One-Step Morphine Test Cassette
Package insert for Morphine Test Cassette.
This Instruction Sheet is for testing of Morphine.
For professional and in vitro diagnostic use only.
The MOP One-Step Morphine Test Cassette is a lateral flow
chromatographic immunoassay for the qualitative detection of
Morphine in urine at the following cut-off concentration of
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.
Opiate refers to any drug that is derived from the opium poppy,
including the natural products, morphine and codeine, and the
semi-synthetic drugs such as heroin. Opioid is more general,
referring to any drug that acts on the opioid receptor.
Opioid analgesics comprise a large group of substance which control
pain by depressing the central nervous system. Large doses of
morphine can produce higher tolerance level and physiological
dependency in users, and may lead to substance abuse. Morphine is
excreted unmetabolized, and is also the major metabolic product of
codeine and heroin. Morphine is detectable in the urine for several
days after an opiate dose.
The MOP One-Step Morphine Test Cassette yields a positive result
when the concentration of morphine in urine exceeds 300ng/ml.
The MOP One-Step Morphine Test Cassette is an immunoassay based on
the principle of competitive binding. Drugs which may be present in
the urine specimen compete against their respective drug conjugate
for binding sites on their specific antibody.
During testing, a urine specimen migrates upward by capillary
action. A drug, if present in the urine specimen below its cut-off
concentration, will not saturate the binding sites of its specific
antibody. The antibody will then react with the drug-protein
conjugate and a visible colored line will show up in the test line
region of the specific drug cassette. The presence of drug above
the cut-off concentration will saturate all the binding sites of
the antibody. Therefore, the colored line will not form in the test
A drug-positive urine specimen will not generate a colored line in
the specific test line region of the cassette because of drug
competition, while a drug-negative urine specimen will generate a
line in the test line region because of the absence of drug
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.
- For in vitro diagnostic use only.
- For healthcare professionals and professionals at point of care
- Do not use after the expiration date.
- Please read all the information in this leaflet before performing
- The test panel 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 panel should be discarded according to federal, state
and local regulations.
The test contains a membrane strip coated with drug-protein
conjugates on the test line, a goat-anti-mouse IgG polyclonal
antibody on the control line, and a dye pad which contains
colloidal gold-monoclonal antibody specific to Morphine.
Each box contains test panels and package insert.
- Store as packaged in the sealed pouch at room temperature (2-30℃ or
36-86℉).The kit is stable within the expiration date printed on the
- Once open the pouch, the test should be used within one hour.
Prolonged exposure to hot and humid environment will cause product
|Additional Special Equipment|
ŸSpecimen collection containerŸTimerŸExternal controls
- 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 supernatant for testing.
- 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
Allow the test and urine samples to equilibrate to room temperature
(15-30℃or 59-86℉) prior to testing.
- Remove the test cassette from the sealed pouch.
- Hold the dropper vertically and transfer 3 full drops(approx.
100ml) of urine to the specimen well of the test cassette, and then
begin timing. See the illustration below.
- Wait for colored lines to appear. Interpret the test results at 3-5
minutes. Do not read results after 10 minutes.
|Interpretation of Results|
Negative:*Two lines appear. One red line should be in the control region (C), and another
apparent red or pink line adjacent should be in the test region
(T). This negative result indicates that the drug concentration is
below the detectable level.
*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
Positive: One red line appears in the control region (C). No line appears in
the test region (T). This positive result indicates that the drug concentration is
above the detectable level.
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 panel. If the
problem persists, discontinue using the lot immediately and contact
your local distributor.
A procedural control is included in the test. A red line appearing
in the control region (C) is considered an internal 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.
- The MOP One-Step Morphine Test Cassette provides only a
qualitative, preliminary analytical result. A secondary analytical
method must be used to obtain a confirmed result. Gas
chromatography and mass spectrometry (GC/MS) is the preferred
- There is a possibility that technical or procedural errors, as well
as other interfering substances in the urine specimen may cause
- 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.
- A Positive result does not indicate level or intoxication,
administration route or concentration in urine.
- A Negative result may not necessarily indicate drug-free urine.
Negative results can be obtained when drug is present but below the
cut-off level of the test.
- Test does not distinguish between drugs of abuse and certain
- A positive test result may be obtained from certain foods or food
A side-by-side comparison was conducted using the MOP One-Step
Morphine Test Cassette and commercially available drug rapid tests.
Testing was performed on approximately 300 specimens per drug type
previously collected from subjects presenting for Drug Screen
Testing. Presumptive positive results were confirmed by GC/MS. The
following compounds were quantified by GC/MS and contributed to the
total amount of drugs found in presumptive positive urine samples
|Test||Compounds Contributed to the Totals of GC/MS|
The following results are tabulated from these clinical studies:
|%Agreement with Commercial Kit||%Agreement with GC/MS|
Forty (40) clinical samples for each drug were run using the MOP
One-Step Morphine Test Cassette by an untrained operator at a
Professional Point of Care site. Based on GC/MS data, the operator
obtained statistically similar Positive Agreement, Negative
Agreement and Overall Agreement rates as trained Laboratory
A study was conducted at three physician offices by untrained
operators using three different lots of product to demonstrate the
within run, between run and between operator precision. An
identical panel of coded specimens, containing drugs at the
concentration of ± 50% and ± 25% cut-off level, was labeled as a
blind and tested at each site. The results are given below:
|n per site||Site A||Site B||Site C|
A drug-free urine pool was spiked with drugs at concentrations
listed. The results are summarized below.
The following table lists the concentration of compounds (ng/ml)
that are detected positive in urine by the MOP One-Step Morphine
Test Cassette at 3-5 minutes.
|Morphine (MOP 300)||Concentration (ng/ml)|
|Effect of Urinary Specific Gravity|
Fifteen (15) urine samples of normal, high, and low specific
gravity ranges (1.000-1.037) were spiked with drugs at 50% below
and 50% above cut-off levels respectively. The MOP One-Step
Morphine Test Cassette was tested in duplicate using fifteen
drug-free urine and spiked urine samples. The results demonstrate
that varying ranges of urinary specific gravity does not affect the
The pH of an aliquoted negative urine pool was adjusted to a pH
range of 5 to 9 in 1 pH unit increments and spiked with drugs at
50% below and 50% above cut-off levels. The spiked, pH-adjusted
urine was tested with the MOP One-Step Morphine Test Cassette. The
results demonstrate that varying ranges of pH does not interfere
with the performance of the test.
A study was conducted to determine the cross-reactivity of the test
with compounds in either drug-free urine or Morphine positive
urine. The following compounds show no cross-reactivity when tested
with the MOP One-Step Morphine Test Cassette at a concentration of
|Non Cross-Reacting Compounds|
|Diphenhydramine||Ecgonine methyl ester|
|[1R,2S] (-) Ephedrine||L(–)-Epinephrine|
|Tetrahydrozoline||Tetrahydrocortisone 3 (β-D-glucuronide)|
*Parent compound only; metabolizes amphetamine and methamphetamine
- Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 6th Ed. Biomedical Publ., Davis, CA. 2002; 129.
- FDA Guidance Document: Guidance for Premarket Submission for Kits
for Screening Drugs of Abuse to be Used by the Consumer, 1997.
- A Handbook of Drug and Alcohol Abuse, Gail Winger, Third Edition,
Oxford Press, 1992, page 146.
- Tietz NW. Textbook of Clinical Chemistry. W.B. Saunders Company.
- Hawks RL, CN Chiang. Urine Testing for Drugs of Abuse. National
Institute for Drug Abuse (NIDA), Research Monograph 73, 1986.
|Index of Symbols|
|Do not reuse||For in vitro diagnostic use only|
|Stored between 2-30℃||Consult instruction for use|
|Use by||Contains sufficient for <n> tests|
|Keep away from sunlight||Keep dry|
|Manufacturer||Do not use if package is damaged|
|Authorized Representative in the European Community|
Effective Date: Feb. 24, 2012
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