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The KET Rapid Test Cassette (Urine) is a rapid chromatographic immunoassay for the detection ofKeta/mine in human urine at a cut-off concentration of 500ng/ml. This test will detect other relatedcompounds, please refer to the Analytical Specificity table in this package insert.
This assay provides only a preliminary analytical test result. A more specific alternate chemicalmethod must be used in order to obtain a confirmed analytical result. Gas chromatography/massspectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professionaljudgment should be applied to any drug of abuse test result, particularly when preliminary positiveresults are used.
SUMMARY
Keta/mine is a dissociative anesthetic developed in 1963 to replace PCP (Phen/cyclidine). WhileKeta/mine is still used in human anesthesia and veterinary medicine, it is becoming increasinglyabused as a street drug. Keta/mine is molecularly similar to PCP and thus creates similar effectsincluding numbness, loss of coordination, sense of invulnerability, muscle rigidity, aggressive / violentbehavior, slurred or blocked speech, exaggerated sense of strength, and a blank stare.
There isdepression of respiratory function but not of the central nervous system, and cardiovascular function ismaintained. The effects of Keta/mine generally last 4-6 hours following use. Keta/mine is excreted inthe 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 theuse of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels ofKeta/mine in urine. The KET Rapid Test Cassette (Urine) yields a positive result when Keta/mine inurine exceeds 500ng/ml.
PRINCIPLE
The KET Rapid Test Cassette (Urine) is a rapid chromatographic immunoassay based on the principleof competitive binding. Drugs which may be present in the urine specimen compete against the drugconjugate for binding sites on the antibody.
During testing, a urine specimen migrates upward by capillary action. Keta/mine, if present in the urinespecimen below 500ng/ml, will not saturate the binding sites of the antibody coated particles in thetest. The antibody coated particles will then be captured by immobilized Keta/mine conjugate and avisible colored line will show up in the test line region. The colored line will not form in the test lineregion if the Keta/mine level exceeds 500ng/ml because it will saturate all the binding sites ofanti-Keta/mine antibodies.
A drug-positive urine specimen will not generate a colored line in the test line region because of drugcompetition, while a drug-negative urine specimen or a specimen containing a drug concentration lessthan the cut-off will generate a line in the test line region. To serve as a procedural control, a coloredline will always appear at the control line region indicating that proper volume of specimen has beenadded and membrane wicking has occurred.
REAGENTS
The test contains mouse monoclonal anti-Keta/mine antibody-coupled particles and Keta/mine-proteinconjugate. 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 aninfectious 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 sealedpouch and use it within one hour.
2. Place the test cassette on a clean and level surface. Hold the dropper vertically and transfer 3 fulldrops of urine (approx. 120 uL) to the specimen well (S) of the test cassette, and then start thetimer. 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 theresult 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 anotherapparent colored line should be in the test line region (T). This negative result indicates that theKeta/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 concentrationof keta/mine present in the specimen. Therefore, any shade of color in the test line region (T) should beconsidered negative.
POSITIVE: One colored line appears in the control line region (C). No line appears in the test lineregion (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 proceduraltechniques are the most likely reasons for control line failure. Review the procedure and repeat thetest using a new test. If the problem persists, discontinue using the lot immediately and contact yourlocal distributor.
QUALITY CONTROL
A procedural control is included in the test. A colored line appearing in the control line region (C) isconsidered an internal procedural control. It confirms sufficient specimen volume, adequatemembrane 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 practiceto 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
Company Details
Bronze Gleitlager
,
Bronze Sleeve Bushings
and
Graphite Plugged Bushings
from Quality China Factory
Business Type:
Manufacturer,Exporter,Trading Company
Total Annual:
80000000-100000000
Employee Number:
500~10000
Ecer Certification：
Verified Supplier
CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies.
... CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies.
...
