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Urine Identification
Test
One-Step
Urine IgG Test
A visual one-step immunoassay for the qualitative detection
of human immunoglobulin G (IgG) in human urine.
For determination of urine status. Not For Medical Use.
Order Now! Value price only $1.00 per test!
INTENDED USE
The Urine Identification (Urine ID) Test is a lateral flow, one-step
immunoassay for the qualitative detection of human IgG in human
urine at a cut-off concentration of 0.5 ug/ml. This product is used
to obtain a visual, qualitative result and is intended for professional
use. The assay should not be used without proper supervision and
is not intended for over the counter sale to lay persons.
This assay provides only a visual test tool to aid in the detection
of urine substitution, gross dilution and adulteration for drugs
of abuse tests. A more specific alternative method must be used
in order to obtain a confirmed analytical result. Clinical consideration
and professional judgment should be applied particularly when urine
adulteration is suspected.
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SUMMARY
Sample adulteration is a serious problem in forensic urine drug
testing. Sample adulteration is usually achieved by substitution,
dilution or adition of adulterants. The Urine ID Test is a one step
urine IgG test to identify human urine samples and to exclude liquid
substitutions and grossly diluted urine samples. The test can also
exclude human urine samples that are so adulterated that the immuno-reaction
between human IgG and anti-human IgG is interupted. IgG is a normal
component of urine. Human IgG is unique to human body fluid but
is not present in any other liquids or animal urine.
Urine ID is based on the principle of the highly specific immunological
reactions that are used for the analysis of human IgG in biological
fluids. The Urine ID test can be used as a rapid, visual, qualitative
method to detect human IgG in human urine at a cut-off concentration
of 0.5 ug/ml.
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TEST PRINCIPLE
The Urine ID is a one-step chromatographic immunoassay for the rapid
qualitative determination of human IgG protein in urine. The membrane
is pre-coated with anti-human IgG on test band region. During testing,
Human IgG in urine sample reacts with colloidal gold particles that
have been pre-coated with monoclonal anti-human IgG. The mixture
then moves across the membrane chromatographically by capillary
action. This solution then migrates to the immobilized anti-human
IgG on the test band region to form a color band with a specific
antibody - human IgG - antibody - colloidal gold particle complex
on the test region. The absence of a colored band indicates that
the sample has been substituted, grossly diluted or adulterated.
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STORAGE AND STABILITY
The test should be stored refrigerated or at room temperature 2-307C
(36-867F). Each device should remain in its sealed can for the duration
of the shelf-life.
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PRECAUTIONS
- Urine specimens and all materials coming in contact with them
should be handled and disposed of as if capable of transmitting
infection. Avoid contact with skin by wearing gloves and proper
laboratory attire.
- Avoid cross-contamination of urine samples by using a new specimen
collection container and specimen pipette for each urine sample.
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REAGENTS AND MATERIALS SUPPLIED
- 25 Strips in a can.
- One instruction sheet.
MATERIAL REQUIRED BUT NOT PROVIDED
- Specimen collection container.
- Timer.
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SPECIMEN COLLECTION AND HANDLING
The SureStrip Urine ID is designed for use with urine specimens.
Fresh urine does not require any special handling or pretreatment.
Testing should be performed soon after the urine specimen is collected,
preferably during the same day. The specimen may be refrigerated
at 2-87C for 2 days or frozen at -207C for a longer period of time.
Specimens that have been refrigerated must be equilibrated to room
temperature prior to testing. Specimens previously frozen must be
thawed, equilibrated to room temperature, and mixed thoroughly prior
to testing.
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TEST PROCEDURE
Review "Specimen Collection" instructions. If refrigerated
test strip and patient samples should be brought to room temperature
(20-307C) prior to testing. Do not open test can until ready to
perform the assay.
1. Remove the test strip from the protective can.
2. Immerse the test strip in urine sample until it is observed that
a pink color begins to migrate across the result window (approximately
30 seconds) then place the strip on a flat surface.
3. Results may appear as early as 3 minutes. Verify positive results
at a lead time of 8 minutes. Do not read result after 8 minutes.
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INTERPRETATION OF RESULTS
 Negative:
Two distinct pink-colored lines will appear, one in the test region
(T), the human IgG test line and one in the control region (C).
The test line intensity may be weaker or stronger than that of the
control line.
Positive:
Only one pink-colored line appears in the control region (C). The
absence of a test line indicates that sample has been grossly diluted,
substituted or adulterated.
Invalid:
No line appears in the control region which indicates improper testing
procedures or deterioration of product may have ocurred.
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QUALITY CONTROL
Good laboratory practice recommends the use of control materials
to ensure proper kit performance. Quality control specimens are
available from commercial sources. When testing the positive and
negative controls, use the same assay procedure as with a urine
specimen.
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LIMITATIONS
- The assay is designed for use with human urine only.
- A positive result indicates that the urine sample has been
grossly diluted, substituted or adulterated. It does not indicate
the adulterant or measure the level of adulteration.
- Excessive consumption of water or other fluids may cause a
positive test result.
- There is a possibility that technical or procedural errors
as well as other substances or factors not listed may interfere
with the test and cause false results. See SPECIFICITY for a list
of substances that will produce positive results, or that do not
interfere with test performance.
- If it is suspected that the samples have been mislabeled or
deteriorated, a new specimen should be collected and the test
should be repeated.
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PERFORMANCE CHARACTERISTICS
Dilution
One hundred twelve human urine samples were tested with the Urine
ID Test and an EIA test. The human IgG concentration assayed by
EIA were ranged from 0.71 - 50 ug/ml. All samples were identified
as human urine by the Urine ID Test.
In another study, one hundred twelve urine samples were diluted
sequentially with tap water, 36.6% of the urine samples after being
diluted six times and 76% of urine samples after being diluted ten
times showed positive results. The results are shown below:
2. Substitution Test
The following non-urine liquids showed positive results:
D.I. water wine, tap water, alcoholic beverages, apple juice, bleach,
beer, diluted detergent (2 - 10%), cranberry juice, Drano, coke,
diluted ethylene glycol (<50% ), coffee, hydrogen peroxide (30%),
grape juice, diluted NaHCO 3 solution (1%), Mountain Dew, diluted
NaCI solution (5 - 20%), orange juice, Lime - A -way (30%), Pepsi,
Vanish, (1%), Sprite, Squirt, tea
3. Adulteration
The following chemicals produced positive results when the chemicals
were added in pooled human urine at the following concentrations:
Bleach > 20%
Drano > 10%
Sodium hydroxide > 5%
Vanish > 1%
4. Specificity
The specificity for the SureStrip Urine ID was tested by adding
various drugs, drug metabolites, and other compounds that are likely
to be present in urine. All compounds were prepared in Buffer or
in human urine.
The following compounds do not cross-react or interfere with the
test result when tested at concentrations up to 100 µg/ml.
Acetaminophen, Acetone, Albumin, Ampicillin, Aspartame, Aspirin,
Atropine, Benzocaine, Benzoylecgonine, Bilirubin, Caffeine, (+)-Chlorpheniramine,
(+/-)-Chlorpheniramine, Chlorpromazine, Chlorprothixene, Creatine,
Deoxyephedrine, Dexbrompheniramine, Dextromethorphan, 4-Dimethylaminoantipyrine,
Dopamine, Doxylamine, (-)-Ephedrine, (+/-)-Epinephrine, Erythromycin,
Ethanol , Furosemide, Glucose, Guaiacol Glyceryl, Hemoglobin, Hydromorphone,
Hydrocodone, Naphthalene acetic acid, (+)-Naproxen, (+/-)-Norephedrine,
11-nor-.9 -THC-9-carboxylic acid, Oxalic Acid, Oxycodone, Penicillin-G,
Phentermine, Pentobarbital, Pheniramine, Phenobarbital, Phenothiazine,
l-Phenylephrine, Ether d-Propoxyphene, Quinidine, Riboflavin, Secobarbital,
Sodium Chloride, Sulindac, Tenocyclidine, Thioridazine, Trimethobenzamide,
Trifluoperazine, Tyramine, Vitamin C
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