Support
Share Your Questions and Feedback
Frequently Asked Questions
CYTOVALE SUPPORT
1. How do I contact the Cytovale technical support team?
For contacting the Cytovale technical support team, you can email us with your query to support@cytovale.com or you can call 415-417-2188 and choose option
2. What are the Cytovale technical support hours of operation?
Cytovale provides 24/7 technical support throughout the year for all of our customers.
3. How do I contact the Cytovale support team to order reagents and consumables for my Cytovale system?
For ordering reagents and consumables for the Cytovale system, please contact us via email at customerservice@cytovale.com or you can call 415-417-2188 and choose Option 2.
Intellisep Test
1. Is the IntelliSep test FDA cleared?
Yes, the IntelliSep test is FDA cleared (510(k) clearance) for use in U.S. based hospital laboratories for aiding in early detection of sepsis.
2. Is the IntelliSep test patented?
Yes, you can find the Cytovalae System and IntelliSep test patent statements at www.cytovale.com/patents.
3. What are the Indications for Use for the IntelliSep test?
The Cytovale IntelliSep test is intended for use in conjunction with clinical assessments and laboratory findings to aid in the early detection of sepsis with organ dysfunction manifesting within the first 3 days after testing. It is indicated for use in adult patients with signs and symptoms of infection who present to the Emergency Department.
4. Do I need a specialized sample collection tube or workflow for the IntelliSep test?
The IntelliSep test fits into the existing blood collection workflows. The test uses 100 µL of whole blood from a standard “purple top” K2 EDTA collection tube
Please see the IntelliSep IFU for more information.
5. How much blood is required to perform a test?
The IntelliSep test only requires a minimum of 100 µL of whole blood from a standard “purple top” K2 EDTA collection tube.
6. What are the IntelliSep test band ranges?
The Intellisep test with the help of Cytovale System assesses the immune activation level of the patient’s white blood cells and reports a numerical score between 0.1 and 10.0 with 3 discrete bands as follows:
- Band 1: 0.1-4.9 (Low Probability of Sepsis)
- Band 2: 5.0-6.2
- Band 3: 6.3-10.0 (High Probability of Sepsis)
All results should be interpreted in the context of the other clinical observations and laboratory test results for the patient.
Cytovale System
1. What is used to clean the Cytovale system?
70% ethanol or 10% bleach with water can be used to clean the Cytovale System.
2. What are the operational temperature and humidity ranges for the Cytovale system?
The operational temperature range for the Cytovale System is 18.0-28.0° C and the humidity range is 20-80%.
3. Are the IntelliSep test cartridges single use or multi-use?
The IntelliSep test cartridges are single-use only.
4. At what temperature should the IntelliSep test cartridges be stored at?
The IntelliSep test cartridges should be stored at 15-30° C.
5. What temperature should the Quality Control (QC) Kit be stored at?
The IntelliSep test QC Kit should be stored between 2-10° C.
6. How long does the Quality Control (QC) Kit last after it is opened?
The QC Kit can last up to 30 days after opening or until the expiry date when properly stored. Please check the IntelliSep Quality Control Kit IFU for more information.