Urine drug test THC Rapid Diagnostic Test,4mm dipcard detecting
Marijuana in urine, Quickly, Gold colloidal method
The THC Rapid Test Device (Urine) is a rapid visual immunoassay for
the qualitative presumptive detection of THC metabolites
(11-nor-Δ9-THC-9-carboxylic acid) in human urine specimens.
The THC Rapid Test Device (Urine) has been designed to detect the
THC metabolites through visual interpretation of color development
in the internal strip. The membrane was immobilized with THC
conjugates on the test region, and the sample pad was pre-coated
with colored anti-THC metabolites antibodies colloidal gold
conjugates. After specimens were added, the gold-conjugates move
along the membrane chromatographically by capillary action and
antibodies get to the test region. If there is no drug molecule in
the urine the antibody gold conjugate would attach to the drug
conjugate to form a visible line. Therefore, the formation of a
visible precipitant in the test region occurs when the urine is
negative for the drug. If THC metabolites are present in the urine,
the drug antigen competes with the immobilized drug conjugate on
the test region for limited antibody sites. In case of sufficient
concentration of the drug, it fills the limited antibody binding
sites. This will prevent attachment of the colored
antibody-colloidal gold conjugate to the drug conjugate zone on the
test region. Therefore, absence of the colored band on the test
region indicates a positive result. Appearance of a colored band at
the control region serves as a procedural control. This indicates
that proper volume of specimen has been added and membrane wicking
DIRECTIONS FOR USE
Bring tests, specimens, and/or controls to room temperature
(15-30°C) before use.
Remove the test from its sealed pouch, and place it on a clean,
level surface. Label the test with patient or control
identification. For best results, the assay should be performed
within one hour.
Using the provided disposable pipette, transfer 3 drops of specimen
(approximately 120 µL) to the specimen well (S) of the device and
start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add
any solution to the result area.
As the test begins to work, color will migrate across the membrane.
Wait for the colored band(s) to appear. The result should be read
at 5 minutes. Do not interpret the result after 8 minutes
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE:* A colored line appears in the Control region (C) and
colored lines appears in the Test region (T). This negative result
means that the concentrations in the urine sample are below the
designated cut-off levels for a particular drug tested.
*NOTE: The shade of the colored lines(s) in the Test region (T) may
vary. The result should be considered negative whenever there is
even a faint line.
POSITIVE: A colored line appears in the Control region (C) and NO
line appears in the Test region (T). The positive result means that
the drug concentration in the urine sample is greater than the
designated cut-off for a specific drug.
INVALID: No line appears in the Control region (C). Insufficient
specimen volume or incorrect procedural techniques are the most
likely reasons for Control line failure. Read the directions again
and repeat the test with a new test card. If the result is still
invalid, contact your manufacturer.
A procedural control is included in the test. A line appearing in
the control region
(C) is considered an internal procedural control. It confirms
sufficient specimen volume, adequate membrane wicking and correct
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.
The specimen correlation study was performed on 300 urine
specimens. All specimens were confirmed by GC/MS. These specimens
were randomized and tested using the THC One Step Marijuana Test
Strip (Urine). Specimens were rated as either positive or negative
at 5minutes. The test results are shown in Table 1.
Table 1: Specimen Correlation
When compared to GC/MS at 50 ng/mL, the following results were
|THC One Step Test Strip||+||-|
Positive agreement with GC/MS: 118/(118+4) = 97%
Negative agreement with GC/MS: 156/(156+22) = 88%
Total agreement with GC/MS: (118+156)/(118+4+22+156) = 91%
When compared to GC/MS at 25 ng/mL, the following results were
|THC One Step Test Strip||+||-|
Positive agreement with GC/MS: 135/(135+6) = 96%
Negative agreement with GC/MS: 154/(154+5) =97%
Total agreement with GC/MS: (135+154)/(135+6+5+154) = 96%