easy@Home Multi-Drug Screen Test

Product Overview

The easy@Home® Multi-Drug Screen Test (Cat.No.: EDOAP-124) provides a fast, accurate, and easy method for drug testing. This kit is designed to detect two drug metabolites: 11-nor-A9-THC-9-COOH (THC) and Cotinine (COT). THC is a metabolite of marijuana, and Cotinine is a metabolite of nicotine, indicating tobacco use. This dual-panel test is intended for in-vitro diagnostic and over-the-counter use.

Intended Use

The easy@Home® Multi-Drug Screen Test (Cat. No.: EDOAP-124) is a rapid urine screening test. It is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human urine at defined cutoff concentrations. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are positive. This test provides a preliminary screening result; confirmatory methods are recommended for definitive results.

Principle

The easy@Home® Multi-Drug Screen Test is a competitive immunoassay used to screen for the presence of drugs of abuse in urine. In this chromatographic absorbent device, drugs or drug metabolites in a sample competitively bind to a limited number of antibody-dye conjugate binding sites. As urine is absorbed upward by capillary action, it mixes with the antibody-dye conjugate and flows across the pre-coated membrane. When sample drug levels are at or above the target cutoff, the drug in the sample binds to the antibody-dye conjugate, preventing it from binding to the drug-protein pre-coated in the test region (T). This results in no distinct colored band in the test region (T), indicating a potentially positive result. When sample drug levels are zero or below the target cutoff, the antibody-dye conjugate binds to the drug-protein pre-coated in the test region (T), producing a colored test line, indicating a negative result. A colored line will also appear in the control region (C) if the test has been performed properly, serving as a procedural control.

Warnings and Precautions

• This kit is for external use only. Do not swallow.
• Discard after use. The test cannot be used more than once.
• Do not use the test kit beyond its expiration date.
• Do not use the kit if the pouch is punctured or not well sealed.
• Keep out of the reach of children.

Storage and Stability

• Store at 40°F-86°F (4°C-30°C) up to the expiration date.
• Keep away from sunlight, moisture, and heat.
• DO NOT FREEZE.

Specimen Collection and Preparation

Collect a urine sample in a collection cup (not included). Urine specimens may be refrigerated (36°F-47°F or 2°C-8°C) and stored for up to forty-eight hours. For longer storage, freeze samples at -4°F (-20°C) or below. Bring frozen or refrigerated samples to room temperature before testing. Use only clear aliquots for testing.

Test Procedure

Ensure the test is performed at room temperature (65°F-86°F or 18°C-30°C).

1. Open the sealed pouch by tearing along the notch. Remove the test device from the pouch.
2. Hold the device with one hand. Use the other hand to pull off the cap, exposing the absorbent end.
3. Immerse the absorbent end into the urine sample for about 10 seconds. Ensure the test is dipped into the urine up to, but not past, the mark line "MAX" printed on the device.
4. Lay the device flat on a clean, dry, non-absorbent surface.
5. Read the result in 5 minutes. Do not read after 5 minutes.

Content of the Kit

• Test devices in one pouch with one desiccant. The desiccants are for storage purposes only and are not used in the test procedure.
• Package Insert.

Material Required But Not Provided

• Timer
• Urine collection cup

Limitations

• This test has been developed for testing urine samples only. The performance of this test using other specimens has not been substantiated.
• Adulterated urine samples may produce erroneous results. Strong oxidizing agents such as bleach (hypochlorite) can oxidize drug analyses. If a sample is suspected of being adulterated, obtain a new sample.
• This test is a qualitative screening assay. It is not designed to determine the quantitative concentration of drugs or the level of intoxication.
• It is possible that technical or procedural errors, as well as other interfering substances in the urine specimen, may cause erroneous results.
• A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when a drug is present but below the cut-off level of the test.
• The test result does not distinguish between drugs of abuse and certain medicines.
• A false positive result might be obtained from certain foods or food supplements.

Questions and Answers

1. What does the drug of abuse urine test do?

The drug of abuse urine test indicates if one or more prescription or illegal drugs are present in urine. This easy@Home drug test kit is designed to detect the presence of Marijuana and Cotinine.

2. What is cotinine and why do we test for it?

Cotinine is the first-stage metabolite of nicotine. Nicotine is a drug to which virtually every member of a tobacco-smoking society is exposed, whether through direct contact or second-hand inhalation. In addition to tobacco, nicotine is also commercially available as the active ingredient in smoking replacement therapies such as nicotine gum, transdermal patches, and nasal sprays. Nicotine and cotinine are rapidly eliminated by the kidney; the plasma half-life of nicotine is approximately 60 minutes following inhalation or parenteral administration, while cotinine can be detected in urine up to 2-3 days after nicotine use. As a result, cotinine is considered a good biological marker for determining nicotine use.

3. What is "cut-off level"?

The cut-off level is the specified concentration of a drug in a urine sample. Above that concentration, the test result is called positive, and below that concentration, it is called negative.

4. What are the Common Street Names for the Drugs to be detected?

Drug	Street Names
Marijuana(THC)	Weed, dank, pot, ganja, zig zag, bud, grass, hydro
Cotinine(COT)	Tobacco, cigarettes, smokes, cigs, fags, butts, nicotine

5. How accurate is the test?

The tests are sensitive to drugs and accurate. These tests, however, are not as accurate as confirmatory lab tests. In some cases, certain foods and drugs may cause false positives as well as false negatives for those who use drug-testing kits. These are known as cross-reactions.

6. If the test results are negative, can the conclusion be that the person is free of drugs?

This means that if the sample was collected properly and if the test was performed according to the directions, then none of the screened drugs were present in the urine. The concentration of the screened drug in the urine specimen was zero or below the cutoff level.

7. Does the COT test panel pick up on secondhand tobacco smoke?

It is possible for people who do not or have not used tobacco to test positive for a low level of cotinine if they are exposed to secondhand smoke. If you use nicotine replacement medicine, such as gum or a patch, the cotinine test result most likely will be affected as well.

8. Will I get a positive test result if I had one cigarette in the past 72 hours?

Nicotine and cotinine are rapidly eliminated by the kidney; Cotinine can be detected in urine up to 2-3 days after nicotine use. Maximum detection time is 1-7 days in most cases. If the amount of cotinine metabolite in the body reaches the cutoff of 200 ng/mL, the result will show positive if you test during this detection time frame.

9. What is the principle of easy@Home® Multi-Drug Screen Test?

easy@Home® Multi-Drug Screen Tests are competitive immunoassays used to screen for the presence of drugs of abuse in urine. When the test is activated, urine is absorbed into the device by capillary action. Then, flowing across the pre-coated membrane, it mixes with the respective drug antibody conjugates. If concentrations of sample drugs are below corresponding detected drugs' cutoffs, respective drug antibody conjugates bind to the respective drug-protein conjugates immobilized in the Test Region (T) of the device. This produces a colored line in the test region that indicates a negative result. Conversely, if concentrations of sample drugs are at or above corresponding detected drugs' cutoffs, the free drugs of the sample bind to the respective drug antibody conjugates. This prevents the respective drug antibody conjugates from binding to the respective drug-protein conjugates immobilized in the Test Region (T) of the device. Therefore, there is no colored line in the test region, indicating a preliminary positive result. To serve as a procedure control, if the test has been performed properly, a colored line will appear at the Control Region (C).

Meaning of Symbols on Package

• IVD: For in vitro diagnostic use
• Keep away from sunlight: Protect from direct sunlight.
• Store between 40°F-86°F (4°C-30°C): Recommended storage temperature range.
• Keep dry: Protect from moisture.
• Do not re-use: Single-use device.
• iConsult instructions for use: Refer to the package insert for detailed instructions.

Contact Information

Any questions, please call toll-free at 1-855-822-6999.

Monday - Friday 9:00 a.m.-5:00 p.m. Central Time.

To learn more, please visit: www.healthcare-manager.com

Manufactured for Easy Healthcare Corporation, 360 Shore Dr. Burr Ridge, IL US 60527

Made in China

Version: V01: 20220810