FKET Rapid Test Panel For The Qualitative Detection Of F-Ketamine In Human Urine

A rapid test for the qualitative detection of F-Ketamine in human urine , FKET Rapid Test Panel

【INTENDED USE】

The FKET Rapid Test Panel (Urine) is a rapid chromatographic immunoassay for the detection of F-Ketamine in human urine at a cut-off concentration of 1000 ng/ml.

This assay provides only a qualitative, 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】

F-Ketamine is generally used as the replacement of ketamine with hallucinogenic properties.When abused, people are immersed in anesthesia situation with distorting perceptions of sight and sound and feeling out of control1. Currently, there is limited research and using regulation of F-Ketamine. Therefore, a large number of people abuse F-Ketamine instead of ketamine. But nowadays, the detection of F-Ketamine is restricted to high performance liquid chromatography (HPLC), gas chromatograph-mass spectrometer (GC-MS), thin layer chromatography (TLC), etc. which require not only expensive equipment but professional analysis2. At the same time, high purity of test material and complex operation are necessary as well. Therefore, it is a tendency that the test methods of FKET become fast and convenient.

The FKET Rapid Test Panel (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 F-Ketamine in urine. The FKET Rapid Test Panel (Urine) yields a positive result when F-Ketamine in urine exceeds 1000ng/ml.

【PRINCIPLE】

The FKET Rapid Test Panel (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. F-Ketamine, if present in the urine specimen below 1000 ng/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 F-Ketamine 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 F-Ketamine level exceeds 1000 ng/ml because it will saturate all the binding sites of anti-F-Ketamine 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 in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

【DIRECTIONS FOR USE】

Allow the test, urine specimen, and/or controls to reach room temperature (15-30ºC) prior to testing.

• Bring the pouch to room temperature before opening it. Remove the test panel from the sealed pouch and use it within one hour.
• Remove the cap.
• With the arrow pointing toward the urine specimen, immerse the test panel vertically in the urine specimen for at least 10 to 15 seconds. Immerse the strip to at least the level of the wavy lines, but not above the arrow on the test panel.

Replace the cap and place the test panel on a non-absorbent flat surface.

 Start the timer and wait for the colored 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 colored 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). A negative result indicates that the F-Ketamine concentration is below the detectable level (1000ng/ml).

*NOTE: The shade of color in the test line region (T) may vary, but it should be considered negative whenever there is even a faint colored line.

POSITIVE: One colored line appears in the control line region (C). No line appears in the test line region(T). A positive result indicates that the F-Ketamine concentration exceeds the detectable level (1000ng/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 testing practice to confirm the test procedure and to verify proper test performance.