Gabapentin (GAB) Rapid Test, cut-off concentration of 2000ng/ml. Drug Abuse Test Kit
| Principle |
Chromatographic Immunoassay |
| Format |
Dipstick, Cassette, Panel, Cup |
| Specimen |
Urine |
| Certificate |
CE |
| Reading Time |
5 minutes |
| Pack |
40T/50T |
| Storage Temperature |
2-30°C |
| Shelf Life |
2 Years |
| Sensitivity |
92.30% |
| Specificity |
98.50% |
| Accuracy |
96.70% |
| Cut-Off |
2000 ng/mL
|
A rapid test for the qualitative detection of Gabapentin in human urine.
For medical and other professional in vitro diagnostic use only.
INTENDED USE
The GAB Rapid Test Cassette (Urine) is a rapid chromatographic immunoassay for the detection of Gabapentin in urine at a cut-off concentration of 2000ng/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.
SUMMARY
Gabapentin, sold under the brand name Neurontin among others, is a medication which is used to treat epilepsy (specifically partial seizures), neuropathic pain, hot flashes, and restless legs syndrome.
Common side effects of gabapentin include sleepiness and dizziness. Serious side effects include an increased risk of suicide, aggressive behavior, and drug reaction with eosinophilia and systemic symptoms.1 In 2009 the U.S. Food and Drug Administration issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking some anticonvulsant drugs, including gabapentin,3 modifying the packaging inserts to reflect this. The oral bioavailability of gabapentin enacarbil (as gabapentin) is greater than or equal to 68%, across all doses assessed (up to 2,800 mg), with a mean of approximately 75%.5,6 Gabapentin undergoes little or no metabolism.7,8The T-max of the instant-release (IR) formulation of gabapentin enacarbil (as active gabapentin) is about 2.1 to 2.6 hours across all doses (350– 2,800 mg) with single administration and 1.6 to 1.9 hours across all doses (350–2,100 mg) with repeated administration.
The GAB Rapid Test Cassette (Urine) is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes an antibody to selectively detect elevated levels of gabapentin in urine. The GAB Rapid Test Cassette (Urine) yields a positive result when gabapentin in urine exceeds 2000ng/ml.
PRINCIPLE
The GAB Rapid Test Cassette (Urine) is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.
During testing, a urine specimen migrates upward by capillary action. Gabapentin, if present in the urine specimen below the cut-off level, will not saturate the binding sites of the antibody in the test. The antibody coated particles will then be captured by immobilized drug-protein conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the Gabapentin level exceeds the cut-off level, because it will saturate all the binding sites of anti-drug antibody.
A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen or a specimen containing a drug concentration less than the cut-off will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
DIRECTIONS FOR 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. 120 uL) 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 10 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE:* Two colored 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 Gabapentin 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 Gabapentin 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.
