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 |
