A rapid test for the qualitative detection of Pregabalinin human
urine CE certified
The PGB Rapid Test Panel (Urine) 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
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.
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.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. 
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%) . the Pregabalin mean elimination half-life is 6.3 hours.  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. 
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. 
How to use?
Allow the test, urine specimen, and/or controls to reach room
temperature (15-30°C) prior to testing.
- Remove the test Panel from the sealed pouch and use it as soon as
- Remove the cap.
- 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.
- Replace the cap and place the test Panel on a non-absorbent flat
- Start the timer and wait for the colored line(s) to appear.
- The result should be read at 5 minutes. Results may be stable up to
1 hour after test initiation.
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
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
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.
A procedural control is included in the test. A colored line
appearing in the control line 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 testing practice to confirm the test procedure and to
verify proper test performance.