| Principle | Chromatographic Immunoassay |
| Format | Dipstick, Cassette, Panel, Cup |
| Specimen | Urine |
| Certificate | CE |
| Reading Time | 5 minutes |
| Pack | 40T/50T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
| Sensitivity | 97.10% |
| Specificity | 98.40% |
| Accuracy | 97.80% |
| Cut-Off | 25 ng/mL |
A rapid test for the qualitative detection of UR-144 in human
urine. For medical and other professional in vitro diagnostic use only.
INTENDED USE
The UR-144 Rapid Test Cassette (Urine) is a rapid chromatographic
immunoassay for the detection of UR-144 5-Pentanoic acid in human urine at a cut-off concentration
of 25 ng/mL.
This assay provides only a qualitative, preliminary analytical test
result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical
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 drug of abuse test result, particularly when preliminary positive results are used.
SUMMARY
UR-144 is a synthetic cannabinoid receptor agonist (SCRA) and has
affinity for CB1 and CB2 receptors. It has a high selectivity for the CB2-receptors.
UR-144 is a psychoactive substance and has effects similar to
delta-9-tetrahydrocannabinol (THC), though slightly less potent than THC. UR-144 has been detected in herbal
products marketed under a variety of names. In mice, UR-144 is moderately potent in reducing in a time- and
dose-dependent manner the locomotor activity (ID50-value 7.8 mg/kg), induces an anti-nociceptive
effect, and decreases rectal temperature and ring immobility with potencies several-fold greater than THC. In mice,
UR-144 substituted for THC in a THC discrimination study (ED50-value 7.1 to 7.4 µmol/kg
intra-peritoneal), an effect antagonized by rimonabant.
The UR-144 Rapid Test Cassette (Urine) yields a positive result
when UR-144 5-Pentanoic acid in urine exceeds 25 ng/mL.
PRINCIPLE
The UR-144 Rapid Test Cassette (Urine) is an immunoassay based on
the principle of competitive binding. Drugs which may be present in the urine specimen compete against
the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by
capillary action. UR-144, if present in the urine specimen below 25 ng/mL, will not saturate the binding sites
of antibody-coated particles in the test.
The antibody-coated particles will then be captured by immobilized
UR-144 conjugate and a visible colored line will show up in the test line region. The colored line will
not form in the test line region if the UR-144 5-Pentanoic acid level exceeds 25 ng/mL because it will saturate
all the binding sites of anti-UR-144 antibodies. A drug-positive urine specimen will not generate a
colored line in the test line region because of drug competition, while a drug-negative urine specimen or a
specimen containing a drug concentration lower than the cut-off will generate a line in the test line region. To
serve as a procedural control, a colored line will always appear in the control line region, indicating that proper
volume of specimen has been added and membrane wicking has occurred.
REAGENTS
The test contains mouse monoclonal UR-144 antibody-coupled
particles and UR-144-protein conjugate. A goat antibody is employed in the control line system.
PRECAUTIONS
• For medical and other professional in vitro diagnostic use only.
Do not use after the expiration date.
• The test should remain in the sealed pouch until use.
• All specimens should be considered potentially hazardous and
handled in the same manner as an infectious agent.
• The used test should be discarded according to local regulations.
STORAGE AND STABILITY
Store as packaged in the sealed pouch either at room temperature or
refrigerated (2-30 °C). The test is stable through the expiration date printed on the sealed pouch. The test
must remain in the sealed pouch until use.
DO NOT FREEZE. Do not use beyond the expiration date.
DIRECTIONS FOR USE
Allow the test, urine specimen, and/or controls to reach room
temperature (15-30 ºC) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove
the test cassette from the sealed pouch and use it within one hour.
2. Place the test device on a clean and level surface. Hold the
dropper vertically and transfer 3 full drops of urine (approx. 120 µL) to the specimen well (S) of the test
cassette, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the illustration
below.
3. Wait for the colored line(s) to appear. Read results at 5
minutes. Do not interpret the result after 10 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE:* Two distinct colored lines appear. One colored line
should be in the control line region (C), and another apparent colored line should be in the test line region
(T). This negative result indicates that the UR-144 5-Pentanoic acid concentrations are below the detectable
level (25 ng/mL).
*NOTE: The shade of color in the test line region (T) will vary,
but it should be considered negative whenever there is even a faint colored line.
POSITIVE: One colored line appears in the control region (C). No
line appears in the test line region (T). This positive result indicates that the UR-144 5-Pentanoic acid
concentration exceeds the detectable level (25 ng/mL).
INVALID: Control line (C) fails to appear. Insufficient specimen
volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the
procedure and repeat the test using a new test. If the problem persists, discontinue using the lot immediately and
contact your local distributor.
QUALITY CONTROL
A procedural control is included in the test. A colored line
appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen
volume, adequate membrane wicking and correct procedural technique.
Control standards are not supplied with this kit; however it is
recommended that positive and negative controls be tested as good laboratory practice to confirm the test
procedure and to verify proper test performance.
