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Oxycodone Drug Test FAQs
1. URINE SPECIMEN
Q: How can specimens be stored prior to
testing?
A: 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
well before testing.
Q: How should urine specimens be
collected?
A: 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 a clear specimen for testing.
2. DRUG TEST PROCEDURE
Q: Q: How does the test work?
A: The One Step Oxycodone Test Strip is a
lateral flow chromatographic immunoassay for the qualitative detection of
oxycodone in human urine at a cut-off concentration of 100 ng/mL.
Q: If the test is used before the
refrigerated specimen reaches room temperature, is the result reliable?
A: No. If refrigerated, the test and the
specimen must be at room temperature (15-30°C) before the test is performed.
Specimen at body temperature does not need to reach room temperature before
running the test.
Q: What factors could cause the test to
be invalid?
A: Improper testing procedure, unsealed
packaging, damaged membrane and unsuitable specimens could cause the test to
be invalid.
Q: If the test strip was removed from the
foil pouch and dropped on the floor prior to using it, will it still work?
A: If the test is intact and the exposed
membrane in the “reaction window” was not damaged, it can still be used and
expected to function properly.
Q: How many tests is it possible to run
at a time?
A: It depends on the proficiency of the
user. However, even in experienced hands, we do not recommend running more
than 10 tests at a time.
3. DRUG TEST INTERPRETATION
Q: Do I have to wait the full 5 minutes
before reading my results?
A: Yes. It is important that you wait to see
if a line in the test region appears before reading your result. This might
take up to 5 minutes for the test region line to appear.
Q: Can the test results be read after 5
minutes?
A: Yes. The test card and panel results
remain stable for up to 4 hours after test initiation.
Q: The test line is very faint and the
control line is very strong at the 5 minute read time. What does this mean?
A: The shade of red in the test line region
(T) will vary, but it should be considered negative whenever there is even a
faint pink line.
Q: Does a negative result indicate
drug-free urine?
A: A negative result does not necessarily
indicate drug-free urine. Negative results may be obtained when a drug is
present in the urine but below the cut-off level of the test.
Q: When the specimen sample is added to
the test, red/pink fluid can be seen migrating up the membrane. Is this
normal?
A: A red/pink background is normal as the
sample flows up the test strip and will not affect the test result. As long
as it does not interfere with the interpretation of the line(s), the
background can be disregarded.
Q: How does on know that the test has
been performed properly?
A: As an internal procedural control, a red
line appearing in the control (C) region confirms the addition of sufficient
specimen volume and the performance of correct procedural technique.
Q: A negative result is read when two
distinct red lines appear, one in the control region (C) and another in the
test region (T). Do the two lines need to be of the same intensity?
A: No. The intensity of the red color in the
test line region (T) will vary. Any shade of a red line in the test (T)
region (darker than, the same color as, or lighter than the control line)
along with a red line in the control (C) region is considered a negative
result.
Q: Can the result be read before the
specified read time?
A: No. Even though a negative result may
appear earlier, it is important that the test be allowed to fully develop
for 5 minutes.
Q: I performed the test with water and
obtained a positive result. Why would this happen, and should I be concerned
about the performance of the test?
A: The One Step Oxycodone Test Strip is for
use with urine only. The One Step Oxycodone Test Strip product performance
using any other types of samples, including water, has not been validated
and should not be relied upon. Please use only urine on the drug devices.
Q: Does the specimen need to be sent to a
laboratory for confirmation?
A: The One Step Oxycodone Test Strip
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) is the preferred confirmatory
method.
4. DRUG TEST STORAGE
Q: How should the test kits be stored?
A: 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.
Q: Can the test be used beyond the
expiration date?
A: No. The test device should not be used
under any circumstances past their expiration date.
OXYCODONE
One Step Oxycodone Test
Strip Package Insert
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 professional in vitro
diagnostic use only.
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The OXYCODONE One Step Oxycodone Test Strip is a lateral flow
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.
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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.
The OXYCODONE One Step Oxycodone
Test Strip 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
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The OXYCODONE One
Step Oxycodone Test Strip 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-coated particles in the test strip.
The antibody-coated particles will then be captured by immobilized oxycodone
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 oxycodone
level exceeds 100 ng/mL because it will saturate all the binding sites of
anti-oxycodone antibodies. 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 the target drug in a
concentration less than the cut-off level of the assay 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.
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The test strip contains mouse
monoclonal anti-oxycodone antibody-coupled particles and oxycodone-protein
conjugate. A goat antibody is employed in the control line system.
---------------------
.
• For healthcare professionals including professionals
at point of care sites.
.
• For professional in vitro diagnostic use only.
Do not use after the expiration date.
.
• The test strips should remain in the sealed pouch
until use.
.
• All specimens should be considered potentially
hazardous and handled in the same manner as an infectious agent.
.
• The used test strip should be discarded according to
federal, state and local regulations.
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Store as packaged in the sealed
pouch at 2-30°C. The test strip is stable through the expiration date
printed on the sealed pouch. The test strip must remain in the sealed pouch
until use. DO NOT FREEZE. Do not use beyond the expiration date.
---------------------
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 particles should be
centrifuged, filtered, or allowed to settle to obtain a clear specimen for
testing.
---------------------
Urine specimens may be stored at
2-8°C for up to 48 hours prior to assay. For long-term storage, specimens
may be frozen and stored below -20°C. Frozen specimens should be thawed and
mixed before testing.
---------------------
.
• Test strips
.
• Package insert
.
• Specimen collection container
.
• Timer
.
• External controls
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Allow the test strip, urine specimen, and/or controls to reach room
temperature (15-30şC) prior to testing.
1. Bring the pouch to room temperature before opening it.
Remove the test strip from the sealed pouch and use it as soon as possible.
2. With arrows pointing toward the urine specimen,
immerse the test strip vertically in the urine specimen for at least 10 to
15 seconds. Do not pass the maximum line (MAX) on the test strip when
immersing the strip. See the illustration below.
3.Place the test strip on a non-absorbent flat surface,
start the timer and 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.
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(Please refer to illustration below)
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 line region (T) will 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 (T). This positive result indicates that the oxycodone concentration
exceeds 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 strip. If
the problem persists, discontinue use of the lot immediately and contact
the manufacturer.
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NegativePositive
A procedural control is included
in the test. A red line appearing in the control region (C) is considered an
internal positive 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 practice to confirm the test procedure and to
verify proper test performance. Users should follow local, state, and
federal guidelines for testing QC materials.
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1. The OXYCODONE One Step Oxycodone Test Strip 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) is the preferred confirmatory method.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 indicates presence of the drug or
its metabolites but 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.
