(13 days)
A workplace drug screening and confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: Phencyclidine (PCP), Amphetamine, THC (marijuana), Cocaine and Opiates.
At Work Drug Test is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentrations of this test are as follows: Phencyclidine (PCP); 25 ng/ml, amphetamine; 1000 ng/ml, cocaine; 300 ng/ml and opiates; #9145 25C at 300 ng/ml and 9177 25C at 2000 ng/ml. This assay is intended for use in the workplace assist in the prevention of drug abuse. This kit, as supplied, incorporates a mechanism for confirmation testing by GC/MS, to be performed at a certified laboratory. The At Work Drug Test, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology.
Here's an analysis of the provided text to extract the requested information about the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Cut-off Concentrations) | Reported Device Performance |
|---|---|
| Phencyclidine (PCP): 25 ng/ml | >97% overall accuracy |
| Amphetamine: 1000 ng/ml | |
| Cocaine: 300 ng/ml | |
| Opiates (Model 9145 25C): 300 ng/ml | |
| Opiates (Model 9177 25C): 2000 ng/ml | |
| Substantially equivalent to predicate devices | Yes, claimed "substantially equivalent" |
| Correlation with Behring EMIT II and GC/MS | >98% correlation |
| Accuracy in professional use | >97% overall accuracy |
| Accuracy in lay use (via "At Home Drug Test") | >96.4% overall accuracy |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated. The document mentions "clinical samples" for the correlation study and "clinical studies" performed at two independent laboratories. For the consumer study, it refers to "a consumer study" without specifying the number of participants.
- Data provenance: Not explicitly stated, but the mention of "clinical samples" and "clinical studies... at two independent laboratories" suggests real-world urine samples. No information on country of origin or whether it was retrospective or prospective is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not explicitly stated.
- Qualifications of experts: The "Performance" section mentions that the Phamatech At Work Drug Test "exhibited excellent overall accuracy (>97%) in the hands of professional users." This implies that the validation of the device's performance against the ground truth was assessed by professionals, but their specific qualifications (e.g., medical technologists, toxicologists, years of experience) are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication method: Not explicitly stated. The document mentions "GC/MS methodology" as a comparative method and a "mechanism for confirmation testing by GC/MS, to be performed at a certified laboratory." This implies that GC/MS was used as a confirmatory "gold standard" for the ground truth, but the process of how results were reconciled if initial screening conflicted with GC/MS is not described.
5. 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:
- MRMC study: Not applicable. This device is an immunoassay drug test, not an AI-assisted diagnostic tool for human readers. No mention of AI assistance or human reader involvement in interpreting results (beyond visual observation for the test's color changes) is made. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone performance: Yes, in essence, the "At Work Drug Test" is a standalone device. It's a "rapid, qualitative immunoassay" that provides a visual result. While it's used by "professional users" and "lay users," the device itself generates the result without interpretation assistance from a complex algorithm or AI. The stated accuracy numbers (>97% professional, >96.4% lay user) reflect its standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of ground truth: Gas Chromatography-Mass Spectrometry (GC/MS) methodology. The document states: "Correlations studies, using clinical specimens. produced a >98% correlation when compared to the Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology." This clearly indicates GC/MS as the gold standard.
8. The sample size for the training set:
- Sample size for training set: Not applicable/not provided. This is a traditional immunoassay device, not a machine learning model. Therefore, there is no "training set" in the context of AI. The development of the device would have involved an R&D phase with various experiments and optimization, but not a distinct "training set" as understood in AI studies.
9. How the ground truth for the training set was established:
- Ground truth for training set: Not applicable, as there is no training set for this type of device. The development and validation of the immunoassay would rely on established analytical chemistry principles and comparison to recognized gold standards (like GC/MS) to ensure its accuracy against known drug concentrations in samples.
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