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The Psychemedics Microplate EIA For Fentanyl in Hair is an in vitro diagnostic device for the qualitative detection of fentanyl in hair. The assay is intended for use in workplace settings for the qualitative analysis of human head and body hair. The assay uses a cutoff calibrator of 0.2 ng fentanyl/10 mg hair.

Psychemedics plans to perform this test at one site. Psychemedics has not performed an evaluation of reproducibility at different laboratories.

The Psychemedics Microplate EIA For Fentanyl in Hair provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Liquid Chromatography/Mass spectrometry/Mass spectrometry (LC/MS/MS) using deuterated internal standards in multiple reaction monitoring (MRM) mode is the confirmatory method used by Psychemedics Corporation. This confirmatory method uses a cutoff of 0.2 ng of fentanyl/10 mg hair.

The Psychemedics Microplate EIA For Fentanyl in Hair consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Fentanyl. The screening portion of the test system consists of (1) microplate wells coated with fentanyl conjugated to bovine serum albumin (BSA), monoclonal rabbit anti-fentanyl, goat anti-rabbit secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify (and stop the reaction), and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.

Here's a breakdown of the acceptance criteria and the supporting study for the Psychemedics Microplate EIA for Fentanyl in Hair device:

Acceptance Criteria and Reported Device Performance

• B₀ (-100%): 10 negative, 0 positive
• -75%: 10 negative, 0 positive
• -50%: 10 negative, 0 positive
• -25%: 10 negative, 0 positive
• Plus 25%: 0 negative, 10 positive
• Plus 50%: 0 negative, 10 positive
• Plus 75%: 0 negative, 10 positive
• Plus 100%: 0 negative, 10 positive

Inter-Assay Precision:

• B₀ (-100%): 50 negative, 0 positive
• -75%: 50 negative, 0 positive
• -50%: 50 negative, 0 positive
• -25%: 50 negative, 0 positive
• Plus 25%: 0 negative, 50 positive
• Plus 50%: 0 negative, 50 positive
• Plus 75%: 0 negative, 50 positive
• Plus 100%: 0 negative, 50 positive |
  | Comparison Testing | No False Negatives relative to LC/MS/MS | No false negative EIA results occurred relative to LC/MS/MS. |
  | | Limited False Positives relative to LC/MS/MS at cutoff. | Ten positive EIA results did not confirm at or above the 0.2 ng fentanyl/10 mg hair cutoff by LC/MS/MS due to washing effects or cross-reactivity with other fentanyl compounds. |
  | Cross-Reactivity | Expected cross-reactivity for related compounds, no cross-reactivity for unrelated compounds. | - Fentanyl and several analogs (Butyryl, Valeryl, Furanyl, Acetyl, o-Fluorofentanyl, Acryl, Cyclopropyl, Isobutyryl, Ocfentanil, 4-Fluoro-isobutyryl) showed high cross-reactivity (100% to 200%).
• Other related compounds show lower cross-reactivity (e.g., (+/-)-cis-3-methylfentanyl at 9.1%, Methyl fentanyl at 2%).
• Many unrelated compounds (e.g., stimulants, opiates, benzodiazepines, cannabinoids, etc.) showed no cross-reactivity. |
  | Interference | No significant interference from commonly found substances. | A wide range of specified compounds (e.g., amoxicillin, caffeine, ibuprofen, naproxen, various illicit drugs like cocaine, heroin metabolites) and mixes showed no interference in the Fentanyl EIA assay. |
  | Cosmetic Treatments | EIA results for negative and positive samples are unaffected by cosmetic treatments (bleach, perm, dye, relaxer, shampoo). | - Negative hair samples remained negative after bleach, permanent wave, dye, relaxer, and shampoo treatments.
• For positive samples, fentanyl concentration change ranged from 98.4% (shampoo) to 106.5% (relaxer) of untreated samples for dye, relaxer, shampoo, and perm, indicating no significant loss or false positivity. |
  | Environmental Contamination | Environmental contamination does not lead to false positives above cutoff after washing procedure. | After an extensive washing procedure, samples contaminated with 2 ng fentanyl/mL of saline resulted in concentrations from below LOQ to 0.0527 ng/10 mg hair, which is well below the 0.2 ng/10 mg hair cutoff. |
  | Sample Stability | Fentanyl in hair samples remains stable during shipping and storage. | Five samples showed no significant differences between results before and after shipping and one month of storage. |
  | Recovery (EIA) | Sufficient recovery of fentanyl after hair digestion. | Recovery of fentanyl in the digestion method was shown to be at least 80% complete at 2 hours. |
  | Recovery (LC/MS/MS) | High recovery of fentanyl and norfentanyl from hair. | Recovery of fentanyl and norfentanyl from 5 authentic samples was greater than 96%. Recoveries of analytes and internal standards with SPE were greater than 50% with 0.995. Actual data points deviated 90% of target and

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