- General
- LIS/LIMS and Workflow
- Antibiotic Susceptibility Testing
- Identification Testing
- Quality Control Testing
- Colony Counting
- System Support and Maintenance
- General
- Is the BIOMIC System US-FDA approved?
- Our lab currently has VITEK/MicroScan/Phoenix, why do we need another system?
- Why should I automate testing?
- Is a computer provided with BIOMIC V3?
- What are the BIOMIC V3 computer requirements?
- Can the BIOMIC V3 computer be used for additional applications?
- Can antibiotic test plate, ID panel and colony count plate images be saved?
- Do test plates and panels need to be prepared before inserting into BIOMIC V3?
- How often does BIOMIC V3 need to be calibrated?
- How many different species can be tested for antibiotic susceptibility and identification with BIOMIC V3?
- Does BIOMIC V3 provide multiple levels of user access?
- Does Giles Scientific sell antibiotic disks, plates, media, ID panels, etc?
- LIS/LIMS and Workflow
- Will BIOMIC V3 interface with our LIS/LIMS provider?
- Is there an additional cost to interface BIOMIC V3 to our LIS/LIMS?
- Is a bar code reader included with BIOMIC V3?
- How fast can BIOMIC V3 read and interpret tests?
- Are plates and panels inserted one at a time into BIOMIC V3?
- Can test specimen information and test results be manually entered?
- Antibiotic Susceptiblity Testing
- What size plates can be read?
- How many antibiotic disks may be tested on each plate?
- What is the Resistance Monitoring Center™?
- Are expert rule messages printed on test reports?
- If an expert rule is triggered and changes a test result interpretation (category S,R), is it shown on-screen?
- Can BIOMIC V3 detect ESBL, MRSA, and VRSA?
- Can BIOMIC V3 read and interpret the D-Test?
- What are BIOMIC V3 user expert rules?
- Can BIOMIC V3 read Etest® strips and new M.I.C. Evaluator strips?
- Are all antibiotic guidelines programmed in BIOMIC V3?
- How are new antibiotics added?
- Can epidemiology/antibiogram reports be generated?
- Can a user adjust the automatic zone measurements with BIOMIC V3?
- How does BIOMIC V3 read and interpret trimethoprim sulfa zones?
- How does BIOMIC V3 read difficult (ex: low growth / fastidious / blood) plates?
- How does BIOMIC V3 interpret small colonies inside the zone of inhibition?
- How does BIOMIC V3 interpret double zones and feathered edges?
- How does BIOMIC V3 recognize each antibiotic disk on the plate?
- How precisely do disks need to be positioned on test plates?
- Is it necessary to remove labels and writing from the bottom of test plates?
- Identification Testing
- What identification (ID) panels can be read and interpreted with BIOMIC V3?
- Can a user adjust ID panel test well reactions (+/-)?
- What if additional reagents need to be added to ID panels?
- What if additional tests are required to confirm an ID panel result?
- Quality Control Testing
- Can BIOMIC V3 read and interpret antibiotic disk Quality Control (QC) testing?
- Can disk lots and media lots be recorded for QC tests?
- Can BIOMIC V3 read and interpret ID panel QC testing?
- Are QC plate and panel images and results saved?
- How does BIOMIC V3 update QC antimicrobial zone ranges?
- How are QC Summary Reports created?
- Colony Counting
- What types of assay plates can be read automatically?
- Can the colonies be counted with debris in the agar?
- Can blood and dark colored agar be read?
- Can touching and overlapping colonies be divided into separate counts?
- What is the smallest detectable colony read?
- Can plates that are divided into several segments be read automatically?
- Are colonies differentiated based on size?
- System Support and Maintenance
- What is included in the BIOMIC V3 Service Contract?
- How long is the installation and setup process for BIOMIC V3?
- Does the BIOMIC V3 require routine maintenance?
- How often is the BIOMIC V3 software upgraded?
- What training is provided with BIOMIC V3?
- Prior to a purchase, can I send sample digital plate images to Giles Scientific for analysis?
- After a purchase, can I send sample difficult or unique digital plate images to Giles Scientific for analysis?
- General
- Is the BIOMIC System US-FDA approved?
Yes, it has successfully passed US-FDA 510(k) reviews.
- Our lab currently has VITEK/MicroScan/Phoenix, why do we need another system?
BIOMIC V3 is utilized as both a primary and secondary Antibiotic Susceptibility Testing and Identification (AST-ID) instrument. BIOMIC V3 provides the broadest range of testing capabilities to fill in the gaps for other commercial systems. Approximately 50% of BIOMIC V3 Systems compliment another automated AST-ID system while the remaining 50% are utilized as a primary AST-ID system. Learn more 
- Why should I automate testing?
BIOMIC V3 reduces over 95% of the time involved in reading and calculating test results, eliminates human transcription errors, and minimizes reading variability. This provides more consistent, accurate and reliable test results than manual reading and measurements. BIOMIC V3 provides an electronic record of test results and images.
- Is a computer provided with BIOMIC V3?
No, the computer should be supplied locally and must comply with the specifications below (Question #5). BIOMIC V3 does include a built-in 15 inch touch-screen.
- What are the BIOMIC V3 computer requirements?
- Pentium 4 or equivalent
- 512 meg RAM (minimum), 1 gig RAM (recommended for optimal performance)
- Windows 2000, Windows XP, or Windows Vista (XP Professional recommended)
- Three (3) available USB ports
- Serial port for LIS/LIMS connection
- Internet connection (strongly recommended)
- Surge protector
*No monitor is required as a 15 inch touch-screen is built-in to BIOMIC V3.
- Can the BIOMIC V3 computer be used for additional applications?
Yes, the computer can be used for multiple functions, including BIOMIC V3, LIS/LIMS, other software programs, email, Internet etc. The touch screen on the BIOMIC V3 may also be used for multiple applications.
- Can antibiotic test plate, ID panel and colony count plate images be saved?
Yes, high resolution color digital plate and panel images are saved and can be reviewed at any time.
- Do test plates and panels need to be prepared before inserting into BIOMIC V3?
Yes. All plate and panel preparation (incubation, inoculation, etc) is performed following current laboratory methods. BIOMIC V3 provides instant reading, interpretation, and reporting of these tests.
- How often does BIOMIC V3 need to be calibrated?
Calibration is performed when BIOMIC V3 is:
1. Initially setup
2. Moved to a new location
3. Updated with new software
A calibration template verifies zone reading measurements and color reactions. The calibration process takes less than one minute.
- How many different species can be tested for antibiotic susceptibility and identification with BIOMIC V3?
All clinically relevant bacteria and yeast can be identified, and all bacteria and yeast with CLSI or BSAC guidelines can be tested for antibiotic susceptibility.
- Does BIOMIC V3 provide multiple levels of user access?
Yes, multiple level access controls with User ID and Password are built in the software. For example, the supervisor may be granted administrative rights to access the system setup functions.
- Does Giles Scientific sell antibiotic disks, plates, media, ID panels, etc?
No. Giles Scientific only designs, manufactures, sells, and supports BIOMIC V3. All test consumables (disks, plates, media, ID panels, etc) may be purchased from a separate vendor. Giles Scientific does not require lock-in contracts.
- LIS/LIMS and Workflow
- Will BIOMIC V3 interface with our LIS/LIMS provider?
Yes, a flexible 2-way ASTM standard or VITEK compatible LIS/LIMS interface is built into the BIOMIC V3 software. Test results are easily transferred to any LIS/LIMS provider, including Cerner, Orchard, HBOC, Soft Computer, Meditech, CPSI, McKesson, Dawning, Dairyland, LabDAQ, Misys (formerly Sunquest), by others. Contact Giles Scientific for LIS specifications.
- Is there an additional cost to interface BIOMIC V3 to our LIS/LIMS?
There is no additional cost from Giles Scientific. Additional costs for an LIS/LIMS interface may be charged from your LIS/LIMS provider.
- Is a bar code reader included with BIOMIC V3?
Yes, a bar code reader is included. Utilizing bar code entry optimizes the system and eliminates transcription errors associated with manual entry.
- How fast can BIOMIC V3 read and interpret tests?
Plates and panels can be entered, read and interpreted by BIOMIC V3 at up to six tests per minute. Workflow is optimized by use of a 2-way LIS interface, worklist download, batch reading mode, and bar code specimen information entry.
- Are plates and panels inserted one at a time into BIOMIC V3?
Yes, plates and panels are inserted one at a time into the BIOMIC V3 drawer. A mechanical plate stacker has been evaluated but added no benefit. A plate stacker would require added setup, potential mechanical breakdowns, and create safety and service/support issues.
- Can test specimen information and test results be manually entered?
Yes, a user may manually enter all test information and results by keyboard entry on-screen. However, an LIS/LIMS interface is highly recommended to speed workflow and can eliminate all typing and associated transcription errors. BIOMIC® V3
- Antibiotic Susceptibility Testing
- What size plates can be read?
90mm to 150mm plates.
- How many antibiotic disks may be tested on each plate?
It is recommended that a maximum of 6 disks (90mm plates) or 12 disks (150mm plates) per plate. However, more disks can be added to each plate but the customer should be careful not be place highly active antibiotics next to each other. This may result in unwanted heavy zone overlapping, add synergy, antagonism or an additive effect.
- What is the Resistance Monitoring Center™?
The BIOMIC V3 Resistance Monitoring Center™ has over 2500 expert rules based on CLSI (USA), BSAC (UK), French, German and published recommendations. Expert rules detect antibiotic resistance and report unlikely test results.
- Are expert rule messages printed on test reports?
Yes, expert rule messages that may be helpful to physicians are printed on test reports as footnotes. Expert rule messages that may be helpful to technologists are shown on-screen.
- If an expert rule is triggered and changes a test result interpretation (category S,R), is it shown on-screen?
Yes, when an expert rule changes a test result interpretation (e.g. S to R, or deleted), the original and expert interpreted test results are both shown on-screen, but only the changed results are printed or sent to the LIS.
- Can BIOMIC V3 detect ESBL, MRSA, and VRSA?
Yes, BIOMIC V3 utilizes CLSI and BSAC recommended test methods to detect and report these resistance mechanisms.
- Can BIOMIC V3 read and interpret the D-Test?
Yes. BIOMIC V3 instantly reads, interprets, and records D-Test results when erythromycin and clindamycin disks are placed, and the appropriate organism conditions (macrolide-resistant isolates of S. aureus, coagulase-negative Staphylococcus spp., or beta-hemolytic streptococci) recommended by CLSI are met. When a flattening of the clindamycin zone is detected and displayed on-screen, these isolates are reported as ‘clindamycin resistant’.
- What are BIOMIC V3 user expert rules?
User expert rules are laboratory specific rules created by the customer. The two types of user expert rules are “Do no report/print drug when…” and “Insert Comment when…”
Example 1: Do not report/print Ampicillin for Wound cultures.
Example 2: Do not report/print Cefepime if Oxacillin is Susceptible.
Example 3: If Ampicillin is Resistant for Staph, insert comment ABC.
Example 4: If Gentamycin is Suseceptible for Wound, insert comment XYZ.
- Can BIOMIC V3 read Etest® strips and new M.I.C. Evaluator strips?
BIOMIC V3 contains “Etest Click and Read”, a semi-automated reading feature for all varieties of Etest (AB BIODISK) and the M.I.C. Evaluator (Oxoid). An enlarged plate image with the MIC strip(s) and its drug specific MIC scale is displayed on-screen. The user selects the appropriate MIC value, triggering an automatic S-I-R interpretation. MIC values can be printed or transferred to your lab’s LIS. High resolution color MIC strip images can also be saved for future review.
- Are all antibiotic guidelines programmed in BIOMIC V3?
Yes, BIOMIC V3 contains an extensive list of all current antibiotics and their CLSI and BSAC guidelines. Customers select from a master list to add antibiotics to their customized drug panels.
- How are new antibiotics added?
New antibiotics and guidelines are provided annually with BIOMIC V3 software updates via CD or website download. Customers may also add new/investigation antibiotic and guidelines separate from the software updates.
- Can epidemiology/antibiogram reports be generated?
Yes, BIOMIC V3 includes a comprehensive list of epidemiology/antibiogram, including CLSI M39 recommendations. Custom user-defined report formats can be saved for reuse.
- Can a user adjust the automatic zone measurements with BIOMIC V3?
Yes, users can adjust all zone measurements on-screen.
- How does BIOMIC V3 read and interpret trimethoprim sulfa zones?
With trimethoprim and sulfonamides, antagonists in the agar medium may allow slight growth. BIOMIC V3 disregards this slight growth and the zone is measured at approximately 80% inhibition as recommended by CLSI.
- How does BIOMIC V3 read difficult (ex: low growth / fastidious / blood) plates?
BIOMIC V3 reads difficult plates very well, and it includes image enhancement functions to assist in the reading of difficult plates. This includes contrast enhancement for dark or blood plates (example: hemolytic streptococci) and growth enhancement for low growth, fastidious organisms (example: enterococci).
- How does BIOMIC V3 interpret small colonies inside the zone of inhibition?
Small colonies are visible on-screen. BIOMIC V3 interprets these colonies based on specific drug-organism combinations. Generally, if BIOMIC V3 detects 4-5 readily visible colonies within the zone of inhibition, the automated zone measurement will be drawn inside of these colonies. For specific organisms, such as Staph, the zone is automatically drawn inside any colonies observed. These reading functions have all been carefully calibrated against experts reading zones manually.
- How does BIOMIC V3 interpret double zones and feathered edges?
Drug-organism combinations that produce double zones or feathered edges are programmed to be interpreted by BIOMIC V3. (Example: E. coli and ciprofloxacin feathered edges are interpreted where no growth is visible by eye, whereas Candida and fluconazole double zones read the outer zone.)
- How does BIOMIC V3 recognize each antibiotic disk on the plate?
The user creates a drug panel by selecting the drugs to be tested from an extensive list of antibiotics and assigning each to a unique location on the plate. When a specific drug panel is selected on-screen, BIOMIC V3 software will locate the position of each disk, then the diffusion zone on the plate, thus activating the appropriate drug guidelines/interpretations and expert rules. This entire process takes less than 1 second for the entire plate.
- How precisely do disks need to be positioned on test plates?
BIOMIC V3 searches an area around the designated disk position on the plate. After locating the disk, a zone measurement is automatically drawn on-screen. This compensates for disk position variation caused by disks flipping over or shifting. For best results, always use a disk dispenser.
- Is it necessary to remove labels and writing from the bottom of test plates?
Yes, we recommend placing labels on the side of the plate to prevent interference with image. It is not recommended to have labels on the bottom of the plate. Alternatively, write on plates with fine point pens, preferably red, green or yellow. Wide black print may interfere with image analysis. Plate lids should also be removed during reading.
- Identification Testing
- What identification (ID) panels can be read and interpreted with BIOMIC V3?
All varieties of API® (bioMerieux), RapID™ (Remel), Crystal™ (BD), CHROMagar™ (BD) ID panels can be read with BIOMIC V3. Additional brands of ID panels may be read on request.
- Can a user adjust ID panel test well reactions (+/-)?
Yes, users may adjust individual test well reactions, overriding the BIOMIC V3 automated reading. ID code number and organism ID lookup will also change based on these manual adjustments.
- What if additional reagents need to be added to ID panels?
When additional reagents are required, BIOMIC V3 provides manufacturer instructions on-screen and reads the ID panels as required. (Remel RapID™ example: Add additional reagents after the first reading, wait 30 seconds to 2 minutes, then re-read.) Following the addition of reagents, BIOMIC V3 provides instant test results on-screen. Both images (before and after reagents) are displayed.
- What if additional tests are required to confirm an ID panel result?
If required, BIOMIC V3 lists additional tests (oxidase, catalase, etc) on-screen following manufacturer instructions. Additional tests are performed manually by the customer and then entered on-screen as positive or negative.
- Quality Control Testing
- Can BIOMIC V3 read and interpret antibiotic disk Quality Control (QC) testing?
Yes, BIOMIC V3 automatically reads and interprets antibiotic disk QC tests based on the latest CLSI and BSAC guidelines.
- Can disk lots and media lots be recorded for QC tests?
Yes, disk lot and media lot information (manufacturer, in-use date, out-use date, lot #, expiration date, user comments, etc) can be recorded for each QC test. This information may also be included in QC Summary Reports.
- Can BIOMIC V3 read and interpret ID panel QC testing?
Yes, BIOMIC V3 automatically reads and interprets API® (bioMerieux), RapID™ (Remel), or Crystal™ (BD) commercial ID panels based on the manufacturer’s guidelines.
- Are QC plate and panel images and results saved?
Yes, all QC plate and panel images and test results are saved for future review.
- How does BIOMIC V3 update QC antimicrobial zone ranges?
Current QC zone ranges are updated annually via website software download. Customers may also edit zone ranges prior to software updates.
- How are QC Summary Reports created?
QC Summary Reports are created from a list of 10 common QC formats following CLSI, CAP and JCAHO requirements. Customers then choose a date range, antimicrobials, organisms, and other parameters to customize their reports.
- Colony Counting
- What types of assay plates can be read automatically?
Many plate types and sizes can be read including: Plates up to 150 mm in diameter, 3M™ Petrifilm™, Ames assays, phage/plaque assays, pour plates, spiral inoculated plates, filter membrane agar plates (with or without printed grids), and chromogenic agars.
- Can the colonies be counted with debris in the agar?
Yes. Most debris are distinguished from colonies by color and/or size. Large debris area(s) may be excluded manually.
- Can blood and dark colored agar be read?
Yes, clear, opaque, blood and dark colored agar can be read. BIOMIC V3 contains a closed cabinet with upper and lower LED lighting for both light and darkfield. A closed cabinet (drawer) is critical for difficult reading situations.
- Can touching and overlapping colonies be divided into separate counts?
Yes. Colonies that are touching or overlapping can be separated by size and shape into multiple counts automatically. Large colonies may be divided into multiple counts based on a flexible size variable. These settings can be turned on or off. These colonies can also be manually added or deleted from the automated count using the touch-screen or mouse click.
- What is the smallest detectable colony read?
The smallest detectable colony is 0.1mm and smallest colony size discrimination is 0.15mm.
- Can plates that are divided into several segments be read automatically?
Yes, entire plate, half-plates, quadrants, or custom defined areas can be read. Each plate segment is counted independently in addition to total plate count.
- Are colonies differentiated based on size?
Yes, colonies may be differentiated based on size. Up to 10 size ranges can be defined and counted simultaneously. Counted colonies may be differentiated based on color similarities with user adjustable color ranges. One or any number of user-defined colors can be counted as well.
- System Support and Maintenance
- What is included in the BIOMIC V3 Service Contract?
1. Live customer support by telephone and email (7 days/week)
2. Complete hardware warranty
3. All software updates with new CLSI and BSAC guidelines
4. All software updates with new BIOMIC V3 product features
- How long is the installation and setup process for BIOMIC V3?
Most customers install and set up BIOMIC V3 themselves or with their own computer (IT) representative in less than one hour. BIOMIC V3 is plug and play on a Windows XP/2000/Vista computer. Easy-to-follow instructions are in the product manual and on-screen Help include extensive step-by-step Training Programs. Giles Scientific is available by telephone and email to assist with the installation and training process until each customer is completely satisfied.
- Does the BIOMIC V3 require routine maintenance?
BIOMIC V3 requires no routine maintenance; it contains no motors, scanners, mirrors or moving parts, only solid state digital electronics. Less than 3% of our image analysis systems require service within 5 years of purchase. BIOMIC V3 is highly reliable and rarely the source of a problem.
- How often is the BIOMIC V3 software upgraded?
BIOMIC V3 software upgrades occur at least once per year via website download, typically after CLSI or BSAC guidelines have been updated. Additional software upgrades are provided if significant product features have been added during the year.
- What training is provided with BIOMIC V3?
Extensive training is provided, including:
1. Product Manual (electronic and hard copy)
2. Keyword indexed help
3. Step-by-step instructions on-screen
4. Training in species identification in two extensive modules
5. CDC Antimicrobial Susceptibility Testing training program
6. Training with V3 product specialist via teleconference and email
- Prior to a purchase, can I send sample digital plate images to Giles Scientific for analysis?
Yes. We encourage you to email digital pictures of your plates to us for analysis. After analysis, we provide direct feedback as to the accuracy of our reading. There is no cost for this service.
- After a purchase, can I send sample difficult or unique digital plate images to Giles Scientific for analysis?
Yes. We encourage you to email digital pictures of your plates to us for analysis. After analysis, we provide direct feedback as to how to improve the accuracy of our automated reading, and in some cases we may be able to add or modify our software to optimize reading of your plates. There is no cost for this service as part of our Service Contract.
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