TOM Kits Factsheet

Attachment 3. TOM Kits Factsheet

*

Traceable Opioid Material* Kits
to Improve Laboratory Detection
of Synthetic Opioids in the U.S.

The Centers for Disease Control and Prevention (CDC) is leading the
development of Traceable Opioid Material* Kits (TOM Kits*) to support
detection of emerging opioids. CDC maintains the contents of the TOM
Kits* based on new needs identified, in part, through DEA Emerging
Threat Reports. The DEA 2018 mid-year data indicate that fentanyl and
fentanyl-related compounds account for approximately 75% of their
opioid identifications.
These kits are reference materials and do not eliminate the need to meet
analytical method requirements of other federal agencies. TOM Kits*
are NOT for Diagnostic Use.

Two TOM Kits* Are Now Available
Opioid Certified Reference Material (CRM) Kit

Fentanyl Analog Screening (FAS) Kit

• Manufactured and distributed by Cerilliant Corporation

• Manufactured and distributed by Cayman Chemical

• Includes 1 milligram each of 22 opioids and their
matched, stable isotopes (carbon-13; nitrogen-15)

• Includes 200 micrograms each of 120+ fentanyl analog
analytical reference materials

• Addresses 99.5% of DEA fentanyl/fentanyl-related
cases in the DEA 2018 Q1 Report

• Provides largest collection of available fentanyl analog
reference materials

• Improves confirmation of mass spectrometry
methods analysis

• Improves immunoassay and mass spectrometry
screening methods

• Includes unprecedented isotopically-labeled
internal standards

• Includes structural variability for fentanyl analog
cross-reactivity and method validation

Laboratories requesting one or both of the kits:
• Can be from any sector — academic, public, or private.
• Must be located in the United States.
• Must have current DEA registration.
• Must comply with respective state and local regulations.
• Must submit requests directly to the respective vendor.

The kits are available at no charge. Although laboratories may request multiple kits, supplies are limited and requests will
be filled based on product availability.
* TRACEABLE OPIOID MATERIAL, TOM KITS, and the TOM KITS Logo are marks of the U.S. Department of Health and Human Services

U.S. Department of
Health and Human Services
Centers for Disease
Control and Prevention
CS304377-A

April 25, 2019