Q: How much urine sample is required to run the test using Serenity FentaScan Analyzer?
A: Only 3 drops of urine sample are required to run the test.
Q: Do you need to run a control test with the Serenity FentaScan Analyzer Test Kit?
A: Yes, controls are recommended to be tested with the reader and tests and are available separately for sale.
Q: Can the Serenity FentaScan Analyzer Test Kit be used and stored at room temperature?
A: Yes, both the reader and tests should be used and stored at Room temperature.
Q: Is there a proof that Fentanyl Test Strips are inaccurate as compared to the Serenity FentaScan Analyzer Fentanyl FIA Test and have a high level of cross-reactivity with other drugs ?
A: Yes , we have detailed White Paper on file , that is available upon request that proves that the Serenity FentaScan Analyzer along with the Serenity FentaScan Cartridge has a true Sensitivity of 1ng/ml of fentanyl in a urine sample with a Specificity of 100%.
Q: Is there any other reader like Serenity FentaScan Analyzer available in the U.S Market?
A: No, Serenity FentaScan Analyzer is the only reader that is a break-through device approved by the FDA as 510K cleared , CLIA waived, and OTC approved.
Q: Is Serenity FentaScan Analyzer, cartridges and accessories available in the U.S.?
A: Yes, all products are available ex-Stock and ship the same day from our central warehouse located in Boynton Beach, FL.
Q: Can you use a test that has already been used?
A: No, the code chip in the back of the test cassette and its advanced programing do not allow re-use of a used test and will be rejected with a warning on the screen.
Q: Can you use an expired test ?
A: No, the code chip in the back of the test cassette and its advanced programing do not allow the use of an expired test and the test will be rejected with a warning on the screen.
Q: What is the memory of the Serenity FentaScan Analyzer?
A: The Serenity FentaScan Analyzer has an internal memory of 999 Patient Readings.
Q: What is the Sensitivity and Specificity of the Serenity FentaScan Test?
A: The Sensitivity is 1 ng/ml and Specificity is 100%.
Q: How does the FentaScan Test work?
a: The FentaScan test uses fluorescence immunoassay technology. A urine sample is applied to the test strip, and the fluorescent reader analyzes the results based on competitive binding.
Q: Is the Serenity Fentanyl Analyzer accurate?
A: Yes, the Serenity Fentanyl test demonstrates high precision. Cross-referenced with gold-standard methods like LC-MS/MS, it shows reliable accuracy at the 1 ng/mL cutoff.
Q: What does a CLIA waived status mean?
A: It signifies that the test is designed for simplicity and meets CLIA quality standards for use outside traditional laboratory settings.
Q: Can the FentaScan test detect fentanyl analogs?
A: Yes, the test shows cross-reactivity with certain fentanyl analogs like acetyl fentanyl and butyryl fentanyl, providing added diagnostic value.Â
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