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The CLUNGENE Multi-Drug Test Easy Cup is a lateral flow immunoassay for the qualitative detection of Morphine, Methamphetamine, Cocaine, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP (Methadone metabolite), Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-Monoacetylmorphine and Fentanyl in human urine at the following cut off concentrations:

The single or multi-test cups can consist of any combination of the above listed drug analytes, but only one cut off concentration under same drug condition will be included per device.

This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The CLUNGENE Multi-Drug Home Test Easy Cup is a lateral flow immunoassay for the qualitative detection of Morphine, Methamphetamine, Cocaine, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP (Methadone metabolite), Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-Monoacetylmorphine and Fentanyl in human urine at the following cut off concentrations:

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

It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

This document provides details on the performance characteristics of the CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy Cup. Since this is an in vitro diagnostic device (specifically, a drug screening test), the acceptance criteria and study design are typically focused on analytical performance (accuracy, precision, analytical specificity) rather than a multi-reader multi-case (MRMC) comparative effectiveness study, which is more common for imaging AI. Similarly, "human readers improving with AI vs without AI" is not applicable here as the device is the test, not an aid to human interpretation of another modality.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for qualitative drug screening tests like this is accurate detection around a specific cutoff concentration. The reported performance demonstrates the device's ability to correctly classify samples as positive or negative relative to these cutoffs.

Table of Acceptance Criteria and Reported Device Performance (Analytical Precision/Reproducibility)

The "Acceptance Criteria" column represents the desired performance for a qualitative assay around its cutoff. For positive results, this means detecting drug concentrations above the cutoff, and for negative results, it means not detecting concentrations below the cutoff. The provided precision data shows the number of positive (+) and negative (-) results out of 50 tests for various concentrations relative to the cutoff. An ideal performance would show 100% positive for concentrations above cutoff and 100% negative for concentrations below, with roughly 50/50 split at the cutoff itself (due to inherent variability).

Note: The implicit acceptance criterion for a qualitative test like this is generally that samples significantly above the cutoff should consistently yield positive results, samples significantly below the cutoff should consistently yield negative results, and samples near the cutoff (e.g., +/- 25% or 50% of the cutoff) will show varying results due to inherent assay variability, which is considered acceptable.

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Analytical Performance (Precision/Reproducibility): For each drug and each concentration point (9 concentration levels per drug), 50 tests were performed (2 runs per day for 25 days). Given there are 20 analytes (including the alternative cutoffs), this amounts to 20 drugs * 9 concentrations * 50 tests/concentration = 9000 tests.
   • Analytical Specificity/Interference: Not explicitly stated as a "test set" size with a fixed number of samples, but "drug metabolites and other components" were "spiked into drug-free urine" and tested using three lots of the device. For compounds showing no interference, they were tested at a "concentration of 100µg/mL or specified concentrations" in both drug-free urine and urine containing target drugs at +/- 50% cutoff. Over 100 compounds were listed.
   • Method Comparison Study: For each drug, 80 "unaltered urine clinical samples" were used (40 negative and 40 positive). These were "blind labeled." With 20 analytes, this sums to 20 drugs * 80 samples/drug = 1600 clinical samples.
   • Lay Person Study: 280 lay persons participated. Urine samples were prepared at 7 concentration levels (-100%, +/-75%, +/-50%, +/-25% of cutoff). Each participant received 1 blind-labeled sample and 1 device. The tables suggest that for each configuration (1 and 2), for each drug, 20 samples were tested at each concentration level. Thus, for Configuration 1, there are 17 drugs, so 17 drugs * 7 concentrations * 20 samples/conc = 2380 samples. For Configuration 2, there are 17 drugs, so 17 drugs * 7 concentrations * 20 samples/conc = 2380 samples.
   • Data Provenance: The analytical and method comparison studies were performed "in-house." The lay user study was performed "at three intended user sites." The origin of the urine samples (e.g., country of origin) is not specified. It is implied these are prospective tests using prepared or collected samples for the purpose of the study.

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

   • Analytical Precision/Reproducibility, Analytical Specificity/Interference, and Method Comparison: The ground truth for these studies was established by LC-MS/MS or GC/MS (or LC-MS/MS), which are reference analytical methods, not human expert consensus. The text states:
     • "Each drug concentration was confirmed by LC-MS/MS" for precision studies.
     • "The samples were…compared to LC-MS/MS results" for the method comparison study.
     • "The concentrations of the samples were confirmed by LC-MS/MS" for the lay person study.
   • Therefore, human experts were not directly establishing the ground truth for classification.

3. Adjudication Method for the Test Set:

   • Not applicable as the ground truth was established by LC-MS/MS/GC/MS, a definitive chemical analysis method, not by human expert reading requiring adjudication. The device itself is an immunoassay, the results of which are compared to the LC-MS/MS gold standard.

4. 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, an MRMC comparative effectiveness study was not done. This type of study design is not applicable to a lateral flow immunoassay drug test. The device is a diagnostic test itself, not an AI assisting human interpretation of another modality.

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

   • Yes, implicitly. The precision, specificity, and method comparison studies evaluate the performance of the device itself (the immunoassay) against confirmed concentrations (LC-MS/MS), which represents its "standalone" analytical performance. However, there is a human element in reading the qualitative bands (positive/negative line), which is addressed in the lay-person study.

6. The Type of Ground Truth Used:

   • The primary ground truth used across all analytical studies (precision, specificity, method comparison, lay person study) was LC-MS/MS or GC/MS results. This is considered a highly accurate and definitive chemical confirmatory method for drug concentrations in urine.

7. The Sample Size for the Training Set:

   • This device is a lateral flow immunoassay, not a machine learning/AI algorithm that requires a "training set" in the computational sense. Its "training" is inherent in its chemical and biological design. Therefore, this question is not applicable.

8. How the Ground Truth for the Training Set was Established:

   • As this is not an AI/ML device relying on a training set, this question is not applicable. The device's performance is governed by its chemical design (antibodies, reagents) and manufacturing process, which are developed and validated through iterative biochemical and engineering studies, not by a data-driven training process in the AI sense.

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