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Updates to Urine Opiate/ Confirmatory Cutoffs On August 1, 2019, the cut-off levels for all urine opiate and opioid quantitated confirmatory levels will change. The laboratory is implementing a sample preparation step that will enzymatically cleave bound glucuronides from component drugs. As a result, the quantitative values of drugs that are heavily glucuronidated such as , , and will be notably higher. Cutoff levels for these drugs are being increased to reduce the likelihood of misinterpreting morphine and codeine levels occurring from poppy seed ingestion as drug use. The retired assay measured only free levels of urine opiates and . Please refer to the table below for a complete summary of changes:

Epic Test Component Current Cutoff New Cutoff LAB417: DRUGS OF ABUSE, Codeine, Confirm, Urine 10 ng/mL 150 ng/mL OPIATES, CONFIRM, URINE LAB417: DRUGS OF ABUSE, Morphine, Confirm, Urine 10 ng/mL 500 ng/mL OPIATES, CONFIRM, URINE LAB417: DRUGS OF ABUSE, 6-Acetylmorphine, Confirm, 10 ng/mL 10 ng/mL OPIATES, CONFIRM, URINE Urine LAB417: DRUGS OF ABUSE, , Confirm, Urine 10 ng/mL 30 ng/mL OPIATES, CONFIRM, URINE LAB417: DRUGS OF ABUSE, , Confirm, 10 ng/mL 30 ng/mL OPIATES, CONFIRM, URINE Urine LAB417: DRUGS OF ABUSE, Hydromorphone, Confirm, 10 ng/mL 30 ng/mL OPIATES, CONFIRM, URINE Urine LAB417: DRUGS OF ABUSE, , Confirm, Urine 10 ng/mL 30 ng/mL OPIATES, CONFIRM, URINE LAB417: DRUGS OF ABUSE, , Confirm, 10 ng/mL 30 ng/mL OPIATES, CONFIRM, URINE Urine LAB417: DRUGS OF ABUSE, Oxymorphone, Confirm, Urine 10 ng/mL 30 ng/mL OPIATES, CONFIRM, URINE LAB2191: DRUGS OF ABUSE, Confirmation 10 ng/mL 30 ng/mL METHADONE, CONFIRM, URINE Urine LAB2191: DRUGS OF ABUSE, Methadone Metabolite 10 ng/mL 30 ng/mL METHADONE, CONFIRM, URINE (EDDP) Confirm, Urine LAB448: DRUGS OF ABUSE, , Urine 10 ng/mL 30 ng/mL TRAMADOL LAB448: DRUGS OF ABUSE, O-Desmethyltramadol, Urine 10 ng/mL 30 ng/mL TRAMADOL LAB393: AND Fentanyl, Confirm, Urine 1 ng/mL 3 ng/mL METABOLITE, URINE LAB393: FENTANYL AND Norfentanyl Confirm, Urine 1 ng/mL 3 ng/mL METABOLITE, URINE

These assays are for medical purposes only. They are not valid for forensic use. August, 2019

The absence of expected drug(s) and/or drug metabolite(s) may indicate noncompliance, inappropriate timing of specimen collection relative to drug administration, poor drug absorption, diluted or adulterated urine, or limitations of testing.

The concentration value must be greater than or equal to the cutoff to be considered positive. Interpretive questions should be directed to the laboratory.

Ingestion of foods or beverages containing poppy seeds can also cause codeine and morphine to be excreted in urine. If excessively large amounts are consumed, this can result in urine morphine concentrations up to 2,000 ng/mL for a period of 6 to 12 hours after ingestion.

These assays were developed and characteristics determined by Providence Regional Laboratory – Oregon. The US Food and Drug Administration has not approved or cleared these assays; however, FDA clearance or approval are not currently required for clinical use.

The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Please direct any questions regarding this Clinical Update to Providence Regional Laboratory Client Services at (503)215-6555.

August, 2019