5 Panel - Info

The Accu-Stat™ THC-COC-METH-OPIATES, a simple one-step immunoassay is intended for use in the qualitative detection of THC, COCAINE,METHAMPHETAMINE and OPIATES metabolites in human urine with a cut-off at 300 ng/mL for opiates. Click here for information on (THC / Cocaine).

The Accu-Stat™ THC-COC-METH-OPIATES 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.

THC (9-tetrahydrocannabinol) is the primary active ingredient in cannabinoids (marijuana). When ingested or smoked, it produces euphoric effects. Users have impairment of short term memory and THC use slows learning. Also, it may cause transient episodes of confusion, anxiety, or even frank toxic delirium. Long term, relatively heavy use may be associated with behavioral disorders. The peak effect of smoking THC occurs in 20-30 minutes and the duration is 90-120 minutes after one cigarette. Elevated levels of urinary metabolites are found within hours of exposure and remain detectable for 3-10 days after smoking. The main metabolite excreted in the urine is 11-nor-9-tetrahydrocannabinol-9-carboxylic acid.

Cocaine derived from the leaves of cocoa plant is a potent central nervous systems (CNS) stimulant and local anesthetic. Cocaine induces euphoria, confidence and a sense of increased energy in the user. These psychological effects are accompanied by increased heart rate, dilation of the pupils, fever, tremors, and sweating. Cocaine is used by smoking, intravenous or oral administration and is excreted in the urine primarily as benzolecgonine in a short time(1). Benzoylecgonine has a longer biological half-life (5-8 hours) than cocaine (0.5-1.5 hours) and can generally be detected for 24-60 hours after cocaine use or exposure.

The Accu-Stat™ THC-COC-METH-OPIATES test uses solid-phase immunoassay technology for the qualitative detection of THC, COCAINE, METHAMPHETAMINE and OPIATES metabolite, benzoylecgonine, 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 upward. 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.

The Accu-Stat™ THC-COC-METH-OPIATES provides only a qualitative test results. To obtain a confirmed analytical results, more specific alternative methods such as gas chromatography/mass spectrometer (GC/MS) should be used(3).

The Accu-Stat™ THC-COC-METH-OPIATES test kit contains all the reagents necessary to perform test.
Accu-Stat™ THC-COC-METH-OPIATES device. The test device contains a membrane coated with drug conjugate and a pad with antibenzoylecgonine antibody-dye conjugate.
Disposable specimen dispenser.
Instructions for use.
New U.S. domestic test also includes

Labeled confirmation vial
Transportation pouch
Pre-addressed mailing box
PRECAUTIONS

Avoid cross contamination of urine samples by using a new urine specimen container and dropper for each urine sample.
The Accu-Stat™ THC-COC-METH-OPIATES device should remain in its original sealed pouch until ready for use.
Do not use the test kit after the expiration date.
Urine specimens are potentially infectious. Proper handling and disposal methods should be followed.
STORAGE AND STABILITY

The Accu-Stat™ THC-COC-METH-OPIATES test kits should be stored at 4-30 C (40-86 F) in its original sealed pouch.

Approximately 4 drops 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 Sample well of the device and watching for the appearance of colored lines in the Test window.

For each test, open one Accu-Stat™ THC-COC-METH-OPIATES test.
Holding the dropper vertically, dispense 4 drops (200 uL) of the urine sample into the Sample well.
Read the results after 3 minutes, but within 10 minutes.

INTERPRETATION OF RESULTS

Negative Four Lines:

The appearance of four reddish-purple lines in the Test window and one in the Control window indicates a negative test result; ie., THC, COCAINE, METH or OPIATES above the cut-off levels have not been detected. The colored lines will appear within 1 to 3 minutes. The color of the Test lines may be weaker or stronger than that of the Control line.

Positive One Line:

The appearance of only one reddish-purple line in the Control window and no distinct line in the Test window for either THC-COC-METH-OPIATES indicates the result is positive (i.e., the specimen contains drug metabolite levels greater than the cut off level for the drug indicated).

Invalid:

A distinct colored line should always appear in the Control window. The test is invalid if no line forms in the Control window.
Note: A very faint line in the Test window, visible in 10 minutes, indicates that the amount of cocaine in the sample is near or below the cut-off level of the test. These urine specimens must be retested, or confirmed with a more specific alternative method such as gas chromatography/mass spectrometry, before positive determinations are made.

The test is designed for use with unadulterated urine only.
There is a possibility that factors such as technical or procedural errors, as well as other substances in the urine sample may interfere with the test and cause erroneous results.
This test detects only the presence of THC, COCAINE, METHAMPHETAMINE and OPIATES and/or their metabolites in human urine. A positive test result does not provide any indication of the level of intoxication or urinary concentration.
The test result read after 10 minutes may not be consistent with the original reading obtained within the 10 minute reading period.
The test must be read within 10 minutes of sample application.
User Quality Control

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 Worldwide Medical’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 Worldwide Medical for technical assistance.

The Accu-Stat™ THC-COC-METH-OPIATES 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 300 ng/ml for opiates . The Accu-Stat™ THC-COC-METH-OPIATES test has been shown to detect an average of 300 ng/ml or more for opiates or its metabolites in urine. The accuracy of Accu-Stat™ THC-COC-METH-OPIATES was evaluated in comparison to a commercially available immunoassay at a cut-off of 300 ng/ml. A total of 1021 samples were tested by both procedures with 97% agreement.

In a separate study, Accu-Stat™ THC-COC-METH-OPIATES 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.

The Accu-Stat™ THC-COC-METH-OPIATES 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.

Compound	Concentration (ng/mL)
Benzoylecgonine	1,000
Cocaine HCI	500
Ecgonine HCI	1,000

REFERENCES

Custom Rich-Text Page Cocaine Drug Test Kit