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Thank you for participating in this survey about instruments used to analyze blood lead levels in the laboratory setting. As a clinical laboratory professional your opinions and insights are very important to us. If you are selected to complete the full survey, it should take about 15-20 minutes. This survey will be live for the next 7 days.
Your participation in this study is completely voluntary and your survey responses will be strictly confidential. The results of this survey are solely for the purposes of internal product evaluation and development and will not be shared outside of our organization. If you have questions at any time about the survey or the procedures, you may contact Susan Garramone at [email protected].
Thank you very much for your time and assistance. Please start with the survey now by clicking on the Continue button below.
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| * How do you currently perform the majority of your blood lead testing? |
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| * How many lead tests does your laboratory process each month? | | |
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| * How many lead tests per month need a STAT result? | | |
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| Over the next 2-3 years, do you expect your lab’s lead testing volume will: |
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| * How many hours per week does your lab spend preparing, packaging, and sending out your lead tests? | | |
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| * How many times per month does your lab have to repeat a lead test that was sent out because the result was inconclusive? | | | | * How many days does it take to get a lead test result back? | | |
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| Current System & Practices |
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| * How many instruments do you have in your lab to perform lead testing? | | |
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| * What is the lower limit of your reportable range for blood lead testing (in μg/dL)? | | | | * What is the upper limit of your reportable range for blood lead testing (in μg/dL)? | | |
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| Please provide an estimate of your cost per reportable blood lead result
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| Who is responsible for connecting a new laboratory instrument to your LIMS system? |
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| Quality Control Procedures |
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| * From whom do you purchase your blood lead quality control materials? | | |
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| * How many times per year do you purchase blood lead quality control material? | | | | * How many times per year do you perform value assignment on your blood lead quality controls? | | | | * How many levels of quality control do you routinely run for blood lead testing? | | |
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| Please answer the following questions in terms of what you do for each blood lead testing run: |
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| * What is the maximum number of blood lead patient samples you can process per run? | | |
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| * What is the total time per run for blood lead testing (including QC, calibration and patient samples)? |
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| * The average laboratory technician “hands-on” time spent per blood lead testing run is |
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| Instrument Maintenance and Repair |
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| * How many hours per month are spent performing routine instrument maintenance? | | | | * How many times per month does a blood lead testing run fail? | | | | * How many times per year does the instrument require outside service? | | |
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| * Do you have a service contract for this instrument? |
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| * What is the cost per year of the contract? | | |
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| Proposed New Product - Feedback |
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When considering the questions in this section, please keep in mind the following proposed product attributes.
An FDA cleared quantitative blood lead testing system for the detection of lead in whole blood.
• CLIA Classification: Moderately Complex
• Technology: Anodic Stripping Voltammetry (ASV)
• Sample type: Venous or capillary whole blood, collected with EDTA or heparin
• Reportable range: 2 μg/dL - 65 μg/dL
• Sample stability: Test within 72 hours of blood draw
• Six channels, allowing 1-6 samples per run; random access
• Analysis time: 3 minutes per run
• Estimated throughput: 75 samples per hour
Instrument Description
- Benchtop footprint: 21” (w) x 25” (d) x 18” (h)
- Analyzer plus complete workstation (computer, accessories, software)
- Barcode reader
- LIMS compatibility
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| Please respond to the following questions indicating the extent to which you agree with the statements about the system as described above.
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| Is there anything else about the product description you would like to comment on? | | |
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| Expected Performance Specifications |
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| Please respond to the following questions indicating the extent to which you agree with the statements.
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Precision
The table below provides precision data at four lead concentrations.
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Accuracy
The system’s expected accuracy, as determined by method comparison with Graphite Furnace Atomic Absorption Spectroscopy (GFAAS) is described in the following table.
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Linearity
The system’s correlation coefficient (R), based on regression analysis, is expected to = 0.990.
The slope (95% confidence interval) is expected to be = 1.06 - 1.10.
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| Is there anything else about the expected product performance you would like to comment on? | | |
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| Proposed System Operation |
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| The following brief video is intended to provide a demonstration of the basic steps in performing a test - inserting sensors, adding test solution to the sensors, and test processing/results. |
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The system is expected to operate using consumables packaged in kits with material to perform 192 tests. Each kit will include:
- Disposable sensors (192)
- Reagent tubes (192)
- 2 levels of control material (Level 1: 7 μg/dL; Level 2: 25 μg/dL)
- An electronic calibration button, calibration will take less than 5 seconds.
Please respond to the following statements about the proposed system operation.
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| If you needed to perform in-house control value assignment for this system, at what frequency would this be acceptable to your laboratory?
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| | Every 3 months | Every 12 months |
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| * Which features of this system are most attractive/important for your laboratory? | | |
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| * What do you consider the drawbacks of this system for your laboratory? | | |
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| Is there anything else about the system’s operation that you would like to comment on? | | |
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| * Given what you've learned about this system, how much would you expect to pay for the instrument? | | |
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| * And, what would you expect to spend per test, assuming that you purchased the instrument? | | |
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| * What would you expect to pay per test if you chose not to pay for the instrument upfront and instead paid a higher amount per test ("reagent rental" model)? | | |
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| How likely is it that you would consider purchasing this system?
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| * Who in your institution must approve the acquisition of a new instrument such as the one we’ve described? Please check all that apply: |
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| Any comments about pricing or purchasing patterns at your institution that you think would be helpful for us to understand? | | |
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Thank you very much for participating in our survey, your input is very important to us.
In appreciation of participants who complete the full survey, we are offering a $75 honorarium. If you would like to receive this honorarium, please provide your name, and the best mailing address to which we should send the check, in the space below. |
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