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| Customization: | Available |
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| Type: | IVD Reagent |
| Certificates: | ISO13485//Cfda |
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Intended use
The Multi-drug One Step Test Kit(Colloidal Gold Method) is a rapid chromatograpic immunoassay for the qualitative detection for the drugs and drug metabolites in human urine.
Pack Formats
Panel: 25 tests/box
Cassette: 25tests/box
Cup: 20 tests/box
Certificate
IVDD
Product superiority
1. High sensitivity and specificity;
2. Can test multiple drugs at one time;
3. Adulteration strips can be added to prevent inaccuracies caused by urine mixing with interfering substances.
Application
The test is used to obtain visual qualitative result and is intended for healthcare professionals use including professionals at point of care sites toassist in the determination of drug compliance.
Key Advantages
1. High Accuracy
Over 99% accuracy, fully compliant with international drug abuse monitoring standards.
2. Strong Specificity
Monoclonal antibodies with high specificity effectively reduce the risk of cross-reactivity.
3. Easy to Use
No instruments or additional tools required. Samples are easy to collect and testing can be conducted directly on site.
4. Rapid Results
Results are ready to interpret within 5 minutes, saving valuable time.
5. Multi-Drug Screening
Capable of detecting multiple drugs simultaneously, offering comprehensive testing solutions.
| Format | cassette, panel, and cup |
| Cassette Format | Customized, up to 6 panelspanel format: up to 16 panels |
| Cup Format | up to 18 panels |
Testing Procedures
Interpretation of Results:
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Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T). The absence of a line in the test region (T)indicates a positive result. The positive result indicates that the drug concentration in the urine specimen is above the designated cut-off level for that specific drug. |
| Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T). The negative result indicates that the drug concentration in the urine specimen is below the designated cut-off level for that specific drug. |
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| Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor. |
Test Limitations
1. Failure to use this kit as directed may result in an insufficient sample or an inaccurate screening result.
2. The possibility exists that substances and factors not described in this instruction may interfere with the test, causing false results (e.g. technical or procedural error).
3. This test provides a screening result t is not designed to determine the actual concentration of a drug or the level of intoxication.
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