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Accu-Stat™ THC-COC-OPI-mAMP-PCP-AMP-MDMA, a simple one-step immunoassay is intended for use in the qualitative detection of MARIJUANA, COCAINE, OPIATES, METHAMPHETAMINES, PHENCYCLIDINE, AMPHETAMINE and ECSTASY. metabolites in human urine.

Accu-Stat™ THC-COC-OPI-mAMP-PCP-AMP-MDMA test provides a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography, mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result , particularly when preliminary positive results are indicated. The newly packaged test for U.S. domestic market includes optional confirmation testing at no additional charge.

Accu-Stat™ THC-COC-OPI-mAMP-PCP-AMP-MDMA test uses solid-phase immunoassay technology for the qualitative detection of MARIJUANA, COCAINE, OPIATES, METHAMPHETAMINES, PHENCYCLIDINE, AMPHETAMINE and ECSTASY metabolite in human urine. This test is based on the competition for the limited antibodies between immobilized drug conjugate on the membrane and drug or drug metabolite which may be present in the urine being tested. In the test procedure, a sample of urine is placed in the sample well and is allowed to migrate downward. When the drug is present in the urine sample, it competes with drug conjugates which are immobilized on the membrane for the limited amount of antibodies present in the dye-antibody conjugate. When sufficient amount of drug or drug metabolite above the cut-off level is present, it will occupy all the antibody binding sites, and thus inhibit the binding of dye-antibodies to the drug conjugate preventing the formation of a line on the membrane. In addition to the Test line that may appear in the Test window, a Control line is added in the Control window to confirm the viability of the test. This Control line should always be seen if the test is conducted properly. Therefore, the presence of two lines, one in the Test window and the other in the Control window, indicates a negative result; while the absence of a line in the Test window indicates a positive results.

Accu-Stat™ THC-COC-OPI-mAMP-PCP-AMP-MDMA provides only a qualitative test results. To obtain a confirmed analytical results, more specific alternative methods such as gas chromatography/mass spectrometer (GC/MS) must be used.

Accu-Stat™ THC-COC-OPI-mAMP-PCP-AMP-MDMA test cup should be stored at 4-30 C (40-86 F) in its original sealed pouch.

Approximately 1 ounce of urine sample is required for each test. Fresh urine specimens do not require any special handling or pretreatment. If testing will not be performed immediately, specimens should be refrigerated (2-8 C) or frozen. Specimens should be brought to room temperature before testing.

The test procedure consists of adding the urine sample to the test cup and watching for the appearance of colored lines in the Test window.

Control standards (for professional use) are not supplied with this kit; however, it is recommended that a control be tested as good laboratory testing practice. For information on how to obtain controls, contact Accu-Stat™’s Technical Services. Before using a new kit with patient specimens, positive and negative controls should be tested to confirm the test procedure, and to verify the tests produce the expected Q.C. results.

The Control line can be considered an internal control. A distinct reddish-purple Control line should always appear if the test procedure is performed properly and the test reagents are working. If the Control line does not appear, the test is invalid and a new test should be performed. If the problem persists, contact Accu-Stat™ for technical assistance.

Accu-Stat™ THC-COC-OPI-mAMP-PCP-AMP-MDMA is qualitative assay. The amount of drugs and metabolites present in the urine cannot be estimated by the assay. The assay results distinguish positive from negative samples. A positive results indicates the sample contains drug metabolites above the cut-off concentration.

The National Institute on Drug Abuse has suggested that the screening cut-off for positive samples be 2000 ng/ml for opiates . Accu-Stat™ THC-COC-OPI-mAMP-PCP-AMP-MDMA test has been shown to detect an average of 2000 ng/ml or more for opiates or its metabolites in urine. The accuracy of Accu-Stat™ THC-COC-OPI-mAMP-PCP-AMP-MDMA was evaluated in comparison to a commercially available immunoassay at a cut-off of 2000 ng/ml. A total of 1021 samples were tested by both procedures with 97% agreement.

In a separate study, Accu-Stat™ THC-COC-OPI-mAMP-PCP-AMP-MDMA was evaluated against specimens confirmed as positive by GC/MS. Of 78 samples confirmed as positive, 77 samples were positive when tested with >Accu-Stat™ for 99% agreement.

Accu-Stat™ THC-COC-OPI-mAMP-PCP-AMP-MDMA test detects the cocaine metabolite, benzoylecgonine. The following table lists compounds that cross react in this test. The results are expressed as the concentration required to produce a positive result.