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  5. Emit II Plus Oxycodone Assay

Emit II Plus Oxycodone Assay

Enabling early detection of pain prescription abuse
EMIT II Plus Oxycodone Assay

EMIT II Plus Oxycodone Assay

The Centers for Disease Control and Prevention estimates that the total economic burden of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.1

Oxycodone is a semisynthetic opioid analgesic prescribed for the relief of moderate to severe pain. Oxycodone structurally resembles codeine and morphine, with similar analgesic properties and potential for addiction and abuse. Oxycodone is a DEA schedule II drug. The drug oxycodone is prescribed in controlled-release form (OXYCONTIN), or in combination with acetaminophen (PERCOCET) or with aspirin (PERCODAN).

  • Features & Benefits
  • Technical Specifications
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Features & Benefits

The Emit II Plus Oxycodone assay offers 100 ng/mL and 300 ng/mL cutoffs and no cross-reactivity to structurally related compounds such as buprenorphine and hydrocodone.

  • Achieve high specificity for oxycodone and oxymorphone to provide confidence for accurate results while meeting the SAMHSA requirements for oxycodone screening
  • Reduce false results with an assay that has 98% agreement to LC-MS/MS for positive samples and 100% agreement for negatives.1
  • Consolidate opioid testing with other Siemens Healthineers assays, enabling providers to screen patients on one trusted system

Technical Specifications

EMIT II Plus Oxycodone Assay Performance*

Assay Principle

Homogeneous enzyme immunoassay

Sample Type

Urine

Sample Volume

12 µL (100 ng/mL)
4 µL (300 ng/mL)

Assay Range

50—400 ng/mL (100 ng/mL cutoff)
75—1000 ng/mL (300 ng/mL cutoff)

Reagent Stability

Stable unopened or opened until exp., when stored refrigerated at 2–8°C

Cutoff Level

100 ng/mL and 300 ng/mL

Calibration Range

0—1000 ng/mL

Levels

0, 100, 300, 500, 1000 ng/mL

Limit of Detection

29 ng/mL (100 ng/mL cutoff)
44 ng/mL (300 ng/mL cutoff)

Cutoff Overlap Precision

0% overlap between cutoff and ±25% controls

Onboard Reagent Stability

4 weeks

Calibration Frequency

As indicated by QC results

1Florence CS, Zhou C, Luo F, Xu L. The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in the United States, 2013. Med Care. 2016;54(10):901-906. doi:10.1097/MLR.0000000000000625.

*Future availability cannot be guaranteed

1. When using the 300 ng/mL cutoff. Data from the Emit II Plus Oxycodone Assay IFU

*Data collected on Viva-E® Drug Testing System and verified from the following sources: verification report, stability report, IFU and application sheets