot-release

ATMP Kit: Autologous cell transplants (ATMPs)

RESEARCH Kit: Cell culture material; academic or R&D use only		 3 hr 3 hr for 1-10 samples; 4-5 hr up to 96 samples and controls AMP Kit: 200 µL to 18 mL (18 mL can be concentrated to 200 µL increase sensitivity)

ATMP Kit: 200 µL

RESEARCH Kit: 2 µL		 AMP and ATMP Kits: <10

RESEARCH Kit: <100 CFU		 150 Mollicutes species; AMP and ATMP kits validated for EP Mycoplasmas A standard DNA extraction (using standard silica columns) followed by a TaqMan® probe real-time qPCR is used for the detection of Mycoplasma DNA (at the conserved region of 16S rRNA). The isolated DNA is amplified in a qPCR cycler and the evaluation can be performed with the standard cycler software. The lyophilized master mix includes primers, nucleotides and polymerase. and can be supplemented by an internal amplification control. Measure 520 nm (Mycoplasma) and 610 nm (control) at the same time.
Vivione Biosciences, LLC
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RAPID-B 		Flow cytometry
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Incoming inspection, sterility confirmation, bioburden, drug development, process control		 20 min for quantitative results
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Up to 8 hr for qualitative results		 96-160 per 8 hrs 75-225 uL 1 CFU after enrichment TB, Chlamydia and Staphylococcus for clinical samples. Salmonella, E. Coli O157, non-O157 STECs, Staphylococcus, and Vibrio for food samples Samples and reagent are added to a vial and mixed (5-10 min). The RAPID-B system analyzes the sample using flow cytometry, with results available within 3-5 minutes. Light scatter resolution of around 130nm shows separation of bacteria populations via size and refractive index alone. The system utilizes a multi-parametric detection approach: a phenotypic library to identify the bacteria, an immunoprobe to specifically tag the target organism and a DNA dye to ascertain the live or dead cells of the target organism. The workflow is also based on the limit of detection (LOD) required and the target of interest (may include enrichment, filtration, centrifugation and dilution).

Quantitative Technologies


Company
•
Product
Name		 Scientific
Method
•
Applications		 Time to Result Throughput Sample Size or Type Sensitivity Organism
Libraries		 Workflow
bioMérieux
•
EviSight™ Compact TOTAL VISION		 Growth based & staining free; High-Magnification Imaging
•
Bioburden of raw material, in-process samples & finished product, water analysis		 24-48 hr 240 per 48 hr Filtrable samples, solid medium 1 CFU after growth Bacteria, yeast, mold, spores Samples are prepared according to the compendial method (membrane filtration or direct inoculation on solid medium). The system incubates the plates (from 20 to 55°C) and automatically acquires high magnified images (X50) of micro-colonies. The image processing software analyzes information on size and shape and provides an enumeration for each plate every 30 minutes. The system is non-destructive, allowing for follow up analysis.
bioMérieux
•
Chemunex D-Count, BactiFlow and BactiFlow ALS		 Viability staining and flow cytometry
•
Bioburden of raw material and in-process samples, finished product, EM, water		 30 min 15 per hour (BactiFlow)
25 per hour (BactiFlow ALS)
50 per hour (D-Count)		 Liquids, usually less than 1 mL 10-50 cells Bacteria, yeast, mold Viable cells in a liquid sample are labeled with a non-fluorescent substrate. Within the cytoplasm of metabolically active cells, the substrate is enzymatically cleaved (by esterase) to release a fluorochrome. Cells with intact membranes will retain the fluorescent label. The labeled organisms pass through a argon ion laser in the flow cell. Two fluorescence detectors provide an enumeration in cells per mL.
bioMérieux
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Chemunex ScanRDI		 Viability staining and solid phase cytometry
•
Bioburden of raw material and in-process samples, finished product, EM, water, sterility testing		 1.5-3 hr 30 per day Filterable samples 1 cell Bacteria, yeast, mold, spores The test sample is filtered through a polyester membrane. Microorganisms retained on the filter are labeled with a non-fluorescent substrate. Within the cytoplasm of metabolically active cells, the substrate is enzymatically cleaved (by esterase) to release a fluorochrome. Cells with intact membranes will retain the fluorescent label. An argon laser scans the surface of the membrane within 3 minutes, and viable cells are detected. Auto-fluorescent particles, membrane fluorescence and background noise are rejected and a total viable count is reported. Viable cells may be subsequently observed using a phase-contrast microscope and an automated stage.
BWT Pharma & Biotech Inc.
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AQU@Sense MB		 Flow cytometry
•
Bioburden of water, pure water, water for injection		 20 min 2 per hr 90 μL 1 cell All living cells Staining with two DNA specific dyes to identify living cells. Measurement of side scatter, red and grenn fluorescence. Can be used At-line or Off-line. Liquids are hermetically sealed in a cartridge that need to be replaced after 1000 measurements.
Charles River Laboratories
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Endosafe® nexgen-PTS™		 LAL assay
•
Detection of endotoxin in finished product and water		 15 min 4 per hr 25 μL 0.005-10 EU/mL Endotoxin The Endosafe® nexgen-PTS™ is a rapid, point-of-use handheld spectrophotometer that utilizes disposable FDA-licensed cartridges for real-time endotoxin testing. Using USP/BET-compliant testing, the nexgen-PTS™ uses the compendial LAL kinetic chromogenic methodology that measures a color intensity that is directly related to the endotoxin concentration in a sample. Each cartridge contains precise amounts of LAL reagent (95% less LAL than traditional methods), chromogenic substrate and control standard endotoxin (CSE). Pipette 25 μL of a sample into each of the four sample reservoirs of the disposable cartridge. The portable, handheld reader draws and mixes the sample with the LAL reagent in two channels (the Sample Channels) and with the LAL reagent and positive product control in the other two channels (the Spike Channels). The sample is incubated and then combined with the chromogenic substrate. After mixing, the optical density of the wells is measured and kinetically analyzed against an internally-archived standard curve.
Charles River Laboratories
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Endosafe® nexgen-MCS™		 LAL assay
•
Detection of endotoxin in finished product and water		 15 min 20 per hr 25 μL 0.005-10 EU/mL Endotoxin The Endosafe® nexgen-MCS™ system is comprised of five individual spectrophotometers built into a unit with ethernet that links to a desktop computer. The MCS uses the compendial LAL kinetic chromogenic methodology that measures color intensity directly related to the endotoxin concentration in a sample. FDA-licensed disposable cartridges, which use 95% less LAL than traditional methods, used to run an assay contain precise amounts of LAL reagent, chromogenic substrate and control standard endotoxin (CSE). Pipette 25 μL of a sample into each of the four sample reservoirs of a cartridge. The reader draws and mixes the sample with the reagents. After mixing, the optical density of the wells is measured and analyzed against an internally-archived standard curve.
Charles River Laboratories
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Endosafe® Nexus™		 LAL assay
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Detection of endotoxin in finished product and water		 15 min per sample 48-60 samples per run 25 μL 0.005-10 EU/mL Endotoxin The Endosafe® Nexus™ is a fully automated robotic system that uses the compendial LAL kinetic chromogenic methodology that measures color intensity directly related to the endotoxin concentration in a sample. Designed for high-volume water testing or samples that require dilutions, the system uses disposable FDA-licensed cartridges with precise amounts of LAL reagent (95% less than traditional methods), chromogenic substrate and control standard endotoxin (CSE). Pipette 25 μL of a sample into each of the four sample reservoirs of a cartridge. The reader draws and mixes the sample with the reagents. After mixing, the optical density of the wells is measured and analyzed against an internally-archived standard curve.
Clever Culture Systems
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APAS Independence		 Culture plate - Automated detection of microbial growth on agar
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Enumeration of environmental monitoring samples		 18 seconds per plate 200 plates per hour Culture plate (90mm or 55mm) 1 CFU Bacteria, yeast, mold, all organisms that grow on agar media. Culture plates are loaded into the instrument following incubation according to site procedures. The plates are bulk loaded using dedicated input carriers with a loading capacity of 240 plates. Plates are processed automatically without human intervention. An image is taken of the plate and AI algorithms interpret the presence of microbial growth. Plates with no growth are sorted and separated from plates with growth in real time. Those plates with no growth can be automatically reported to the laboratory information management system without review. For plates with growth, a total colony count will be reported which should be reviewed (and further processed if required) according to local laboratory procedures. Plate images, associated meta data, and resulting reports can be retained (if deemed necessary) and exported to laboratory information systems, which improves data integrity by eliminating human error associated with transcription and traceability.
Diamidex
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MICA Advance Legionella		 Culture, click-chemistry, fluorescence
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Water analysis; identification and enumeration		 48 hours 250 per 8 hours 20 mL to 1 liter CFU/liter Legionella pneumophila, all serotypes Four step protocol: (1) filtration, (2) 48 hours incubation, (3) revelation, (4) automatic enumeration in CFU/L. Only one GVPC plate per sample. 21FR Part 11 and ISO 11731:2017 compliant.
Interscience
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ScanStation		 Growth-based
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Sterility testing, raw material or finished product quality control, bioburden, EM, challenge test		 Real-time: about 50% of incubation saving time 100, 200 or 300 Petri dish capacity From 55 to 90 mm Petri dish, contact plate or filtration membrane 1 CFU; 0.05 mm colony diameter Bacteria, yeasts and molds The ScanStation is a smart incubator that maintains an optimal temperature for microbial growth while analysing colony development in real time for enumeration. This real time growth monitoring allows more accurate enumerations and anticipated results. In addition, the ScanStation is 21 CFR part 11 certified, guaranteeing data protection and results traceability.
IntuBio
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IntuGrow		 Growth-Based
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Bioburden, in-process-control, contamination control of fermentation, sterility 		First detection: 3-4 hours, final concen-tration: 6-10 hours 12 per 12 hours Filterable 1-100 mL; unfilterable for complex sample types 1 CFU Bacteria, yeast, mold, all organisms that grow on agar media Samples with low microbiology concentrations upstream and downstream are prepared according to compendial methods with a specially designed filtration system. Following filtration agar-based culture medium is added directly to the filter ring. The plate with up to twelve samples is incubated in the instrument, while image data is acquired with intervals of one hour giving an updated CFU/vol count after each measurement cycle using the specialized image analysis software. The method is non-destructive allowing for further analysis and ID on recovered microorganisms. Complex samples can be cultured directly on agar or mixed with agar using the Intubio mini-dish.
LumiByte BV MuScan
•
Innosieve Diagnostics Test Kits		 Viability staining and solid phase cytometry; fluorescence microscopy
•
Bioburden of raw material and in-process samples, finished product, EM, water, sterility testing		 10-65 minutes 100 per 8 hours Filterable samples; 1 uL to 1L 1 - 105 cells Bacteria, yeast, fungal spores The test sample is filtered/concentrated through a 0.45um micro sieve. Microorganisms are retained on the membrane and subsequently labeled with a viability stain and/or a species-specific stain. Available are total viable count, total live-dead ratio, total species-specific count and total species-specific viable count. After staining a scanning period using MuScan digital fluorescent microscopy at specific excitation and emission wavelengths is performed. The image processing software analyzes fluorescent objects on size, shape and fluorescent signals of all microbes. The assay can be user-customized with different types of fluorescent stains, labeled antibodies, DNA-probes, etc., depending on the organism(s) to be detected. Examples of test kits for specific organisms include Legionella, Salmonella, Listeria, Chronobacter and E. coli. The method is non-destructive such that detected microbes can be subsequently cultured.
LumiByte BV ColonyTracker Growth based; automated detection of growing micro-colonies
•
Sterility testing, bioburden, EM, water testing		 Positive results in hours 6-17 per batch Standard samples 1 CFU Bacteria, yeast, fungi Samples are prepared the same as traditional culturing. Samples (standard petri dishes plus a holder) are placed in the CTV (insite incubator.) CTV monitors samples at multiple time points and micro-colonies are identified when growth is detected. The principle of detection is optical time lapse imaging. Notification when the number of micro-colonies exceeds a custom set htreshhold level. Non-growing objects are ignored.
METTLER TOLEDO Thornton
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7000RMS Microbial Detection Analyzer		 Intrinsic Fluorescence and Mie Scattering
•
Monitoring pure water		 2 seconds Continuous monitoring 30 mL/minute 1 cell Bacteria, yeast, mold The instrument is installed at-line and water is drawn into the instrument at 30mL/min. As the sample passes through the flow cell it is illuminated by a laser diode which causes two events to occur, Mie scattering and fluorescence. Mie scattering enables the particles to be sized while fluorescence enables the detection of metabolites (NADH and riboflavin) in the microorganisms. Through the use of sophisticated algorithms the 7000RMS analyzes these two events and is able to quantify the presence of microorganisms down to single cell levels.
mibic
•
GRAMRAY		 Viable Staining and Imaging LED Raman Spectroscopy
•
Identification and enumeration		 3-10 min 300-600 ID's per hour Cells from colony, liquid medium, product/raw material, surfaces 1 cell is identified and quantified > 150 bacterial and spore entries; customizable The sample material is collected on metal foil using impaction or filtration methods. Viability staining and automated image analysis using dark field illumination detects viable particle quantity, shape, and size ranging from 0.5 μm and larger. Raman spectroscopy is then performed on each viable particle and a spectral signature is provided. The spectral signatures are statistically correlated to a library of known microorganisms. Non-destructive for further analysis.
Microbs
•
IAN®		 Viability staining , Solid Phase Cytometry (SPC), Artificial Intelligence
•
Bioburden of raw material, in-process samples, finished products, EM, waters, sterility testing		 15 min from 100 µL to 10 ml sample, less than 40 min for 100 ml sample 32 samples per shift Filterable samples from 100 µL to 200 ml 1 cell Total Flora, bacteria, yeast, mold, spores The test sample is filtered through a track-etched membrane. Microorganisms retained on the filter are labelled with multiple viability dyes. This cell labelling can enumerate viable microorganisms as well as VBNC (viable but non-culturable). Through the association of a LED induced fluorescence and Artificial Intelligence the viable cells are detected. Auto-fluorescent particles and background noise are rejected, and only viable microorganism counts are reported.
Micronview Limited
•
BAMS BioAerosol Monitoring System		 Intrinsic fluorescence and Mie scattering
•
Active air monitoring		 Real Time Continuous or episodic monitoring 5 L/min 1 cell Bacteria, yeast, mold, spores Air is pulled into the instrument at a rate of 5 liters per minute where all particles pass through a 405 nm laser. Each particle is assessed for size (0.5 - 10 microns), using Mie scattering principle, and auto-fluorescence from metabolites in viable particles. The instrument provides on screen real time particle and bio counts, by size, down to a single cell.
Microtechnix
•
EMMA		 Automated, high resolution imaging of CFU with AI
•
Environmental monitoring; bioburden and sterility optional		 Same as traditional visual inspection 120 Petri dishes per hour per EMMA unit 55 or 90 mm Petri dish 1 CFU Bacteria, yeast, mold Load Petri dish (optional robot available for automatic loading), identify barcode, take series of images, analyse positive/negative using AI. Optional: count using AI as a tool. Images & XML data per Petri dish are available. Integration with LIMS is possible and easy (MODA-EM, Labware & others supported).
Millipore
•
Milliflex Rapid		 Growth-based; ATP bioluminescence
•
Bioburden of raw material and in-process samples, finished product, EM, water, sterility		 24-28 hr 60 per day Filterable samples 1 CFU after growth Bacteria, yeast, mold Utilizes a membrane filter to capture individual cells. Filter the sample and place the membrane on an appropriate agar medium to allow the growth of micro-colonies. Micro-colonies are then treated with an ATP-releasing reagent, followed by the addition of luciferin and luciferase. Photons of light from each micro-colony are detected by a luminometer, and a cell count is reported. May be able to continue incubation to form larger colonies for subsequent microbial identification.
Millipore
•
Milliflex Quantum		 Growth-based; viability staining and cellular fluorescence
•
Bioburden of raw material and in-process samples, finished product, EM, water, sterility		 24-28 hr 60 per day Filterable samples 1 CFU after growth Bacteria, yeast, mold Filter the sample, and incubate the membrane an an agar cassette to form micro-colonies. Add non-fluorescent substrate and incubate an additional 30 min. Within the cell, the substrate is enzymatically cleaved, releasing a free fluorochrome into the microorganism cytoplasm. As fluorochrome accumulates inside the cells, the signal is naturally amplified. The membrane is placed in a reader and exposed to the excitation wavelength of the fluorochrome. Fluorescent micro-colonies are then automatically enumerated. Non-destructive; can continue to incubate media to obtain colonies for microbial identification.
Pall Corporation
•
GeneDisc® Rapid Microbiology System		 qPCR
•
Estimation of cell count		 3 to 8 hours including sample filtration, nucleic acid prep, and PCR 96 per PCR run 1-300 mL. Protocol adapted for solids and non-filterable samples. 1 CFU after enrichment for 6 to 24 hours. >100 CFU without enrichment. E. coli, Salmonella, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Aspergillus brasiliensis, STEC, E. coli 0157, Listeria, Legionella, Enterococcus, Cyanobacteria Samples are filtered and microorganisms collected on the membrane are lysed by a combination of reagents, sonication and heating. DNA is purified and concentrated by further filtration. The DNA and Master Mix (polymerase and deoxynucleotides) are added to the GeneDisc plate, preloaded with the primers and probes. The plate is transferred into the GeneDisc Cycler, and it rotates through four temperature zones during the qPCR amplification process. With each amplification cycle a fluorescent signal is generated from the probe. The point at which the signal reaches above the background is called Cycle Threshold (Ct) value. The higher the DNA copy (e.g., higher microorganisms), the less amplification cycles will be required to reach the Ct value (i.e., faster detection). Built-in software calculates the number of genomic copies (e.g., amount of DNA, which is directly related to the number of microbial cells/CFUs) present in the initial sample. Identification is possible by DNA sequencing of the remaining DNA sample.
Particle Measuring Systems
•
BioLaz™ Real-Time Microbial Monitor		 Intrinsic fluorescence and Mie scattering
•
Active air monitoring		 Real Time Continuous monitoring 3.6 L/min 1 cell Bacteria, yeast, mold, spores Air is drawn into the instrument sensing area via a stainless steel sample probe. As the air passes through the system it is illuminated by a laser. Biological particles that contain NADH or riboflavin will auto-fluoresce as they pass through the laser. Those fluorescing biological particles are then counted in one of two size channels. The system can be integrated into an existing Environmental Monitoring data management platform or can be used with a local PC with available interface software.
Plair SA
•
Rapid-C+ Real-Time Air Microbial Detector		 Mie light scattering, laser-induced fluorescence spectroscopy, and machine learning for real-time microbial counting and classification, plus active air sampling for microbial identification
•
Environmental monitoring		 Real Time Continuous or episodic monitoring 5 L/min 1 cell, 1 CFU Bacteria, bacterial and fungal spores, yeast Rapid-C+ optically analyzes each individual particle drawn into the instrument in the range of 0.5-100 micrometers and provides viable and total particle counts in real-time. The same particles are then sampled on traditional agar media for identification. Long-duration active air sampling also fulfills the requirement for continuous sampling. Rapid-C+ uses advanced laser analysis based on combined time-resolved morphological characterization and deep-UV-induced fluorescence spectroscopy analysis. Microorganisms are detected with high sensitivity and classified with extremely low false positive rate versus interfering fluorescent inert materials.
Rapid Micro Biosystems
•
The Growth Direct™ System		 Growth-based; automated detection of cellular auto-florescence
•
Water analysis, Bioburden, Sterility, Environmental Monitoring		 Final results in one-half the time of the compendial method
•
Positive results within hours		 400 samples for 3-day EM Test
•
280 samples for 5-day water or bioburden tests
•
20-40 samples per day for Sterility Test		 Filterable samples
•
Standard Environmental Monitoring samples		 1 CFU Bacteria, yeast, mold, all organisms that grow on agar media Samples are prepared as per the compendial method and loaded into the system which manages the incubation and colony enumeration for the sample. Proprietary digital imaging technology automatically enumerates micro-colonies in one-half the time than traditional visual plate counting methods. The sample is collected onto a filter placed onto an agar medium cassette with an optically clear lid. Illumination with blue light excites micro-colonies to auto-fluoresce (without the addition of any reagents), which are enumerated by a CCD imaging system. The system automatically incubates and analyzes each cassette for the formation of micro-colonies over time. Particles that do not grow in size over time are ignored. Non-destructive; can continue to incubate media to obtain colonies for microbial identification.
Redberry
•
Red One		 Viability staining and solid phase cytometry
•
Bioburden of raw material, in-process samples & finished product, water analysis		 10 minutes (10 CFU); 24 h (1 CFU) 50 per day 10 CFU within 10 minutes; 1 CFU after growth Filtrable samples from 1 to 100 ml Bacteria, yeast, mold The sample is automatically filtered through polyester or mixed cellulose membranes. Microorganisms retained on the membrane are either directly labeled with a viability stain (or a species-specific stain) or cultivated if required. The high resolution imaging system is capable to monitor the evolution of fluorescence emitted by each microorganism or microcolony over time. To that end, pictures of samples are taken before, during and after the staining process. Inerts and autofluorescent particles are thus differentiated from viable microorganisms thanks to picture comparison and analysis of fluorescence emission over time.
TSI Inc.
•
BioTrak™ Real-Time Viable Particle Counter		 Intrinsic fluorescence and Mie scattering
•
Active air monitoring		 Real Time Continuous or episodic monitoring 28.3 L/min 1 cell Bacteria, yeast, mold, spores Air is drawn into the instrument and both viable and total particulates are simultaneously detected, sized and enumerated via a 685 nm laser diode (for particle sizing) and a 405 nm laser diode (for viability detection). The size range for detection is from 0.5 to 25 microns. The counting efficiency is 50% at 0.5 microns and 100% for particles > 0.75 microns (per ISO 21501-4 and JIS B9921). The system can be calibrated using NIST traceable standards. Also included is an integrated particle collection filter (gelatin filter) to capture microorganisms for subsequent growth and identification.
Veolia
•
Sievers Soleil Rapid Bioburden Analyzer		 High throughput flow cytometry in conjunction with viability based stains
•
Bioburden for water, raw materials, in process samples, cleaning validation		 45 minutes 8 mL/minute 20-100mL with the output in total viable cells/ volume measured 5 CFU/100 mL Bacteria, yeast, mold, spore-forming organisms The Soleil can be used either at line or in a laboratory. The user will collect the sample, place it in the onboard incubator for at least 15 minutes in order for the sample to reach 37C. Once the thermal stabilization step is complete, the user will add two proprietary reagents and place the sample back in the incubator for 15 minutes. Once this is complete, the user adds one more reagent and then introduces the sample to the Soleil. Depending on the sample volume, the analysis in the instrument takes up to 15 minutes. The results are displayed in biotic counts (viable cell counts) and abiotic counts (non-viable cells or particulates).
Veolia
•
Sievers Eclipse BET Analyzer		 Kinetic chromogenic BET assay
•
Bacterial endotoxin testing (BET)		 ~ 1 hour 21 samples per plate 55 μL 0.005 EU/mL Endotoxin The Eclipse software walks the user through the set up of the BET assay using color coordinated visuals in under 10 minutes. The user dispenses 55uL of sample into each segment and 55uL of LRW in each of the standard curve segments. The Eclipse uses commercially available reagents from any LAL vendor but only requires 1mL of reagent per assay, while still maintaining a 1:1 sample to reagent ratio. The reagents are delivered to each well using precise microfluidics and centripetal force. The Eclipse software is 21 CFR Part 11 compliant and is fully customizable.
Vivione Biosciences, LLC
•
RAPID-B 		Flow cytometry
•
Incoming inspection, sterility confirmation, bioburden, drug development, process control		 20 min for quanti-tative results
•
Up to 8 hr for qualitative results		 96-160 per 8 hrs 75-225 uL 1 CFU after enrichment TB, Chlamydia and Staphylococcus for clinical samples. Salmonella, E. Coli O157, non-O157 STECs, Staphylococcus, and Vibrio for food samples Samples and reagent are added to a vial and mixed (5-10 min). The RAPID-B system analyzes the sample using flow cytometry, with results available within 3-5 minutes. Light scatter resolution of around 130nm shows separation of bacteria populations via size and refractive index alone. The system utilizes a multi-parametric detection approach: a phenotypic library to identify the bacteria, an immunoprobe to specifically tag the target organism and a DNA dye to ascertain the live or dead cells of the target organism. The workflow is also based on the limit of detection (LOD) required and the target of interest (may include enrichment, filtration, centrifugation and dilution).

Microbial Identification Technologies


Company
•
Product
Name		 Scientific
Method
•
Applications		 Time to Result Throughput Sample Size or Type Sensitivity Organism
Libraries		 Workflow
Applied Biosystems / Thermo Fisher
•
MicroSEQ		 PCR and gene sequencing
•
Identification		 4-5 hr 80 per day. Higher with greater capacity capillary analyzers. Cells from colony Not applicable >1800 bacteria

>90 Mycoplasma

>1100 yeast and mold		 DNA is extracted from cells originating from isolated colonies. Amplify target 16S rDNA for bacteria or the D2 region of large-subunit rDNA for fungi using PCR. Perform sequencing of the PCR amplicons, resulting in DNA fragments of various sizes ending in different nucleotides/dyes. A genetic analyzer separates the fragments by size and a laser detects the fluorescence color from each dye, producing a full gene sequence of the target DNA. The resulting sequence is compared with an internal database of known sequences. No Gram staining is required.
BD Diagnostic Systems
•
Phoenix		 Growth-based; biochemical utilization and antibiotic susceptibility
•
Identification		 3 hr 100 per day Cells from colony Not applicable >225 bacteria Cells from isolated colonies are used to prepare a microbial suspension, which is then added to specific test cards containing substrates (in wells) for biochemical utilization. Color or fluorescence changes in each well are compared with an internal library. Gram staining is required to determine the correct test card to use.
Biolog
•
OmniLog;
MicroStation;
MicroLog		 Growth-based; carbohydrate utilization.
•
Identification		 2-72 hr 50 per day Cells from colony Not applicable >1226 bacteria and >885 yeast/mold (GEN II cards)

>1000 bacteria (GEN III card)		 Cells from isolated colonies are used to prepare a microbial suspension, which is then added to specific test cards containing a variety of carbohydrates and a colorless tetrazolium violet dye. If growth occurs, the dye turns violet in color. The resulting color patterns are compared with an internal library. Gram staining is required when using GEN II test cards for bacteria, yeast and mold. No Gram stain is required for the GEN III bacterial card (ID's both Gram + and - bacteria).
bioMérieux
•
Vitek 2 Compact		 Growth-based; biochemical and carbohydrate utilization.
•
Identification		 2-18 hr 30-60 per day Cells from colony Not applicable >285 bacteria

>48 yeast		 Cells from isolated colonies are used to prepare a microbial suspension, which is then added to specific test cards containing substrates for enzymatic utilization, carbohydrate acidification and other tests. Color or turbidity changes in each well are measured every 15 minutes and results are compared with an internal library. Gram staining is required to determine the correct test card to use.
bioMérieux
•
Vitek MS		 MALDI TOF mass spectrometry
•
Identification		 2 min 480 every 8 hr Cells from colony Not applicable 508 bacteria

78 fungi		 Cells from isolated colonies or liquid medium are added to a stainless steel target plate and allowed to dry. A UV-absorbing matrix is added and the cells are ionized by a laser. The ionized particles are accelerated in an electric field and enter the time of flight (TOF) tube, where protein and peptide molecules are separated according to their mass to charge ratio. The resulting MALDI-TOF mass spectrum is compared with an internal database. Gram staining is not required. Mixed culture ID possible.
Bruker Daltonics
•
MALDI Biotyper		 MALDI-TOF mass spectrometry
•
Identification		 1-2 min 30-60 per hr Cells from colony or liquid sample Not applicable > 2,000 species and > 4,010 strains of bacteria, yeast and mold Cells from isolated colonies or liquid medium are added to a stainless steel target plate and allowed to dry. A UV-absorbing matrix is added and the cells are ionized by a laser. The ionized particles are accelerated in an electric field and enter the time of flight (TOF) tube, where protein and peptide molecules are separated according to their mass to charge ratio. The resulting MALDI-TOF mass spectrum is compared with an internal database. Gram staining is not required. Mixed culture ID possible.
Bruker Daltonics
•
TENSOR 27+HTS-XT		 Fourier Transform–Infrared (FT-IR) Spectrometry
•
Identification		 Minutes Continuous sampling on 96 and 384 plate formats Cells from colony Not applicable Yeast, bacilli, Coryneforms, Micrococci, Staphylococci, Bifido, Clostridia, Pseudomonads, Lactobacilli, Acetobactereaceae Microorganisms are harvested from the cultivation medium, suspended in water and then transferred on a special IR-transparent, reusable sample plate. The measurement is performed after drying of the samples. The dried biofilm is then analyzed by the FT-IR microplate reader. The FT-IR spectrum is then compared with an internal library.
ceeram
•
ceeramTools Genotyping Kits LP		 MLVA (Multi Locus VNTR Analysis)
•
Genotyping		 2 days 100 samples in 2 days DNA or culture cell Not applicable Legionella pneumophila, Staphylococcus aureus, Pseudomonas aeruginosa MLVA is a PCR based typing method that relies on the inherent variability found in many regions of repetitive DNA called VNTR (Variable Number Tandem Repeat) which represent sources of polymorphisms. The MLVA assay for L. pneumophila examines 12 loci and the assay for S. aureus and P. aeruginosa examines 16 loci. Thus, each isolate is defined by a 12 or 16-digit numeric code corresponding to the number of repeats at each VNTR. Efficient amplification of the markers is performed in a single or 2 multiplex PCR reactions. An ABI sequencer is required to analyze the amplicons.
Diamidex
•
MICA Advance Legionella		 Culture, click-chemistry, fluorescence
•
Water analysis; identification and enumeration		 48 hours 250 per 8 hr 20 mL to 1 liter CFU/liter Legionella pneumophila, all serotypes Four step protocol: (1) filtration, (2) 48 hours incubation, (3) revelation, (4) automatic enumeration in CFU/L. Only one GVPC plate per sample. 21FR Part 11 and ISO 11731:2017 compliant.
Hygiena
•
Riboprinter		 Ribotyping of DNA fragments
•
Identification		 8 hr 32 per day Cells from colony Not applicable >1,440 bacteria

>8,500 strain or sub-species patterns		 DNA is extracted from cells originating from isolated colonies. The DNA is cut into fragments using a restriction enzyme, which are then separated according to size. The DNA is immobilized on a nylon membrane, denatured to produce single-stranded DNA, and then hybridized with a DNA probe (derived from an E. coli rRNA operon). An antibody-enzyme conjugate is bound to the probe and a chemiluminescent agent is added, resulting in a banding pattern that is compared with an internal database. Fully automated; no Gram staining required.
Greiner Bio-One
•
CytoInspect		 PCR and microarray analysis
•
Mycoplasma detection and identification		 5 hr 100 per day Cell culture Detection of > 90 species of Mycoplasma and identification of 40 Mycoplasma species A microarray based test kit for the detection and identification of mycoplasma species in cell cultures and other biological materials. DNA is extracted and PCR performed using primers specific for conserved and species-specific regions of the 16S-23S rRNA intergenic transcribed spacer (ITS) of Mycoplasma DNA. The fluorescently labeled fragments are then hybridized to the microarray chip. The chip contains probes for both species-specific targets and a universal probe for all Mycoplasma.
mibic
•
GRAMRAY		 Viable Staining and Imaging LED Raman Spectroscopy
•
Identification and enumeration		 3-10 min > 150 samples per 8 hr Cells from colony, liquid medium, product/raw material, surfaces 1 cell is identified and quantified > 30 bacteria; can add new entries The sample material is collected on metal foil. Viability staining and automated image analysis using dark field illumination detects viable particle quantity, shape, and size for particles ranging from 0.5 μm and larger. Raman spectroscopy is then performed on each viable particle, and a spectral signature is provided. The spectral signatures are statistically correlated to a library of known microorganisms. Non-destructive for further analysis.
MIDI
•
Sherlock MIS		 Detection of fatty acids.
•
Identification		 Standard method (2 hr);
Instant FAME method (<15 min)		 100 per day Cells from colony Not applicable >1,200 bacteria

>200 yeast/mold		 Fatty acids are extracted from cells originating from isolated colonies. The fatty acids are purified and analyzed using gas chromatography. The resulting GC chromatogram is compared with an internal library. No Gram staining is required.
Pathogenetix, Inc.
•
RESOLUTION® Microbial Genotyping System		 Fluorescent tagging of single molecules of genomic DNA
•
Identification, analysis of microbial mixtures, epidemiology, contamination source tracing		 3.5 - 4.5 hr 50 samples per 24 hr 107 - 109 cells in 0.1 - 5 mL of culture or from colony 0.1% of microbial target mixed with other bacteria 1,000+ organisms including bacteria, yeast, mold, and Mycoplasma. Library can be customized. Rack of tubes with suspended cells is inserted into an automated Sample Preparation Module to be processed in parallel. The Module isolates and purifies DNA, specifically digests it, tags DNA with fluorescent probes, and elutes the samples for consecutive measurement with the microfluidic Detector Module. The fragments of genomic DNA are stretched and fluorescent signatures generated by the probes are measured one-by-one. Each signature is compared with internal database to identify an isolate or elucidate the composition of microbial mixture.
Thermo Scientific
•
Nicolet		 Fourier Transform–Infrared (FT-IR) Spectrometry
•
Identification		 2 hr 350 per day Cells from colony Not applicable Bacteria Cells from isolated colonies are incubated in liquid medium for 18 hr, followed by washing, centrifugation and resuspension in distilled water. 50 uL of the suspension is transferred onto a special IR-transparent, reusable sample plate and dried at 40-45°C under vacuum to create a biofilm. The biofilm is then analyzed and biomolecules such as proteins, lipids, carbohydrates and DNA/RNA are identified and quantified. The FT-IR spectrum is then compared with an internal library.

Sample Preparation Technologies


Company
•
Product
Name		 Scientific
Method
•
Applications		 Time to Result Throughput Sample Size or Type Sensitivity Organism
Libraries		 Workflow
InnovaPrep
•
Concentrating Pipette Select		 Automated large volume concentration
•
Biological and particulate contamination in water, media, parenteral fluids, compounded drugs, and environmental samples		 30 sec - 30 min 200 mL/min ~Up to 5 L Up to 104 x concentration factor Bacteria, parasites, molds, fungal spores and fragments, whole cells and viruses The one-pass method uses filtration through a high-flow single-use pipette tips to remove micro-organisms from the fluid sample matrix. Once the sample has been filtered, the instant wet foam elution process recovers and delivers the micro-organisms into micro liter volume (user-selectable from 150 uL) of clean buffer ready for analysis by modern or classical methods. Replace pipette tip and it's ready for the next sample.