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The Cozart RapiScan Oral Fluid Drug Test System - Opiates and Methadone is intended for Point of Care testing in a number of settings such as prescription workplace, drug dependency clinics, and criminal justice. It provides qualitative screening results for opiates and methadone in human oral fluid at a cut-off concentration equivalent to 40ng/mL and 30ng/mL respectively in neat oral fluid. The cozart collection system involves a 1:3 dilution of the oral fluid sample, this dilution factor is corrected for in the Cozart RapiScan Drug Test and therefore the remainder of this document will refer to the cut-offs as 13ng/mL for opiates and 10ng/ml for methadone.

This kit has to be used in conjunction with the Cozart RapiScan instrument. Please refer to the sampling and testing procedures in the instructions for use leaflet.

This assay is for professional use only and provides only a preliminary analytical test result. Clinical consideration and professional judgement must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a more confirmed analytical result a more specific alternative chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method.

It is the responsibility of those organisations required to follow department of transportation (DOT) or the Substance Abuse and Mental Health Services Administration (SAMHSA) Workplace Drug Testing guidelines to determine that this product satisfies the criteria for workplace testing established under DOT and SAMHSA.

The Cozart RapiScan opiates and methadone test system is composed of three parts - the oral fluid collection device, the opiates and methadone test cartridge and the Cozart RapiScan instrument.

1. Oral fluid Collection Device: composed of an oral fluid collector pad, a transport tube containing run buffer and a dispense filter tube.
2. Opiate and Methadone Test Cartridge: composed of a white reaction strip with immobilized drug sites for opiates and methadone contained in a blue plastic casing. The cartridge also has a pad containing gold labeled anti-morphine and gold labeled anti-methadone antibodies. In addition, the cartridge has a built in control line of sheep anti-mouse IgG antibody.
3. Cozart RapiScan Instrument: a battery-powered instrument whose function is to automate the analysis of the opiate/methadone test cartridge. It is a hand-held low voltage optical scanner.

Here's an analysis of the Cozart RapiScan Oral Fluid Drug Test System for Opiates and Methadone, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the Cozart RapiScan are primarily defined by its ability to accurately detect opiates and methadone in oral fluid at specified cut-off concentrations, as validated against GC/MS. The study demonstrates the device's performance in terms of sensitivity, specificity, precision, and stability under various conditions.

Table of Acceptance Criteria and Reported Device Performance

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Method Comparison Test Set:
     • Total Samples: 454 oral fluid samples.
     • Opiates: 99 RapiScan positive (93 GC/MS confirmed), 124 RapiScan negative (123 GC/MS confirmed). (Total: 223 samples for opiates analysis against GC/MS)
     • Methadone: 116 RapiScan positive (116 GC/MS confirmed), 115 RapiScan negative (115 GC/MS confirmed). (Total: 231 samples for methadone analysis against GC/MS)
     • Special Samples:
       • 24 opiate samples within +/- 50% of cut-off (14 previously diluted with blank saliva).
       • 24 methadone samples within +/- 50% of cut-off (20 previously diluted with blank saliva).
     • Provenance: All samples were oral fluid.
       • 99 opiate-positive samples and 116 methadone-positive samples were from "drug users enrolled at a drug rehabilitation clinic."
       • 103 opiate-negative samples and 102 methadone-negative samples were from "drug free volunteers."
       • 21 opiate-negative samples and 13 methadone-negative samples were from "known drug users."
       • The samples were tested by Cozart Bioscience Ltd staff, and GC/MS performed by FSS Chepstow UK, University of Glasgow, Scotland, and The Analytical Laboratory at Cozart Bioscience Ltd, UK. This suggests a retrospective collection of samples from clinics and volunteers, followed by prospective testing with the RapiScan and GC/MS. The origin is primarily the UK.
   • Precision Test Set (Laboratory): Four oral fluid samples (negative, cutoff, 50% above cutoff, 50% below cutoff) tested in duplicate every day for 20 days (4 samples * 2 duplicates * 20 days = 160 tests per drug).
   • Precision Test Set (Point of Care - POC): Four oral fluid samples (spiked at 0, 6.5, 13, 19.5 ng/mL for opiates and 0, 5, 10, 15 ng/mL for methadone) from drug-free volunteers, tested up to 9 times at 3 POC sites.
   • Sensitivity Test Set: Eight negative oral fluid samples, fortified at 50% above cut-off and serially diluted.
   • Specificity Test Set: Not explicitly stated, but 28 potentially interfering substances and 13 opiate/4 methadone related substances were tested.
   • Cutoff Concentration Test Set: 8 fortified oral fluid samples at various concentrations (cutoff, +/- 50% cutoff, +/- 100% cutoff).
   • Interference Studies Test Set: Not explicitly stated, but various parameters (dye, hemoglobin, common consumables) were tested.
   • Stability Studies Test Set: Four fortified samples (2 at 50% above cutoff, 2 at 50% below cutoff) and two negative samples from volunteers.
   • Time of Day Comparison Test Set: Samples from 4 volunteers at 3 different times of day, fortified.
   • Instrument Comparison Test Set: Samples from 4 volunteers, fortified, tested on 3 different instruments.
   • Operator Comparison Test Set: Samples from 4 volunteers, fortified, tested by "inexperienced operators" (number not specified, but likely at least 3 given the results statement mentions "all three operators").

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

   • The ground truth for the test set (method comparison) was established by Gas Chromatography/Mass Spectrometry (GC/MS). While GC/MS is an analytical method, not human experts, it is considered the "preferred confirmatory method" and gold standard for drug testing. The performing laboratories were FSS Chepstow UK, University of Glasgow, Scotland, and The Analytical Laboratory at Cozart Bioscience Ltd, UK. The qualifications of the GC/MS operators are implied to be standard for analytical laboratory personnel competent in this method.

3. Adjudication method for the test set:

   • Not applicable in the typical sense for medical imaging or clinical decision-making. The "adjudication" here is the direct comparison of the Cozart RapiScan qualitative result (positive/negative) against the quantitative GC/MS result, using the defined cut-off concentrations. Discrepancies would be identified based on whether the RapiScan result matched the GC/MS result relative to the cut-off.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a point-of-care test read by an instrument, not by human readers interpreting complex images or data. The instrument automatically displays results as "positive or negative," eliminating human subjectivity in reading.

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

   • Yes, the performance study described is essentially a standalone algorithm performance study. The Cozart RapiScan instrument, which incorporates the device's "algorithm" for reading the test cartridge, operates without human interpretation of the test line. The human interaction involves initiating the test and reading the displayed digital result (positive or negative). The study evaluates the objective output of this system compared to the gold standard. The note that the "Cozart RapiScan instrument must be used to read the cartridges, this eliminates the subjectivity of reading by eye" further supports this being a standalone evaluation of the device's automated reading.

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

   • The ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS), which is the "preferred confirmatory method" and considered the analytical gold standard for drug detection and quantification in biological samples.

7. The sample size for the training set:

   • The document does not explicitly state a separate training set size. The studies described are performance validation studies. It's common for such devices (especially those using immunoassay principles rather than complex machine learning algorithms) not to have a distinct "training set" in the sense of AI/ML models. The design and optimization of the immunoassay itself (e.g., antibody selection, cut-off determination) would be based on internal development and verification processes that precede the formal validation studies presented here.

8. How the ground truth for the training set was established:

   • As no explicit training set is mentioned in the context of advanced machine learning, the concept of establishing ground truth for a training set in the typical AI/ML sense is not directly applicable. For the development of the immunoassay, the "ground truth" for calibrating the system and establishing the cut-off concentrations would likely have involved controlled samples with known concentrations of opiates and methadone, confirmed by analytical methods like GC/MS during the R&D phase of the test's design. The "Cutoff Concentration" study described within the document is part of the verification of these established cutoffs.

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'RapidOne'-Methadone Test is a one-step, lateral flow immunoassay for the detection of methadone in urine.

'RapidOne'-Methadone Test is intended for the qualitative detection of methadone in human urine at 300 ng/ml.

'RapidOne'-Methadone Test is intended for professional use. It is not intended for over the counter sale to nonprofessionals. The assay is easy to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS).

'RapidOne'-Methadone Test provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a more confirmed result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particulary when preliminary results are used.

The assay employed in the 'RapidOne'-Methadone' Test is based on the same principle of highly specific reaction between antigens and antibodies.

This assay is a one-step, immunoassay in which a specially labeled drug (drug conjugate) competes with drug that may be present in the sample for the limited number of binding sites on the antibody. The test device consists of a membrane strip onto which a drug conjugate has been immobilized. A colloidal gold-antibody complex is dried at one end of a membrane. In the absence of any drug in the urine sample, the colloidal goldantibody moves with the urine by capillary action to contact the immobilized drug coniugate. An antibody-antigen reaction occurs forming a visible line in the 'test' area. The formation of a visible line in the 'test' area occurs when the test is negative.

When drug is present in the urine sample, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the limited antibody sites on the colloidal gold-antibody complex. If sufficient amount of drug is present, it will fill all of the available binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the 'test' area is indicative of a positive result.

A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The 'control; line is not influenced by the presence or absence of drug in the urine, and therefore, should be present in all reactions.

This document describes the 'RapidOne'-Methadone Test, an immunoassay for the qualitative detection of methadone in human urine, and its performance characteristics as submitted for 510(k) clearance.

1. Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the 'RapidOne'-Methadone Test is its ability to detect methadone at a concentration of 300 ng/ml in urine, and its performance relative to a predicate device and confirmatory GC/MS testing. The reproducibility study further quantifies its performance at concentrations above and below this cut-off.

• Out of 40 Syva Emit II positive samples (confirmed and quantified by GC/MS from 146 to 1072 ng/ml), both 'RapidOne' and the predicate device correctly identified all as positive. |
  | Reproducibility (at cut-off and surrounding concentrations) | No drug (0 ng/ml): 120/120 Negative (100%)
  150 ng/ml (below cut-off): 6 Positive, 114 Negative (95% negative)
  225 ng/ml (near cut-off): 106 Positive, 14 Negative (88.3% positive)
  375 ng/ml (above cut-off): 120 Positive, 0 Negative (100% positive) |

Note: The reproducibility table's "RDS Result" column is missing a header for the two sub-columns, but based on context, it appears to represent "Number of Positive" and "Number of Negative" results respectively for each concentration.

2. Sample Size and Data Provenance

• Test Set Size: 90 samples were used for the comparison study with the predicate device and GC/MS. This included 50 drug-free samples and 40 positive samples. For the reproducibility study, 120 replicates were tested at each of four concentrations (total 480 tests).
• Data Provenance: Not explicitly stated (e.g., country of origin). The data appears to be retrospective, as samples were "selected for evaluation" and had already been tested by Syva Emit II and quantified by GC/MS.

3. Number of Experts and Qualifications for Ground Truth for Test Set

• The document does not mention the use of experts to establish ground truth for the test set. Instead, it relies on a confirmatory analytical method, GC/MS, to establish the definitive presence and concentration of methadone in the positive samples.

4. Adjudication Method for the Test Set

• No adjudication method by human experts is described for the test set. The direct comparison is made between the 'RapidOne' device, the predicate device, and the GC/MS results (for positive samples). For negative samples, the "drug-free" status appears to be the ground truth.

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

• No MRMC comparative effectiveness study was performed or described. The study focuses on the device's performance against a predicate and a gold standard analytical method, not on human reader improvement with or without AI assistance. The device is a "RapidOne"-Methadone Test, an immunoassay, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance was done. The entire study describes the performance of the 'RapidOne'-Methadone Test device itself, without human-in-the-loop assistance. Operators administered the test according to its instructions and recorded the results.

7. Type of Ground Truth Used

• For positive samples: The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is explicitly mentioned as the preferred confirmatory method. The positive specimens were "confirmed as positive and quantified by GC/MS."
• For negative (drug-free) samples: The ground truth was based on the samples being "found to be drug-free," implying a prior determination that those samples contained no drug. The method for this initial finding is not detailed but is assumed to be a reliable screening method or known origin.

8. Sample Size for the Training Set

• The document does not describe a "training set." This type of in vitro diagnostic device (immunoassay) typically does not involve a machine learning model that requires a distinct training and test set in the same way an AI/ML algorithm would. The development of the assay itself is an iterative process, but the provided documentation focuses on its validation.

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

• As there is no mention of a traditional "training set" for an AI/ML model, this question is not applicable to the provided information. The development of the immunoassay involves chemical and biological principles rather than algorithm training on data.

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