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 OXYCODONE
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. Urine Assay
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 QUALITY CONTROL
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 Specimen Storage
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 MATERIALS
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- Materials Provided
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 LIMITATIONS
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 PRINCIPLE
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
p-Hydroxymethamphetamine p-Hydroxytyramine 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 Oxycodone Test
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 Analytical Sensitivity
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: Cross-Reactivity
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 Specificity
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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