(28 days)
CR3 Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine is a rapid test for the qualitative detection of Phencyclidine and Methylenedioxymethamphetamine in human urine at a cutoff concentration of 25ng/mL and 500ng/mL. respectively.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.
The CR3 Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine test uses immunochromatographic assays for phencyclidine and methylenedioxymethamphetamine. The test is a lateral flow, one step system for the qualitative detection of phencyclidine and methylenedioxymethamphetamine in human urine.
The provided document describes the performance characteristics of the "CR3 Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine" device, a rapid test for the qualitative detection of Phencyclidine (PCP) and Methylenedioxymethamphetamine (MDMA) in human urine.
Here's an analysis based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific percentages for sensitivity, specificity, or overall agreement. However, it presents the results of several performance studies that demonstrate the device's capabilities, particularly around the established cut-off concentrations.
For the purpose of this analysis, we can infer the "acceptance criteria" from the performance reported in the "Precision" and "Lay-user study" sections, generally looking for high agreement around non-cutoff concentrations and a predictable range of positive/negative results at the cutoff.
Implied Acceptance Criteria and Reported Performance:
| Study Type / Metric | Acceptance Criteria (Inferred from common practice for drug tests) | Reported Device Performance (PCP) | Reported Device Performance (MDMA) |
|---|---|---|---|
| Precision Study | |||
| -100% Cut-off | 100% Negative | 50/0+ (50 Negative, 0 Positive) across 3 lots | 50/0+ (50 Negative, 0 Positive) across 3 lots |
| -75% Cut-off | 100% Negative | 50/0+ across 3 lots | 50/0+ across 3 lots |
| -50% Cut-off | 100% Negative | 50/0+ across 3 lots | 50/0+ across 3 lots |
| -25% Cut-off | 100% Negative (or very high percentage negative) | 50/0+ across 3 lots | 50/0+ across 3 lots |
At Cut-off (25 ng/mL for PCP, 500 ng/mL for MDMA) | Expected to show a mix of positive and negative results, demonstrating sensitivity at the cutoff, but no specific ratio is typically set as an acceptance criterion; rather, it should demonstrate the cutoff is truly a discrimination point. | 42+/8- (Lot 1 & 2), 43+/7- (Lot 3) for 50 tests | 42+/8- (Lot 1), 43+/7- (Lot 2 & 3) for 50 tests |
| +25% Cut-off | 100% Positive (or very high percentage positive) | 50+/0- across 3 lots | 50+/0- across 3 lots |
| +50% Cut-off | 100% Positive | 50+/0- across 3 lots | 50+/0- across 3 lots |
| +75% Cut-off | 100% Positive | 50+/0- across 3 lots | 50+/0- across 3 lots |
| +100% Cut-off | 100% Positive | 50+/0- across 3 lots | 50+/0- across 3 lots |
| Lay-User Study | |||
| Drug-free (-100%) | 100% Agreement with GC/MS (Negative) | 100% | Not applicable (combined drug-free for both) |
| -75% Cut-off | 100% Agreement with GC/MS (Negative) | 100% | 100% |
| -50% Cut-off | 100% Agreement with GC/MS (Negative) | 100% | 100% |
| -25% Cut-off | High Agreement with GC/MS (Negative), ideally >95% | 85% | 90% |
| +25% Cut-off | High Agreement with GC/MS (Positive), ideally >95% | 85% |
N/A