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TUBI's UNISCAN-DoA is a system intended for use in Drugs of Abuse Screening Tests.

This mAMP/Opi/THC panel test is a prescription assay intended for use with UNISCAN-DoA scanner in laboratory by professional personnel. The mAMP/Opi/THC assays were calibrated with d-methamphetamine/morphine/11-nor-△-THC-9-COOH, respectively. It provides qualitative screening results for Methamphetamine/ Opiate/cannabinoids in human urine at a cutoff concentration of 1000/300/50 ng/ml. For In Vitro Diagnostic Use.

This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any Drug of Abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the recommended confirmatory method.

The UNISCAN-DoA system includes UNISCAN-DoA scanner and mAMP/Opi/THC panel test.

The UNISCAN-DoA scanner is a scientific measurement device for color intensity of developed test strip. The color intensity of a test line is detected by the contact image sensor (CIS) inside the device.

The test strip of UNISCAN-DoA system is a one-step, colloidal gold based chromatographic immunoassay for the rapid, qualitative detection of Methamphetamine, Opiates, and THC (Cannabinoid).

The device contains a membrane strip, which is pre-coated with drug-protein conjugate at the test region of the membrane strip. A wicking pad containing anti-drug monoclonal antibody-conjugate is placed at one end of the membrane. The device contains a control region which has a different antigen/antibody from the test region.

The assay relies on the competition for binding antibody between drug conjugate and free drug that may be present in the urine specimen being tested. When drug is present in the urine specimen, it competes with drug conjugate for limited amount of antibody-colloidal gold conjugate. If the drug is present in the urine specimen, it will prevent the binding of drug conjugate to the antibody. Therefore, the color intensity of the test line is reduced. The higher the drug concentration is present in the urine specimen, the lower the color intensity is in the test line of a strip. The color intensity of a test line is inversely proportional to the drug concentration in the urine specimen. The correlation between the color intensity and the drug concentration is described by a calibration curve, whose coefficients are determined via nonlinear regression based on the experimental data. The calibration curve equation and its coefficients are stored in UNISCAN-DoA scanner. Once a developed test strip is inserted into the scanner and is scanned by the device, the color intensity of a test line is detected by the contact image sensor (CIS) inside the device and the signal is converted to drug concentration according to the stored calibration curve equation and its coefficients. The qualitative result is then displayed on the LCD screen of the device.

A control line is present at the control region to work as procedural control. This colored band should always appear at the control region regardless the presence of drugs or metabolite. The UNISCAN-DoA scanner automatically detects the color intensity of a control line. If the control line of an inserted test strip does not be detected by the device, "Strip is Failed!" will be displayed on the LCD screen of the device.

The provided text describes the UNISCAN-DoA system, which consists of a scanner and a mAMP/Opi/THC panel test for qualitative detection of Methamphetamine, Opiates, and THC in human urine. The performance is evaluated against GC/MS analysis.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a pass/fail threshold. However, it presents "Agreement among positives" and "Agreement among negatives" as key performance metrics. We can infer that high percentages in these categories are desirable for acceptance.

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

• Sample Size for Test Set:
  • mAMP: 97 urine specimens
  • Opi: 94 urine specimens
  • THC: 94 urine specimens
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions studies were conducted to evaluate performance.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not mention the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of human reader improvement with AI assistance. The device is a standalone immunoassay system, not an AI-assisted interpretation system for human readers.

6. Standalone Performance Study

Yes, a standalone performance study was clearly done. The performance metrics (Agreement among positives/negatives) are reported for the UNISCAN-DoA system itself, comparing its results to a confirmed analytical method (GC/MS).

7. Type of Ground Truth Used

The ground truth used was Gas Chromatography/Mass Spectroscopy (GC/MS) analysis. This is stated as the recommended confirmatory method: "To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the recommended confirmatory method."

8. Sample Size for the Training Set

The document does not provide information on a separate training set or its sample size. The calibration curve (which could be considered part of model training/fitting) is mentioned: "The correlation between the color intensity and the drug concentration is described by a calibration curve, whose coefficients are determined via nonlinear regression based on the experimental data. The calibration curve equation and its coefficients are stored in UNISCAN-DoA scanner." However, the data used for this calibration is not specified as a "training set" with details like sample size. It's more implied as part of the initial device development.

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

As mentioned above, the document does not explicitly detail a separate "training set" or how its ground truth was established. The calibration curve's coefficients are determined by "nonlinear regression based on the experimental data," but the specifics of this experimental data and its ground truth establishment are not provided for a distinct training phase. It's likely that standards and known concentrations were used, but not specified as a "training set" with ground truth in the context of the study reported.

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