CAT Rapid Diagnostic Test/ Cathinone Rapid Diagnostic Test High Sensitivity Cut - Off 150ng/Ml

CAT Rapid Diagnostic Test/ Cathinone Rapid Diagnostic Test High Sensitivity Cut - Off 150ng/Ml

Product Name

CAT Rapid Diagnostic Test/ Cathinone Rapid Diagnostic Test

Specimen: Urine

Background

Cathine, also known as d-norpseudoephedrine, is a psychoactive drug of the phenethylamine and amphetamine chemical classes which acts as a stimulant. Along with cathinone, it is found naturally in Catha edulis (Khat), and contributes to its overall effects. It has approximately 10-14% the potency of amphetamine.Cathine is a Schedule III drug under the Convention on Psychotropic Substances.

Detection of Cathine in urine thus provides evidence of presence of Cathinone and/ or Cathine use, by the person, whose urine is tested.

Intended Use

The CAT Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative presumptive detection of Cathine in human urine specimens.

Test Principle

During testing, a urine specimen migrates upward by capillary action. A drug, if present in the urine specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test region of the specific drug dipstick. The presence of drug above the cut-off concentration will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test region.

A drug-positive urine specimen will not generate a colored line in the specific test region of the dipstick because of drug competition, while a drug-negative urine specimen will generate a line in the test region because of the absence of drug competition.

To serve as a procedural control, a colored line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

LIMITATION

1. The CAT Rapid Test Cassette (Urine) 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. 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. A positive result indicates presence of the drug or its metabolites but does not indicates level of intoxication, administration route or concentration in urine.

5. A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cut-off level of the test.

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

INTERPRETATION OF RESULTS

NEGATIVE:* A colored line appears in the Control region (C) and colored lines appears in the Test region (T). This negative result means that the concentrations in the urine sample are below the designated cut-off levels for a particular drug tested.

*NOTE: The shade of the colored lines(s) in the Test region (T) may vary. The result should be considered negative whenever there is even a faint line.

POSITIVE: A colored line appears in the Control region (C) and NO line appears in the Test region (T). The positive result means that the drug concentration in the urine sample is greater than the designated cut-off for a specific drug.

INVALID: No line appears in the Control region (C). Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for Control line failure. Read the directions again and repeat the test with a new test card. If the result is still invalid, contact your manufacturer.

QUALITY CONTROL

A procedural control is included in the test. A line appearing in the control region

(C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.

PRECISION

A study was conducted at 3 hospitals by laypersons using 3 different lots of product to demonstrate the within run, between run and between operator precision. An identical panel of coded specimens containing no alpha-Pyrrolidinovalerophenone, 25% alpha -Pyrrolidinovalerophenone above and below the cutoff and 50% alpha-Pyrrolidinovalerophenone above and below the 1000ng/mL cutoff were provided to each site. The following results were tabulated: