6 Panel Multiple Drug Abuse Test Kit Detecting Drug Metabolites In Human Urine

Intended Use

The Multi-drug Rapid Test Panel (Urine) is rapid chromatographic immunoassays for the qualitative and simultaneous detection up to sixteen of the following drugs in human urine. The designed cutoff concentrations for these drugs are as follows:

Principle

The Multi-drug Rapid Test Panel (Urine) is one-step immunoassay in which chemically labeled drugs (drug-protein conjugates) compete for limited antibody binding sites with drugs which may be present in urine. The test panel contains membrane strips which are pre-coated with drug-protein conjugates on the test band(s). Each strip, the drug antibody-colloidal gold conjugate pad is placed at one end of the membrane. In the absence of drug in the urine, the solution of the colored antibody-colloidal gold conjugate move along with the sample solution upward chromatographically by capillary action across the membrane to the immobilized drug-protein conjugate zone on the test band region. The colored antibody-gold conjugate then attach to the drug-protein conjugates to form visible lines as the antibody complex with the drug conjugate. Therefore, the formation of the visible precipitant in the test zone occurs when the test urine is negative for the drug.When the drug is present in the urine, the drug/metabolite antigen competes with drug-protein conjugate on the test band region for the limited antibody. When a sufficient concentration of the drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored antibody (drug-protein conjugate)-colloidal gold conjugate to the drug-protein conjugate zone on the test band region. Therefore, absence of the color band on the test region indicates a positive result.A control band with a different antigen/antibody reaction is added to the immunochromatographic membrane strip at the control region (C) to indicate that the test has performed properly. This control line should always appear regardless of the presence of drug or metabolite. If the control line does not appear the test panel should be discarded.

STORAGE

Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

LIMITATION

1. The 6-MAM Rapid Test Cassette provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrophotometry (GC/MS) is the preferred confirmatory method2.3.

2. It is possible 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 indicates presence of the drug or its metabolites but does not indicate level of 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.

performance characteristics

A side-by-side comparison was conducted using the Rapid Test Cassette (Urine) and GC/MS. The following results were tabulated:

Specimen Correlation

Table 2: Specimen Correlation

Positive agreement with GC/MS: 132/(132+4) = 97%

Negative agreement with GC/MS: 155/(155+9) = 95%

Total agreement with GC/MS: (132+155)/(132+4+9+155) = 96%

Cross Reactivity

A study was conducted to determine the cross-reactivity of the test with compounds in either drug-free urine or drug positive urine containing, Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Tramadol , Methaqualone, Ketamine ,Phencyclidine, Propoxyphene or Tricyclic Antidepressants. The following compounds show no cross-reactivity when tested with the Multi-Drug Rapid Test Panel with Adulteration at a concentration of 100 µg/mL. Visual interpretations occurred at 5 minutes after specimen application. Results are presented in table below.

Table: Cross Reactivity

Conclusion: The compounds listed in above table show no cross-reactivity when tested at a concentration of 100 mg/ml in 5 minutes.

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.