Accu-Reader® A100
Revolutionizing iFOB Diagnostic Technology
The Hemosure® Accu-Reader® A100, in conjunction with the Hemosure® Accu-Reader® A100 FIT test cartridge and sample collection tube, is an automated in-vitro Fecal Occult Blood diagnostic system designed for hospitals and professional medical testing facilities for the rapid qualitative detection of human hemoglobin in stool sample – whose presence in human fecal samples is used as an indicator of gastrointestinal bleeding.
Frequently Asked Questions
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How is the Accu-Reader® A100 system installed?
Hemosure Inc. product specialist will travel to install the system in the laboratory and provide on-site operation training. Installation services include:
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Installation Qualification (IQ)
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Operational Qualification (OQ)
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On-site Operator Training (Up to 4 individuals)
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Performance Qualification (PQ) suggested protocol & materials
How is the Accu-Reader® A100 operation training provided?
Hemosure Inc. provides initial on-site operation training following installation and IQ/OQ. The user may request additional online video conference training for new operators or further education at any time by contacting Hemosure technical support and scheduling a training event
Will the Accu-Reader® A100 connect to our current LIS system?
Yes. The Accu-Reader® A100 is designed to connect to any Hl7 compatible LIS system. All modern LIS systems are designed for HL7 connectivity. Hemosure Inc. may provide a rebate to the user following LIS connection to cover some or all LIS intergration expenses.
How is technical service Accu-Reader® A100 provided?
Hemosure Inc. provides direct technical support to Accu-Reader® A100 users through our hotline, email, or on-site service.
Phone: 1-888-HEMOSURE (436-6787)
Business Hours: 8:30 am-5:30 pm PST
Email: techsupport@hemosure.com
On-site: On-site service calls may be scheduled by contacting Hemosure support.
What if the Accu-Reader® A100 breaks down or has a failure?
Following a quick evaluation by Hemosure Inc. service staff to confirm the cause of the system failure, Hemosure Inc. will provide a replacement/swap system to the user within 24-48 hours.
What is the preventative maintenance (PM) for the Accu-Reader® A100?
As a dry system, the Accu-Reader® A100 maintenance requirements are minimal. Hemosure Inc. recommends cleaning the external surfaces on a weekly basis. No internal cleaning or maintenance is required.
What are the calibration requirements of the Accu-Reader® A100?
The Accu-Reader® A100 should be calibrated once every 90 days. The Accu-Reader® A100 system is provided with a fixed 10-point Calibration Cartridge Kit for calibration check purposes. With proper use and storage, the Calibration Cartridge Kit is viable for up to 5 years.
What is the Sensitivity and Specificity of the Accu-Reader® A100?
Based on a recent multi-site prospective clinical study the performance characteristics of the Accu-Reader® A100 were determined to be:
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Sensitivity: 98.63% (93.51%-99.97% C195)
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Specificity: 98.71% (96.87%-99.76% C195)
Please review the Hemosure® Accu-Reader® A100 FIT System Performance Characteristics for more information regarding the analytical and clinical performance characteristics of the Accu-Reader® A100.
Can the lab conduct 3rd party Proficiency Testing (PT) with the Accu-Reader® A100?
Yes. The laboratory may sample and test fecal occult blood PT samples just as they would a patent sample following the Accu-Reader® A100 Test Cartridge Instructions for use. The Accu-Reader® A100 is currently registered for PT with the College of American Pathologists (CAP). For more information regarding other PT programs, please contact Hemosure technical support.
What are the placement or purchasing options for the Accu-Reader® A100?
Hemosure Inc. and our distribution partners offer a range of options to facilitate the installation and operation of the Accu-Reader® A100. These options include:
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Equipment leasing programs
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Reagent rental programs
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Direct equipment acquisition programs.
For more information regarding which program best suits your laboratory's needs please contact a Hemosure Inc. sales representative for a detailed evaluation.
What is the Accu-Reader® A100 FIT reimbursement CPT code?
CPT code 82274
What is the sample stability/viability for FIT patient samples?
14 days at room temperature (15 degrees C - 30 degrees C)
30 days in refrigerator (2 degrees C - 8 degrees C)
What is the shelf-life of the consumables required to run the Accu-Reader® A100?
There are 3 consumables required for the Accu-Reader® A100
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The Sample Collection Tube (24 months at room temperature)
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The Accu-Reader® A100 FIT Test Cartridges (24 months at room temperature)
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The Accu-Reader® A100 Controls (12 months at 2 degrees C - 8 degrees C)
