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AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. 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.

AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllTest Fentanyl Rapid Test (Urine) device consists of a Test Cassette and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.

Here's a breakdown of the acceptance criteria and the study details for the AllTest Fentanyl Rapid Test (Urine), based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria are generally inferred from the positive and negative agreement with the LC/MS reference method, especially around the cutoff concentration. While explicit numerical acceptance criteria are not stated as "acceptance criteria," the performance in the method comparison study demonstrates the device's ability to classify samples correctly.

• Lot 1: 58-/2+
• Lot 2: 59-/1+
• Lot 3: 60-/0+
  For Cutoff:
• Lot 1: 35+/25-
• Lot 2: 28+/32-
• Lot 3: 26+/34-
  For +25% Cutoff:
• All lots 60+/0- |
  | Interference:
  No interference from common endogenous or exogenous substances at specified concentrations. | Over 80 tested compounds showed no interference at 100 µg/mL or specified concentrations (except Trazodone with 0.1% cross-reactivity). |
  | Specificity (Cross-reactivity):
  Limited cross-reactivity with structurally similar compounds. Other opioids show no cross-reactivity. | Detailed cross-reactivity provided for 17 fentanyl analogs; 21 other opioid compounds showed no cross-reactivity. |
  | Effect of Urine Specific Gravity and pH:
  Accurate results across a range of urine specific gravities and pH levels. | Consistent results (positive for +50% Cut-Off and above, negative for -50% Cut-Off and below) over specific gravity 1.000-1.035 and pH 4-9. |

Study Details

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Operators ran 80 unaltered clinical samples at each of the three testing sites. This means a total of 240 tests were performed on the clinical samples (80 samples * 3 sites). Each sample was characterized by LC/MS results (40 negative and 40 positive for fentanyl).
• Data Provenance: The document states "unaltered clinical samples." The country of origin is not specified, but the device manufacturer is based in Hangzhou, Zhejiang, China. The study appears to be prospective in the sense that the device was used to test these clinical samples, and the results were then compared to LC/MS.

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

• Ground Truth Establishment: The ground truth for the test set was established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is the preferred confirmatory method for drug testing, rather than human experts.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as the ground truth was industrial standard LC/MS. Discordant results were identified by direct comparison to the LC/MS reference.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly done. The study compares the device's performance against a gold standard (LC/MS), not against human readers with and without AI assistance. The device itself is an immunoassay, not an AI-assisted diagnostic tool.

6. Standalone Performance Study

• Standalone Performance: Yes, the described method comparison study is a standalone (algorithm only without human-in-the-loop performance) study, as it evaluates the device's ability to detect fentanyl in urine samples independently and compares its results to LC/MS. Human operators ran the tests, but their interpretation was based on the test line development, which is an intrinsic function of the device's chemistry.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was established by LC/MS/MS results, specifically for fentanyl concentration, with a cutoff of 1.0 ng/mL. LC/MS is a highly accurate and sensitive analytical chemistry technique considered the gold standard for confirming the presence and quantity of drugs in biological samples.

8. Sample Size for the Training Set

• Sample Size for Training Set: The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is an immunoassay and relies on chemical reactions, not on an algorithm that requires a training set. The various analytical performance studies (precision, interference, specificity) are internal validation studies that support the device's design and analytical capability, but these are not typically referred to as "training sets" in the same way as in AI/ML development.

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

• Ground Truth for Training Set: Not applicable, as there is no explicitly defined "training set" for this immunoassay device in the context of AI/ML. All samples used in the analytical performance studies (precision, interference, specificity) involved prepared samples with known concentrations of fentanyl or interfering substances, often confirmed by LC/MS, or drug-free urine.

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