The RMM Product Matrix

Our RMM Product Matrix allows you to compare multiple rapid microbiological method technologies that are commercially available or in development. To learn more about RMM scientific principles and methods of analysis, please visit our Tutorial Pages. For information regarding instrument costs and cost per test (e.g., consumables, reagents, media), please contact the RMM suppliers directly.

The information presented within the RMM Product Matrix is provided by the suppliers and/or what is available in the public domain, and may change without notice. Please review our Terms of Use for copyright information.

HOW TO USE THE TABLES: The matrix is arranged in terms of whether a technology is qualitative (allows for the detection of a specific organism and/or a presence/absence result but no counting data), quantitative (a count is provided; some of these same systems may also be used as a presence/absence test, such as sterility, depending on the capability of the technology), microbial identification (to at least the genus and/or species level) and sample preparation.

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RMMs for Microbial Identification
RMMs for Qualitative Analysis
RMMs for Quantitative Analysis
Sample Preparation Technologies

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RMMs for Microbial Identification

Company • Product Name	Scientific Method • Applications	Time to Result	Throughput	Sample Size or Type	Sensitivity	Organism Libraries	Workflow
Applied Biosystems • 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.
Battelle • REBS	Raman spectroscopy • Identification and enumeration	3 min	160 every 8 hr	Cells from colony, liquid medium, product/raw material, surfaces	1 cell is identified and quantified	Alcaligenes, Pseudomonas, Brevundimonas, Candida, E. coli, Bacillus, Ralstonia, vegetative and spore forms.	Sample material is retained on a supported film. The area is examined for microscopic particulates using Raman spectroscopy and a spectral signature is provided for each particulate. The spectral signatures are statistically correlated to a library of known microorganisms. No need for Gram staining. Mixed cultures and be identified and enumerated. Non-destructive for further analysis.
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).
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.
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.
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.
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.
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.
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.

RMMs for Qualitative Analysis

Company • Product Name	Scientific Method • Applications	Time to Result	Throughput	Sample Size or Type	Sensitivity	Organism Libraries	Workflow
Applied Biosystems • MycoSEQ	PCR • Mycoplasma detection	< 5 hr		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 • Speedy Breedy	Respirometry, pressure sensing • 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 • BACTEC FX	Growth-based; CO2 detection • 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 • BioLumix System	Growth-based; CO2 detection and selective growth • 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 • 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 • Hygiene Screening System	PCR • 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 • ceeramTools RT-PCR Real Time Detection Kits	Real time RT-PCR • 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 • Celsis Advance II™	ATP bioluminescence • 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 • Celsis Accel®	Enzyme-amplification combined with ATP bioluminescence • 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 • 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 • BAX System Q7	PCR • 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.
Greiner Bio-One • CytoInspect	PCR and microarray analysis • 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 • EndoLISA	ELISA • 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 • Real-Time Q-PCR Detection Kits	Q-PCR • 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 • MycoAlert	ATP bioluminescence • 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.
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.
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 • Listeria Right Now	Isothermal replication of rRNA • 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 • GeneDisc® Rapid Microbiology System	qPCR • 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 • Promilite M4A	ATP Bioluminescence • 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 • MycoTOOL Real-Time PCR	PCR • 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 • Microsart® AMP Bacteria Kit	qPCR; TaqMan® probe • 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 • Microsart® AMP Mycoplasma Kit Microsart® ATMP Mycoplasma Kit Microsart® RESEARCH Mycoplasma Kit	qPCR; TaqMan® probe • 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 • RAPID-B	Flow cytometry • Incoming inspection, sterility confirmation, bioburden, drug development, process control	20 min for quantitative 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).

RMMs for Quantitative Analysis

Company • Product Name	Scientific Method • Applications	Time to Result	Throughput	Sample Size or Type	Sensitivity	Organism Libraries	Workflow
Battelle • REBS	Raman spectroscopy • Identification and enumeration	3 min	160 every 8 hr	Cells from colony, liquid medium, product/raw material, surfaces	1 cell is identified and quantified	Alcaligenes, Pseudomonas, Brevundimonas, Candida, E. coli, Bacillus, Ralstonia, vegetative and spore forms.	Sample material is retained on a supported film. The area is examined for microscopic particulates using Raman spectroscopy and a spectral signature is provided for each particulate. The spectral signatures are statistically correlated to a library of known microorganisms. No need for Gram staining. Mixed cultures and be identified and enumerated. Non-destructive for further analysis.
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 • 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. • 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 • 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 • 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 • Endosafe® Nexus™	LAL assay • 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.
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 • 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.
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.
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.
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.
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.
Vivione Biosciences, LLC • RAPID-B	Flow cytometry • Incoming inspection, sterility confirmation, bioburden, drug development, process control	20 min for quantitative 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).

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.