Key Product Features
Multi-Drug Screening
Screen multiple drug classes simultaneously using a single urine test panel.
Rapid Results
Results are read at approximately 5 minutes, providing a rapid screening solution for professional applications.
Visual Interpretation
The test uses visible colored lines, eliminating the need for dedicated analytical instruments during the screening procedure.
Urine Specimen
The assay is designed specifically for human urine specimens. Urine collected at any time of day may be used.
Built-In Procedural Control
The control line provides an internal procedural control for adequate specimen volume and proper membrane migration.
Room-Temperature Storage
The test kit can be stored at 2–30°C until the expiry date shown on the sealed pouch.
The MDP-U501 is intended for human urine specimens only.
For best performance:
Collect urine in a clean, dry container.
Urine collected at any time of day may be used.
Turbid specimens should be centrifuged, filtered, or allowed to settle before testing.
Testing should preferably be performed immediately after specimen collection.
Urine may be stored at 2–8°C for up to 2 days.
For longer-term storage, specimens should be stored below −20°C.
Frozen specimens should be completely thawed and mixed thoroughly before testing.
Avoid repeated freeze-thaw cycles.
| Drug Parameter | Target / Calibrator | Cut-off |
|---|---|---|
| AMP | Amphetamine | 1,000 ng/mL |
| BZO | Oxazepam | 300 ng/mL |
| MOP | Morphine | 300 ng/mL |
| THC | 11-nor-Δ9-THC-9-COOH | 50 ng/mL |
| MET | Methamphetamine | 1,000 ng/mL |
INTRODUCTION
The Drugs of Abuse Test Panel (MDP-U501) is a rapid, qualitative immunochromatographic assay designed for the presumptive detection of selected drugs of abuse and their metabolites in human urine specimens. The test is intended for medical and other professional in vitro diagnostic use.
The MDP-U501 uses a multi-panel lateral flow format to provide simultaneous screening of multiple drug targets in a single urine specimen. The test is based on a competitive immunoassay principle and uses colored particle-based detection for visual interpretation of results.
Depending on the selected configuration, the test panel can be designed to detect a range of drug classes, including amphetamine, benzodiazepines, cocaine, methamphetamine, morphine/heroin, marijuana metabolites, fentanyl, ketamine, oxycodone, methadone and other target substances. The MDP-U501 configuration shown in this product includes AMP, BZO, MOP, THC and MET with defined cut-off concentrations.
The assay provides a preliminary qualitative screening result. A presumptive positive result should be confirmed using an appropriate, more specific analytical method when required.
PRINCIPLE
The Drugs of Abuse Test Panel is based on a competitive lateral flow immunochromatographic assay.
Each test strip contains drug conjugates immobilized in the test region of the membrane, while the conjugate pad contains monoclonal anti-drug antibodies associated with colored particles. When a urine specimen is applied, the specimen migrates through the membrane by capillary action and reacts with the antibody-colored particle conjugate.
When the target drug or metabolite is below the applicable cut-off concentration, the antibody-colored particle conjugate binds to the immobilized drug conjugate in the test region, resulting in the appearance of a visible test line (T).
When the target drug or metabolite is present at or above the applicable cut-off concentration, it competes with the immobilized drug conjugate for the available antibody binding sites. This competition prevents the antibody-colored particle conjugate from binding to the test region, resulting in the absence of the test line (T).
A colored control line (C) must appear to indicate that an adequate specimen volume was applied and that proper membrane migration has occurred. Therefore, the test is interpreted as follows:
Negative: Both C and T lines are visible.
Presumptive Positive: Only the C line is visible; the T line is absent.
Invalid: The C line does not appear.
The intensity of the test line may vary according to the concentration of the target substance; however, any visible test line is interpreted as negative. The test is qualitative and does not determine the actual concentration of the drug or metabolite in the specimen.
FAQ
Q: What is the cut-off level for your Cotinine urine test? Can it be customized?
A: Our standard cut-off is 200 ng/mL for Cotinine, consistent with major international guidelines. We offer customization of cut-off concentrations upon request to align with specific regional regulations or client protocols. Please share your target cut-off and intended application, and we will tailor the product accordingly.
Q: How long after nicotine use can Cotinine be detected in urine?
A: Cotinine has a biological half-life of approximately 16–20 hours and remains detectable in urine for 2–4 days after last nicotine exposure, depending on individual metabolism and frequency of use. This detection window makes it a reliable marker for both recent and regular tobacco use, outperforming nicotine itself which is cleared much faster.
Q: Can Cotinine be combined with other drugs in a multi-panel test?
A: Absolutely. While available as a standalone single-parameter test, we offer flexible multiplex integration-combining Cotinine with other DOA markers such as COC, THC, AMP, MET, MOP, BZO, and more. This is particularly valuable for workplace screening, insurance assessments, and clinical settings where both substance use and tobacco exposure need to be evaluated simultaneously.
Q: How does your test handle cross-reactivity with nicotine or other substances?
A: Our Cotinine test employs highly specific monoclonal antibodies that exhibit minimal cross-reactivity with nicotine (<0.1%), anabasine, cotinine-N-oxide, and other structurally related compounds. Combined with our proprietary anti-interference buffer, this ensures accurate differentiation between smokers and non-smokers, even in samples with high levels of urinary metabolites or endogenous interferences.
Q:What documentation do you provide for regulatory compliance and quality assurance?
A: We provide comprehensive technical dossiers including batch-specific Certificates of Analysis (COA) , stability study reports, IFU (Instruction For Use), and CE/FDA/ISO13485 documentation. For international distributors, we supply additional regulatory support files to assist with customs clearance and local registration in your target markets-whether in Europe, North America, Southeast Asia, the Middle East, or Latin America.
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