- Product Overview
Athendia drug abuse rapid test is a rapid screening test for the qualitative detection of different drugs in human urine at specified cut off levels. Athendia rapid tests are for professional use only and for in vitro diagnostic use only.
- INTENDED USE
Drug Abuse Rapid Test is an Immuno-chromatographic assay for the qualitative determination of the presence of Drug (e.g. Morphine) in the human urine sample.
| Drug | Calibrator | Cut-off level |
| e.g. Morphine | 300ng/mL |
This assay provides only a preliminary analytical test result or screening test. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to each drug specific test result, particularly when preliminary positive results are indicated. For adulterations, some tests result are false negative and Athendia Rapid tests for drug abuse are False Negative Free Tests (FNFT).
- Product Summary
The major pathways of elimination of many drugs are kidneys (urine) and the liver where they are conjugated (e.g. with glucuronic acid). Drug metabolites predominantly can be detected in urine, such as result of heroin, morphine, codeine or poppy seed intake. For example Athendia false negative free test, can detect the concentration of Opiates in urine exceeds 300ng/mL.
- product Principle
Athendia FNFT are competitive immunoassays that use a chromatographic absorbent device to screen for the presence of drug metabolites in urine. In this device, drugs in a urine sample compete with a limited number of drug monoclonal antibody (mouse) conjugate binding sites. When the test is activated, the urine is absorbed into the test by capillary action, mixes with the drug monoclonal antibody conjugate, and flows across a pre-coated membrane. If the drug level in the urine sample is below the test’s detection limit, the drug monoclonal antibody conjugate binds to the drug-protein conjugate immobilized in the Test Region (T) of the test, producing a colored Test line in the Test Region (T). This indicates a negative test result, regardless of the intensity of the line. If the drug level in the sample is at or above the test’s detection limit, the free drug in the sample binds to the drug monoclonal antibody conjugate, preventing the drug monoclonal antibody conjugate from binding to the drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result. A colored line will appear at the Control Region (C) of the Test to serve as a procedure control, indicating that the test was performed properly.
- WARNINGS AND PRECAUTIONS
- Immunoassay for in vitro diagnostic use only.
- Do not use after expiration date.
- The test should remain in the sealed pouch until use.
- The used test should be discarded according to local regulations.
- Content
- Drug Test.
- Desiccant
- Leaflet with instruction for use.
- Storage and Stability
- The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
- The test must remain in the sealed pouch until use.
- Keep away from direct sunlight, moisture and heat.
- Do not freeze.
- Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
- Operation
- Test must be in room temperature ( 15ºC to 30ºC)
- Donor collects urine specimen in a urine cup.
- Open the sealed pouch by tearing along the notch. Remove the test from the pouch and place it on a level surface.
- Hold the sample dropper vertically, and add exactly three drops of the urine specimen into the sample well.
- The result should be read at 5 minutes. Do not interpret the result after 10 minutes. See the illustration below.
- Interpretation of Results
Preliminary positive (+)
Only one colored band appears, in the control region (C). No colored band appears in the test region (T).
True Negative (-)
Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T). No band in interference region (I).
False Negative (+)
One colored bands appear on the membrane. One band appears in the control region (C) and No band appears in the test region (T) and No band in interference region (I). It shows adulteration.
Invalid
Control band fails to appear. Results from any test which has not produced a control band at the specified read 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.