(43 days)
The Chemtrue® BUP/TCA Single/Multi-Panel Drug Screen Dip Card /Cup/Cassette Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine (BUP) and/or Tricyclic Antidepressants (TCA) drugs in human urine. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to distinguish between prescription use or abuse of Buprenorphine and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for Buprenorphine and Tricvclic Antidepressants in urine.
The Chemtrue® Multi-Panel Drug Screen Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Marijuana, Morphine, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants drugs in human urine. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
The Chemtrue® Multi-Panel Drug Screen Dip Card with OPI 2000 Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Marijuana. Opiates 2000. Methamphetamine. Phencyclidine. Benzodiazepines. Barbiturates. Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants drugs in human urine. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
The Chemtrue® Drug Screen Tests are colloidal gold based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in the formats of dip card, cup, or cassette, as indicated by the test name.
Here's a breakdown of the acceptance criteria and the study information for the Chemtrue® BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests, based on the provided text.
Acceptance Criteria and Device Performance
The acceptance criteria for this device are demonstrated through its performance in various studies, primarily focusing on reproducibility (precision) and method comparison (accuracy) against GC/MS (or LC/MS for some lay-user studies). The device aims to provide qualitative detection of drugs of abuse in human urine.
Acceptance Criteria (Implicit from Performance Studies):
The device is expected to:
- Consistently produce negative results for samples with no drug present or drug concentrations significantly below the cutoff (e.g., 50% of cutoff).
- Consistently produce positive results for samples with drug concentrations significantly above the cutoff (e.g., 125%, 150%, 200% of cutoff).
- Show predictable behavior around the cutoff, with a mix of positive and negative results when concentrations are at or near the cutoff (e.g., 75% of cutoff, cutoff).
- Demonstrate high agreement with confirmed analytical methods (GC/MS or LC/MS).
- Be free from interference from common substances/drugs.
- Maintain performance across a range of urine pH and specific gravity.
- Have a stable shelf-life.
- Be easily understood and used by lay-users (for OTC versions).
Table of Acceptance Criteria and Reported Device Performance (BUP & TCA only, as they are the new analytes):
| Study Type | Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Example for BUP Dip Card) |
|---|---|---|---|
| Reproducibility (Precision) | Negative Samples: 100% negative results significantly below cutoff. | ||
| Positive Samples: 100% positive results significantly above cutoff. | |||
| Near Cutoff: Demonstrates consistent performance, with an expected increase in positive results as concentration approaches and exceeds cutoff. | High consistency in results across different operators, lots, and days, especially for samples significantly below and above the cutoff. | BUP Dip Card: |
- Negative (30 samples): 0 (+) / 30 (-)
- 50% Cutoff (30 samples): 0 (+) / 30 (-)
- 75% Cutoff (30 samples): 0 (+) / 30 (-)
- Cutoff (30 samples): 10 (+) / 20 (-)
- 125% Cutoff (30 samples): 30 (+) / 0 (-)
- 150% Cutoff (30 samples): 30 (+) / 0 (-)
TCA Dip Card: - Negative (30): 0 (+)/30 (-); 50% cutoff (30): 0 (+)/30 (-); 75% cutoff (30): 0 (+)/30 (-); Cutoff (30): 1 (+)/29 (-); 125% cutoff (30): 30 (+)/0 (-); 150% cutoff (30): 30 (+)/0 (-) |
| Specificity | Cross-reactivity: No significant false positives from non-target compounds.
Known Cross-reactants: Identified and quantified cross-reactivity for structurally similar compounds. | Low or no cross-reactivity with common substances/drugs at typical concentrations, and expected cross-reactivity with known related compounds. | Buprenorphine (BUP): Norbuprenorphine 10 ng/mL (100% cross-reactivity).
Tricyclic Antidepressants (TCA): Nortriptyline 1000 ng/mL (100% cross-reactivity), Amitriptyline 1000 ng/mL (100%), Desipramine 300 ng/mL (333%), Imipramine 50 ng/mL (2000%), etc.
Interference: Over 100 potential interferents tested and found not to cross-react at 100 µg/mL at ±25% of BUP and TCA cut-off. |
| Method Comparison (Accuracy)| Agreement with GC/MS: High percentage agreement for both positive and negative results when compared to the gold standard GC/MS.
Discordant Results: Limited number of discordant results, primarily near the cutoff concentration. | High sensitivity and specificity demonstrated by high agreement (e.g., >95-100%) with GC/MS for samples well above or below the cutoff. | BUP Dip Card: - Agreement for Positives: 100% (based on 33 samples: 2 near-cutoff neg, 6 near-cutoff pos, 25 GC/MS pos)
- Agreement for Negatives: 96.3% (based on 52 samples: 40 no drug, 7 GC/MS neg, 5 near-cutoff neg)
TCA Dip Card: - Agreement for Positives: 100% (based on 34 samples: 0 near-cutoff neg, 8 near-cutoff pos, 26 GC/MS pos)
- Agreement for Negatives: 100% (based on 55 samples: 40 no drug, 6 GC/MS neg, 9 near-cutoff neg)
Discordant: 2 discordant results for Buprenorphine (9.5 and 9.8 ng/mL GC/MS value, but device read positive). |
| Effect of Urine pH & Specific Gravity | Consistent performance across physiological ranges. | Test performance unaffected by urine pH 3.0 to 8.5 and specific gravity 1.002 to 1.030. |
| Lay-user Studies (OTC) | Agreement with LC/MS: High percentage agreement with LC/MS across various drug concentrations.
Ease of Use: High percentage of users find instructions easy to follow. | High accuracy when used by lay-users; clear and understandable instructions. | BUP Lay-user (Dip Card): 100% agreement across all tested concentrations (no drug, 50%, 75%, 125%, 150%, 200% of cutoff).
TCA Lay-user (Dip Card): 100% agreement except for 75% of cutoff (1 positive/29 negative, 96.7% agreement).
Ease of Use: 99% of lay-users found the instructions easy to follow. Flesch-Kincaid reading grade level
§ 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).