The Clinical Interpretation Guide is designed to aid clinicians in their review of Rx GuardianSM results. It offers potential interpretations and possible next steps and considerations to help physicians make informed decisions about patient care.
For all patients:
- Discuss medication monitoring results with the patient.
- Educate the patient and verify understanding of medication dosing instructions and prescription information. Explore possible issues related to potential non-adherence.
- Reinforce treatment regimen and review pain treatment agreement.
- Review relevant Results Explanations on the Rx GuardianSM results report and continue routine medication monitoring.
If you have additional questions about interpreting your report, contact a Toxicology SpecialistSM by calling our Toxicology Hotline at 866-287-7584. Toxicology SpecialistsSM are available from 8:00 a.m. through 8:00 p.m. (EST). You can also set up an appointment for an in-depth conversation.
What is a standard score and what does it mean?
Patient urine drug levels for specific medications of interest are normalized using the proprietary Rx Guardian CDSM algorithm. A standard score is generated, which is compared against a reference database of patients clinically assessed for adherence.
Less than five percent of patients clinically assessed as adherent have standard scores that fall below -2 or above +2. Less than one percent of patients clinically assessed as adherent have standard scores that fall below -3 or above +3.
Which is positive, the IA or the MS?
Immunoassay (IA) is a very sensitive screening methodology that when positive, identifies specimens that require mass spectrometry (MS) confirmation.
The MS findings provide highly specific test results that identify specific drugs and metabolites. Crossreactivity, contaminants, and a number of other factors can influence the initial IA results, which is why MS confirmation is always needed following a positive IA result.
When a negative IA result is reported, it does not necessarily mean that zero quantity of a drug has been detected. It means that the amount detected, if any, is less than the established cutoff level. These cutoffs have been established to significantly reduce the incidence of false positives that may result from interferents, cross-reactivity, passive exposure in some cases, or another undetermined factor that triggered the weak IA reaction.
What if I suspect a drug interaction or genetic variability in metabolism?
- Consider prescribing a medication that utilizes an alternate metabolic pathway of a drug.
- Consider CYP450 genetic testing.
- Review all medications (both prescription and over-the-counter) that the patient is taking for possible drug-to-drug interactions.
For more information on the Rx GuardianSM process call us at (888) 355-6313 or submit an online request to speak to an Ameritox representative.
If you have additional questions about how to interpret a Rx GuardianSM results you can contact an Ameritox Toxicology Specialist. Our Toxicology Specialists are available from 8:00 a.m. to 8:00 p.m. (ET), Monday through Friday. For answers to important toxicology questions and help interpreting results, call our Toxicology Hotline at (866) 287-7584. You can also set up an appointment for an in-depth consultation.
This information is not intended to be used as medical practice guidelines or standards. The physician is the professional decision maker with respect to patient care issues. Only a licensed clinician should review and interpret Rx GuardianSM results.
Note: The 95 percent Database Reference Ranges are rounded from +1.96 and -1.96.