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Background - Patient Info - Health Provider Info Detection Levels - Common Illicit Drugs Parent Help Info - Workplace Drug Testing Tests Lower Than $30 - See Listing
AutoSplit Drug Test Cup Performance Characteristics Accuracy A side-by-side comparison was conducted using the One Step Single Drug Test Strip and commercially available drug rapid tests. Testing was performed on approximately 1,700 specimens previously collected from subjects presenting for Drug Screen Testing. Presumptive positive 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.
Information For Drug Cut Off Times Is Available Only Upon Request To Dr. Mark Gonzalez Due To It's Sensitive Nature. This Information Will Only Be Distributed To Verfied Sources Due To The Fact That We Do Not Wish For This Information To Be Placed In The Wrong Hands. Thank You For Understanding. Forty (40) clinical samples for each drug were run using each of The One Step Single Drug Test Strip by an untrained operator at a Professional Point of Care site. Based on GC/MS data, the operator obtained statistically similar Positive Agreement, Negative Agreement and Overall Agreement rates as trained laboratory personnel. *Note: TCA was based on HP/LC data.
Sensitivity and SpecificityA study was conducted at three physician offices by untrained operators using three different lots of product to demonstrate the within run, between run and between operator precision. An identical panel of coded specimens, containing drugs at the concentration of ± 50% and ± 25% cut-off level, was labeled, blinded and tested at each site. The results are given below: AMPHETAMINE (AMP)
BARBITURATES (BAR)
BENZODIAZEPINES (BZO)
COCAINE (COC)
*Note: One invalid result was obtained
MARIJUANA (THC)
METHADONE (MTD)
METHAMPHETAMINE (mAMP)
OPIATE 300 (MOP 300 OR OPI 300)
OPIATES (OPI 2000)
PHENCYCLIDINE (PCP)
TRICYCLIC ANTIDEPRESSANT (TCA)
Analytical SpecificityThe following table lists the concentration of compounds (ng/mL) that are detected positive in urine by AutoSplit Integrated Drug Test Cup at 5 minutes.
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. The AutoSplit Integrated Drug Test Cup 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 AutoSplit Integrated Drug Test Cup. 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 Cocaine, Barbiturates, Benzodiazepine, Amphetamine, Methamphetamine, Marijuana, Methadone, Opiate or Phencyclidine. The following compounds show no cross-reactivity when tested with AutoSplit Integrated Drug Test Cup at a concentration of 100 pg/mL. Background - Patient Info - Health Provider Info - Drug Cut Off Times - Common Illicit Drugs - Parent Help Info - Workplace Drug Testing - Tests Lower Than $30 - See Listing | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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NOTE: California Residents - Business and Professions Code 1246.5 Requires That Any Test that has not been approved by the Federal Food and Drug Administration for sale to the public without a prescription as an Over-The-Counter Test kit must be ordered by a Licensed physician acting on a patient's behalf. All orders for test kits within the state of California NOTE: New York State Residents New York State health law prohibits the testing of certain specimens collected in or mailed from New York, and prohibits the transmission of data from our laboratory to NY physicians or residents. Therefore, direct receipt of lab results for NY residents is not possible. International Residents & Orders: Extra shipping charges may be added for international orders. Patients will be contacted by e-mail or telephone to approve charges. |
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