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One Step Barbiturates Test has set the screen cut-off for positive specimens at 300 ng/mL for secobarbital as a calibrator. The test device has been proved to detect above 300 ng/mL of Barbiturates in urine at 5 minutes.
B. Specificity and cross reactivity
To test the specificity of the test, the test device was used to test barbiturates, metabolites and other components of the same class that are likely to be present in urine, All the components were added to drug-free normal human urine. These concentrations below also represent the limits of detection for the specified drugs or metabolites.
Component
Concentration(ng/ml)
Secobarbital
300
Amobarbital
300
Alphenol
150
Aprobarbital
200
Butabarbital
75
Butathal
100
Butalbital
2,500
Cyclopentobarbital
600
Pentobarbital
300
Phenobarbital
100
INTENDED USE
The One Step Barbiturates Test is a lateral flow chromatographic immunoassay for the detection of Barbiturates in human urine at the cut-off concentration of 300 ng/ml. This assay provides only a qualitative, preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Company Advantage
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What do the results mean?
If a drug test result is negative, it means that either:
The drugs that were tested were not found in the sample.
A very small amount of drugs were found, but not enough to be a positive test result for drugs.
If a drug test result is positive, it means that one or more drugs were found in amounts that suggest drug use or misuse. Positive tests require follow-up testing because they may be wrong (false positives). The follow-up test is usually a test that provides more accurate results.