Cassette Test Kit for KET Colloidal Gold Lateral Flow Test 5 Minute Reading Time

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

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

Drug(Identifier)	Calibrator	Cut-off level
(KET)	Ket	1000 ng/mL

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

(e 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

ADVANTAGES
1.Simple steps
2.Can be used in oyers
3.Results available to be photocopied
4.Clear interpretation
5.Cut-off available (1000 ng/mL)

OPERATION
Test must be in room temperature (15ºC to 30ºC)
1. Donor collects urine specimen in a urine cup.
2. Cassette and Strip Operation:
2.1 Cassette: Remove test device/cassette from the sealed pouch. Lay the cassette flat, add 2 drops of urine specimen by sample dropper into the sample well.
2.2 Distick Panel or Strip: Remove test strip from the sealed pouch. Dip the arrowed end of the test strip into the container with urine sample, take it out in 10 seconds and lay flat.
3. The result should be read at 5 minutes. Donot interpretthe result after 10 minutes.

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. Onebandappears in the control region (C) and another bandappearsinthe test region (T). Invalid Control band fails to appear. Results fromanytest whichhas not produced a control band at the specifiedreadtimemust be discarded.
Please review the procedureandrepeatwith a new test. If the problem persists, discontinueusingthekit immediately and contact your local distributor.

PERFORMANCE CHARACTERISTICS
Accuracy
The comparison studies were conducted using  (KET)Rapid Test and commercially available rapid drugs of abuse tests. The studies were performed on approximately 600 clinical specimens previous collected from the clinical settings. Presumptive positive results were confirmed by GC/MS. Results were as follows:

Test	Ket
Positive Agreement	97.62%
Negative Agreement	99.28%

Specificity and cross reactivity
To test the specificity and cross reactivity of the test, the test device was used to test (KET), metabolites and other components of the same class that are likely to be present in urine. All the components were added to drug-free normal human urine. The following structurally related compounds produced positive results with the test when tested at levels equal to or greater than the concentrations listed below.

For further operation or performance details, please refer to final instruction manual.