A rapid test for the qualitative detection of Caff/eine CE certified

Applications:

The CAF Rapid Test Cassette (Urine) is a rapid chromatographic immunoassay for the detection of caf/feine in urine at a cut-off concentration of 1000ng/ml. This test will detect other related compounds, please refer to the Analytical Specificity table in this package insert.

This assay provides only a qualitative, preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used

Description:

How to use?

Allow the test, urine specimen, and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.

2. Place the test cassette on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 120μL) to the specimen well (S) of the test cassette, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the illustration below.

3. Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 10minutes.

DIRECTIONS FOR PANEL USE

Allow the test, urine specimen, and/or controls to reach room temperature (15-30ºC) prior to testing.
1. Remove the test Panel from the sealed pouch and use it as soon as possible.

2. Remove the cap.

3. With the arrow pointing toward the urine specimen, immerse the test panel vertically in the urine specimen for at least 10 to 15 seconds. Immerse the strip to at least the level of the wavy lines, but not above the arrow on the test panel.

4. Replace the cap and place the test panel on a non-absorbent flat surface.

5. Start the timer and wait for the colored line(s) to appear.

6. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.

DIRECTIONS FOR DIPSTICK USE

Allow the test, urine specimen, and/or controls to reach room temperature (15-30ºC) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test dipstick from the sealed pouch and use it within one hour.

2. With arrows pointing toward the urine specimen, immerse the test dipstick vertically in the urine specimen for at least 10-15 seconds. Do not pass the maximum line (MAX) on the Test Dipstick when immersing the strip. See the illustration below.

3. Place the test dipstick on a non-absorbent flat surface, start the timer and wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 10 minutes.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

NEGATIVE:* Two lines appear. One colored line should be in the control line region (C), and another apparent colored line should be in the test line region (T). This negative result indicates that the Caff/eine(CAF) concentration is below the detectable cut-off level.

*NOTE: The shade of color in the test line region (T) may vary, but it should be considered negative whenever there is even a faint colored line.

POSITIVE: One colored line appears in the control line region (C). No line appears in the test line region (T). This positive result indicates that the Caffe/ine(CAF) concentration exceeds the detectable cut-off level.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies.

CITEST manufactures its IVD products in ISO13485:2016 accredited manufacturing facilities under strict quality assurance systems. Our innovative products are developed using industry-leading design control systems, which ensures consistent product quality and performance.

Our products are used in the clinical market to help people live more healthy lives. When you select CITEST products, you can be assured of high performance and accuracy along with a dedicated customer support team.