Please note this product provides only preliminary data which should be confirmed by other methods such as gas chromatography / mass spectrophotometry (GC/MS). This test is not intended to monitor drug levels, but only to screen urine for the presence of the drugs mentioned and their metabolites.
The One Step Multi-Drug Screen Test card is a device composed of up to 12 chromatographic strips designed to detect up to 12 individual drugs of abuse. Each strip consists of a sample pad treated with antibody colloidal gold conjugate and membrane treated with drug conjugate and control reagent. Urine sample initially reacts with the antibody gold conjugate, and then migrates up the strip, by capillary action, to the test area. If sufficient drug is present in the urine, it binds with the conjugate, preventing it from binding to the drug conjugate immobilized on the membrane in the test region. Any unbound conjugate continues to migrate up the strip to the control region where it binds to the control reagent producing a pink/purple band. The control band indicates that the result is valid.
A negative specimen produces two (2) distinct color lines, one in the test area and one in the control area.
A positive specimen produces only one (1) color line in the control area.
1. Bring all materials and specimens to room temperature.
2. Remove test device from the sealed foil pouch.
3. Remove the cap from the device.
4. Immerse the bottom end of the test strips (the sample pads) into urine sample with the arrows pointing toward the specimen. (Keep the level of urine sample below the bottom of plastic card or the maximum line marked on the strips.)
5. Hold the device in the urine until a reddish color appears at the lower edge of the test membrane (approximately 10 seconds).
6. Withdraw the device from urine sample, and replace the cover.
7. Read results between 3 - 8 minutes.
Read Test results between 3 and 8 minutes. Do not interpret results after 8 minutes.
Read and record the results for each individual drug as follows:
Negative: Two (2) pink/purple bands form. In addition to the control band, a pink/purple band also appears in the test region.
Note: This immunoassay is a screening test. A negative result indicates the drug level is below the detection sensitivity. It is important to understand that concentrations of the drug below cut off may cause a faint “ghost line” to form in the test region. This “ghost line” should be considered a negative result.
Positive: One (1) pink/purple band appears in the control region. No band is found in the test region. This is an indication that the drug level is above the detection sensitivity level.
Invalid: If there are no distinct color bands in either the test or control region of the device, the test result is invalid. Retest the sample using a new device.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when results are positive. Positive results should be confirmed by an alternate method such as GC/MS.
1. Each strip has its own control band to indicate that the test is adequately performed. Any invalid result must be repeated using a new Test Card.
2. Good laboratory practice recommends the use of positive and drug free urine controls to validate reagent performance and establish test reliability. Commercial drug urine controls are available to assess the performance of this device.