(14 days)
Syntron's QuikPac II One Step Opiates assay is a rapid, qualitative, competitive binding immunoassay for the determination of Opiates in urine at the cutoff level of 2000 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. Syntron's QuikPac II One Step Opiates Test is not intended to monitor drug levels, but only to screen urines for the presence of Opiates and its metabolites.
Syntron's QuikPac II One Step Opiate 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 2000 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 an analysis of the acceptance criteria and study detailed in the provided text for the QuikPac II One Step Opiate Test:
Acceptance Criteria and Device Performance for QuikPac II One Step Opiate Test
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Relative Sensitivity (Positive Agreement) | 100% |
| Relative Specificity (Negative Agreement) | 100% |
| Accuracy | 100% |
2. Sample Size and Data Provenance
- Sample Size (Test Set): 829 samples were used in clinical trials.
- Data Provenance: The text does not explicitly state the country of origin. It conducted "in-house testing" and "clinical trials," and mentions "independent clinical trial." It does not specify whether the data was retrospective or prospective, though clinical trials typically imply prospective data collection.
3. Number of Experts and Qualifications for Ground Truth
- The text does not explicitly state the number of experts used.
- Qualifications of Experts: Not specified. The reference methods (Syva EMIT® II and GC/MS) serve as the primary ground truth, which are laboratory methods rather than expert human interpretation in this context.
4. Adjudication Method for the Test Set
- None directly applicable. For this type of chemical assay, adjudication methods like 2+1 or 3+1 are not typically used for establishing ground truth. The ground truth was established by objective laboratory methods (Syva EMIT® II and GC/MS). The text states: "All positive samples by either screening method were confirmed by GC/MS." This implies a confirmatory approach rather than expert adjudication of the screening results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC study was not done. This device is a standalone diagnostic test for chemical analysis (drug detection), not an imaging or interpretive device that would involve human readers.
6. Standalone Performance Study
- Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The performance metrics (sensitivity, specificity, accuracy) are for the device itself when compared against established laboratory methods.
7. Type of Ground Truth Used
- Laboratory Reference Methods: The primary ground truth was established by:
- Syva EMIT® II (Enzyme Multiplied Immunoassay Technique)
- Gas Chromatography/Mass Spectrophotometry (GC/MS) – specifically used to confirm all positive samples from either screening method.
8. Sample Size for the Training Set
- Not specified. The document mentions "in-house testing" but does not detail a separate training set size. For this type of immunoassay, extensive "training set" data for algorithm development in the modern sense is less common; rather, the device is developed and optimized based on biochemical principles and then validated.
9. How the Ground Truth for the Training Set Was Established
- Not specified as a distinct training set. The development and calibration would typically rely on known positive and negative samples, likely characterized by reference laboratory methods similar to those used for validation (e.g., GC/MS). The text focuses on the performance of the final device, implying that any internal development or "training" would have used similarly robust methods for ground truth if applicable.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).