Interpretive Data

Drugs/Drug classes reported as "Positive" are automatically reflexed to mass spectrometry confirmation/quantitation. An unconfirmed positive immunoassay screen result may be useful for medical purposes but does not meet forensic standards. The absence of expected drug(s) and/or drug metabolite(s) may indicate non-compliance, inappropriate timing of specimen collection relative to drug administration, poor drug absorption, or limitations of testing. The concentration at which the screening test can detect a drug or metabolite varies within a drug class. Specimens for which drugs or drug classes are detected by the screen are automatically reflexed to a second, more specific technology (GC/MS and/or LC-MS/MS). The concentration value must be greater than or equal to the cutoff to be reported as positive. Interpretive questions should be directed to the laboratory.

For medical purposes only; not valid for forensic use.
 

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.