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WARNINGS AND PRECAUTIONS
For forensic use only
For professional use only
Follow proper handling and disposal procedures because urine specimens are potentially infectious.
Use only the test devices supplied. Avoid cross-contamination of urine specimens RapidOneTM OXY is a one-step, lateral flow immunoassay for the detection of by using a new container for each urine specimen.
the oxycodone drug analyte in urine. The RapidOneTM OXY is intended for use The foil pouch containing the test card must be completely sealed. Do not use if foil
in the qualitative detection of oxycodone in human urine at the concentration level pouch seal is not intact.
Prior to use, ensure that the product has not expired by verifying that the date of use is prior to the expiration date embossed on the top of the foil pouch. The expiration date is the first four digits of the number embossed on the pouch. Forexample, 09/00 means the product expires in September 2000.
RapidOneTM OXY provides only a preliminary analytical test result.
SUMMARY AND EXPLANATION
RapidOneTM OXY is a competitive immunoassay utilizing a highly specific The RapidOneTM OXY dip stick should be stored at room temperature (15° to reaction between antibodies and antigens for the detection of oxycodone in urine.
30°C) or refrigerated (2° to 8°C). Allow test device to warm up to room The length of time following drug use for which a positive result may occur is temperature before conducting any testing.
dependent upon several factors including frequency and amount of drug, metabolicrate, excretion rate, drug half-life, and the drug user's age, weight, activity, and diet.
SPECIMEN COLLECTION AND HANDLING
PRINCIPLES OF THE TEST
Use fresh urine specimens. Urine specimens do not require any special handlingor pretreatment. It is best to test urine specimens immediately after collection.
Each RapidOneTM OXY assay is a one-step immunoassay. The specifically However, if necessary, urine specimens may be refrigerated at 2° to 8°C for two labeled drug (drug conjugate) competes for antibody binding sites with drugs or days or frozen at -20°C or colder for longer periods.
metabolites that may be present in the urine specimen. The test device consists of It is essential that none of the urine specimen (or other liquid) contact the test area
a membrane strip with an immobilized drug conjugate. A colloidal gold-labeled window of the RapidOneTM OXY test device.
antibody complex is dried at one end of the membrane. A control line, comprised Handle and dispose of urine specimens as if they were infectious and capable of of a different antibody/antigen reaction, is present on the membrane strip. The transmitting infection. Avoid contact with skin.
control line is not influenced by the presence or absence of a drug analyte in theurine specimen, and therefore, it should be present in all reactions.
In the absence of any drug in the urine specimen, the colloidal gold-labeled PROCEDURES
antibody complex moves with the urine by capillary action to contact theimmobilized drug conjugate. An antibody-antigen reaction occurs forming a visible RapidOneTM OXY SINGLE DIP STICK PROCEDURE line in the ‘test’ area. The formation of two visible lines occurs when the test
is negative or below the cut-off for the drug.
1. Allow test device to warm up to room temperature before conducting any When a drug analyte is present in the urine specimen, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the antibody 2. Remove the test device from the foil pouch. Do not use if foil pouch is not intact.
binding sites on the colloidal gold-labeled antibody complex. If a sufficient amount of drug analyte is present, it will fill all of the available binding sites, thus preventing 3. Insert the bottom end of the test device into the sample until the sample level attachment of the labeled antibody to the drug conjugate. The formation of one
is within the blue area on the test device.
visible line is indicative of a positive result.
4. Hold the test device in the sample until a reddish purple color begins to appearin the test results area. When this occurs, remove the test device from the sample REAGENTS AND MATERIALS SUPPLIED
and lay flat. Allow the test to proceed undisturbed until a reddish-purple control lineappears and the test background has cleared. The control line [C] is the uppermost line in the test area. Once the control line is visible, the test is ready to be read; typically this occurs in 3-5 minutes.
1. 50 RapidOneTM OXY test sticks: The test device consists of a dip stick and
dessicant sealed in a foil pouch. The dip stick contains one channel for the 5. Read results as explained under Interpretation of Results.
complete immunoassay of oxycodone. The channel contains a membrane with twoattached absorbent pads and a pad containing the immobilized colloidal gold-labeled antibody complex. The upper pad acts as a reservoir for the specimen after INTERPRETATION OF RESULTS
it migrates through the membrane. The test line contains a BSA-drug conjugate for The control line is the uppermost line appearing in each test area. The test line may the individual analyte, dried on the membrane. A second line (control), containing or may not appear directly below the control line [C].
an appropriate IgG, is placed above the test line on all membranes.
Once a reddish-purple control line with a clear background forms in all channels
the test may be read.
A NEGATIVE result is the presence of two reddish-purple lines, called the test line
[T] and the control line [C], without regard to intensity; i.e., two lines, no matter how
dark or light, indicate a negative result.
A POSITIVE result is the presence of ONLY one line (the control line).
If no control line appears after approximately 10 minutes, consider the test invalid.
RapidOneTM OXY results are stable up to 60 minutes as long as the device is The following drugs are not detected by RapidOneTM OXY at Do not read results after 60 minutes.
concentrations less than 100,000 ng/mL unless otherwise specified by asterisk: CONTROL LINE
TEST LINE
INTERPRETATION
No control line present No test line present Acetaminophen (4-Acetamidophenol; 2-Bromo-α-ergocryptine (Bromocryptine * Note If a test line appears but no control line appears, the test is also invalid.
QUALITY CONTROL
A procedural control (the control line [C]) is built into each test channel, indicating that the reagents on the device are present and functioning properly. It is also good laboratory practice to use positive and negative controls to ensure proper test Allobarbital (5,5-Diallybarbituric Acid) performance. Control samples are commercially available. In order to conserve the Allopurinol (4-Hydroxypyrazole(3,4-) use of control materials, it is recommended that the low volume procedure be used 2-Butynoic Acid Ethyl Ester (Ethyl-2- for testing. Positive and negative controls should be used prior to using a new lot/shipment of test devices, if the product has been stored outside the recommended storage conditions, or in accordance with your laboratory defined policies.
Caffeine (1,3,7-Trimethylxanthine) LIMITATIONS OF PROCEDURE
The assay is designed for use with human urine only.
RapidOneTM OXY provides only a preliminary qualitative test result. Use a
more specific alternate quantitative analytical method to obtain a confirmed
analytical result. Gas chromatography/mass spectrometry (GC/MS) is the
preferred confirmatory method (1). HPLC may be used as the confirmatory
method for tricyclic antidepressants. Apply clinical and professional
judgment to any drug of abuse test result, particularly when preliminary
positive results are obtained. (2).
Other substances and/or factors not listed may interfere with the test and cause erroneous results, such as adulterants, procedural errors or cross reactivity with other drugs or agents. Refer to the Performance Characteristics section for more information. If adulteration is suspected, obtain a fresh urine specimen and PERFORMANCE CHARACTERISTICS
SPECIFICITY
Interference and cross reactivity studies were performed by testing the drug analytes in the RapidOneTM OXY device with various other drugs. Below is the list of drugs that will give a positive result at or above the concentration stated. All of the following drugs were added to normal, drug-free urine.
Compound
CONCENTRATION (ng/mL)
Chemicals
Trihydroxypyrimidine; Malonylurea) Benzocaine (Ethyl-p-Aminobenzoate) Isonicotinic Acid (Pyridine-4-Carboxylic 6 α-Methylprednisolone (Medrol) Ethamivan (N,N-Diethylvanillamide) Methyl Viologen (Gramoxone; Paraquat Fenoprofen [ (+/-)-2-(3-Phenoxyphenyl) (+/-) Lorazepam 4,4’-Diaminophenyl Sulfone (Dapsone) Ferrous Sulfate Dichloromethane (Methylene Chloride) Flunitrazepam Digoxin (12 β-Hydroxydigitoxin) Dimercaprol (2,3,-Dimercaptopropanol) Heroin (Diacetylmorphine)* (10ug/mL) Hydralazine (1-Hydrazinophthalazine) (S)-6-Methoxy-α-Methyl-2-Naphthalene Noroxymorphone (S)-6-Methoxy-α-Methyl-2-Naphthalene Noscapine Orotic Acid (Uracil-6-Carboxylic Acid) 5-Methoxytryptamine (Methoxamine; 4-Hydroxy-3-Methoxyphenylacetic Acid 2-Methyl-3-(3,4-Dihydroxyphenyl)-DL- 6 α-Methyl-17 α-Hydroxyprogesterone Oxyphenbutazone (+/-) 3,4-Methylenedioxyamphetamine Pargyline (+/-) 3,4 Methylenedioxymethamphetamine Pentobarbital (Nembutal) 6 α-Methyl-17-α-Hydroxyprogesterone Phencyclidine SENSITIVITY
1) Known concentrations of drug were added to normal, drug-free urine. Ten (10) determinations were made at each serial dilution of the single analyte. Sensitivity is defined as that concentration which produced positive responses in all 10 replicates.
AVERAGE CONCENTRATION
(α,α-Dimethylphenethylamine) No immunoassay that produces a single response in relation to the presence of multiple components in a mixture can reliably quantify Theobromine (3,7-Dimethylxanthine) the concentration of these components. The Rapid OneTM OXY test Theophylline (1,3-Dimethylxanthine) detects several opiates. Attempts to establish semi- quantitative concentrations with Rapid OneTM OXY are not recommended. The sensitivity of this test to detect oxycodone is at an average Thymol (5-Methyl-2-Isopropylphenol) ACCURACY
The RapidOneTM OXY was compared to GC/MS at the claimed cut-off level.
RapidOneTM OXY was proven to correlate greater than 99% with GC/MS at a Triamcinolone (Fluoxyprednisolone) Probenecid [ p-(Dipropylsulfamoyl) Oxycodone
REPRODUCIBILITY
Reproducibility studies were carried out using commercially available standards.
Each standard was diluted in normal, drug-free urine to give the appropriate 2-Propylpentanoic Acid (Valproic Acid) concentration. Each specimen, at the concentration of analyte, was tested four times daily, in duplicate, for five consecutive days using two different lots of Concentration
Precision
Tryptamine [ 3-(2-Aminoethyl) Indole ] DL-Tryptophan (3 β-Indolylalanine; (+/-)-α-Amino-3-Indolepropionic Acid) Tyramine (4-Hydroxyphenethylamine) BIBLIOGRAPHY
1. Urine Testing for Drugs of Abuse, National Institute for Drug Abuse (NIDA), 2. R. C. Baselt, Disposition of Toxic Drugs and Chemicals in Man, 2nd Ed., Biomedical Publications, Davis Ca., 1982.
Salicylic Acid (2-Hydroxybenzoic Acid) Zomepirac Any express or implied warranty offered by American Bio Medica
Corporation is contingent upon observance of its published directions with
respect to the use of American Bio Medica’s diagnostic products. Under no
circumstances will American Bio Medica Corporation be liable for any
indirect or consequential damages.

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