Intended Use
Ketamine (KET) Rapid Test is an immuno-chromatographic assay for the qualitative determination of the presence of Ketamine (KET) listed in the table below.
Drug (Identifier) |
Calibrator |
Cut-off Level |
Ketamine (KET) |
Ketamine |
250ng/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 Ketamine (KET) of abuse test result, particularly when preliminary positive results are indicated.
Features
1. Simple, no need extra laboratory equipment or trainees;
2. Fast, reading results in 5 mins;
3. Accurate, total agreement 99.28%;
4. Affordable, high cost performance.
Principle
Ketamin (KET)Rapid Test is a competitive immunoassay that is used to screen for the presence of Ketamine (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.
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.
Instructions
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.
4. Results reading.
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 bandappearsinthe test region (T).
Invalid
Control band fails to appear.
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Company Profile
Dewei Medical Equipment Co., Ltd. is a high-tech enterprise specialized in developing and marketing of Medical Consmuables like Colloidal Gold Rapid Test Kits for Human and Vet, Hematology Analyzer and Reagents, Washing Solutions, Urine Sediment Reagents and DNA/RNA Preservation Kits.
Dewei products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories.
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