TRENDS IN DRUG USE BY CHRISTINE MOORE, PHD, DSC, DABCC, FAACC, IMMUNALYSIS CORPORATION


Oral Fluid Split Collections: A Paradigm Shift in Workplace Drug Testing


I


ntroduction: Te Substance Abuse and Mental Health Service Administration (SAMHSA) is moving toward the


approval of oral fluid as an allowable specimen for testing in the Federal Drug- free Workplace Program. One of the main areas of concern with the proposed testing guidelines has been the lack of commercially-available oral fluid collection devices that can simultaneously collect adequate volume to accommodate a split sample (analogous to a urine specimen, which is poured into two separate containers aſter collection—“A” & “B”).


Current collection devices: Tere are some devices which collect expectorated neat oral fluid and divide the sample into two separate graduated containers, e.g., Ultra-Sal 2 (Neogen). However, it is more common to use devices that contain a collection pad and buffer, predominantly to assist in drug removal from the pad, and stabilize drugs in the oral fluid during transportation and storage. Currently, there are FDA 510(k) cleared oral fluid collection devices available that adhere to the proposed SAMHSA guidelines by allowing the collection of 1mL ±10% of neat oral fluid: examples include Quantisal® (Figure 1, Immunalysis) and OralEze®


(Quest Diagnostics). Such device types would need to be used in one of two ways: a. Simultaneously: Two devices in the mouth at the same time, or


b. Consecutively: Collection of the second sample should start within two minutes of first device completion.


There are drawbacks to both of these approaches. a. In simultaneous collection, donors may not be comfortable with two devices placed in the mouth at the same time, especially as some devices are relatively large. Further, it is difficult to determine if the rate of saliva deposition onto each pad is the same, potentially causing discrepant results between the two samples. Positioning of the device in the mouth may cause one collection to be complete before the other—again, possibly causing discrepant results. Tere are no available data or peer- reviewed literature reports supporting this approach for any of the SAMHSA drug classes.


b. In the second scenario, where samples are collected consecutively, there is limited, if any, published data showing that drug concentration in the second sample is similar to the first (within a specific tolerance range). Tere are


several drugs to be analyzed within the testing program, and none have peer-reviewed literature to support this approach.


New collection devices: Based on industry and governmental requirements, the Quantisal® II oral fluid collection device has been developed. Te patented device allows simultaneous collection of oral fluid comprising two pads on a single stem (Figure 2). Te overall design is based upon the existing FDA 510(k) cleared Quantisal® device, manufactured with the same materials in the same facility. Briefly, the Quantisal® II collection


device is placed into the mouth until the blue dye is activated in the plastic stem, indicating that adequate volume has been collected. In our facility, all volunteers (n=50) provided adequate oral fluid within 10 minutes; in fact, the collection time for the adequacy volume indicator to turn blue had an average collection time of 3.43 minutes (median = 3 minutes). Te pads are then separated (Figure 3)


and placed into two individual transportation tubes containing Quantisal® buffer (3mL) (Figure 4), capped (“A” and “B”) and shipped to a laboratory for analysis of the “A” sample. Each individual pad collects 1mL ±10% of neat oral fluid.


Figure 1. FDA 510(k) cleared Quantisal® device.


16 datia focus


Figure 2. Quantisal® II: Two collection pads on one stem (side and front view).


Figure 3. Pad separation aſter oral fluid collection.


Figure 4. “A” and “B” splits placed in transportation tubes.


spring 2018


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