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
For in vitro diagnostic use only.
Format: Strip, Cassette, Cup,and Panel
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.
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
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.
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
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
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
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