Configurations of the One Step Multi-Drug Screen Test Card with the
Integrated iCup can consist of any combination of the above listed drug analytes.
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 indicated.
PRINCIPLE
The One Step Multi-Drug Screen Test Card with the integrated iCup 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 strip. 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 line region.
A drug-positive urine specimen will not generate a colored line in the
specific test line region of the strip 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 competition.
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.
REAGENTS
The test contains a membrane strip coated with drug-protein conjugates
(purified bovine albumin) on the test line, a goat polyclonal antibody against
gold-protein conjugate at the control line, and a dye pad which contains
colloidal gold particles coated with mouse monoclonal antibody specific to
Amphetamine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine,
THC, Phencyclidine, Benzodiazepine, Methadone, Barbiturate or Tricyclic
antidepressants.
PRECAUTIONS
• For healthcare professionals including professionals at point of care
sites.
• For in vitro diagnostic use only. Do not use after the expiration date.
• 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 card should be discarded according to federal, state and local
regulations.
STORAGE AND STABILITY
Store as packaged in the sealed pouch at 2-30°C. The test is stable
through the expiration date printed on the sealed pouch. The test devices must
remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the
expiration date.
SPECIMEN COLLECTION AND PREPARATION
Urine Assay
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 specimen for testing.
Specimen Storage
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 before testing.
MATERIALS
Materials Provided
• iCup with multi-drug card
• Security seal label
• Package insert
Materials Required But Not Provided
• Timer
• External controls
DIRECTIONS FOR USE
Allow the test card, urine specimen, and/or controls to equilibrate to
room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the cup
from the sealed pouch and use it as soon as possible.
2. Donor provides specimen.
3. Technician replaces and secures cap while the cup is on a flat surface.
4. Technician dates and initials the security seal and attaches the security
seal over the cup cap.
5. Technician peels off the label on the multi-drug test card to view results.
6. Start the timer and wait for the red lines to appear. The results should be
read at 5 minutes. Do not interpret results after 10 minutes. See the
illustration below. For detailed operation instructions, please refer to the
Procedure Card.
INTERPRETATION OF RESULTS
(Please refer to the illustration below)
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 line.
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.
QUALITY CONTROL
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.
LIMITATIONS
1. The One Step Multi Drug Screen Test Card with the iCup provides only a
qualitative, preliminary analytical result. A secondary analytical method must
be used to obtain a confirmed result. Gas chromatography/mass spectrometry
(GC/MS) is the preferred confirmatory method. 3,4,7
2. There is a possibility that technical or procedural errors, as well as other
interfering substances in the urine specimen may cause erroneous results.
3. 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.
4. A Positive result does not indicate level or intoxication, administration
route or concentration in urine.
5. 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.
6. Test does not distinguish between drugs of abuse and certain medications.
7. A positive test result may be obtained from certain foods or food
supplements.
ADULTERATION LIMITATIONS
1. The adulteration tests included with this product are meant to aid in
the determination of abnormal specimens. While comprehensive, these tests are
not meant to be an "all-inclusive" representation of possible adulterants.
2. Oxidants - The presence of high levels of antioxidants in the specimen, such
as ascorbic acid, may result in false negative results for the oxidant pad.
3. Specific Gravity - Elevated levels of protein in urine may cause specific
gravity values to be higher.
