Card Test INTENDED USE
coated membrane and a pad containing the antibody-dye
The One Step Cocaine/Benzoyl Ecgonine assay is a rapid,
conjugate in a protein matrix containing a 0.1 % sodium azide.
qualitative, competitive binding immunoassay for thedetermination of benzoyl ecgonine in human urine. The test
MATERIALS REQUIRED, BUT NOT PROVIDED
provides only preliminary data which should be confirmed by
other methods1, 2,3,4 such as gas chromatography / mass
spectrophotometry (GC/MS). The preliminary positive resultsshould be justified with compelling clinical consideration and
WARNINGS AND PRECAUTIONS
1. For in vitro diagnostic use only. 2. For professional use only. SUMMARY AND EXPLANATION OF THE TEST
3. Do not use kit beyond expiration date imprinted on the
The method employs unique monoclonal antibodies to
selectively identify benzoyl ecgonine in test samples with a
4. Urine specimens may be infections. Properly handle and
high degree of sensitivity. Cocaine is an alkaloid present in the
dispose of all used reaction devices in a biohazard
Coca leaves (Erythroxylon coca) and its pharmacological
properties, such as stimulating and euphoric effects, have beenknown for many centuries.5 Cocaine has been used medicinally
as a local anesthetic agent, but its addictive properties have
The reagents contained in the OneStep Cocaine/Benzoyl
minimized its modern daily use.6 Cocaine is most often self-
Ecgonine test kit should be stored at room temperature (15-
administered by IV injection, nasal insufflation, (snorting) and by
30°C) and will be stable until the expiration date.
inhaling vapor from heating of free base (smoking). Theavailability of "crack" (a street form of free base) has increased
SAMPLE COLLECTION AND PREPARATION
the use by this latter route.7 Elimination of cocaine is
Urine (1.0ml) - the sample must be collected in a clean, dry
predominantly controlled by its biotransformation. Very low
container, either plastic or glass, without any preservatives.
concentrations of cocaine are detected in urine during the initial
Urine specimens may be refrigerated (2 - 8°C) and stored up to
several hours, and benzoyl ecgonine, a hydrolytic degradation
48 hours, or frozen (-20°C or colder) prior to assaying. If
product, persists in urine at a detectable level for 48 hours.8
samples are refrigerated, they must be equilibrated to room
Immunoassay testing has been developed for the determination
of benzoyl ecgonine in the urine at the concentration of 300ng/ml set by the National Institute on Drug Abuse.9
The OneStep Cocaine/Benzoyl Ecgonine test kit is an easy, fast,
1. Bring the test kits to room temperature before opening the
and visually read screening method without the need for
2. Remove the reaction device from its foil wrapper by tearingalong the "splice " and place it on a flat surface. PRINCIPLE OF THE TEST
3. Fill the urine dropper with sample by holding the dropper
The One-Step Cocaine/Benzoyl Ecgonine Test consists of a
vertically and dispense two to three (2 - 3) full drops of
chromatographic absorbent device in which the drug or drug
urine (without air bubbles) into the sample well.
metabolites in the sample compete (with a drug conjugate
immobilized on a porous membrane support for limitedantibody sites). As the test sample flows up through the
INTERPRETATION OF RESULTS
absorbent device, the labeled antibody-dye conjugate binds tothe free drug in the specimen forming an antibody-antigencomplex. This complex competes with immobilized antigenconjugate in the positive reaction zone and will not produce apink-rose color bend when the drug is higher than the detectionlevel of 300 ng/ml. Unbound dye conjugate binds to thereagent in the negative control zone, producing a pink-rosecolor band, demonstrating that the reagents and device arefunctioning correctly. A negative specimen produces two distinctcolor bands in both the test line and reference line. A positivespecimen produces only one color band in the reference line. Positive: One pink-rose band appears on the control region. REAGENTS AND MATERIALS SUPPLIED
No apparent band in the test region (T), in which the benzoyl
Each kit contains 20 protected foil pouches. Each pouch
ecgonine level is above the detection sensitivity level of 300
contains one "reaction device" and one disposable plastic
dropper. The reaction device contains a drug-protein conjugate
Negative: In addition to the control band, a pink-rose band Card Test
also appears in the test region (T). If this is the case, the
benzoyl ecgonine level is below the detection sensitivity level of
1. Hoyt, D.W., Finnigan, R.E., Nee, T., Shuits, T.F., and Butler,
T.J., J. Am. Med. Asso. 258:504 - 509 (1987). 2. MacGregor, R.R., Fowler, J.S., and Wolf, A.P., J. of
Invalid: If there is no distinct color band visible both in the
Chromatography, 590:354 - 358 (1992).
"T" and "C" region, or there is a visible band only in the "T"
3. Cone, E.J., Yousefnejad, D., Dickerson, S.L., J. of ForensicSciences, 35 (4): 786 - 791 (1990).
region and not the "C" region, then the test is invalid. It is
4. Cone, E.J., Menchen, S.L., Paul, B.D., Mell, L.D., and Mitchell,
recommended that the specimen be retested.
J., J. of Forensic Sciences, 34 (1): 15 - 31 (1989). NOTE: In order to prevent any incorrect results, the test results
5. Holmstedt, B., and Fredga, A., J. Ethnopharmacol.,3:113 - 147
should not be interpreted after 5 minutes.
(1981). 6. Inaba, T., Can. J. Physiol. Pharmacol., 67: 1154 - 1157 (1989). QUALITY CONTROL
7. Jeffcoat, A.R., Perez-Reyers, M., Hill, J.M., Sadler, B.M., and
1. An internal procedure control has been incorporate into the
Cook, C.E., Drug Metabolism and Dispostion, 17 (2) :153 - 159
test to ensure product performance and reliability.
2. Good laboratory practice dictates the use of control
8. Baselt, R.C., and Chang, R., J. Anal. Toxicol., 11:81 -82 (1987).
material to test each product shipment, or whenever
9. Federal Register, 53 (69): 11970-11989 (1988).
necessary, to validate reagent performance and reliabilityCommercial controls are available for the purpose. LIMITATIONS 1. This product is designed to be used for the detection of Cocaine and its metabolites in human urine only. 2. Although the OneStep Cocaine/Benzoyl Ecgonine test is very accurate in detecting the urine benzoyl ecgonine level, there is a possibility of false results due to the presence of interfering substance in the urine. 3. The test is a qualitative screening assay and is not suggested for determining the quantitative benzoyl ecgonine level of urine, or the level of intoxication. 4. Adulterants, such as bleach or other strong oxidizing agents, when added to urine specimens, may produce erroneous test results regardless of the analyst method used. If adulteration is suspected, obtain another urine specimen. PERFORMANCE CHARACTERISTICS Sensitivity The OneStep Cocaine/Benzoyl Ecgonine test had been designed for the detection of benzoyl ecgonine in urine at the detection sensitivity of 300 ng/ml, which is suggested for the immunoassay method. Specificity The OneStep Cocaine/Benzoyl Ecgonine test can specifically detect benzoyl ecgonine in urine. There is no interference by the following substances at a 10 ug/ml concentration in urine: Morphine Cannabidiol (+), Amphetamine (+), Deoxyephedrine, Phencyclidine, and Phenobarbital.
EVIDENCIA-ALAPÚ SZAKMAI ÁLLÁSFOGLALÁS AZ AUTIZMUS SPEKTRUM ZAVARRAL ÉLŐ SZEMÉLYEK ELLÁTÁSÁRÓL Készítette: Dr. Balázs Anna, gyermekpszichiáter; Gy. Stefanik Krisztina, pszichológus; Őszi Tamásné, gyógypedagógus – az Autizmus Alapítvány vezető szakemberei Az autizmus spektrum zavarok diagnosztikája a viselkedéses képre épül. A fejlődést részletesen és cé
UNITED STATES ATTORNEY’S OFFICE MANHATTAN U.S. ATTORNEY AND FBI ASSISTANT DIRECTOR-IN-CHARGE ANNOUNCE 24 ARRESTS IN EIGHT COUNTRIES AS PART OF INTERNATIONAL CYBER CRIME TAKEDOWN Two-Year FBI Undercover “Carding” Operation Protected Over 400,000 Potential Cyber Crime Victims and Prevented Over $205 Million in Losses Preet Bharara, the United States Attorney for the S