The One Step Multi Test Cup, Split Specimen Cup is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against their respective drug conjugate for binding sites on their specific antibody. During testing, a urine specimen migrates upward by capillary action. A drug, if present in the urine specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test line region of the specific drug strip. The presence of drug above the cut-off concentration will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test line region. Multi Test Cup works as a pre-employment drug test. Multi Test Cup Drug Screen split specimen Cup. Multi test cup, is a one step urine Multi Drug Test with the test kit integrated in the cup and does all the work for you. Multi test cup can be used as a pre-employment drug test for employee pre-screening or as a random drug test for screening employees on a monthly basis. Multi Test Cup, Multi Drug Test, for drugs of abuse drug screening. Multi Test Cup, On-site Drug Test, is very effective as a pre-employment drug test. Pre-employment drug testing: A pre-employment drug test is part of the hiring process due to the fact that a pre-employment drug test is many times required as part of a conditional offer of employment. Employees who test positive in pre-employment drug tests are 66% more likely to be absent and 77% more likely to be discharged within 3 years than those who tested negative.

Multi-Drug Test Cup, is a rapid drug test that detects multiple drugs in a single test. Multi-Drug Test Cup, detects the presence of drugs in minutes. Multi-Drug Test Cup split specimen Cup. Multi (multiple) just means that you can test for more than one drugs at the same time simultaneously, and the test will display the results all at one time. Reproducibility studies were carried out using commercially available standards. Each standard was diluted in normal, drug-free urine to give the appropriate concentration. Each specimen, at each concentration of analyst, was tested four times daily, in duplicate, for five consecutive days. A total of 40 determinations were made at each concentration. The results are given below: Fifteen (15) urine samples of normal, high, and low specific gravity ranges (1.005, 1.015, 1.03) were spiked with drugs at 50% below and 50% above cut-off levels respectively. The One Step Drug of Abuse Test was tested in duplicate using ten drug-free urine and spiked urine samples. The results demonstrate that varying ranges of urinary specific gravity do not affect the test results. The pH of an alaquated negative urine pool was adjusted to pH ranges of 4.0, 4.5, 5.0, 6.0 and 9.0, and spiked with drugs at 50% below and 50% above cut-off levels. The spiked, pH-adjusted urine was tested with the One Step Multi-Drug Test Cup. The results demonstrate that varying ranges of pH do not interfere with the performance of the test. During testing, a urine specimen migrates upward by capillary action. A drug, if present in the urine specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test line region of the specific drug strip. The presence of drug above the cut-off concentration will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test line region.

This Multi-Drug Test Cup, Split Specimen Cup detects the presence of the drug metabolites in minutes. 5 Panel Multi Drug Test, Split Specimen Cup comes with a fully integrated design eliminates handling of the urine. Only the collector can activate the test, thus eliminating donor manipulation. Label hides test result from those who do not need to view results. The test is a fast visual, competitive panel immunoassay that can be used for the simultaneous, qualitative detection of a specific drug metabolite in human urine. 5 Panel Multi-Drug Test Cup, Split Specimen Cup is ideal for pre-employment, random drug testing, reasonable cause drug testing, corrections drug testing, clinical drug testing, hospital drug testing. A drug-positive urine specimen will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug-negative urine specimen will generate a line in the test line region because of the absence of drug competition. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may be used. Urine specimens exhibiting visible precipitates should be allowed to settle to obtain a clear specimen for testing. A side-by-side comparison was conducted using The One Step Multi-Drug Test Cup and other commercially available rapid drug tests. Testing was performed on 120 specimens per drug type previously collected from subjects presenting for drug screen testing. All the presumptive positive and negative results were confirmed by GC/MS. The following compounds were quantified by GC/MS and contributed to the total amount of drugs found in presumptive positive urine samples tested. Forty (40) clinical samples for each drug were run using each strip contained within The One Step Drug of Abuse Test by an untrained operator at a Professional Point of Care site. Based on GC/MS data, the untrained operator obtained statistically similar Positive Agreement, Negative Agreement and Overall Agreement rates as trained laboratory personnel.

Random Drug Testing: Random Drug Testing is mandated by the U.S. Department of Transportation, which means that many employers in the USA have no choice but to implement random drug testing programs. Even when random drug testing is not legally required, many organizations use small scale random drug testing as an effective deterrence against drugs of abuse to enforce their drug free workplace policy. random drug testing is simply pulling from an employee data base and selecting employees to be tested on a random pool, usually once a month. The Multi-Drug Test Cup, Drug Screen makes a great random drug test product. On-site Drug Test, Multi Drug Test. A no step split specimen drug test cup with fast 5 minute results. The On-site Drug Test, Multi Drug Test with keyless split specimen Test procedure is easy to use and FDA Cleared. On-site Drug Test works as a pre-employment drug test screening. On-site Drug Test is a one step urine drug test with the test kit integrated in the cup and does all the work for you. Multi Test Cup can be used as a Pre-employment drug test for employee pre-screening or as a random drug test for screening employees on a monthly basis.

Allow the test cup, and urine specimen to come to room temperature [15-30°C (59-86°F)] prior to testing. A study was conducted to determine the cross-reactivity of the Multi Drug Test with compounds in either drug-free urine or drug positive urine. A drug-positive urine specimen will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug-negative urine specimen will generate a line in the test line region because of the absence of drug competition. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred. The Multi Test Cup contains a membrane strip coated with drug-protein conjugates (purified bovine albumin) on the test line, a goat polyclonal antibody against gold-protein conjugate at the control line, and a dye pad which contains colloidal gold particles coated with mouse monoclonal antibody specific to the drugs being tested.

PRECAUTIONS

· For Professional Use Only.
· For In Vitro Diagnostic Use Only.
· Do not use after the expiration date.
· The test panel should remain in the sealed pouch until use.
· While urine is not classified by OSHA or the CDC as a biological hazard unless visibly contaminated with blood , the use of gloves is recommended to avoid unnecessary contact with the specimen.
· The used test card and urine specimen should be discarded according to federal, state and local regulations.

STORAGE AND STABILITY

Store as packaged in the sealed pouch at 2-30°C (36-86°F). The test is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

SPECIMEN COLLECTION AND PREPARATION

Urine Assay
The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may be used. Urine specimens exhibiting visible precipitates should be allowed to settle to obtain a clear specimen for testing.

Specimen Storage
Urine specimens may be stored at 2-8°C (36-46°F) for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed well before testing.


DIRECTIONS FOR USE
DO NOT INTERPRET RESULT AFTER 10 MINUTES.

Please follow the instructions on the Procedure Card.

INTERPRETATION OF RESULTS

NEGATIVE: Two lines appear. One red line should be in the control region (C), and another apparent
red or pink line adjacent should be in the test region (T). This negative result indicates that the drug
concentration is below the detectable level.
NOTE: The shade of red in the test line region (T) will vary, but it should be considered negative
whenever there is even a faint pink line.
POSITIVE: One red line appears in the control region (C). No line appears in the test region (T).
This positive result indicates that the drug concentration is above the detectable level.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques
are the most likely reasons for control line failure. Review the procedure and repeat the test using a new
test device. If the problem persists, discontinue using the lot immediately and contact your supplier.

QUALITY CONTROL

A procedural control is included in the test. A red line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

LIMITATIONS

1. The Multi Drug Test provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass
spectrometry (GC/MS) is the preferred confirmatory method. 3,4,7
2. There is a possibility that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.
3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen and a new test device.
4. A Positive result does not indicate intoxication of the donor, the concentration of drug in the urine, or
the route of drug administration.
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. Test does not distinguish between drugs of abuse and certain medications.
7.A positive test result may be obtained from certain foods or food supplements.

PERFORMANCE CHARACTERISTICS

Accuracy
A side-by-side comparison was conducted using The Multi-Drug Test Cup and other commercially available rapid drug tests. Testing was performed on 120 specimens per drug type previously collected from subjects presenting for drug screen testing. All the presumptive positive and negative results were confirmed by GC/MS. The following compounds were quantified by GC/MS and contributed to the total amount of drugs found in presumptive positive urine samples test

Forty (40) clinical samples for each drug were run using each strip contained within The Multi Drug Test by an untrained operator at a Professional Point of Care site. Based on GC/MS data, the untrained operator obtained statistically similar Positive Agreement, Negative Agreement and
Overall Agreement rates as trained laboratory personnel.
Note: TCA was based on HPLC data.

Reproducibility
Reproducibility studies were carried out using commercially available standards. Each standard was diluted in normal, drug-free urine to give the appropriate concentration. Each specimen, at each concentration of analyte, was tested four times daily, in duplicate, for five consecutive days. A total of 40 determinations were made at each concentration.