KET Cassette Rapid Test Kit for Urine Sample

KET Cassette Rapid Test Kit for Urine Sample

KET Rapid Test is a rapid, screening test for the qualitative detection of KET and metabolites in human urine at specified cut off levels.

For professional use only.

For in vitro diagnostic use only.

【INTENDED USE】

KET Rapid Test is an immuno-chromatographic assay for the qualitative determination of the presence of KET listed in the table below.

This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to KET of abuse test result, particularly when preliminary positive results are indicated.

【SUMMARY】

KET is a dissociative anesthetic developed in 1963 to replace PCP. While KET is still used in human anesthesia and veterinary medicine, it is becoming increasingly abused as a street drug. KET 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 KET generally last 4-6 hours following use. KET is excreted in the urine as unchanged drug (2.3%) and metabolites (96.8%).

【PRINCIPLE】

KET Rapid Test is a competitive immunoassay that is used to screen for the presence of KET and metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody (mouse) conjugate binding sites.

When the test is activated, the urine is absorbed into test Cassette by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test Cassette. This produces a colored Test line in the Test Region (T) of the Cassette, which, regardless of its intensity, indicates a negative test result.

When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.

To serve as a procedure control, a colored line will appear at the Control Region (C) of Cassette, if the test has been performed properly.

【WARNINGS AND PRECAUTIONS】

• Immunoassay for in vitro diagnostic use only.
• Do not use after expiration date.
• The test should remain in the sealed pouch until use.
• The used test should be discarded according to local regulations.

【CONTENTS】

• Drug Test.
• Desiccant
• Leaflet with instruction for use.

【STORAGE AND STABILITY】

• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Keep away from direct sunlight, moisture and heat.
• Do not freeze.
• Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.

【OPERATION】

Test must be in room temperature (15ºC to 30ºC)

1. Donor collects urine specimen in a urine cup.
2. Open the sealed pouch by tearing along the notch. Remove the test from the pouch and place it on a level surface.
3. Hold the sample dropper vertically, and add exactly three drops of the urine specimen into the sample well.
4. The result should be read at 5 minutes. Do not interpret the result after 10 minutes. See the illustration below.

【INTERPRETATION OF RESULTS】

Preliminary positive (+)

Only one colored band appears, in the control region (C). No colored band appears in the test region (T).

Negative (-)

Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

Invalid

Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.