One Step Ketamine Test Device Package Insert

A rapid, one step test for the qualitative detection of Ketamine in human urine.

For healthcare professionals including professionals at point of care sites.

For in vitro diagnostic use only.

MOR/MET/THC/AMP/MDMA/MTD/COC/TCA/BAR/BZO, up to 15 kinds of Drug Tests

Format: Strip, Cassette, Cup,and Panel 

INTENDED USE

The KET One Step Ketamine Test Device is a lateral flow chromatographic immunoassay for the detection of  ketamine   in urine at a cut-off concentration of 1000 ng/mL.

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.

PRINCIPLE

The KET One Step Ketamine Test Device 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. Ketamine, if present in the urine specimen below the cutoff level, will not saturate the binding sites of the antibody in the test device. The ketamine conjugate will be captured by antibody 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 keamine level exceeds the cutoff concentration because it will saturate all the binding sites of anti-ketamine 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 will generate a line in the test line region because of the absence of drug competition.

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. 

POSITIVE: One colored line appears in the control region (C). No line appears in the test region (T).  This positive result indicates that the ketamine concentration exceeds the detectable level (1000 ng/mL).

NEGATIVE RESULT:Two lines appear. One colored line should be in the control region (C), and another colored line should be in the test region (T). This negative result indicates that the ketamine concentration is below the detectable level (1000 ng/mL).

INVALID RESULT: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 with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

LIMITATIONS

1.     The KET One Step ketamine Test Device provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. ^2,3

2.     It is possible that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.

3.     Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.

4.     Certain medications containing ketamine derivatives may produce a positive result. Additionally, foods and tea containing poppy products (the origin of the ketamine) may also produce a positive result.

5.     A Positive Result indicates presence of the drug or its metabolites but does not indicate level of intoxication, administration route or concentration in urine.

6.     A Negative Result may not necessarily indicate drug-free urine.  Negative results can be obtained when drug is present but below the cutoff level of the test.

7.   Test does not distinguish between drugs of abuse and certain medications.