(87 days)
Syntron's QuikPac II One Step Cocaine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Cocaine in urine at the cutoff level of 150 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 indicated6. Syntron's QuikPac II One Step Cocaine Test is not intended to monitor drug levels, but only to screen urines for the presence of Cocaine and its metabolites.
Syntron's QuikPac II One Step Cocaine 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 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 150 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.
Here's a breakdown of the acceptance criteria and study details for the QuikPac II One Step Cocaine Test based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria values for sensitivity, specificity, and accuracy. Instead, it presents the calculated performance against a commercial EIA test, with GC/MS confirmation for positive samples. We can infer that the reported values met the internal standards for the device to be submitted.
| Metric | Acceptance Criteria (Inferred) | Reported Device Performance (Clinical Trial) |
|---|---|---|
| Sensitivity | High agreement with EIA | 99.49% |
| Specificity | High agreement with EIA | 100% |
| Accuracy | High overall agreement with EIA | 99.75% |
Note: The document also mentions "In-house testing" results (sensitivity 1.000, specificity 0.9839, accuracy 99.03%) when tested against a commercial EIA and "samples documented to be positive by GC/MS." However, the clinical trial data are generally considered more robust for regulatory submission, so the clinical trial results are presented here.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 304 samples
- Data Provenance: Not explicitly stated, but the submission is from Syntron Bioresearch, Inc. in Carlsbad, California, suggesting the study was conducted in the United States. The study is a prospective clinical trial as distinct from "in-house testing".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The ground truth was established by comparison to a commercial EIA test, with positive results confirmed by GC/MS. This suggests the experts involved were likely laboratory personnel or clinicians interpreting the results of these established methods.
4. Adjudication Method (for the test set)
- Adjudication Method: The primary comparison was against a commercial EIA test. For all positive samples by either screening method (QuikPac II or EIA), confirmation was done by GC/MS. This acts as a definitive adjudicator for positive results. For negative results where both screening methods agreed, no further adjudication (like GC/MS) is mentioned, implying agreement between the two screening methods was sufficient for negative calls.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done. This device is a rapid diagnostic test, not an imaging analysis device where multiple human readers would typically be involved in interpreting the output in the same way. The performance is assessed based on the device's output compared to a reference method.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, a standalone study was done. The clinical trial explicitly measures the performance of the "QuikPac II One Step Cocaine Test" itself in detecting cocaine and its metabolites in urine, comparing its results directly to established reference methods (commercial EIA and GC/MS). This is a standalone performance assessment.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for positive samples was established by gas chromatography/mass spectrophotometry (GC/MS), which is a highly accurate and definitive method for drug identification and quantification. For negative samples, the agreement of a commercial EIA test with the QuikPac II test served as an initial ground truth, implicitly supported by the absence of GC/MS confirmation if both were negative.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not explicitly stated in the provided text. The document focuses on the performance of the device in a clinical trial, which typically uses a separate, independent test set. In-house testing is mentioned, which may have contributed to development and refinement, but no specific number or details about a formal training set are given.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not explicitly stated. Given the "in-house testing" mention, it's reasonable to infer that similar methods (commercial EIA and GC/MS) were used to establish ground truth during the development and optimization phases, but no specific details are provided.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).