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The Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 1.0 ng/mL. The assay is intended for use in laboratories for the qualitative analysis of Fentanyl in human urine with automated clinical chemistry analyzers. This assay is calibrated against Fentanyl. This in vitro diagnostic device is for prescription use only.

The Immunalysis SEFRIA Fentanyl Urine Enzyne Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Immunalysis Fentanyl Urine Calibrators:

The Immunalysis Fentanyl Urine Calibrators are used as calibrators in the Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay for the qualitative determination of Fentanyl in urine on automated clinical chemistry analyzers.

The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes EA protein and rabbit antibodies to Fentanyl in PIPES buffer with sodium azide as a preservative. The enzyme conjugate reagent includes ED peptide labeled with Fentanyl and CPRG substrate in malic acid buffer with sodium azide as a preservative. Calibrators and controls are included as part of the test system and provided separately. The Fentanyl calibrators consist of a Level 1 calibrator at 1 ng/mL, a Level 2 calibrator at 2 ng/mL, and a Level 3 calibrator at 4 ng/mL. The control set contains a LOW control at 0.5 ng/mL and a HIGH control at 1.5 ng/mL.

Automated clinical chemistry analyzers capable of maintaining a constant temperature, pipetting samples and reagents, mixing reagents, timing the reaction accurately and measuring enzymatic rates at 570nm can be used to perform the assay.

The SEFRIA™ technology is based on artificial fragments of the E. coli enzyme ß-galactosidase. A mutant enzyme, termed Enzyme Acceptor (EA), is created by deletion of 28 amino acids in the amino-terminal region of the sequence. EA is inactive, but can combine with peptides, termed Enzyme Donors (ED's), containing the deleted sequence, to form active B-galactosidase. This process is termed complementation, and the active enzyme formed as a result can be measured by hydrolysis of a chromogenic substrate such as chlorophenolred ß-D-galactopyranoside (CPRG). The ED peptides can be modified by attachment of a derivative of fentanyl, which does not interfere with the formation of active ß-galactosidase. However antibodies to fentanyl bind to the ED-fentanyl conjugate, and block complementation. The assay is based on the competition of fentanyl in a urine sample with the ED-fentanyl conjugate for the fixed amount of antibody binding sites. In the absence of the free drug in the sample, the antibody binds the ED-fentanyl conjugate, resulting in inhibition of enzyme formation. As the fentanyl concentration in the sample increases, ED-fentanyl becomes available for complementation, creating a dose response relationship between fentanyl concentration in the urine and enzyme formation. The Bgalactosidase activity is determined spectrophotometrically at 570 nm by the conversion of CPRG (orange) to chlorophenol red (red) and galactose.

Here's a breakdown of the acceptance criteria and study information for the Immunalysis SEFRIA™ Fentanyl Urine Enzyme Immunoassay, based on the provided text:

Important Note: This document describes an in vitro diagnostic (IVD) device, not an AI/ML powered device for image analysis. Therefore, some of the requested information (like experts for ground truth, adjudication methods, MRMC studies, effect size of human readers with AI assistance, and standalone algorithm performance) is not applicable or not present in the context of this type of device. I will address only the information that can be extracted from the provided text for this specific device type.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are mainly demonstrated through various performance studies, showing that the device accurately identifies fentanyl in urine at defined concentrations and is not significantly affected by interferences. Since specific numerical acceptance criteria (e.g., "must achieve >95% accuracy") are not explicitly stated in a consolidated table, I've inferred them from the study results presented as "verification" of performance.

Acceptance Criteria & Reported Device Performance for Immunalysis SEFRIA™ Fentanyl Urine Enzyme Immunoassay

2. Sample Size Used for the Test Set and Data Provenance

• Precision/Cutoff Characterization/Reproducibility Study:
  • Sample Size: 80 drug-free urine samples, spiked with fentanyl at 9 different concentrations, each tested in replicates of 4 over 10 days (total determinations = 80 per concentration point).
  • Data Provenance: Drug-free urine was spiked with fentanyl. The provenance of the original drug-free urine is not specified (e.g., country of origin). The study is prospective in nature as samples were intentionally prepared for the test.
• Specificity and Cross-Reactivity Study:
  • Sample Size: Not explicitly stated, samples were spiked with various compounds to represent different concentrations.
  • Data Provenance: Not explicitly stated, samples were spiked into drug-free urine.
• Interference (Structurally Unrelated & Endogenous Compounds), Boric Acid, pH, and Specific Gravity Interference Studies:
  • Sample Size: Not explicitly detailed per compound, but samples were spiked into drug-free urine containing fentanyl at ±50% of the cutoff.
  • Data Provenance: Samples were spiked into drug-free urine.
• Method Comparison Study:
  • Sample Size: 80 de-identified, unaltered leftover clinical urine samples.
  • Data Provenance: Obtained from clinical testing laboratories. Specific country of origin is not mentioned, but it implies a retrospective collection of existing clinical samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This device is an in vitro diagnostic immunoassay, not an imaging AI device requiring expert interpretation for ground truth.

• Ground Truth Establishment for Analytical Studies (Precision, Specificity, Interference): The "ground truth" was established by precisely spiking known concentrations of fentanyl or other compounds into drug-free urine, and/or confirming concentrations via mass spectrometry (LC-MS/MS). No human experts are used for this.
• Ground Truth Establishment for Method Comparison Study: The ground truth was established by a confirmatory method, Liquid Chromatography / Mass Spectrometry (LC/MS or LC-MS/MS), which is considered the gold standard for drug quantification. No human experts are mentioned for establishing this ground truth.

4. Adjudication Method for the Test Set

Not applicable for this type of IVD device. Adjudication methods like 2+1 or 3+1 typically apply to human readers interpreting complex data (e.g., medical images) where discrepancies need to be resolved. For an immunoassay, the result is quantitative (absorbance) and then interpreted qualitatively based on a cutoff. Confirmatory testing (e.g., LC-MS/MS) serves as the definitive assessment, not a human adjudication process.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, this is not applicable. MRMC studies evaluate the performance of human readers, sometimes with and without AI assistance, on a set of cases. This device is an automated laboratory test, not an AI-powered reader for medical images or other data that requires human interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies evaluate the performance of the device itself (the immunoassay) in a standalone fashion. Human involvement is limited to preparing samples, loading them onto the automated clinical chemistry analyzer, and reading the qualitative result (positive/negative) that the instrument provides based on its internal reaction and cutoff. There is no "human-in-the-loop" performance as would be understood in an AI-assisted diagnostic context for interpretation.

7. The Type of Ground Truth Used

• Analytical Studies (Precision, Specificity, Interference): Ground truth was established by known concentrations of spiked analytes in drug-free urine, often confirmed by Mass Spectrometry (MS).
• Method Comparison Study: Ground truth was established by Liquid Chromatography / Mass Spectrometry (LC/MS or LC-MS/MS), which is the preferred confirmatory method mentioned in the "Indications for Use" and is considered the gold standard.

8. The Sample Size for the Training Set

This is not an AI/ML device that requires a "training set" in the traditional sense. The device is a chemical immunoassay based on enzymatic reactions and antibody binding. Its "development" involves chemical formulation and optimization, not machine learning model training.

9. How the Ground Truth for the Training Set was Established

As noted above, there is no "training set" for this immunoassay device in the context of AI/ML. The development and optimization of the immunoassay reagents (antibodies, enzymes, etc.) would have relied on biochemical principles and extensive internal testing with known Fentanyl concentrations. The calibrators themselves have their values assigned based on mass spectrometry, as described in section 10 of the performance characteristics.

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