A rapid test for the qualitative detection of Keta/mine in human
urine.
For medical and other professional in vitro diagnostic use only.
| Principle | Chromatographic Immunoassay |
| Format | Dipstick, Cassette, Panel, Device, Cup |
| Specimen | Urine,Oral Fluid,Powder,WB/S/P,Hair |
| Certificate | CE |
| Reading Time | 5 minutes |
| Pack | 10T/25T/40T/50T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
| Sensitivity | 97.50% |
| Specificity | 98.20% |
| Accuracy | 98.00% |
| Cut-Off | 50 ng/mL* ,100 ng/mL, 200 ng/mL, 300 ng/mL, 500 ng/mL, 1000
ng/mL*,0.2 ng/mg |
INTENDED USE
The KET Rapid Test Cassette (Urine) is a rapid chromatographic
immunoassay for the detection of Keta/mine in human urine at a cut-off concentration of 500ng/ml.
This test will detect other related compounds, please refer to the Analytical Specificity table in this
package insert.
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.
SUMMARY
Keta/mine is a dissociative anesthetic developed in 1963 to replace
PCP (Phen/cyclidine). While Keta/mine is still used in human anesthesia and veterinary
medicine, it is becoming increasingly abused as a street drug. Keta/mine is molecularly similar to PCP
and thus creates similar effects including numbness, loss of coordination, sense of invulnerability,
muscle rigidity, aggressive / violent behavior, slurred or blocked speech, exaggerated sense of strength,
and a blank stare.
There is depression of respiratory function but not of the central nervous
system, and cardiovascular function is maintained. The effects of Keta/mine generally last 4-6 hours
following use. Keta/mine is excreted in the urine as unchanged drug (2.3%) and metabolites (96.8%).
The KET Rapid Test Cassette (Urine) is a rapid urine screening test
that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to
selectively detect elevated levels of Keta/mine in urine. The KET Rapid Test Cassette (Urine) yields a
positive result when Keta/mine in urine exceeds 500ng/ml.
PRINCIPLE
The KET Rapid Test Cassette (Urine) is a rapid chromatographic
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. Keta/mine, if present in the urine specimen below 500ng/ml, will not saturate the binding sites of the
antibody coated particles in the test. The antibody coated particles will then be captured by
immobilized Keta/mine 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 Keta/mine level exceeds 500ng/ml because it will
saturate all the binding sites of anti-Keta/mine 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 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.
REAGENTS
The test contains mouse monoclonal anti-Keta/mine antibody-coupled
particles and Keta/mine-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.
DIRECTIONS FOR USE
Allow the test, urine specimen, and/or controls to reach room
temperature (15-30ºC) 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 cassette on a clean and level surface. Hold the
dropper vertically and transfer 3 full drops of urine (approx. 120 uL) 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 color line(s) to appear. The result should be read
at 5 minutes. Do not interpret the result after 10 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE:* Two 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 Keta/mine concentration is below the detectable level (500ng/ml).
*NOTE: The intensity of the color in the test line region (T) may
vary depending on the concentration of keta/mine present in the specimen. Therefore, any shade of color
in the test line region (T) should be considered negative.
POSITIVE: One colored line appears in the control line region (C).
No line appears in the test line region (T). This positive result indicates that the Keta/mine
concentration exceeds the detectable level (500ng/ml).
INVALID: Control line 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 line 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.
Order Information
| Cat. No. | Product | Specimen | Pack |
| DKE-102 | Keta/mine (KET)Rapid Test Cassette | Urine | 40T |
| DKE-114 | Keta/mine (KET)Rapid Test Panel | Urine | 40 T |
| DKE-101 | Ket/amine (KET)Rapid Test Dipstick | Urine | 50 T |
| DKE-802 | Keta/mine(KET) Rapid Test Cassette | Oral Fluid | 25 T |
| DKE-803 | Keta/mine(KET) Rapid Test Device | Oral Fluid | 25 T |
| DKE-402 | Keta/mine(KET) Rapid Test Cassette | WB/S/P | 40 T |
| DKE-X14 | Keta/mine (KET)Rapid Test Panel | Powder | 25 T |
| DKE-H902 | Keta/mine (KET)Rapid Test Cassette | Hair | 10 T |
