PGB Rapid Test Cassette/ Dipstick/Panel For Pregabalin in human urine Qualitative Detection

A rapid test for the qualitative detection of Pregabalinin human urine CE certified

Applications: 

The PGB Rapid Test is a rapid chromatographic immunoassay for the detection of Pregabalin in urine at a cut-off concentration of 50ug/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: 

Pregabalin, also known as β-isobutyl-γ-amino butyric acid (beta-isobutyl-GABA), is a medication used to treat epilepsy, neuropathic pain, fibromyalgia, and generalized anxiety disorder.^[1]Common side effects include: sleepiness, confusion, trouble with memory, poor coordination, dry mouth, problem with vision, and weight gain. Potentially serious side effects include angioedema, drug misuse, and an increased suicide risk. ^[2]

The typical dosage for diabetic pain is 50mg three times a day; for epilepsy is 75mg twice a day or 50mg three times a day up to 600mg a day; for fibromyalgia, it is 75mg twice a day up to 450mg daily; for spinal cord injuries and nerve pain, it is 75mg to 150mg twice a day up to 600mg per day.

Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. The Pregabalin is predominantly excreted unchanged in urine (≥ 98%) ^[3]. the Pregabalin mean elimination half-life is 6.3 hours. ^[4] 50% would be expected to have negative urine specimens within 3 days and a total of 5 days would be needed to achieve negative urine specimens in the subject with the maximum urinary concentration measured. ^[5]

In that study, including 4799 Pregabalin positive urinary samples from 57,542 pain patients, the mean (range) and median concentrations of Pregabalin in specimens containing both drugs were 188.7µg/ml and 116.0µg/ml, respectively. ^[6]

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 (15-30°C) prior to testing.
1. Remove the test panle from the sealed pouch and use it within one hour.
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 do not touch the plastic device.
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 (15-30°C) 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 Pregabalin 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 Pregabalin 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.