Synopsis: QuidelOrtho Corp. added an immunoassay intended for the qualitative detection of fentanyl to its Vitros systems, providing hospitals and emergency rooms with on-site fentanyl testing capabilities.

Key Takeaways:

  • QuidelOrtho Corp. expands its Vitros systems with the ARK Fentanyl II Assay to address the rising demand for opioid testing amidst increasing overdose fatalities. 
  • The assay detects norfentanyl, a major metabolite of fentanyl, reducing the risk of false negatives and providing preliminary analytical results in less than 10 minutes.
  • Integration of fentanyl testing into existing protocols streamlines laboratory efficiency, facilitates prompt clinical decisions, and addresses the need for rapid drugs-of-abuse detection in emergency departments.

QuidelOrtho Corp. has added the ARK Fentanyl II Assay to its U.S. Vitros XT 7600 and 5600 Integrated Systems as well as its Vitros 4600 Chemistry System menu of assays as a MicroTip Partnership Assay (MPA). 

On-Site Fentanyl Testing

This Fentanyl assay will help hospital and emergency room customers respond to the critical demand for enhanced opioid testing, allowing on-site fentanyl testing in less than 10 minutes to aid in immediate clinical decisions.

Rise in Fentanyl Overdoses

According to the Centers for Disease Control and Prevention (CDC), the number of fatalities resulting from fentanyl overdoses has tripled from 2016 to 2021, with an ongoing upward trend.1 The CDC highlights California, Florida, New York, Pennsylvania and Ohio as states with the highest mortality rates attributed to fentanyl.1 Consequently, several states have responded by implementing regulations requiring fentanyl testing to be included as a required component of drugs-of-abuse test panels.

“This assay transforms laboratory efficiency by integrating fentanyl testing with existing protocols to eliminate the need for external screening tests, and consolidates a lab’s drugs-of-abuse panel into a singular, streamlined system, reducing intervention time and ultimately helping to save lives,” says Lily Li, senior director of medical and clinical affairs at QuidelOrtho. “Our relentless commitment to diagnostics lies in empowering our customers with impactful assays, particularly those capable of delivering rapid drugs-of-abuse detection amidst the escalating opioid crisis.”

What the ARK Fentanyl II Assay Offers Labs

Ninety percent of fentanyl is excreted as norfentanyl, which is a synthetic opioid and is not detected on standard drug screening.1 The ARK Fentanyl II Assay provides preliminary analytical test results by detecting this major metabolite, reducing the risk of false negatives. As part of QuidelOrtho’s Vitros systems’ menu of assays, the test offers clinical fentanyl testing for hospitals and emergency departments, providing an effective approach to preliminary urine drug testing.

Further reading: Combination Fentanyl and Xylazine Test Strip to Combat Opioid Deaths

Drug Testing in Emergency Departments

Drug test results obtained in emergency departments play a crucial role in addressing unique hospital challenges. When patients test positive for opioids on a standard drug test, they’re usually directed to drug treatment programs. However, these standard tests fail to identify synthetic opioids, such as fentanyl.1 Without specifically testing for fentanyl, instances of fentanyl exposure might be disregarded, potentially leading to missed opportunities for life-saving interventions like administering naloxone, an opioid overdose reversal medication.

“Substance use is always changing, and medicine must change to address the problems our patients face,” says Zachary Dezman, MD, a collaborating ED physician in Baltimore and Assistant Professor with the University of Maryland School of Medicine, after working with the Cesar Center for Substance Abuse, Addiction and Health Research.2 “We cannot treat a problem if we don’t detect it.”


  1. Center for Disease Control and Prevention. Opioid overdose. Accessed March 28, 2024.
  2. CESAR Center for Substance Abuse, Addiction and Health Research. UMD-led system shows success in helping hospitals understand fentanyl use in their communities. Accessed March 29, 2024.