Ifu amp amphetamine monlabtest strip

In the absence of the drug in the urine, the colored antibody-colloid gold AMP AMPHETAMINE
conjugate moves with the sample fluid by capillary action along the membrane until it reaches the immobilized drug conjugate in the test band MonlabTest®
region. At this point, the antibody-colloid gold conjugate reacts with the pre-coated drug conjugate to produce a visible pink colored line as the antibodies form complexes with the drug conjugate. The formation of a
visible color line on the test band region indicates the urine sample
tested is negative for amphetamine.
Product code:
PRESENTATION
When the drug is present in the urine, the drug/metabolite antigen will compete with the drug conjugate coated in the test band region for the MO-806010 20 strips MonlabTest
limited antibody sites. When a sufficient concentration of drug is present, it Only for in vitro diagnostic use
will fill the limited antibody binding sites, and thus preventing the attachment of the colored antibody-colloid gold conjugate to drug conjugates pre-coated in the test band region. An absence of the color band
on the test region indicates a positive result.
INTENDED USE
A control band with a different antigen/antibody reaction is also added to membrane strip to indicate that the test is performed properly. This control immunochromatographic assay intended for professional laboratory use line should always be seen. A negative urine sample produces two distinct only in the qualitative detection of Amphetamine metabolite, D- color bands. A positive sample produces only one color band in the control Amphetamine in urine with a cutoff at 1000ng/ml. It is for professional zone. If insufficient urine sample volume is used, there may not be a laboratory use and for in-vitro diagnostic use only. Control line, indicating the test is invalid. Note: This test provides only a preliminary analytical result. A more MATERIALS PROVIDED
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. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test MATERIALS NEEDED BUT NOT PROVIDED
result, particularly when preliminary positive results are used. Clean glass or plastic container for specimens collection SUMMARY & EXPLANATION
Amphetamine is a sympathomimetic amine whose biological effects REAGENTS
include potent central nervous system stimulation, appetite reduction, hyperthermia, insomnia, increase in heart rate, increase in blood pressure, and the feeling of euphoria. It is usually taken orally, a. Control region (C): Goat anti-mouse (IgG) polyclonal antibody intravenously, or by smoking. Amphetamines are readily absorbed from b. Test region (T): Amphetamine-BSA conjugate the gastrointestinal tract. They are then either deactivated by the liver or excreted in its unchanged form in the urine. Amphetamine is metabolized Colloidal gold conjugate of mouse monoclonal anti-Amphetamine into deaminated hippuric and benzoic acids and hydroxylated metabolites. Studies have shown that heavy dosage may result in permanent damage to certain essential nerve structures in the brain. The SPECIMEN COLLECTION
effects of amphetamines generally last 2–4 hours following use, and the drug has a half-life of 4–24 hours in the body. About 30% of A fresh urine specimen should be used, no special pre-treatment is amphetamines are excreted in the urine in unchanged form, with the necessary. Specimens should be collected in a clean glass or plastic remainder as hydroxylated and deaminated derivatives container. The specimen may be refrigerated (2-8°C) and stored up to 2 days. For longer storage, freeze samples at -20°C or below. Refrigerated The AMP Amphetamine MonlabTest® is a fast, qualitative, and visually samples should be allowed to come to room temperature and mixed read, immunoassay for screening without the use of an instrument. The thoroughly before assaying. Frozen samples should be thawed completely method employs a unique monoclonal antibody to selectively identify D- allowed to come to room temperature, and mixed thoroughly before Amphetamine in test urine at or above the concentration of 1000 ng/mL. This product is not intended to monitor drug levels, but only to screen TEST PROCEDURE
PRINCIPLE OF THE TEST
To begin the testing, open the foil pouch at the notch and remove the test strip from the pouch and use it as soon as possible. The AMP Amphetamine MonlabTest® is based on the principle of a competitive inhibition immunoassay, in which a chemically labeled drug Immerse the strip into the urine sample with the arrow end pointing (drug conjugate) competes with the drug which may be present in urine towards the urine. Do not immerse past the Mark line. Take the strip out for the limited number of antibody binding sites. The test device consists after 3 seconds and lay the strip flat on a clean, dry, non-absorbent surface of a membrane strip, which is pre-coated with Amphetamine-BSA conjugate on the test band region, and a colored anti-amphetamine monoclonal antibody-colloid gold conjugate pad placed at the end of the membrane. Monlab SL Selva de Mar 48 08019 BCN +34 93 433 58 60 Fax +34 93 436 38 94 [email protected] www.monlab.es Rev: june 2006
Read results in 10-20 minutes. It is important that the background is clear before the result is read. Results obtained after more than 20 LIMITATIONS
1. This test is a qualitative, competitive screening assay. It is not designed to determine the quantitative concentration of drugs or the level of 2. All positive samples must be confirmed by another method. Gas chromatography / mass spectrometry (GC/MS) is the method of choice to confirm the presence and concentration of the drug in urine. 3. The possibility exists that substances and factors not described in this directional insert may interfere with the test, causing false results (e.g., 4. This test has been developed for testing urine samples only. The performance of this test using other specimens has not been substantiated. 5. Adulterated urine samples may produce erroneous results. Strong oxidizing agents such as bleach (hypochlorite) can oxidize drug analytes. If a sample is suspected of being adulterated, obtain a new sample. 6. As the AMP Amphetamine MonlabTest® is a competitive assay, no INTERPRETATION OF RESULTS
7. Samples containing target drug concentrations below the cutoff sensitivity for the test may produce a positive result occasionally. Negative: In addition to one pink colored control (C) line in the
8. Result read after 20 minutes may not be consistence with the original control region, a distinct pink colored line will also appear in the test (T) reading obtain within the result window within 10-20 minutes. region. The color intensity of the test line may be weaker or stronger than PERFORMANCE CHARACTERISTICS
Positive: Only one pink colored line appears in the control (C) region.
No apparent line in the test (T) region. This indicates the presence of amphetamine at a level of 1000 ng/mL or above. Sensitivity – The sensitivity of the AMP Amphetamine MonlabTest® was Invalid: No line appears in the control zone “C”, the test should be
determined in-house by trained technicians. Concentrations tested were voided since an improper test procedure may have been performed or zero, at the cutoff, the cutoff minus 25%, and the cutoff plus 25% using deterioration of reagents may have occurred. This is due o the internal spiked drug-free clinical urine samples. Results were as follows in Table 1. control built in which a distinct control region (C) line always appears. Repeat the test using a new device. If the problem persists, discontinue Table 1: Cutoff Characterization of Amphetamine using the test kit immediately and contact your local distributor. D-Amphetamine
1250 ng / mL
Note: A faint line on the test region indicates the amphetamine in sample
Negative
is near the cut-off level for the test. These samples should be re-tested or confirmed with a more specific method before a clinical determination is Positive
Specificity – The specificity of the AMP Amphetamine MonlabTest® was determined by adding various drugs and drug metabolites to drug-free control urine specimens and tested with the kit. The results are expressed in terms of the concentration required to produce a positive result. The following compounds exhibited no interference when dissolved in drug-free control urine at 100µg/ml (Table 2). PH and specific gravity studies completed concurrently on the spiked drug-free control urine specimens also showed that there was no interference between the Table 2 Non-Cross Reacting Compounds (100µg/ml)
Mark line
Negative Positive Invalid
Monlab SL Selva de Mar 48 08019 BCN +34 93 433 58 60 Fax +34 93 436 38 94 [email protected] www.monlab.es Rev: june 2006
WARNINGS & PRECAUTION
2. For professional use only. 3. Do not use test kit beyond the expiry date. 4. The test device should not be reused. 5. Urine specimens may be infectious; insure proper handling and dispose of all used reaction devices into a biohazard container. STORAGE AND STABILITY
The test kit can be stored at temperatures between 2 to 30°C in the sealed pouch to the date of expiration. The test kit should be kept away from direct sunlight, moisture and heat. The expiration dating was established under these storage conditions. QUALITY CONTROL
Good laboratory practice recommends the use of external controls (negative and positive) to ensure proper kit performances which are available from commercial sources. BIBLIOGRAPHY & SUGGESTED REFERENCE
a. Urine Testing for Drugs of Abuse, National Institute on Drug Abuse (NIDA), The following Amphetamine -related compounds were positively detected in spiked drug-free control urine samples with the AMP b. Critical Issues in Urinalysis of Abused Substances: Report of the Substance Abuse Amphetamine MonlabTest® at the concentration shown (Table 3) Testing committee, clinical Chemistry, 34(3), 617 (1988) c. Blum, K., Handbook of Abusable drugs, Gardener Press, Inc., NewYork, NY, 1st Table 3 Cross-reactivity study of AMP Amphetamine MonlabTest® kit d. Baselt RC., Disposition of Toxic Drugs and Chemicals in Man, 3rd Ed.,Chicago, IL. Year Book Medical Publishers Inc., 780-783, (1990). e. Mandatory Guidelines for Federal Workplace, Drug Testing Programs, Fed. Reg. f. Liu R.H., Goldberger B.A., Hand book of Workplace Drug Testing, AACC Press Karch S.B., Drug Abuse Handbook, CRC Press (1998) h. Inaba T., Journal of Canadian Physuology and Pharmacology, 67:1554-57 (1989) Method Comparison – The accuracy of the AMP Amphetamine MonlabTest® was evaluated on clinical urine samples with GC/MS 1629 Fosters Way Delta BC V3M 6S7 Canada concentrations for D-Amphetamine. 75 samples including 35 positive and 40 negatives clinical samples (30 drug-free) were purchased and tested on site using IND Diagnostic One-Step Amphetamine Test Kit by a trained 76 Stockport Road, Timperley, UK WA15 7SN technician. Overall, the percent agreement was 74/75 or 98.7%. Results were run again further by another technician showing strong agreement between results. Detailed results are shown in Table 4. Table 4 Comparison of One-step Amphetamine Test with GC/MS Positive
Agreement
Negative
Positive
( > 50 %
with GC / MS
(between
(between
Percent Agreement among Positives: 100.0% Percent Agreement among Negatives: 97.5% Monlab SL Selva de Mar 48 08019 BCN +34 93 433 58 60 Fax +34 93 436 38 94 [email protected] www.monlab.es Rev: june 2006

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