Search Results

The Superbio Fentanyl Urine Detection Kit is a fluorescence immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with Superbio Immunofluorescence Analyzer EASY-11. This in vitro diagnostic device is for prescription use only.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

This test uses a lateral flow design with location-dependent lines and zones. The Immunofluorescence Analyzer EASY-11 scans the test strip and displays results. The sample is added to the sample well of the test card, and the sample is drawn by capillary action into and through the fluorescent labeled pad, through the nitrocellulose strip and into the adsorption pad.

Within the fluorescent labeled pad, the specimen comes into contact with antibodies conjugated with fluorescent microspheres. During this interaction, if the amount of fentanyl antigen in the sample is greater than or equal to the detection limit, the antigen in the sample and the fluorescence-labeled antibody bind to the FTY antigen-antibody complex when the sample passes through a pad of fluorescence-microbead-labeled antibody conjugate. As the sample flows and reaches the FTY antigen coated by the T-line of nitrocellulose membrane, the FTY antigen coated by the T-line and the antigen in the sample competitively bind the FTY antibody labeled with fluorescence, then the T-line captures no fluorescence signal. When the samples do not contain fentanyl antigen or levels below the detection limit, as the sample flow, fluorescent microsphere labeled antibody to nitrocellulose membrane T line captures fluorescent signal. Whether or not FTY antigen was present in the sample, the rabbit IgG fluorescent microsphere conjugate not bound to the test line continued to flow with the rest of the sample and soon encountered a control line composed of sheep antirabbit IgG. The position of C-line will accumulate fluorescence signal. The C-line control area was scanned to confirm that adequate sample flow had occurred. High resolution, narrow band SMD LED was used as light source in the Immunofluorescence Analyzer. The central wavelength of the excitation spectrum is 365nm. The central response wavelength is 610nm.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text.

Acceptance Criteria and Device Performance for Superbio Fentanyl Urine Detection Kit

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, the performance characteristics are reported as results of various analytical studies.

Table 1: Analytical Performance of the Superbio Fentanyl Urine Detection Kit

• 7/7 low negative samples correctly identified.
• 17/17 very low negative samples correctly identified.
• 13/16 near-cutoff negative samples correctly identified.
• 21/24 near-cutoff positive samples correctly identified.
• 16/16 high positive samples correctly identified.
  Site 2 & 3: Very similar results with minimal variations in near-cutoff performance. Total 80 samples per site. |

2. Sample size used for the test set and data provenance

• Test Set Sample Size:
  • Precision Study: For each of 9 concentration levels, 6 runs per day for 10 days per device lot were performed. With 3 lots, this implies 9 concentrations * 6 runs * 10 days * 3 lots = 1620 individual tests (though not explicitly stated as unique samples for each test). Samples were prepared by spiking fentanyl in negative samples.
  • Interference Study: Not explicitly stated, but "three batches of each device" were used, and samples were drug-free urine and target drug fentanyl urine spiked at specific concentrations.
  • Specificity (Cross-Reactivity) Study: "Three batches of device" were used with various fentanyl analogs and other opioid compounds.
  • Effect of Urine Specific Gravity and Urine pH: "Three lots of device" were used.
  • Method Comparison Study: 80 unaltered clinical samples were used per site across three different testing sites, totaling 240 clinical samples.
• Data Provenance: The document does not explicitly state the country of origin for the clinical samples used in the method comparison study. The samples were described as "unaltered clinical samples." It does not specify if these were retrospective or prospective, but the context of "clinical samples" for method comparison suggests they were collected for diagnostic purposes, which could be either.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts

• Ground Truth for Test Set: The ground truth for the clinical samples in the method comparison study was established by LC/MS (Liquid Chromatography/Mass Spectrometry). This is a highly accurate and commonly accepted confirmatory method for drug testing, often considered the gold standard.
• Number and Qualifications of Experts: The document does not mention the use of human experts to establish the ground truth for the test set. LC/MS results are objective chemical measurements, not subjective expert interpretations.

4. Adjudication method for the test set

• Not applicable as the ground truth was established by LC/MS, which is an objective analytical method, not human interpretation requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study was done or reported. This device is an in vitro diagnostic (IVD) kit that is read by an automated immunofluorescence analyzer (Superbio Immunofluorescence Analyzer EASY-11), not by human readers interpreting images. Therefore, the concept of human readers improving with AI assistance is not relevant in this context.

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

• Yes, the performance studies described are essentially standalone algorithm performance (though the "algorithm" is embedded in the immunoassay and analyzer's interpretation). The Superbio Fentanyl Urine Detection Kit, combined with the Superbio Immunofluorescence Analyzer EASY-11, functions as a system that provides a qualitative result (positive/negative) based on the fluorescent signal. The method comparison study directly compares the device's output to the LC/MS ground truth, representing its standalone performance. The operator's role is to run the test, not interpret the result.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• LC/MS (Liquid Chromatography/Mass Spectrometry) was used as the ground truth for the clinical samples in the method comparison study. For the analytical studies (precision, interference, specificity), ground truth was established by preparing samples with known concentrations (e.g., spiking fentanyl into negative urine) and confirming these concentrations with LC/MS where applicable.

8. The sample size for the training set

• The document does not describe a training set or machine learning model in the conventional sense. The Superbio Fentanyl Urine Detection Kit and Superbio Immunofluorescence Analyzer EASY-11 operate based on established immunochemical principles and fixed analytical protocols, not a trainable artificial intelligence algorithm. Therefore, there is no "training set" to report.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set for this type of IVD device.

Ask a specific question about this device