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Bionike's AQ™ Phencyclidine (PCP) assay is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine at the cutoff level of 25 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated". Bionike Laboratories' AQ™ Phencyclidine (PCP) Test is not intended to monitor drug levels, but only to screen urines for the presence of Phencyclidine (PCP) and its metabolites.

Bionike Laboratories' AQ™ Phencyclidine (PCP) Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 25 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

1. Acceptance Criteria and Device Performance

Note: The document states the device "yielded relative sensitivity or agreement within positive samples of 1.000 and relative specificity or agreement within negative samples of 1.000 and an accuracy of 100%," implying these were the target acceptance criteria.

2. Sample Size and Data Provenance

• Test Set Sample Size: 286 samples
• Data Provenance: Not explicitly stated, but based on the "clinical trial" wording, it suggests prospective collection for the purpose of the study. The absence of specific country information usually implies domestic (US) data for FDA submissions unless otherwise mentioned.

3. Number of Experts and Qualifications

• Not applicable. The ground truth was established by laboratory methods (chemical analysis) rather than expert human interpretation of images or clinical cases.

4. Adjudication Method

• Not applicable. The ground truth was established by laboratory methods, not through reconciliation of multiple human readers.

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

• No, a multi-reader multi-case comparative effectiveness study was not done. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The Bionike AQ™ Phencyclidine (PCP) Test's performance (sensitivity, specificity, accuracy) was evaluated directly against a reference method (Syva EMIT® (25) II, confirmed by GC/MS).

7. Type of Ground Truth Used

• The primary ground truth for the test set was established using Gas Chromatography/Mass Spectrometry (GC/MS) at a cutoff of 25 ng/ml. Syva EMIT® (25) II was used as an initial comparator, but GC/MS served as the definitive confirmation method.

8. Sample Size for the Training Set

• The document does not explicitly mention a separate "training set" for the device development. The reported performance refers to the in-house testing and a clinical trial. Given the nature of a rapid immunoassay, it's more likely that the device's design and operating parameters were established through iterative development and testing, rather than a distinct machine learning "training set."

9. How Ground Truth for the Training Set Was Established

• Not applicable, as a distinct training set in the context of machine learning is not described. For the device's development/optimization (analogous to training), it's implied that various samples with known PCP concentrations (likely determined by GC/MS or similar precise analytical methods) would have been used during the research and development phases to establish the assay's sensitivity, specificity, and cutoff levels.

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