# IS3: iScreen Drug Test 3 panel urine drug testing kits are available as on-site tests, or laboratory analysis. Referred to as "the gold standard", urinalysis is the most common test type and used by federally mandated drug testing programs. Urine drug testing (UDT) is widely used for testing for opioids and illicit drugs. iScreen Drug Test 3 panel urine drug test 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 urine drug 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.
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.
REAGENTS
iScreen Drug Test 3 panel urine drug test 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 healthcare professionals including professionals at point of care sites.
For in vitro diagnostic use only. Do not use after the expiration date.
The test card should remain in the sealed pouch until use.
All specimens should be considered potentially hazardous and handled in the same manner as an
infectious agent.
The used test card should be discarded according to federal, state and local regulations.
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 centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.
Effect of Urinary Specific Gravity
Fifteen (15) urine samples of normal, high, and low specific gravity ranges (1.000-1.037) were spiked with drugs at 50% below and 50% above cut-off levels respectively.
iScreen Drug Test 3 panel urine drug test was tested in duplicate using fifteen drug-free urine and spiked urine samples. The results demonstrate that varying ranges of urinary specific gravity does not affect the test results.
Effect of the Urinary pH
The pH of an aliquoted negative urine pool was adjusted to a pH range of 5 to 9 in 1 pH unit increments and spiked with drugs at 50% below and 50% above cut-off levels. The spiked, pH-adjusted urine was tested with iScreen Drug test 3 panel urine drug test. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.
Cross-Reactivity
A study was conducted to determine the cross-reactivity of the test with compounds in either drug-free urine or drug positive urine containing, Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Opiate, Oxycodone, Phencyclidine, Propoxyphene or Tricyclic Antidepressants. The following compounds show no crossreactivity when tested with iScreen Drug Test at a concentration of 100 ėg/mL.
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