easy Home EDTH-114, EDCO-114 Single Drug Screen Test User Guide

easy Home EDTH-114, EDCO-114 Single Drug Screen

Easy@Home Single Drug Screen Test offers fast, accurate and easy drug testing. Easy@Home” Single Drug Screen Test (Cat. No.: EDTH-114, Cat. No.: EDCO-114) can detect 2 of the following commonly abused drugs: Marijuana(THC), Cocaine (COC).
This package insert applies to all Single Drug Screen Tests. Therefore, some information on the performance characteristics of the product may not be relevant to your test. Please refer to the labels on the packaging and the prints on the test strip to identify which drugs are included in your test.
A rapid one step test for the qualitative detection of drug of abuse and their principal metabolites in human urine at specified cut off level.
For in vitro diagnostic use only.

INTENDED USE

Easy@Home Single Drug Screen Test is rapid urine screening test. The test is a lateral fiow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human urine at the following cut off concentrations:

This assay provides only a preliminary test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GCIMS) is the preferred confirmatory method, Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are positive.

PRINCIPLE

DRUG TESTS

Easy@Home Single Drug Screen Test is a competitive immunoassay that is used to screen for the presence of drugs of abuse in urine. It is chromatographic absorbent device in which drugs or drug metabolites in a sample competitively combined to a limited number of antibody-dye conjugate binding sites.
When testing, the urine is absorbed upward by capillary action, 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 the antibody-dye conjugate from binding to the drug-protein pre-coated in the test region (T). This prevents the development of a distinct oolored band in the test region indicating a potentialy positive result. When sample drug levels are zero or below the target cutoff (the detection sensitivity of the test). antibody-dye conjugate binds to the drug-protein pre-coated in the test region (T) of the device. This produces a colored test line that, regardless of its intensity, indicates a negative result. To serve as a procedure control, a colored line will appear on the control region (C), if the test has been performed properly.

WARNINGS AND PRECAUTIONS

• This kit is for external use only. Do not swallow.
• Discard after first use. The test cannot be used more than once.
• Do not use the test kit beyond the 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 4°C-30°C (40°F-86°F) up to the expiration date. Keep away from sunlight, moisture, and heat.

DO NOT FREEZE.

• After opening the pouch, please use the drug panel as soon as possible, no more than 1 hour.

MATERIAL

• The material provided was One pouch containing a test panel and a desiccant.
• Package insert

Material Required But Not Provided

• Timer
• Urine cup

SPECIMEN COLLECTION AND PREPARATION

Collect a urine sample in the urine cup. Urine specimens may be refrigerated 2°C-8°C (36°F-47°F) and stored up to forty-eight hours. For longer storage, freeze the samples at-20°C (4°F) or below. Bring frozen or refrigerated samples to room temperature before testing. Use only clear aliquots for testing
TEST PROCEDURE
Test must be in room temperature 10°C-30°C (50°F-86°F).

1. Open the sealed pouch by tearing along the notch. Remove the test device from the pouch.
2. Hold the one side of the device with one hand. Use the other hand to pull out the cap and expose the absorbent end.
3. Immerse the absorbent end into the urine sample about 10 seconds. Make sure that the urine level is not above the “MAX” line printed on the front of 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.

Step 1: Pull the cap off and immerse the strips into urine for 10 seconds

Step 2: Read the result in 5 minutes. Do not read after 5 minutes.

INTERPRETATION OF RESULTS

Positive (+)
A rose-pink band is visible in each control region. No color band appears in the appropriate test region. It indicates a positive result for the corresponding drug of that specific test zone.

Negative (-)
A rose-pink band is visible in each control region and the appropriate test region. It indicates that the concentration of the corresponding drug of that specific test zone is zero or below the detection limit of the test.

Invalid
If a color band is not visible in each of the control regions or a color band is only visible in each of the test regions, the test is invalid. Another test should be run to re-evaluate the specimen. Please contact the distributor or the store, where you bought the product, with the lot number.

Note:

1. There is no meaning attributed to line color intensity or width.
2. The abbreviations of drug names in the product images are just for demonstration. Please refer to the labels on the packaging and the prints on the test strip to identify which drugs are included in your test.

QUALITY CONTROL

Users should follow the appropriate federal state, and local guidelines concerning the frequency of assaying external quality control materials. Though there is an internal procedural control line in the test device of control region, the use of external controls is strongly recommended as good laboratory testing practice to confirm the test procedure and to verify proper test performance. Positive and negative controls should give the expected results. When testing the positive and negative controls, the same assay procedure should be adopted.
LIMITATIONS

1. This test has been developed for testing urine samples only. The performance of this test using other specimens has not been substantiated.
2. 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.
3. This test is a qualitative screening assay. It is not designed to determine the quantitative concentra tion of drugs or the level of intoxication
4. It is possible that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.
5. A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cut-off level of the test.
6. The test result does not distinguish between drugs of abuse and certain medicines
7. A positive result might be obtained from certain foods or food supplements.

MEANING OF SYMBOLS ON PACKAGE

• Keep away from sunlight
• Store between 4°C-30°C (40°F-86°F)
• Keep dry
• Do not reuse
• Manufacturer
• For in vitro diagnostic use only
• Consult instructions for use
• CE marking of conformity
• Authorized representative in the European community
• Recyclable
• Tests per kit
• Batch code
• Expiry date
• Catalog number

Questions?
If you have any questions, please contact us via email at s ervice @healthcare-manager.com
Scan the code to get the manual in more languages. www.healthcare- manager.com
Distributed by Easy Healthcare Corporation 360 Shore Dr., Burr Ridge, IL USA 60527

QUESTIONS AND ANSWERS

• The Test Line is lighter than the Control Line. Does this mean some drug is present?
  No. Any line next to the word Drug or the drug abbreviation (depending on the test you have purchased), no matter how dark or light, is considered a Negative Result, and no further testing is required. It is possible that the intensity of the lines ill varies among the drugs being tested for due to a variety of reasons such as: how diluted the urine is, the pH or protein level of the urine, or interference from a metabolite in the urine that closely resembles the drug.

• How soon can I read my results?
  Any negative result is available to read as long as two lines appeared in the results window. For positive results, you have to wait for 5 minutes when only a red or pink colored line appeared next to the letter C and there is no line that appeared next to the letter T.

• Are there any factors that can affect the test result?
  Certain over-the-counter medications or prescription drugs may cross-react with the Easy@Home Drug Test and cause a Preliminary Positive Result The test will only give accurate results on fresh human urine samples. Old or diluted urine samples may not be suitable for testing. If you are testing someone else, keep in mind that Easy@Home Drug Tests are only as accurate as the urine sample being tested. Samples can easily be ‘adulterated” (.e., contaminated or tampered with) with common household products such as bleach and other liquids if you’re not closely supervising the entire process. This test provides a screening result only. It is not designed to determine the actual concentration of a drug, or the level of intoxication nor is it to be used for legal purposes.

• What cut-off levels do Easy@Home Drug Tests use for detecting drugs in urine?
  The cut-of level for each drug varies (depending on the type of drug) and is measured in nanograms (ng/ml). Although Easy@Home Drug Tests are designed to detect a very small amount of a drug in urine, if the amount is below the established cut-off level, you may test negative for that drug even though you may have taken the drug. How soon after taking the drug can you detect it in urine with an Easy@Home Drug Test and how

• long can a drug be detected in urine?
  Most drugs can be detected in urine with an Easy@Home Drug Test within a few hours after taking the drug; however this can vary depending on the type of drug taken, the amount taken, the frequency of Use and the metabolism of the person being tested Each drug is cleared by the body at different rates. Some drugs, for example, marijuana, can stay in the body for up to several weeks after use.
  I test negative with an Easy@Home Drug Test, does this guarantee I will test negative on

• other drug tests administered by a professional?
  Many Easy@Home Drug testing products are more than 99 percent accurate in detecting specific drugs according to the designated cut-off levels. However, if a more sensitive test is administered. there is a chance of testing positive if drugs are present in urine.

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