CAT Rapid Diagnostic Test/ Cathinone Rapid Diagnostic Test Cassete

CAT Rapid Diagnostic Test/ Cathinone Rapid Diagnostic Test

Specimen: Urine

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.

DIRECTIONS FOR USE

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.

Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.

Using the provided disposable pipette, transfer 3 drops of specimen (approximately 120 µL) to the specimen well (S) of the device and start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

As the test begins to work, color will migrate across the membrane.

Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 8 minutes

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.

performance characteristics

The specimen correlation study was performed on 300 urine specimens. All specimens were confirmed by GC/MS. These specimens were randomized and tested using the CAT One Step Cathine Test Strip (Urine). Specimens were rated as either positive or negative at 5minutes. The test results are shown in Table 1.

1: Specimen Correlation

When compared to GC/MS at 150 ng/mL, the following results were tabulated:

Positive agreement with GC/MS: 118/(118+4) = 97%

Negative agreement with GC/MS: 156/(156+22) = 88%

Total agreement with GC/MS: (118+156)/(118+4+22+156) = 91%