COMMON QUESTIONS
- General
- Zone Reading
- Colony Counting
- General
- Does TRINITY V3 function for more than one type of assay?
- Does TRINITY V3 conform to CFR Part 11 requirements for electronic record signature?
- Can TRINITY V3 software be customized for our unique application?
- Why should I automate reading of my test assays?
- Are IQ, OQ, PQ validation protocols and training certification included with purchase?
- How often does TRINITY V3 need to be calibrated?
- Is a computer provided with TRINITY V3?
- What are the TRINITY V3 computer requirements?
- Can the TRINITY V3 computer be used for additional applications?
- What training is provided with TRINITY V3?
- What is included in TRINITY V3’s Service Contract?
- How long is the installation and setup process for TRINITY V3?
- Does TRINITY V3 require routine maintenance?
- How often is TRINITY V3 software upgraded?
- How fast does TRINITY V3 measure zones and count colonies?
- Does TRINITY V3 save plate images?
- What is the maximum plate size TRINITY V3 will read?
- Can TRINITY V3 export test results to other programs?
- Can a bar code reader be used with TRINITY V3?
- Do I have to change my current testing methods?
- Are test information input fields and the printout format flexible and configurable by the user?
- Is it necessary to remove labels and writing from the bottom of test plates?
- Are plates inserted one at a time into TRINITY V3?
- Zone Reading
- What different antibiotic potency assay methods are read and calculated?
- What size plates can be read with AutoAssay software?
- Are zone diameters viewed on-screen?
- Can zones be re-measured or deleted?
- Is plate to plate variation accounted and corrected for in USP method calculations?
- What purpose does the standard curve graph serve? (USP/CFR/AOAC only)
- Is there an option to automatically check for outliers? (USP/CFR/AOAC only)
- Can samples be put onto paper disks, into wells cut in the agar, and into metal cylinders?
- How many standard concentrations can I have?
- Colony Counting
- What types of assay plates can be read automatically?
- Can the colonies be counted when there is food or 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?
- 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
- Does TRINITY V3 function for more than one type of assay?
Yes, TRINITY V3 is one system that functions for two primary types of assays: automated zone reading of antibiotic potency assays (AutoAssay®), and automated colony counting assays (DigiCounter™). AutoAssay follows strictly USP/CFR/AOAC/EP/BP/JP methods of antimicrobial concentration assays. DigiCounter strictly conforms to US-FDA/CFSAN Bacteriological Analytical Manual (BAM) for the Aerobic Plate Count Method.
- Does TRINITY V3 conform to CFR Part 11 requirements for electronic record signature?
Yes, full CFR Part 11 compliance features include multi-level access control with User ID and Password, login, configuration and data audit trails. TRINITY V3 also meets GLP (Good Laboratory Practice) standards.
- Can TRINITY V3 software be customized for our unique application?
Yes, Giles Scientific often customizes the software to accommodate specific and unique laboratory image analysis assay applications. Contact us for information and cost.
- Why should I automate reading of my test assays?
TRINITY V3 reduces over 95% of the time involved in reading and calculating test results, and eliminates all transcription errors. This provides more consistent, accurate and reliable test results than manual measurements. TRINITY V3 provides an electronic record of raw data and results in a standard format with electronic tracking of changes, as required by many regulatory agencies.
- Are IQ, OQ, PQ validation protocols and training certification included with purchase?
Yes. Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) validation documents are included with purchase. Training certification is also provided with a TRINITY V3 system. Validation protocols can be customized to meet each lab’s unique requirements.
- How often does TRINITY V3 need to be calibrated?
Calibration is performed when TRINITY 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.
- Is a computer provided with TRINITY V3?
No, the computer should be supplied locally and must comply with the specifications below (Question #7). TRINITY V3 does include a built-in 15 inch touch-screen.
- What are the TRINITY V3 computer requirements?
1. Pentium 4 or equivalent
2. 512 meg RAM (minimum), 1 gig RAM (recommended for optimal performance)
3. Windows 2000, Windows XP, or Windows Vista (XP Professional recommended)
4. Three (3) available USB ports
5. Internet connection (strongly recommended)
6. Surge protector
*No monitor is required as a 15 inch touch-screen is built-in to TRINITY V3.
- Can the TRINITY V3 computer be used for additional applications?
Yes, the computer can be used for multiple functions, including TRINITY V3, LIS/LIMS, other software programs, email, Internet etc. The touch screen on the TRINITY V3 may also be used for multiple applications.
- What training is provided with TRINITY V3?
Extensive training is provided and includes:
• Product manual (electronic and hard copy)
• Step-by-step on-screen instructions
• Training with V3 Product Specialist via teleconference and email
- What is included in TRINITY V3’s Service Contract?
• Live customer support by telephone and email (7 days per week)
• Complete hardware warranty
• All software updates with new TRINITY V3 product features
- How long is the installation and setup process for TRINITY V3?
Most customers setup TRINITY V3 themselves or with their own computer (IT) representative in less than one hour. TRINITY V3 is plug and play on a Windows 2000/XP/Vista computer. Easy-to-follow instructions are provided in the product manual and on-screen Help. Giles Scientific is available by email and telephone to assist with the installation and training process until the customer is completely satisfied.
- Does TRINITY V3 require routine maintenance?
No. TRINITY V3 requires no routine maintenance; it contains no motors or moving parts, only solid state digital electronics. Less than 3% of our image analysis systems require service within 5 years of purchase. TRINITY V3 is highly reliable and rarely the source of a problem.
- How often is TRINITY V3 software upgraded?
TRINITY V3 software upgrades occur about once per year via CD or website download. Additional software upgrades are provided if significant product features have been added during the year. All software updates are included with the Service Contract.
- How fast does TRINITY V3 measure zones and count colonies?
Each plate is read instantly (less than 1 second), whether it is measuring zones or counting colonies. When setup optimally, it can read 6 plates per minute.
- Does TRINITY V3 save plate images?
Yes, an unlimited number of high resolution color digital test plate images may be printed and saved permanently with test results in electronic format.
- What is the maximum plate size TRINITY V3 will read?
TRINITY V3 reads plates up to 150mm in diameter. For larger plates and dishes, the electronic caliper included with the system and software reads any size plate and sample layout, including 243 mm bioassay dishes (NUNC in Denmark).
- Can TRINITY V3 export test results to other programs?
Yes, test results may be exported in text format, which can be read by other software programs.
- Can a bar code reader be used with TRINITY V3?
Yes, a standard bar code reader can be used to input the "identifier number". This setup eliminates transcription errors associated with manual entry.
- Do I have to change my current testing methods?
No. TRINITY V3 was designed to fit into your routine use without altering your current methods, materials, organisms, and layout pattern or government documentation.
- Are test information input fields and the printout format flexible and configurable by the user?
Yes, users can configure the test information input fields and the printout format.
- 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. Plate lids should be removed during reading because of the moisture commonly on the lid.
- Are plates inserted one at a time into TRINITY V3?
Yes, plates are inserted one at a time into the TRINITY 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.
- Zone Reading
- What different antibiotic potency assay methods are read and calculated?
USP (United States Pharmacopoeia), EP (European Pharmacopoeia), BP (British Pharmacopoeia), JP (Japanese Pharmacopoeia), AOAC (American Association of Analytical Chemists), US-CFR (Code of Federal Registry) and a custom single plate method. Giles Scientific may customize the software for your unique method/procedure.
- What size plates can be read with AutoAssay software?
AutoAssay automatically reads 90-100mm plates. However, any size plate may be read with the included electronic caliper.
- Are zone diameters viewed on-screen?
Yes, all automated zone measurements are viewed on-screen to adjust or accept by the user.
- Can zones be re-measured or deleted?
Yes, zones may be re-measured or deleted including outlying points. Recalculations are performed automatically. If zone diameter values are changed after viewing the results, the previous value is stored and displayed in the assay notes.
- Is plate to plate variation accounted and corrected for in USP method calculations?
Yes. Sometimes the depth of agar, temperature differences in an incubator, or other factors may result in conditions that should be corrected in the calculations of sample concentrations. This is automatically performed by the standard sample layout and calculations in the USP/CFR/AOAC methods.
- What purpose does the standard curve graph serve? (USP/CFR/AOAC only)
The standard curve graph is displayed on-screen to help the user visualize where the standard and unknown samples are plotted relative to the curve. The graph is not used for calculations; the calculations are performed by mathematical formulas.
- Is there an option to automatically check for outliers? (USP/CFR/AOAC only)
Yes, each set of zone measurements can be automatically checked for outliers using the USP Outlier Test. Outlier values are marked on-screen and automatically excluded from calculated results.
- Can samples be put onto paper disks, into wells cut in the agar, and into metal cylinders?
Yes, liquid samples may be placed in any of these. Some method guidelines specify which of these may be used.
- How many standard concentrations can I have?
The number of standard concentrations is defined in each published method.
- Colony Counting
- What types of assay plates can be read automatically?
A variety of 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 when there is food or debris in the agar?
Yes. Most food and debris are distinguished from colonies by color and/or size.
- Can blood and dark colored agar be read?
Yes, clear, opaque, blood and dark colored agar can be read. TRINITY V3 contains a closed cabinet with upper and lower LED lighting for both light and darkfield, or combined. 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.
- 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.
|
