Oxycodone one step oxycodone test device package insert
exceeds 100 ng/mL because it will saturate all the binding sites of anti-Oxycodone
3. Wait for the red line(s) to appear. The result should be read at 5 minutes. Results may be
stable up to 4 hours after test initiation.
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
Oxycodone Test Device Package Insert
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
A rapid, one step test for the qualitative detection of oxycodone in human urine. REAGENTS For healthcare professionals including professionals at point of care sites
The test device contains monoclonal anti-Oxycodone antibody-coupled particles and
For in vitro diagnostic use only.
Oxycodone-protein conjugate. A goat antibody is employed in the control line.
INTENDED USE PRECAUTIONS INTERPRETATION OF RESULTS
The OXYCODONE One Step Oxycodone Test Device is a rapid chromatographic
• For healthcare professionals including professionals at point of care sites.
immunoassay for the qualitative detection of oxycodone in human urine at a cut-off
• For in vitro diagnostic use only. Do not use after the expiration date.
NEGATIVE:* Two lines appear. One red line should be in the control region (C), and
• The test device should remain in the sealed pouch until ready for use.
another apparent red or pink line should be in the test region (T). This negative result
This assay provides only a preliminary analytical test result. A more specific
• All specimens should be considered potentially hazardous and handled in the same
indicates that the Oxycodone concentration is below the detectable level (100 ng/mL).
alternate chemical method must be used in order to obtain a confirmed * NOTE: The shade of red in the test region (T) may vary, but it should be considered analytical result. Gas chromatography/mass spectrometry (GC/MS) is the
• Used test device should be discarded according to federal, state and local
negative whenever there is even a faint pink line.
preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when POSITIVE: One red line appears in the control region (C). No line appears in the STORAGE AND STABILITY preliminary positive results are used.
test region. This positive result indicates that the Oxycodone concentration is above
Store as packaged in the sealed pouch at 2-30°C. The test device is stable through the
expiration date printed on the sealed pouch. The test device must remain in the sealed
INVALID:Control line fails to appear. Insufficient specimen volume or
Oxycodone is a semi-synthetic opioid with a structural similarity to codeine. The
pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
incorrect procedural techniques are the most likely reasons for control line
drug is manufactured by modifying thebaine, an alkaloid found in the opium poppy.
SPECIMEN COLLECTION AND PREPARATION
failure. Review the procedure and repeat the test using a new test device. If the
Oxycodone, like all opiate agonists, provides pain relief by acting on opioid
problem persists, discontinue using the lot immediately and contact your local
receptors in the spinal cord, brain, and possibly directly in the affected tissues.
Oxycodone is prescribed for the relief of moderate to high pain under the well-
The urine specimen must be collected in a clean and dry container. Urine collected at
known pharmaceutical trade names of OxyContin®, Tylox®, Percodan® and
any time of the day may be used. Urine specimens exhibiting visible precipitates should
Percocet®. While Tylox, Percodan and Percocet contain only small doses of
be centrifuged, filtered, or allowed to settle to obtain clear specimen for testing.
A procedural control is included in the test. A red line appearing in the control region (C)
oxycodone hydrochloride combined with other analgesics such as acetaminophen or
is considered as an internal procedural control. It confirms sufficient specimen volume,
aspirin, OxyContin consists solely of oxycodone hydrochloride in a time-release
Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For
prolonged storage, specimens may be frozen and stored below -20°C. Frozen
adequate membrane wicking and correct procedural technique.
Oxycodone is known to metabolize by demethylation into oxymorphone and
specimens should be thawed and mixed before testing.
Control standards are not supplied with this kit; however, it is recommended that positive
noroxycodone. In a 24-hour urine, 33-61% of a single, 5mg oral dose is excreted
and negative controls be tested as a good laboratory practice to confirm the test procedure
with the primary constituents being unchanged drug (13-19%), conjugated drug (7-
and to verify proper test performance. Users should follow local, state, and federal
29%) and conjugated oxymorphone (13-14%)1. The window of detection for
oxycodone in urine is expected to be similar to that of other opioids such as
The OXYCODONE One Step Oxycodone Test Device yields a positive result when
1. The OXYCODONE One Step Oxycodone Test Device provides only a qualitative,
the oxycodone level in urine exceeds 100 ng/mL. At present, the Substance Abuse
Materials Required But Not Provided
preliminary analytical result. A secondary analytical method must be used to obtain a
and Mental Health Services Administration (SAMHSA) does not have a
confirmed result. Gas chromatography/mass spectrometry (GC/MS) are the preferred
recommended screening cutoff for oxycodone positive specimens.
2. It is possible that technical or procedural errors, as well as other interfering substances
in the urine specimen may cause erroneous results.
The OXYCODONE One Step Oxycodone Test Device is an immunoassay based on
DIRECTIONS FOR USE
3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous
the principle of competitive binding. Drugs which may be present in the urine
Allow test device, urine specimen, and/or controls to equilibrate to room
results regardless of the analytical method used. If adulteration is suspected, the test
specimen compete against the drug conjugate for binding sites on the antibody.
temperature (15-30°C) prior to testing.
should be repeated with another urine specimen.
During testing, a urine specimen migrates upward by capillary action. Oxycodone, if
1. Bring the pouch to room temperature before opening it. Remove the test device
4. A Positive Result does not indicate level or intoxication, administration route or
present in the urine specimen below 100 ng/mL, will not saturate the binding sites of
from the sealed pouch and use it as soon as possible.
antibody in the test device. The antibody coated particles will then be captured by
2. Place the test device on a clean and level surface. Hold the dropper vertically and
5. A Negative Result may not necessarily indicate drug-free urine. Negative results can
immobilized Oxycodone conjugate and a visible colored line will appear in the test line
transfer 3 full drops of urine (approx. 100µl) to the specimen well (S) of the test device, and
be obtained when drug is present but below the cutoff level of the test.
region. The colored line will not form in the test line region if the Oxycodone level
then start the timer. Avoid trapping air bubbles in the specimen well (S). Refer to illustration.
6. Test does not distinguish between drugs of abuse and certain medications.
PERFORMANCE CHARACTERISTICS Precision Accuracy
A study was conducted at three independent physician’s office sites (A. internal
A side-by-side comparison was conducted by laboratory personnel using the
medicine, B. pediatrics, C. general practice) by three independent, untrained,
OXYCODONE One Step Oxycodone Test Device and a commercially available
licensed medical assistants using three different lots of product and run in three
rapid test. Testing was performed on specimens previously collected from subjects
consecutive days to demonstrate the within-run, between-run and between-operator
presenting for Drug Screen Testing. Presumptive positive results were confirmed by
precision. An identical panel of coded specimens containing no oxycodone,
GC/MS. The following results were tabulated:
oxycodone spiked at levels +/- 25% of the assay cut-off and oxycodone spiked at
levels +/-50% of the 100 ng/mL assay cut-off were provided to each site. The results
Other OXY Rapid Test
The OXYCODONE One Results
Positive Negative Results Step Oxycodone Test Total Results % Agreement with commercial kit
When compared to GC/MS at the cut-off of 100 ng/mL, the following results were tabulated:
Agreement The OXYCODONE Effect of Urinary Specific Gravity
Fifteen (15) urine samples of normal, high, and low specific gravity ranges were
spiked with 50 ng/mL and 150 ng/mL of Oxycodone respectively. The
OXYCODONE One Step Oxycodone Test Device was tested in duplicate using the
fifteen neat and spiked urine samples. The results demonstrate that varying ranges of
Eight (80) of these clinical samples were also run using the OXYCODONE One
urinary specific gravity does not affect the test results.
Step Oxycodone Test Device by an untrained operator at a different site. Based on
Effect of the Urinary pH
GC/MS data, the operator obtained a statistically similar Positive Agreement,
The pH of an aliquoted negative urine pool was adjusted to a pH range of 5 to 9 in 1
Negative Agreement and Overall Agreement rate as the laboratory personnel.
pH unit increments and spiked with Benzoylecgonine to 50 ng/mL and 150 ng/mL.
The spiked, pH-adjusted urine was tested with the OXYCODONE One Step
Phenelzine Trans-2-phenylcyclopropylamine hydrochloride
A drug-free urine pool was spiked with Oxycodone at the following concentrations:
Oxycodone Test Device in duplicate and interpreted according to the package insert.
0 ng/mL, 50 ng/mL, 75 ng/mL, 100 ng/mL, 125 ng/mL, 150 ng/mL and 200 ng/mL.
The results demonstrate that varying ranges of pH does not interfere with the
The result demonstrates 100% accuracy at 50% above and 50% below the cut-off
concentration. The data are summarized below:
A study was conducted to determine the cross-reactivity of the test with compounds
Oxycodone Percent of Visual Result Concentration (ng/mL)
in either drug-negative urine or Oxycodone positive urine. The following
compounds show no interference when tested with the OXYCODONE One Step
Oxycodone Test Device at a concentration of 100 µg/mL.
Non Cross-Reacting Compounds
Tetrahydrocortisone 3 (β-D-glucuronide) Tetrahydrozoline
The following table lists compounds that are positively detected in urine by the
OXYCODONE One Step Oxycodone Test Device at 5 minutes.
Compound Concentration BIBLIOGRAPHY
Dihydrocodeine 12,500 Cannabinol Chloralhydrate
1. Baselt, R.C. Disposition of Toxic Drugs and Chemicals in Man, 4th edition, Chemical
2. Hawks RL, CN Chiang. Urine Testing for Drugs of Abuse. National Institute for
Hydromorphone 12,500 Cholesterol Clomipramine
Drug Abuse (NIDA), Research Monograph 73, 1986.
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