1. Our lab currently has VITEK/MicroScan/Phoenix, why do we need another AST-ID system?
BIOMIC V3 is utilized as both a primary and secondary Antibiotic Susceptibility Testing and Identification (AST-ID) instrument. BIOMIC V3 automates a variety of manually read clinical microbiology tests. Approximately 50% of BIOMIC V3 Systems complement another automated AST-ID system while the remaining 50% are utilized as a primary AST-ID system.
2. Can BIOMIC V3 interface with MALDI-TOF Mass Spec Systems?
Many labs use BIOMIC V3 with MALDI Mass Spec Systems including MALDI Biotyper (Bruker) and VITEK MS (bioMerieux). ID results can be sent from MALDI to BIOMIC V3 via LIS/LIMS or middleware. AST tests including antibiotic disk diffusion, Etest/MIC Test Strips and 96-well microtiter plates* can be read automatically with BIOMIC V3. This provides an ideal ID-AST solution.
3. 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. Test results can be transferred electronically to the lab’s LIS/LIMS.
4. Can I remotely access BIOMIC V3 from other computers in the lab?
Yes, customers can remotely access BIOMIC V3 from additional computers in the lab network. This feature provides significant labor savings as customers can instantly review test and QC results, reports, and plate images from any office or workstation in the lab. This 'Remote Access' feature is optional.
Example 1: Supervisor reviews and confirms test results in their office prior to LIS/LIMS transfer.
Example 2: Technologist enters QC & inventory control data including disk/reagent/media lots from a separate computer.
Example 3: Director generates antibiogram and QC reports from their office.
Example 4: Technologists at separate benches may review and modify test results after plates have been read into BIOMIC V3.
5. Is a computer provided with BIOMIC V3?
No. The computer should be supplied locally and must comply with the specifications below (Question #6). BIOMIC V3 does include a built-in 21 inch touch-screen.
6. What are the BIOMIC V3 computer requirements?
- Pentium 4 or equivalent (minimum), Core 2 Duo (recommended for optimal performance)
- 512 meg RAM (minimum), 2 gig RAM (recommended for optimal performance)
- Windows Vista, Windows 7, Windows 8
- All Microsoft Service Packs and Critical Updates must be applied
- Three available USB ports
- Serial port for LIS/LIMS connection
- Internet connection (strongly recommended)
- Surge protector
*No monitor is required as a 21 inch touch-screen is built-in to BIOMIC V3.
7. 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.
8. Can test plate and panel images be saved?
Yes. High resolution color digital plate and panel images are saved and can be reviewed at any time.
9. 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 lab methods. BIOMIC V3 provides instant reading, interpretation, and reporting of these tests.
10. How often does BIOMIC V3 need to be calibrated?
Calibration is performed when BIOMIC V3 is:
- Initially setup
- Moved to a new location
- Updated with new software
A calibration template verifies reading measurements and color reactions. The calibration process takes less than one minute.
11. 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, EUCAST or BSAC guidelines can be tested for antibiotic susceptibility.
12. 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.
13. 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, reagents, ID panels, etc) may be purchased from a separate vendor. Giles Scientific does not require lock-in contracts of commercial brands. BIOMIC V3 was designed to read and interpret all brands of AST and ID tests.
14. How many languages is BIOMIC V3 available in?
BIOMIC V3 is currently available in 12 languages including English, Spanish, French, Chinese (Simplified & Traditional), German, Italian, Polish, Portuguese, Romanian, Russian, and Turkish. Other languages available upon request.
II. LIS/LIMS Workflow
1. Will BIOMIC V3 interface with our LIS/LIMS?
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 Classic and Millennium, Orchard, HBOC, Soft Computer, Meditech, CPSI, McKesson, Dawning, Dairyland, LabDAQ, Misys (formerly Sunquest), EPIC, Data Innovations, STAR LIMS, SchuyLab, Telepath, Winpath, Clinisys, and others. Contact Giles Scientific for LIS specifications.
2. 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 by your LIS/LIMS provider.
3. Can BIOMIC V3 test results be exported to WHONET?
Yes. BIOMIC V3 antibiotic susceptibility test results may be exported to a file opened in WHONET.
Data export options include:
- Test Date Range
- Laboratory Identification (3 letters)
- Confidential Format (patient ID and name will not be exported)
A complete list of WHONET codes for antibiotics, organisms, locations, and specimen types may be reviewed and changed to conform with your data format.
4. 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.
5. 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.
6. 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.
7. 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.
III. Antibiotic Susceptibility Testing
1. What size plates can be read?
BIOMIC V3 reads 90mm to 150mm round plates, and 120mm square plates.
2. How many antibiotic disks may be tested on each plate?
We recommend a maximum of 6 disks (90mm plates) or 12 disks (150mm plates) per plate. However, more disks can be added to each plate but do not place highly active antibiotics next to each other. This may result in unwanted heavy zone overlapping, synergy, antagonism or an additive effect.
3. Can BIOMIC V3 automatically read Etests (bioMerieux), MIC Test Strips (Liofilchem), and M.I.C.E strips (Oxoid)?
Yes. BIOMIC V3 provides automated strip location, drug code recognition, MIC zone reading, and S-I-R interpretation. After the plate is placed in the drawer, an enlarged plate image is displayed and confirmed on-screen by the user. Automated strip code recognition prevents user entry error by confirming the correct drug code. No prior setup is required.
4. Can strips and antibiotic disks be read on the same plate?
Yes. A combination of disks and strips may be read on the same plate.
5. How many Etest/MIC strips may be tested on each plate?
We recommend a maximum of 2 strips (90mm round plates) or 6 strips (150mm round plates) per plate.
6. How does BIOMIC V3 read Etest/MIC Strips with inner colonies/haze/swarming?
BIOMIC V3 reads each strip based on the specific drug and/or organism per manufacturer's instructions.
7. How many expert rules are available in BIOMIC V3?
BIOMIC V3 contains over 2500 expert rules based on CLSI, EUCAST, BSAC and published recommendations. Expert rules detect antibiotic resistance, warn users of unlikely test results, and provide additional test recommendations. Expert rules may be turned on or off.
8. 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.
9. 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/LIMS.
10. Can BIOMIC V3 detect ESBL, MRSA, and VRSA?
Yes. BIOMIC V3 utilizes CLSI, EUCAST and BSAC recommended test methods to detect and report these resistance mechanisms.
11. 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’.
12. 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 Not Report drug when…” and “Insert Comment when…”
Example 1: Do not report Ampicillin for Wound cultures.
Example 2: Do not report Cefepime if Oxacillin is Susceptible.
Example 3: If Ampicillin is Resistant for Staph, insert comment ABC.
Example 4: If Gentamycin is Susceptible for Wound, insert comment XYZ.
13. Are all antibiotic guidelines programmed in BIOMIC V3?
Yes. BIOMIC V3 contains an extensive list of current antibiotics and their CLSI, EUCAST and BSAC human and animal health guidelines. Customers select from a master list to add antibiotics to their customized drug panels.
14. How are new antibiotics added?
New antibiotics and guidelines are provided annually with BIOMIC V3 software updates via website download. Customers may also add new or investigational antibiotics and guidelines separate from the software updates.
15. Can epidemiology/antibiogram reports be generated?
Yes. BIOMIC V3 includes a comprehensive list of epidemiology/antibiogram reports, including CLSI M39 recommendations.
Custom user-defined report formats can be saved for reuse.
16. Can automatic zone measurements be adjusted?
Yes. Users can adjust all zone measurements on-screen.
17. 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.
18. 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).
19. 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. This is also true for automated Etest/MIC strips readings.
20. 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.)
21. Does BIOMIC V3 automatically recognize antibiotic disks on the plate?
Yes. BIOMIC V3 automatically recognizes disk codes from several manufacturers including Oxoid, BD and Bio-Rad. Digital imaging technology locates disk positions, recognizes disk codes, and measures zone diameters.
22. How precisely do antibiotic disks need to be positioned on test plates?
BIOMIC V3 searches an area around the disk position on the plate. After locating the disk location and drug code, a zone measurement is automatically drawn on-screen. BIOMIC V3 compensates for disk position variation caused by disks flipping over or shifting. For best results, always use a disk dispenser.
23. Is it necessary to remove labels and writing from the bottom of test plates?
Yes. We recommend placing labels on the side of test plates to prevent interference with image analysis. Do not put labels on the bottom of the plate. Write on plates with a fine point pen in red, green or yellow ink. Wide black writing may interfere with image analysis.
24. Should plate lids be removed prior to reading?
Yes. Plate lids should be removed during reading to optimize the imaging quality.
IV. Organism Identification
1. What identification (ID) panels can be read and interpreted with BIOMIC V3?
All varieties of API® (bioMerieux), RapID™ (Remel), Crystal™ (BD), chromogenic agar (all brands), and Liofilchem® ID panels can be read with BIOMIC V3. Additional brands of ID panels may be read on request.
2. 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.
3. 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.
4. 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.
V. Quality Control & Inventory Management
1. Can BIOMIC V3 read and interpret antibiotic disk and Etest/MIC strip Quality Control (QC) tests?
Yes, BIOMIC V3 automatically reads and interprets antibiotic disk and strip QC tests based on current CLSI, EUCAST and BSAC guidelines.
2. Can BIOMIC V3 read and interpret ID panel QC tests?
Yes, BIOMIC V3 automatically reads and interprets API® (bioMerieux), RapID™ (Remel), Crystal™ (BD), or Liofilchem® commercial ID panels based on the manufacturer’s guidelines.
3. Can BIOMIC V3 read and interpret 96-well microtiter* QC tests?
Yes, BIOMIC V3 automatically reads and interprets 96-well microtiter QC tests based on CLSI, EUCAST, BSAC and manufacturer guidelines.
4. Can BIOMIC V3 record reagent QC tests?
Yes, reagent test (Catalase, Oxidase, PYR, etc) results and lot information can be electronically documented. Reagent QC reports may also be generated.
Sample reagent fields include: Reagent Name, Manufacturer, Lot Number, Expiration Date, Positive Control, Negative Control, Quantity Received, In-Use Date, Out-Use Date, Comments/Corrective Action, Supervisor/Tech Initials, and Custom Fields.
5. Can lot information be recorded with QC tests?
Yes, disk/MIC strip/reagent/media/plate/ID panel lot information (Manufacturer, In-Use Date, Out-Use Date, Lot Number, Expiration Date, User Comments, etc) can be recorded for each QC test. This information may also be included in QC reports.
6. Are QC plate and panel images and results saved?
Yes, all QC plate and panel images and test results are saved for future review.
7. How does BIOMIC V3 update QC breakpoints?
Current QC breakpoints are updated annually via website software download. Customers may also edit zone ranges prior to software updates.
8. How are QC Summary Reports created?
QC Summary Reports are created from a list of 15 common QC formats following CLSI, EUCAST, BSAC, CAP and JCAHO requirements. Customers then choose a date range, antimicrobials, organisms, and other parameters to customize their reports.
9. How can BIOMIC V3 help prepare for lab inspections?
BIOMIC V3 eliminates QC and inventory paperwork by electronically recording and tracking results and lot information. For CAP (College of American Pathologists) inspections, a checklist is provided to help prepare for and streamline lab inspections.
VI. 96-Well Microtiter Plate*
1. What types of microtiter plates can be read with BIOMIC V3?
- Sensititre (TREK) AST* and ID plates
- MicroScan (Siemens) AST* and ID plates
- Custom 96-well AST* and ID plates (all brands)
- In-House (Homemade) 96-well AST* and ID plates
- Additional sizes and shapes of plates are available on request
2. Can microtiter images be viewed on-screen?
Yes. High resolution color images are viewed on-screen.
3. Can microtiter images be saved with test results?
Yes. High resolution color images with test results can be saved for future review.
4. Can I change a well result (+, ?, -) on-screen?
Yes. Users have the option to change the well reactions to +, -, or ?.
5. Can flat, V and round bottom microtiter wells be read?
6. What types of test reactions can be read?
Turbidity, color, UV excited fluorescence, and colony/plaque counts.
7. Can the user adjust the well endpoint thresholds?
Yes. Default threshold settings may be adjusted for individual wells or all wells.
8. After a custom plate layout is setup, named, and adjusted for reading, can it be reused?
Yes. Plate reading formats can be saved, then recalled for reuse.
9. Can MICs be automatically interpreted with CLSI, EUCAST or BSAC guidelines?
VII. Colony Counting
1. What types of colony count 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.
2. 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.
3. 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.
4. 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.
5. What is the smallest detectable colony read?
The smallest detectable colony is 0.05 mm and smallest colony size discrimination is 0.08 mm.
6. 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.
7. 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.
VIII. System Support and Maintenance
1. What is included in the BIOMIC V3 Annual Service Contract?
- Live customer support by telephone and email (7 days/week)
- Complete hardware warranty
- All software updates with new CLSI, EUCAST and BSAC guidelines
- All software updates with new BIOMIC V3 product features
- LIS/LIMS interface support
- Access to Online Customer Support Center
2. How long is the installation and setup process for BIOMIC V3?
BIOMIC V3 is typically setup in under one hour. Simple instructions are provided in the product manual and on-screen Help. Installation videos are also available at the Online Customer Support Center. Giles Scientific is available by email or telephone to assist with the installation and training process until the customer is completely satisfied.
3. Does the BIOMIC V3 require routine maintenance?
BIOMIC V3 requires no routine maintenance as it contains no motors or moving parts, only solid-state digital electronics. Less than 3% of our image analysis systems require service in 5 years. BIOMIC V3 is highly reliable and rarely the source of a problem. Giles Scientific live telephone technical support is available 7 days a week.
4. How often is the BIOMIC V3 software upgraded?
BIOMIC V3 software upgrades occur at least once per year via website download, typically after CLSI, EUCAST or BSAC guidelines have been updated. Additional software upgrades are provided if significant product features have been added during the year. Customers may decide which guideline updates to implement in the software.
5. What training is provided with BIOMIC V3?
Extensive training is provided, including:
- Online Customer Support Center training videos
- Product Manual (hard copy and electronic)
- Keyword indexed help in the software
- Step-by-step instructions on-screen
- Training with BIOMIC V3 product specialist via teleconference
6. Prior to a purchase, can I send sample digital plate images to Giles Scientific for analysis?
Yes. We encourage potential customers 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.
7. After a purchase, can I send sample difficult or unique digital plate images to Giles Scientific for analysis?
Yes. We encourage customers 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 it is part of our Annual Service Contract.
*96-Well Microtiter - Note in USA: For Research Use Only. Not for use in diagnostic procedures.