Artron Fast Detect Multi-Drug Cup
Catalog Number:A04-19-150 (3 Drugs Cup) A04-20-150 (5 Drugs Cup) A04-27-150 (6 Drugs Cup) A04-21-150 (7 Drugs Cup) A04-22-150 (8 Drugs Cup) A04-23-150 (10 Drugs Cup) A04-26-150 (11 Drugs Cup) A04-24-150 (12 Drugs Cup) A04-28-150 (13 Drugs Cup) A04-25-150 (14 Drugs Cup)
INTENDED USE:
Artron Fast DetectTM Multi-Drug Cup is a test intended to provide a qualitative detection for the following drugs: amphetamines (AMP), barbiturates (BAR), benzodiazepines (BZO), cocaine (COC), ecstasy (MDMA), methamphetamines (MET), opiates (OPI), buprenorphine (BUP), oxycodone (OXY), phencyclidine (PCP), tricyclic antidepressants (TCA), marijuana (THC), morphine (MOR) and methadone (MTD) (depending on the test kit purchased).
DESCRIPTION:
This rapid screening test utilizes a competitive inhibition immunochromatographic assay and is only the first step in a two-step process for determining the presence of the above drugs in a urine sample.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be sought in evaluating test results – particularly preliminary positive results. A more specific alternate chemical method is required to obtain a confirmed analytical result. Gas Chromatography/Mass Spectroscopy (GC/MS) is the recommended method for confirmation. For the confirmation of TCA, High-Performance Liquid Chromatography (HPLC) is the preferred method.
Artron Fast DetectTM Multi-Drug Cup is not for legal or medical diagnostic purposes. For diagnostic or treatment purposes, consult with a healthcare or substance abuse professional.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be sought in evaluating test results – particularly preliminary positive results. A more specific alternate chemical method is required to obtain a confirmed analytical result. Gas Chromatography/Mass Spectroscopy (GC/MS) is the recommended method for confirmation. For the confirmation of TCA, High-Performance Liquid Chromatography (HPLC) is the preferred method.
Artron Fast DetectTM Multi-Drug Cup is not for legal or medical diagnostic purposes. For diagnostic or treatment purposes, consult with a healthcare or substance abuse professional.
SAMPLE TYPE:
Time to Results:
10 min (Strong positive specimens may produce positive results in as little time as 1 minute. Confirm negatives in 10-20 minutes.)
Analytical Sensitivity:
n/a
Analytical Specificity:
No cross reactions were observed from all tested specimens
Interference:
No interference from common biological and chemical analytes
Diagnostic Sensitivity:
n/a
Diagnostic Specificity:
n/a
Accuracy:
n/a
Precision
The precision was determined by replicating assays of both positive and negative urine samples with devices from three different production lots. The resultant data indicated no appreciable inter-lot variation when testing both positive and negative samples across three different lots of devices
Storage condition:
Store at 4-30°C, avoid direct sunlight and freezing.
Shelf life:
36 months
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WARNINGS AND PRECAUTIONS
- For professional in vitro diagnostic use only.
- Do not reuse.
- Do not use if the product is sealed barrier or its packaging is compromised.
- Do not use it after the expiration date shown on the pouch.
- Do not mix and interchange different specimens.
- Wear protective clothing such as laboratory coats, disposable gloves, and eye protection while handling potentially infectious material and performing the assay.
- Wash hands thoroughly after finishing the tests.
- Do not eat, drink or smoke in the area where the specimens or kits are handled.
- Clean up spills thoroughly with appropriate disinfectants.
- Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing procedures.
- Dispose of all specimens and used devices in a proper bio-hazard container. The handling and disposal of hazardous materials should follow local, national, or regional regulations.
- Keep out of children’s reach.