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>> INTENDED USE

The Accu-Stat™ THC test is a simple, one-step, immunochromatographic assay for the rapid, qualitative detection of THC in urine. This is intended for use in the qualitative detection of cannabinoids in human urine with a cut-off at 50ng/mL.

The Accu-Stat™ THC test provides only a preliminary analytical result. A more advanced laboratory method must be used in order to obtain a confirmed analytical result. Gas chromatography, mass spectrometry (GC/MS) is the preferred confirmatory process. 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 confirmatory testing at no additional charge.

>> SUMMARY AND PRINCIPLE OR PROCEDURE

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.

The Accu-Stat™ THC test is based on the principle of the highly specific immunochemical reactions between antigens and antibodies which are used for the analysis of specific substances in biological fluids. The test relies on the competition of binding to the antibodies between drug conjugates and drugs which may be present in the urine sample. In the test procedure, a sample of urine is placed in the sample well of the device, and the sample is allowed to migrate upward. If drug is present in the urine sample, it competes with drug conjugate, which is immobilized on the membrane for the limited antibodies present in the form of dye-antibody conjugate. When sufficient amount of drug is present, the drug will saturate the antibodies, and the dye-antibody conjugate cannot bind to the drug conjugate on the membrane. Therefore, a drug-positive urine sample will not generate a line in the test window, indicating a positive result.

>> MATERIALS PROVIDED

The Accu-Stat™ THC test kit contains all the reagents necessary to perform the assay.

Accu-Stat™ THC device The test device contains a membrane coated with drug conjugate and a pad containing anti-THC antibody-dye conjugate in a protein matrix.
Disposable sample 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.
Accu-Stat™ THC 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 test kits should be stored at 4-30 C (40-86 F) in the original sealed pouch.

>> SPECIMEN COLLECTION AND PREPARATION

Approximately 4 drops of urine sample is required for each test. Fresh urine specimens do not require any special handling or pretreatment. Specimens should be collected in a clean glass or plastic container. 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. Specimens should be clarified by centrifuging or allowing to settle before testing.

>> TEST PROCEDURE

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.

>> TEST PROTOCOL

For each test, open one Accu-Stat™ THC pouch.
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 Two Lines

The appearance of two reddish-purple lines one in the Test window and the other in the Control window indicates a negative test result; ie., no THC above the cut-off level has been detected. The color of the Test line 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 indicates the result is positive; i.e., the specimen contains THC at a concentration above the cut-off level.

Confirmation Testing

Samples that are screened as negative do not need further examination. For a sample that is screened as positive, you should send it to our laboratory for further analysis to confirm the actual presence of the drug of abuse. Confirmation testing is performed using a combination of very sophisticated instrumentation and techniques known as gas chromatography/mass spectormetry (GC/MS) which can accurately identify a drug of abuse. Confirmation testing should be performed on all preliminary positive screening results. Laboratory results can be retrieved within 5 to 7 business days from the time the sample is received in the laboratory. The test kit contains detailed instructions and all of lthe materials necessary for mailing the sample to our laboratory for testing. The instructions also describe how to obtain your confidential results. You need only identify yourself by the identification number provided.

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 THC 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.

Limitations

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.
Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the method of analysis. If adulteration is suspected, the test should be repeated with a new sample.
This test detects only the presence of THC and/or its metabolites in 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 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 problem persists, contact Worldwide Medical for technical assistance.

>> EXPECTED VALUES

Accu-Stat™ THC 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 result indicates the sample contains cannabinoids above the cut-off concentration.

>> PERFORMANCE CHARACTERISTICS

Accu-Stat™ THC test has been shown to detect an average of 50 ng/ml or more of THC metabolites in urine. The accuracy of Accu-Stat™ THC was evaluated in comparison to a quantative laboratory test with agreement observed in 99% of the samples.

In a separate study, Accu-Stat™ THC was evaluated against specimens confirmed as positive by GC/MS. Of 88 samples confirmed as positive, 87 samples were positive when tested with Accu-Stat™ for 99% agreement.

>> SPECIFICITY

The following table lists compounds that are detected by Accu-Stat™ THC test. The results are expressed in terms of the concentration required to produce a positive result.

Compound	Concentration (ng/mL)
Cannabinol	15,000
11-nor- 8-THC-9-COOH	30
11-nor- 9-THC-9-COOH	50
8-THC	25,000
9-THC	10,000

>> REFERENCES

R.C. Baselt, Disposition of Toxic Drugs and Chemical in Man, 2nd Ed.,
Biomedical Publ., Davis, CA., 1982, p.488.
Urine testing for Drugs of Abuse, National Institute for Drug Abuse
(NIDA), Research Monograph 73, 198