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Hightop® Home Use Fentanyl Urine Rapid Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of fentanyl, the major metabolite of fentaryl in human urine at the cut-off concentrations listed below:

The test is available in a single test of FYL or a Double panel of FYL and NFYL. It is intended for OTC use. The test provides only a preliminary test result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

Hightop® Fentanyl/Norfentany] Urine Rapid Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of fentanyl, the major metabolite of fentanyl in human urine at the cut-off concentrations listed below:

The test is available in a single test of FYL or NFYL or a Double panel of FYL and NFYL. The test panel provides only a preliminary test result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

The test panel is not intended to distinguish between prescription use or abuse of fentanyl. Clinical consideration and professional judgment should be applied to the test result, particularly in evaluating a preliminary positive result.

The Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel and Hightop® Fentanyl Norfentanyl Urine Rapid Test Panel are immunoassays intended for the qualitative detection of fentanyl and norfentany] in human urine. Each Hightop® fentanyl urine test device consists of a Test Panel and a package insert. Each Test Panel is sealed with sachets of desiccant in an aluminum pouch.

The provided text describes the performance characteristics and studies for the Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel and Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel. However, the document does not explicitly state "acceptance criteria" for precision or method comparison studies in a tabular format with corresponding performance results. Instead, it provides the raw data from these studies.

Based on the provided information, I will infer the acceptance criteria from the typical expectations for such tests (e.g., high correct result percentages for samples well below or above cutoff, and some variability near the cutoff) and present the performance.

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit acceptance criteria are not stated, I will interpret the goal of these studies as demonstrating reliability and accuracy, especially concerning the defined cut-off levels. For precision, the acceptance criterion implicitly is that results should be consistently negative well below the cutoff and consistently positive well above the cutoff, with some expected variability around the cutoff. For method comparison, the acceptance is that the rapid test results should largely agree with the LC/MS reference method. For the lay-user study, the implied acceptance is a high percentage of correct results.

Fentanyl

Norfentanyl

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

• Precision Study:

  • Sample Size: For each analyte (Fentanyl, Norfentanyl) and each of the 9 concentration levels, 6 tests were performed per day for 10 days, across 3 device lots. This equates to 60 tests per concentration per lot.
    • Fentanyl: 9 concentrations * 60 tests/concentration * 3 lots = 1620 tests
    • Norfentanyl: 8 concentrations * 60 tests/concentration * 3 lots = 1440 tests
  • Data Provenance: Samples were prepared by spiking fentanyl/norfentanyl into negative urine samples. "Each fentanyl or norfentanyl concentration was confirmed by LC/MS." This indicates a prospective, controlled laboratory study. Country of origin not explicitly stated for study execution, but the manufacturer is based in China.

• Method Comparison Studies:

  • Sample Size: 80 clinical samples (40 negative and 40 positive) for each analyte (Fentanyl, Norfentanyl). These were tested by three different operators.
    • Fentanyl: 80 samples * 3 operators = 240 results
    • Norfentanyl: 80 samples * 3 operators = 240 results
  • Data Provenance: "unaltered clinical samples." The document does not specify the country of origin or whether they were retrospectively collected or prospectively collected for the study. They were "blind labeled."

• Lay-User Study:

  • Sample Size: 140 lay persons. "Urine samples were prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cut-offs by spiking drug(s) into drug free-pooled urine specimens." There are 7 concentration levels for each analyte. Assuming each lay person tested one sample, the total is 140 samples, evenly distributed across the concentration levels and across the three test sites (1 lot per site). This means 20 samples per concentration level for each analyte (Fentanyl and Norfentanyl data tables confirm 20 samples per concentration).
  • Data Provenance: Samples were prepared by spiking drugs into drug-free pooled urine specimens. Concentrations were confirmed by LC/MS. This is a prospective, controlled usability study. Test sites are not specified by country, but they likely involve the target user population for OTC use.

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

• Precision Study: Ground truth was established by preparation of spiked samples with known concentrations confirmed by LC/MS. No human expert interpretation was involved in establishing the ground truth for these samples beyond the analytical chemists confirming the concentrations.
• Method Comparison Studies: Ground truth was established by LC/MS results. "The samples were blind labeled and compared to LC/MS results." No human expert interpretation for ground truth.
• Lay-User Study: Ground truth was established by the known spiked concentrations of the samples, confirmed by LC/MS. No human expert interpretation for ground truth.

4. Adjudication Method for the Test Set

• Given that the ground truth for all studies was established by LC/MS (a quantitative analytical method) or known spiked concentrations, there was no need for human expert adjudication (e.g., 2+1, 3+1). The sample results were definitively positive or negative based on their concentration relative to the cut-off, as determined by LC/MS.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test panel (likely a lateral flow immunoassay), not an AI-assisted diagnostic device that would involve human readers interpreting images or data with or without AI assistance. The "operators" in the method comparison study directly read the test panel results, which are qualitative (positive/negative line presence).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable in the typical sense of AI algorithms. This is a rapid diagnostic test kit. Its "performance" is its ability to correctly identify the presence or absence of the analyte at and around the defined cutoff. The instructions for use guide how a human reads the result (presence/absence of lines). There's no separate "algorithm" that generates a result independent of the physical test strip being read by a human. The precision, method comparison, and lay-user studies effectively evaluate the standalone performance of the device when used as directed.

7. The Type of Ground Truth Used

• Analytical Ground Truth (LC/MS and Spiked Concentrations): For all studies (precision, method comparison, and lay-user), the ground truth for the presence/absence of Fentanyl and Norfentanyl was established by quantitative analytical methods, specifically LC/MS (Liquid Chromatography-Mass Spectrometry), or by the precisely known concentrations of spiked samples. This is considered a highly objective and accurate method for determining the true concentration of substances in a sample.

8. The Sample Size for the Training Set

• Not applicable. This device is a biochemical rapid diagnostic test, not a machine learning or AI model that requires a "training set" in the computational sense. Its design and performance are based on chemical and immunological principles, not on learning from data.

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

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

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