Hydrocodone Drug Test
- OxyContin®, Percodan®, Percocet®, Oxycodone Test
What is Oxycodone?
Oxycodone is a semi-synthetic opioid with a structural
similarity to codeine. The drug is manufactured by modifying thebaine, an
alkaloid found in the opium poppy. Oxycodone, like all opiate agonists, provides
pain relief by acting on opioid 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-known pharmaceutical trade names
of OxyContin®, Tylox®, Percodan® and Percocet®. While Tylox, Percodan and
Percocet contain only small doses of oxycodone hydrochloride combined with other
analgesics such as acetaminophen or aspirin, OxyContin consists solely of
oxycodone hydrochloride in a time-release form.
Oxycodone is known to metabolize by
demethylation into oxymorphone and noroxycodone. In a 24-hour urine,
33-61% of a single, 5mg oral dose is excreted with the primary constituents
being unchanged drug (13-19%), conjugated drug (7-29%) 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 morphine.
For information on how long drugs stay in your system, see
Drug Detection Window.
The OXYCODONE One Step Oxycodone
Test Device yields a positive result when the oxycodone level in urine exceeds
100 ng/mL.
Oxycodone Drug Test Product Overview
Oxycodone, active
ingredient in the pharmaceutical brands Oxycontin®, Percodan® and Percocet®, is
an opiod drug that is chemically derived from the opiate codeine. Although the
drug has been in existence for decades, the recent awareness of oxycodone as an
abused drug and it’s implication in fatal overdoses warrants an immediate need
for an accurate, rapid drug screen specifically designed to detect oxycodone.
Some relevant statistics include the following:
As of 2001, with sales nearing
$1.5 billion, OxyContin® ranked #1 in retail sales of branded controlled
pharmaceuticals1.
In the 2002 Monitoring the
Future study, 4% of students surveyed indicated Oxycodone use by 12th grade2.
With secondary school enrollment of an estimated 13, 400,000 students, 4%
represents more than 535,000 students admitting to Oxycodone use.
Oxycodone specific mentions in
hospital Emergency Departments rose 59% to 7,828 in the first half of 20023.
While some
commercially available morphine/opiate immunoassays exhibit some degree of
cross-reactivity to oxycodone, most do so at such high levels that they are not
amenable to detecting the drug in routine use. Likewise, most confirmation
laboratories do not include oxycodone in the standard confirmation procedure for
opiates. As such, development of a rapid immunoassay for the specific detection
of oxycodone will enable the test administrator to know whether the person might
be positive for that drug and request the oxycodone-specific confirmation at the
laboratory. In addition, it will be critically important that the
oxycodone assay not routinely cross-react with morphine, codeine or their
respective conjugates.
1
OxyContin® Diversion and Abuse,
U.S. Drug Enforcement Agency (DEA) publication.
http://www.deadiversion.usdoj.gov/drugs_concern/oxycodone/oxy_061102.pdf
2 Johnston,
L.D., O’Malley, C. M., & Bachman, J. G. (2003). Monitoring the Future
national results of adolescent drug use; overview of key findings for 2002.
(NIH publication 03-5374). Bethesda, MD. National Institute on Drug Abuse.
3 Substance
Abuse and Mental Health Services Administration, Office of Applied Studies.
Emergency Department Trends From the Drug Abuse Warning Network, Preliminary
Estimates January-June 2002, DAWN Series: D-22, DHHS Publication No. (SMA)
03-3779, Rockville, MD, 2002.
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The following table lists compounds that produced positive results on the
OXYCODONE One Step Oxycodone Test Strip at a read time of 5 minutes:
| Compound |
Concentration (ng/mL) |
| Oxycodone |
100
|
| Codeine |
50,000 |
| Dihydrocodeine |
12,500 |
| Ethylmorphine |
25,000 |
| Hydrocodone |
1,562
|
| Hydromorphone |
12,500 |
| Oxymorphone |
1,562
|
| Thebaine |
50,000 |
Click here for
Multi-Panel Drug Tests
(to test for 2 to 12 drugs in one test).
TO PURCHASE INSTANT DRUG TEST KITS AND SUPPLIES, JUST CLICK ON ONE OF THE LINKS
TO THE LEFT....
One Step
Oxycodone Test Device
A rapid, one step test for the qualitative
detection of oxycodone in human urine.
For healthcare professionals including professionals at point of care sites
For in vitro diagnostic use only.
The OXYCODONE One Step Oxycodone Test Device is a
rapid chromatographic immunoassay for the qualitative detection of oxycodone in
human urine at a cut-off concentration of 100 ng/mL.
This assay provides
only a 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.
Oxycodone is a semi-synthetic opioid with a
structural similarity to codeine. The drug is manufactured by modifying
thebaine, an alkaloid found in the opium poppy. Oxycodone, like all opiate
agonists, provides pain relief by acting on opioid 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-known pharmaceutical
trade names of OxyContin®, Tylox®, Percodan® and Percocet®. While Tylox,
Percodan and Percocet contain only small doses of oxycodone hydrochloride
combined with other analgesics such as acetaminophen or aspirin, OxyContin
consists solely of oxycodone hydrochloride in a time-release form.
Oxycodone is known to metabolize by demethylation into oxymorphone and
noroxycodone. In a 24-hour urine, 33-61% of a single, 5mg oral dose is excreted
with the primary constituents being unchanged drug (13-19%), conjugated drug
(729%) 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 morphine. The OXYCODONE One Step Oxycodone Test Device
yields a positive result when the oxycodone level in urine exceeds 100 ng/mL.
At present, the Substance Abuse and Mental Health Services Administration
(SAMHSA) does not have a recommended screening cutoff for oxycodone positive
specimens.
The OXYCODONE
One Step Oxycodone Test Device 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. Oxycodone, if
present in the urine specimen below 100 ng/mL, will not saturate the binding
sites of antibody in the test device. The antibody coated particles will then be
captured by immobilized Oxycodone conjugate and a visible colored line will
appear in the test line region. The colored line will not form in the test line
region if the Oxycodone level exceeds 100 ng/mL because it will saturate all the
binding sites of anti-Oxycodone 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.
The test device
contains monoclonal anti-Oxycodone antibody-coupled particles and
Oxycodone-protein conjugate. A
goat antibody is employed in the control line.
·
For healthcare
professionals including professionals at point of care sites.
·
For in vitro
diagnostic use only. Do not use after the expiration date.
·
The test device should
remain in the sealed pouch until ready for use.
·
All specimens should be
considered potentially hazardous and handled in the same manner as an infectious
agent.
·
Used test device should
be discarded according to federal, state and local regulations.
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
pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
Urine Assay
The urine specimen must be
collected in a clean and dry container. Urine collected at any time of the day
may be used. Urine specimens exhibiting visible precipitates should be
centrifuged, filtered, or allowed to settle to obtain clear specimen for
testing.
Specimen Storage
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 specimens should be
thawed and mixed before testing.
·
Test devices
·
Disposable specimen
droppers
·
Package insert
·
Specimen collection
container
·
Timer
·
External controls
Allow test device, urine specimen, and/or
controls to equilibrate to room temperature (15-30°C) prior to testing.
1.
Bring the pouch
to room temperature before opening it. Remove the test device from the sealed
pouch and use it as soon as possible.
2.
Place the test
device on a clean and level surface. Hold the dropper vertically and transfer 3
full drops of urine (approx. 100µl) to the specimen well (S) of the test device,
and then start the timer. Avoid trapping air bubbles in the specimen well (S).
Refer to illustration.
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.
(Please refer to illustration
above)
NEGATIVE:* Two lines appear.
One red line should be in the
control region (C), and another apparent red or pink line should be in the test
region (T). This negative result indicates that the Oxycodone concentration is
below the detectable level (100 ng/mL).
* NOTE: The shade of red in the test region (T) may
vary, but it should be considered negative whenever there is even a faint pink
line.
POSITIVE: One red line appears in the control
region (C).
No line appears in the test region. This positive result indicates
that the Oxycodone concentration is above the detectable level (100 ng/mL).
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 using a new test device. If the problem persists, discontinue using the lot
immediately and contact your local distributor.
A procedural control
is included in the test. A red line appearing in the control region (C) is
considered as 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 a good laboratory practice to confirm the test
procedure and to verify proper test performance. Users should follow
local, state, and federal guidelines for testing QC materials.
1.
The OXYCODONE One
Step Oxycodone Test Device provides only a qualitative, preliminary analytical
result. A secondary analytical method must be used to obtain a confirmed result.
Gas chromatography/mass spectrometry (GC/MS) are the preferred confirmatory
methods.1,2
2.
It is possible
that technical or procedural errors, as well as other interfering substances in
the urine specimen may cause erroneous results.
3.
Adulterants, such
as bleach and/or alum, in urine specimens may produce erroneous results
regardless of the analytical method used. If adulteration is suspected, the test
should be repeated with another urine specimen.
4.
A Positive Result
does not indicate level or intoxication, administration route or concentration
in urine.
5.
A Negative Result
may not necessarily indicate drug-free urine. Negative results can be
obtained when drug is present but below the cutoff level of the test.
6.
Test does not
distinguish between drugs of abuse and certain medications.
FOR MORE INFORMATION ON OTHER DRUGS OF
ABUSE, SEE THE INFORMATION BELOW.
TO PURCHASE INSTANT DRUG TEST
KITS AND SUPPLIES, JUST CLICK ON ONE OF THE LINKS TO THE LEFT....
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