1 ct pkg
Warnings and precautions: 1. For in-vitro diagnostic use. 2. Do not use the test device beyond the expiration date. 3. Collect urine specimen directly into the test cup. Ensure that the sample amount meets the minimum level as indicated on the side of the test cup. 4. Read the results at 5 minutes. Do not interpret results after 30 minutes.
CareOne™ Drug Screen Test. 5 drugs tested. Marijuana. Cocaine. Methamphetamine. Amphetamine. Opiates. Over 99% accurate*. Results in minutes. Professional grade testing device. Clear, sanitary viewing of test results. One (1) self-contained urinalysis test cup with secure lid and 5 test strips (one time use). *Based on clinical patient study. Features: Quick results in only 5 minutes. Professional grade testing device. No instruments needed. Drug screen test does not require any handling or manipulation to activate the test. Just dispense urine into cup and read results in only 5 minutes. Drugs tested in this kit: THC - Marijuana. COC - Cocaine. MET - Methamphetamine. AMP - Amphetamine. OPI - Opiates. MDMA - ecstasy. PCP - phencyclidine. TCA - tricylic antidepressants. BAR - barbiturates. BZD - benzodiazepines. MAD - methadone. OXY - oxycodone. Quality guaranteed or your money back. Intended use: The drug screen test is an immunochromatographic assay for rapid, qualitative detection of drug combinations and their principal metabolites in urine at specified cut-off concentrations. The Drug Screen Test, X may denote any number of drugs. These drug combinations may be composed from any of the following drugs, at the noted cut-off concentrations: 7 illicit drugs: Drug class - abbreviations - sensitivity. Marijuana - THC - 50 ng/ml. Cocaine - COC - 300 ng/ml. Methamphetamine - MET - 1000 ng/ml. Amphetamine - AMP - 1000 ng/ml. Opiates - OPI - 300 ng/ml. Ecstasy - MDMA - 500 ng/ml. Phencyclidine - PCP - 25 ng/ml. 5 prescription drugs: Tricyclic Antidepressants - TCA - 1000 ng/ml. Barbiturates - BAR - 300 ng/ml. Benzodiazepines - BZD - 300 ng/ml. Methadone - MAD - 300 ng/ml. Oxycodone - OXY - 100 ng/ml. An added feature to assess the integrity of the urine samples prior to drug testing, is a visual determination of Creatinine (CRE), Glutaraldehyde (GLU), pH, Specific Gravity (SG) and Nitrite, Pyridinium Chlorochromate, Bleach (NPB). These adulteration strips are built into the test device which may provide information regarding urine sample tampering. Note: The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. Summary and explanation of the test: The drug screen test is an easy, fast, qualitative, visually read competitive binding immunoassay method for screening without the need of instrumentation. The method employs unique mixture of antibodies to selectively identify the drugs of abuse and their metabolites in test samples with a high degree of sensitivity. Drug abuse remains a growing social and economical concern in many developed and developing countries throughout the world. The above stated drugs are among the most frequently abused illicit drugs, according to the U.S. Substance Abuse and Mental Health Services Administration. Opiates are among a class of heavily abused prescription drugs. The sensitivity of the drug screen test is set as required for the screening immunoassays of these drugs in the reference guidelines set by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Department of Health and Human Services. Principle of the test: The drug screen test is a competitive binding immunoassay in which drug and drug metabolites in a urine sample compete with immobilized drug conjugate for limited labeled antibody binding sites. By utilizing antibodies that are specific to different drug classes, the test permits independent, simultaneous detection of any of the drug combinations from a single sample. The approximate run time is 5 minutes. In the assay procedure, urine mixes with labeled antibody-dye conjugate and migrates along a porous membrane. When the concentration of a given drug is below the detection limit of the test, unbound antibody-dye conjugate binds to antigen conjugate immobilized on the membrane, producing a rose-pink color band in the appropriate test zone for that drug. Conversely, when the drug level is at or above the detection limit, free drug competes with the immobilized antigen conjugate on the membrane by binding to antibody-dye conjugate, forming an antigen-antibody complex, preventing the development of a rose-pink color band. Regardless of the drug levels in the sample, a rose pink-color band is produced in each control zone (top bands) by a parallel immunochemical reaction. These bands serve as built-in quality control measures by demonstrating antibody recognition, verifying that the reagents are chemically active. Materials required but not provided: 1. Clock or timer. Interpretation of results of drug test strips: Positive: A rose-pink band is visible in each control zone (top band). No color band appearing in the appropriate test zone (bottom band) indicates a preliminary positive result for the corresponding drug of that specific test zone. Send urine specimen to a certified laboratory for confirmation - Cordant Health Solutions, 1-844-848-5955. Negative: A rose-pink band is visible in each control zone and the appropriate test zone, indicating that the concentration of the corresponding drug of that specific test zone is below the detection limit of the test. Invalid: If a color band is not visible in each of the control zones, the test is invalid. Another test should be run to re-evaluate the specimen. Note: There is no meaning attributed to line color intensity or width. Quality control: An internal procedure control has been incorporated into the test to insure proper kit performance and reliability. The use of an external control is recommended to verify proper kit performance. Quality control samples should be tested according to quality control requirements established by the testing laboratory. Limitations of the test: 1. This product is designed to be used for the detection of drugs of abuse and their metabolites in human urine only. 2. Although the test is very accurate, there is the possibility false results will occur due to the presence of interfering substances in the specimen sample. 3. The test is a qualitative screening assay and is not suggested for quantitative determination of drug levels in urine, or the level of intoxication. 4. Adulterants such as bleach or other strong oxidizing agents, when added to urine specimens, can cause erroneous test results regardless of the analysis method used. 5. If adulteration is suspected, obtain another urine specimen. Performance characteristics: Sensitivity, the drug screen test detects drugs of abuse and their major metabolites in urine at concentrations equal to or greater than the cutoff level for the specific drug, which is suggested by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) for the immunoassay method. Printed in the USA. One step at home drug test. Customer service 1-877-846-9949. ©2017 Ahold Licensing Sarl. All rights reserved.
Directions for use: 1. Insert specimen into the test cup and replace cap. 2. Wait 5 minutes before reading results. 3. If positive, send to laboratory for analysis. This drug test cup provides preliminary test results. A more specific chemical method (such as GC/MS) should be used to confirm the results. Test procedure: 1. Urinate into cup, filling the cup with urine above the minimum level line. 2. Stand the cup upright on a solid surface. 3. Wait 5 minutes. 4. Read results. 5. After test results are confirmed please dispose of the entire cup. Negative: Two lines indicate a negative result. Positive: One line indicates a positive result. Retest: No line requires a retest. See instructions inside for more details about reading results. Please note: This is only a preliminary home drug testing kit for instant results. For confirming results, check with your family physician or health care professional. Storage and stability: Store test kit below 82 degrees F/28 degrees C; do not freeze. If stored at 8 degrees - 40 degrees F/2 degrees - 8 degrees C, allow the test kit to reach room temperature (60 degrees - 82 degrees F/15 degrees - 28 degrees C) before performing the test. Refer to the expiration date for stability. Specimen collection and preparation: Fresh urine specimens should be collected directly into the cup. The drug screen test device employs a thermal strip which should be checked immediately after collection to validate urine specimen. SAMHSA regulations specify that any temperature below 90.5 degrees F must be considered adulterated. No additives or preservatives are required. Note: Urine specimens can be transferred from a urine collection container into the drug screen test cup, if necessary. Test procedure: 1. Do not break the seal of the pouch until ready to begin testing. 2. Remove the test cup from the foil pouch. 3. Collect urine specimen directly into the test cup. Ensure that the sample amount meets the minimum level as indicated on the side of the test cup. 4. Read the results at 5 minutes. Do not interpret results after 30 minutes. Note: The result must be interpreted at five minutes. Waiting more than five minutes may cause the reading to be inaccurate. To avoid confusion, discard the test device after interpreting the result.
Ahold USA, Inc.
Landover, MD 20785