MEDTOX BUPRENORPHINE Manual

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MEDTOX Buprenorphine is a rapid qualitative screening test for buprenorphine and its metabolites in human urine.

1. INTENDED USE

The MEDTOX Buprenorphine Test uses immunochromatographic test strips for the rapid, qualitative detection of buprenorphine and its metabolites in human urine. It is
intended for prescription use only. The MEDTOX Buprenorphine Test is not for over-the-counter sale. It is not intended for use in point-of-care settings.
MEDTOX Buprenorphine detects buprenorphine and its metabolites at the following cutoff concentrations:
BUP Buprenorphine (Buprenorphine)
The MEDTOX Buprenorphine Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed
analytical result. Liquid chromatography/tandem mass spectrometry (LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment
should be applied to any test result.

2. SUMMARY AND EXPLANATION OF THE TEST

The qualitative MEDTOX Buprenorphine Test utilizes a solid phase immunoassay technology to provide a very rapid test requiring no instrumentation. This test may be used
to screen human urine samples for the following drug class prior to confirmatory testing:
Buprenorphine (BUP) is a potent analgesic often used in the treatment of opiate abusers.
Many factors influence the length of time required for drugs to be metabolized and excreted in the urine. A variety of factors influence the time period during which drugs are
detected; the rate of urine production, the volume of fluid consumption, the amount of drug taken, the urine pH, and the length of time over which drug was consumed.
Drinking large volumes of liquid or using diuretics to increase urine volume lowers the drug concentration and decreases the detection period. Although the detection period
for these drugs varies widely depending upon the compound taken, dose and route of administration and individual rates of metabolism, some general times have been
1-3
established and are listed below.

3. PRINCIPLES OF THE PROCEDURE

The MEDTOX Buprenorphine Test contains a device with rapid, competitive, membrane-based immunochromatographic test strips. A single urine sample can be evaluated
for the presence of buprenorphine in a single device. Each test strip contains antibody colloidal gold, a drug conjugate and a control line.
ANTIBODY-COLLOIDAL GOLD -- Mouse monoclonal antibodies were developed specifically targeted to the drug buprenorphine. The antibody only binds buprenorphine
and its metabolites. Antibody-colloidal gold solutions were prepared by absorbing the monoclonal antibodies to colloidal gold. The colloidal gold solution was applied to the
sample well pads on the test strip.
DRUG-CONJUGATES – The drug buprenorphine is conjugated to protein and immobilized as a line on a membrane at the location labeled "T" on the device.
CONTROL LINE -- Each test strip has anti-mouse immunoglobulin antibodies immobilized as a line on the membrane at the location labeled "C" on the device. The anti-
mouse immunoglobulin antibodies bind the mouse antibodies coated on the colloidal gold.
Drug in the urine and the drug conjugated to the protein compete to bind to the antibody-colloidal gold. When the test system cup is tipped or the dip device is dipped, urine
flows into the sample pads of the device, the dried antibody-colloidal gold on the sample pad dissolves and the urine wicks up the white test strips carrying the red antibody-
colloidal gold with it.
Negative Samples
When no drug(s) is present in the urine sample, the red antibody-colloidal gold migrates up the test strip and binds to the drug conjugate immobilized on the membrane. The
binding of the antibody-colloidal gold to the drug conjugate generates an easily visible reddish-purple line at the "T" location on the device. Negative results can be reported
as soon as a test line and a control line are visible.
Non-Negative Samples
When a drug is present in the sample the antibody-colloidal gold binds the drug before it migrates up the test strip. However, when the antibody-colloidal gold binds the drug
in the urine, the antibody-colloidal gold cannot bind to the drug conjugate immobilized on the test strip. When the drug concentration is at or above the cutoff concentration,
the majority of the antibody colloidal gold is bound to the drug from the urine. Therefore, as drug bound antibody-colloidal gold migrates up the test strip, it is unable to bind to
the drug conjugate immobilized on the membrane. Therefore, no line is generated at the "T" location on the device for a non-negative sample. Read non-negative results at 5
minutes.
Control Line
Each test strip has an internal procedural control. A line must form at the control "C" location on the device to indicate that the reagents are migrating properly. If a control
line does not form, the test is considered invalid. A control line forms when the antibody-colloidal gold binds to the anti-mouse immunoglobulin antibody immobilized on the
membrane as a line at the "C" location on the device.

4. MATERIALS PROVIDED/STORAGE CONDITIONS

Each MEDTOX Buprenorphine Test contains all the reagents necessary to test one urine sample for buprenorphine. Test devices are available in Cup or Dip format as
described below.
Kit Contents – Cup Test format
The MEDTOX Buprenorphine Test kit contains twenty-five (25) test bags and one reference guide.
Each Cup Test system bag contains:
1. One (1) test device in a foil package.
The test strip contains a membrane coated with drug conjugate and a pad coated with antibody dye complexes in a protein matrix.
2. One (1) cup with temperature strip attached.
3. One (1) lid.
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MEDTOX BUPRENORPHINE
10 ng/mL
Drug Detection Period
Buprenorphine up to 3 days
1
Detection Period