Frequently Asked Questions

Our devices are easy to operate, convenient to store and deliver results in minutes. Since 1997, we have been serving our clients with the highest quality products at competitive prices while offering superior product training and customer care as well. We welcome the opportunity to work with you. Accu-Stat™ over-the-counter home drug test is a disposable device designed to instantly detect various drugs in urine with reliable results.

These are the same tests that we sell to employers, drug, family and juvenile courts, schools, drug counselors and rehabilitation centers. The Accu-Stat™ home drug tests are classified as immunoassays. Our immunoassays are a type of test that utilizes the principal of highly specific reactions between antibodies and antigens for the detection of drugs. An immunoassay is often considered to be the first step in a two-step process to look for the presence of drugs of abuse in urine.

If your specific situation requires a 100% guarantee of positive test results, then you should take the second step in the two-step drug testing process. That is, confirm your positive immunoassay test results with a more accurate method of drug testing, such as a gas chromatography / mass spectrometry (GC/MS) test. A GC/MS test is considered to be the “gold standard” in the drug testing industry.

Our test kits include this second step for free. A GC/MS confirmation is available and in Accu-Stat™ over-the-counter Panel 1 – Panel 4 drug tests. This service is included at no additional charge for those testing positive and desiring confirmation. The new domestic over-the –counter Accu-Stat™ Home Drug Tests contain a specimen vial (individually identified with a confidential ID number) and a mailer in which you send a urine sample to Spectrum Analytics, our certified in-house laboratory. Within five days after the laboratory receives the urine sample you may contact a member of our professional laboratory staff with your confidential identification number and obtain the accurate quantifiable GC/MS test results. We guarantee that all information is kept in strict confidence.

• Stewart, D.J., Inoba, T., Ducassen, M., and Kalow, W. Clin. Pharmacol. Ther. 25; 264-8 (1979).
• Ambre, J. J. Anal. Toxicol. 9; 241-5 (1985).
• Urine Testing for Drugs of Abuse, National Institute for Drug Abuse (NIDA), Research Monograph 73, 1986.

Is it possible to cheat the iCup® drug screen by substituting or adulterating the specimen?

No. The iCup® A.D. contains a specimen validity test or SVT strip that verifies the validity of a specimen. The SVT strip checks for oxidants, specific gravity and pH in the specimen. For example, if someone tries to substitute water for urine, the specific gravity indicator will show an abnormal reading.

How long are the results valid after administering the tests?

The amount of time for results to remain stable varies according to the rapid test device. Please visit our library section or call us directly for more information.

Is there any specific way these products need to be stored? Do they have to be refrigerated?

All drug test devices can be stored at room temperature up to the date of expiration printed on the individual foil pouch. They cannot be stored in extreme heat or cold and must remain sealed in the foil pouch until use.

What is the minimum amount of specimen needed for a conclusive test result?

It is always important to collect a sufficient amount of specimen in case of a non-negative result. The confirmation laboratory requires a minimum of 15mL of specimen but prefers 30mL for urine testing. For saliva, it is 2mL.

Does the product need to be disposed of in any special way, such as a biohazard bag?

Urine and oral drug screens do not pose a biohazard risk and can be disposed of in regular waste receptacles.

Are there products that can be used in the tests to give a false negative?

What can be done to avoid this? Although there are only a small handful of products that can be used to change the result of an impending test, there are validity screens available which can detect these adulterants. Some are integrated into the tests, such as the iCup®, which has built-in adulteration available, and we also have individual adulteration strips.

Do you have to confirm a non-negative result? If so, how is this done?

Instant Technologies, Inc. strongly recommends that a SAMHSA certified laboratory confirm all non-negative results. Please call us directly for assistance.

Are any of your drug tests FDA Cleared? All of our urine and clinical tests have an FDA 510k clearance.

Is there specific training required to administer these drug tests?

Although there is no official training required to administer the tests, Instant Technologies, Inc. does provide procedure cards, instructional videos, drug test interpretation quizzes and certificates of completion free of charge. These instructional materials help you to administer, interpret and if necessary, package a non negative result for confirmation testing.

What are the differences between the oral fluid tests and the urine drug tests?

An oral fluid drug test involves the use of a swab to collect saliva in the mouth and gums. The test does not require a restroom and the testing procedure can be administered right at your location. A urine drug test comes in a variety of formats, such as dips, pipettes, and cups. The iCup®, for example, has built-in adulteration tests available to check the validity of a urine sample.

>> 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