When a sufficient concentration of drug is present, it will fill the
Onse Step Morphine
limited antibody binding sites. This will prevent attachment of the
MonlabTest®
colored antibody-colloidal gold conjugate to the drug-protein
conjugate zone on the test band region. Therefore, absence of
Only for professional in vitro diagnostic use.
the color band on the test region indicates a positive result. A control band with a different antigen/antibody reaction is also
added to the immunochromatographic membrane strip at the
INTENDED USE
control region (C) to indicate that the test is performed properly.
The One-Step Morphine MonlabTest® is a lateral flow, one-step
This control line should always appear regardless of the presence
immunoassay for qualitative detection of morphine and their
of drug or metabolite. This means that negative urine will
metabolites in human urine at a cut-off of 300ng/ml. This product
produce two colored band, and positive urine will produce only
is used to obtain a visual, qualitative result and is intended for
one band. The presence of this colored band in the control region
professional use. The assay should not be used without proper
also serves as verification that 1) sufficient specimen has been
supervision and is not intended for over the counter sale to lay
added, and 2) that proper flow was obtained.
REAGENTS AND MATERIALS SUPPLIED
This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order
40 individually wrapped test devices which include one
established as the preferred confirmatory method by the National
MATERIALS REQUIRED BUT NOT PROVIDED
Institute on Drug Abuse. Clinical consideration and professional
judgment should be applied to any drug of abuse test result,
particularly when preliminary results are indicated.
STORAGE AND STABILITY
The test kit should be stored at temperature 2-30ºC. Each device
The opiates such as herion, morphine, and codeine are derived
should remain in its sealed pouch for the duration of the shelf life
from the resin of opium poppy. Heroin is quickly metabolized to
morphine. Thus, morphine and morphine glucuronide both might
PRECAUTIONS
be found in the urine of a person who has taken only heroin. The body also changes codeine to morphine. Thus, the presence of
morphine (or the metabolite, morphine glucuronide) in the urine
indicates heroin, morphine and/or codeine use.
Urine specimens may be potentially infectious. Proper
Urine based screening tests for drugs of abuse range from simple
handling and disposal methods should be established.
immunoassay tests to complex analytical procedures. The speed
Avoid cross-contamination of urine samples by using a new
and sensitivity of immunoassays have made them the most
specimen collection container and specimen pipette for each
widely accepted method for screening urine for drugs of abuse.
The One-Step Morphine MonlabTest® is based on the principle of
Do not use it after the expiration date.
highly specific immunochemical reactions of antigens and
SPECIMEN COLLECTION AND HANDLING
antibodies which are use for the analysis of specific compounds in
The One-Step Morphine MonlabTest® is formulated for use with
biological fluids. This test is a rapid, visual, competitive
urine specimens. Fresh urine does not require any special
immunoassay that can be used for the qualitative detection of
handing or pretreatment. Urine samples should be collected such
morphine in human urine at a 300ng/ml cut-off concentration.
that testing may be performed as soon as possible after the
PRINCIPLE
specimen collection, preferably during the same day. The
The One-Step Morphine MonlabTest® is a one-step immunoassay
specimen may be refrigerated at 2-8ºC for 2 days or frozen at
in which a chemically labeled drug (drug-protein conjugate)
-20ºC for a longer period of time. Specimens that have been
competes with the drug which may be present in urine for limited
refrigerated must be equilibrated to room temperature prior to
antibody binding sites. The test device contains a membrane strip
testing. Specimens previously frozen must be thawed,
which is precoated with drug-protein conjugate on the test band.
equilibrated to room temperature, and mixed thoroughly prior to
The colored anti-morphine antibody-colloidal gold conjugate pad
is placed at the end of the membrane. In the absence of drug in
TEST PROCEDURE
the urine, the solution of colored antibody-colloidal gold
Review “Specimen collection” instructions. Test device,
conjugate and urine moves upward chromatographically by
samples of patient, and controls should be brought to room
capillary action across the membrane. This solution then migrates
temperature (10-30ºC) prior to testing. Do not open
to the immobilized drug-protein conjugate zone to form a visible
pouches until ready to perform the assay.
line as the antibody complexes with the drug-protein conjugate.
Remove the test device from its protective pouch (bring the
Therefore, the formation of a visible precipitant in the test band
device to room temperature before opening the pouch to
region occurs when the test urine is negative for the drug.
avoid condensation of moisture on the membrane). Label
When the drug is present in the urine, the drug/metabolite
the device with patient or control number.
antigen competes with the drug-protein conjugate on the test
Hold the dropper vertically and transfer 3 full drops of urine
band region (T) for the limited antibody sites on the
(approx. 0.15ml) to the specimen well (S) of the test device,
anti-morphine antibody-colloidal gold conjugate.
and then start the timer. Use a separate pipette and device
Monlab SL Selva de Mar 48 08019 BCN +34 93 433 58 60 Fax +34 93 436 38 94 pedidos@monlab.com www.monlab.com
found negative by both methods with 100% agreement.
Read result between 3 to 8 minutes after the
In a separate study, fifty (50) urine samples, obtained from a
addition of samples. Do not read result after 8 minutes.
clinical laboratory and determined morphine positive by GC/MS, were tested with One-Step Morphine MonlabTest® in comparison
INTERPRETATION OF RESULTS
to other commercially available methods.
Negative
Two pink-rose lines (bands) are visible in the
control (C) and test (T) areas of the test
window. The intensity of the test line may be less than that of the control line; this still means negative result. Reproducibility The reproducibility of the One-Step Morphine MonlabTest® was
evaluated at four different sites using controls. Of the fifty (50)
Positive
The control line appears in the test window, but
samples with morphine a concentration of 150ng/ml, all were
determined negative. Of the fifty samples with a morphine
concentration of 600ng/ml, all were determining positive.
Precision
The precision of the One-Step Morphine MonlabTest® was determined by conducting the test with spiked controls. The
control at 150ng/ml gave negative results and the control at
The test is invalid if the control line is not visible
at five minutes. The test failed, or the test
Specificity
procedure was not followed properly. Verify the
The specificity for the One-Step Morphine MonlabTest® was
test procedure and repeat the test with a new
tested by adding various drugs, drug metabolites, and other
compounds that are likely to be present in urine. All compounds
were prepared in drug-free normal human urine.
Note: A very faint line in the test region indicates that the THC in The following structurally related compounds produced
the samples is near to the cut-off level for the test. These should
positive results when tested at levels equal to or greater
be re-tested or confirmed with a more specific method before a
than the concentrations listed below. Compound Concentration (ng/ml) LIMITATIONS OF PROCEDURE
The assay is designed for use with human urine only.
A positive result with the tests indicates the presence of a
drug/metabolite only and does not indicate or measure
There is a possibility that technical and/or procedural errors
as well as other substances or factors not listed may
interfere with the test and cause false results. See
The following compounds were found not to cross-react SPECIFICITY for lists of substances that will produce when tested at concentrations up to 100µg/ml.
positive result, or that do not interfere with test
If it is suspected that the samples have been mislabeled or
tampered with, a new specimen should be collected and the
QUALITY CONTROL
Good laboratory practice recommends the use of control
materials to ensure proper kit performance.
Before using a new kit with patient specimens, positive and
negative controls should be tested. Quality control specimens are
available from commercial sources. When testing the positive and
negative controls, use the same assay procedure as with a urine
PERFORMANCE CHARACTERISTICS Accuracy
The accuracy of the One-Step Morphine MonlabTest® was
evaluated in comparison to other commercially available methods.
One hundred fifty (150) urine samples, collected from presumed
non-user volunteers, have been tested by both tests; all were
Monlab SL Selva de Mar 48 08019 BCN +34 93 433 58 60 Fax +34 93 436 38 94 pedidos@monlab.com www.monlab.com
8 . Hofmann F. E, A, Handbook on Drug and Alcohol Abuse:
The Bionedical Aspects. New York, Oxford University Press,
McBay, A, J, Clin. Chem, 22, 33B-4OB,1987
PACKAGING GRAPHICAL SYMBOLS USED
(Ethyl-Aminobenzoate) P s e udoephedrine HCL
European Representative:
Shanghai International Holding Corp. GmbH (Europe)
A d dress: Eiffestrasse 80, 20537 Hamburg Germany
REFERENCES
Base1t. R, C. Disposition of Toxic Drugs and Chemicals in
Man. Biomedical Publications. Davis. CA 1982.
Urine Testing for Drugs of Abuse. National Institute on Drug
Abuse (NIDA). Research Monograph 73, 1986.
E11enhorn. M. J. And Barce1oux, D. G. Medical Toxicology. E1sevier Science Publishing Company. 1nc New York. 1988
Fed. Register. Department of Health and Human Services. Mandatory Guidelines for Federal Workplace Drug Testing Programs, 53, 69, 11970-11979, 1988
Gilman, A, G, and Goodman, L, S, The Pharmacological Basis of Therapeutics. eds. MacMillan Publishing. New York NY, 1980.
Gorodetzkym. C, W, Detection of Drugs of Abuse in
Biological Fluids. In Martin WR(ed)：Drug Addiction 1, New
Harvey, R, A, Champe, P, C, Lippincotts illustrated Reviews . Pharmacology, 91-95,1992.
Monlab SL Selva de Mar 48 08019 BCN +34 93 433 58 60 Fax +34 93 436 38 94 pedidos@monlab.com www.monlab.com
Region 3 Strategic National Stockpile PATIENT MEDICAL HISTORY and CONSENT FORM Please PRINT the Following Information Last Name: _______________________________________ First Name: ___________________________________________ Middle Name: ________________________ Date of Birth: ____/____/____ Age: _______ Gender: M ____ F ____ Mother’s Maiden Name: ____________