Oral Fluid Drug Screen Testing

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We are a CLIA approved lab that does in-house urine drug screens using cpt code 80305 with modifier QW. Recently our clinic started offering Vivitrol injections and part of the patients therapy is to be drug screened. It was decided to do the drug screens using oral fluid due to the swab being capable of detecting the presence of alcohol along with 13 other drug classes through optical observation. Some of the medical staff are concerned that this method isn't CLIA approved and another would like to test for both the urine and the oral fluid; so can anyone tell me if there is a specific brand of swab we need to use or it doesn't matter as long as it is coded once per day with 80305 - QW. Any input would be appreciated.

Thank you,


Glendale, Arizona
Best answers
Hi Lisa,

I would triple check that the device that you are using is actually approved for clinical use and not forensic and is CLIA waived. To my knowledge there is not a CLIA approved Oral fluid device billable as 80305. Most of the Oral fluid devices are used in forensic or law enforcement settings. Also, Vivitrol compliance is best detected via LC-MS/MS testing (definitive) of the long acting metabolites of alcohol (EtG, EtS)- NOT ethanol. The way we like to explain it is that testing of ethanol tells us if the patient is drinking right now- within the last 4 hours, and the assay is highly susceptible to false positives from mouthwash, and food alcohols.

Urine will always be the preferred specimen type for the tesing of drugs of abuse, this is both from a technical method standpoint on the laboratory instruments, as well as from a commercial payer standpoint. Oral fluid can present challenges from a collection standpoint, as well as in finding a definitive testing laboratory to perform testing from the oral fluid collection device of your choice. The Quantisal device is used as the standard collection method for both Quest and LabCorp your network lab partners.