Drug Abuse Test Kit K2 (Synthetic Marijuana) Rapid Diagnostic Test
strip, professional use, urine drug test, 50ng/ml
Product Name
K2 (Synthetic Marijuana) Rapid Diagnostic Test Strip
Specimen: Urine
| Product | Cat No | Specimen | Sensitivity | Format | Kit Size |
| K2 | YD131S3 | Urine | 50 ng/mL | 3mm Strip | 100T |
| YD131C4 | 4mm Cassette | 25T |
Intended Use
The Synthetic Marijuana (K2) Rapid Test Strip (Urine) is a rapid
chromatographic immunoassay for the detection of Synthetic
Marijuana metabolite in human urine. The synthetic marijuana
detected by the test includes, but are not limited to, the
metabolites of JWH-018 and JWH-073. This assay provides only a
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) is
the preferred confirmatory method. Clinical consideration and
professional judgment should be applied to any drug of abuse test
result, particularly when preliminary positive results are used.
| Parameter | Calibrator | Cut-off (ng/mL) |
| K2(Synthetic Marijuana) | Synthetic Marijuana | 50 |
Test Principle
The K2 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. Synthetic Marijuana metabolite, if present in
the urine specimen below 50ng/mL, will not saturate the binding
sites of antibody-coated particles in the test device. The
antibody-coated particles will then be captured by immobilized
synthetic marijuana 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 Synthetic Marijuana metabolite level
exceeds 50ng/mL because it will saturate all the binding sites of
anti- Synthetic Marijuana antibodies. A drug-positive urine
specimen will not generate a colored line in the test line region,
while a drug-negative urine specimen or a specimen containing a
drug concentration less 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 at the control line region indicating that
proper volume of specimen has been added and membrane wicking has
occurred.
DIRECTIONS FOR USE
- Bring the pouch to room temperature before opening it. Remove the
Test Dipstick from the sealed pouch and use it within one hour.
- With arrows pointing towards the urine specimen, immerse the Test
Dipstick vertically in the urine specimen in such a way that urine
does not cross MAX line on the Test Dipstick for 10-15 seconds. See
the illustration below.
- Wait for the color line(s) to appear. The result should be read at
5 minutes. Do not interpret the result after 10 minutes.
INTERPRETATION OF RESULTS
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.
PERFORMANCE:
Accuracy
A side-by-side comparison was conducted using the K2 Rapid Test
Dipstick (Urine) and GC/MS. The following results were tabulated:
| Method | | | | GC/MS | Total Results |
| K2 Rapid | | | Results | Positive | Negative | |
| | Positive | 78 | 3 | 81 |
| Test Dipstick | | |
| Negative | 2 | 167 | 169 |
| |
| Total Results | | 80 | 170 | 250 |
| % Agreement | | 97.5% | 98.2% | 98.0% |
Analytical Sensitivity
A drug-free urine pool was spiked with K2 at the following
concentrations: 0,25,37.5,50,62.5,75 and 150ng/mL. The results
demonstrate >99% accuracy at 50% above and 50% below the cut-off
concentration. The data are summarized below:
| Synthetic Marijuana | Percent of | n | Visual Result |
| Concentration (ng/mL) | Cut-off | Negative | Positive |
|
| 0 | 0% | 30 | 30 | 0 |
| 25 | -50% | 30 | 30 | 0 |
| 37.5 | -25% | 30 | 26 | 4 |
| 50 | Cut-off | 30 | 15 | 15 |
| 62.5 | +25% | 30 | 3 | 27 |
| 75 | +50% | 30 | 0 | 30 |
| 150 | 3X | 30 | 0 | 30 |
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
