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One and Two Steps Oral Fluid Drug Screens An Independent Report on Oratect
®
II for Onsite Oral Drug Screen


EXECUTIVE SUMMARY

This report, commissioned by Branan Medical Corporation, provides an independent analysis on
the efficacy of Oratect
®

II as an efficient oral drug screen by a nationally and internationally
renowned immunologist. Dr. Harley Tse is currently an associate professor at Wayne State
University and the editor of a book Drugs of Abuse: Body Fluid Testing published by Humana
Press. In recent years, there is increasing demand for the use of oral fluids as a matrix for abused
drug testing and Oratect
®
II has met this challenge. This improved version of the original
innovative Oratect
®
drug screen device integrates collection, testing, and confirmation sampling
into a single device. Six drugs can be simultaneously detected with greatly increased sensitivity
at much reduced time. The collection process is simple and has been modified to ensure failsafe
test operation. Total time required for collection and testing result is usually within 7 min.
Recently, the testing has been extended to alcohol, so that a simultaneous determination of drugs
and alcohol is possible.

1. Introduction
Oral fluids offer an attractive alternative matrix for drug testing due to several factors. These
include:
a. reduced chance for adulteration because the collection process is easily observed;
b. specimen readily accessible without the requirement of a toilet facility as in the case of
urine
specimen;
c. non-invasiveness of collection process, unlike the use of needle as in the case of blood

collection or the necessity of a same gender observer in urine donation;
d. oral fluid drug concentration providing closer correlation with serum drug levels as

compared to urine so that it is a better indicator for a person under the influence of drug.

These factors contribute to the increasing acceptability of oral fluid testing as a valid indicator of
drug usage (1-3). To initiate regulation of such testing, guidelines (4) have been established by
the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA).

2. Oral Fluid Test Devices and Design Challenges

There are several notable oral-fluid testing devices on the market. These can be briefly categorized as
follows:
a. Laboratory instrument based devices:

A device is provided for the collection of oral fluids and the specimens are sent to an

off-site laboratory for analysis. Such products include Intercept
®

(manufactured by OraSure

Technologies, Inc.) and Immunalysis Corporations ELISA tests.
b.
On-site instrument based devices:


In this set up, a small instrument is available on-site. Oral fluid is sucked into the instrument via

a tubing and the instrument then perform the analysis. Examples of these instruments include
Uplink
®
by OraSure Technologies, Inc.
c.
O
n-site instant drug screens:

These on-site screening devices have been on the market since the late 1990s. These

1
include Oralab (Varian Corporation), Oralstat (American Bio Medica Corporation),

Oral-Screen (Avitar, Inc.), and Oratect
®
(Branan Medical Corporation). Oralab,

Oralstat and Oral-Screen are two-component devices in which oral fluids, collected by a

sampling device, are transferred to a separate test device for analysis. Oratect, on the

other hand, is a one-step device in which both collection and testing processes are

incorporated into a single device. This simplified design minimizes the dimensions of the

device for portability and enables the testing procedure to be accomplished quickly and
efficiently.


To be successfully used in a quality drug screen program, certain challenges have to be
addressed by onsite devices. These include the following:
a. The collection process must be easy and quick. Since oral fluid testing may be
performed by individuals with minimal technical background, the collection has to be
simple. Moreover, if the device is to be applicable to roadside police use, short
collection time is essential to avoid exposing the officer to a long period of potentially
hazardous situation.
b. Since many chronic abused drug users have dry mouth, test devices must be able to
provide test results using small amount of oral fluids or require a method of
stimulating oral fluid flow.
c. The testing must overcome the inconsistency of the oral fluid matrix. There are large
variations in pH, viscosity and debris contents among individuals being tested.
Therefore, the device must be robust so that it can perform in spite of such variability.
d. The sensitivity of the test must meet the lower drug concentrations present in the oral
cavity. Unlike urine specimens which contain drugs and their metabolites that are
excreted at fairly high concentrations, oral fluids contain drugs either in their un-
metabolized forms or metabolites in much lower concentrations. Hence, the cut-off
levels for oral fluids tests have to be lower. This situation requires the development
of more sensitive tests for the different drugs.
e. The test strip must be able to perform in spite of the slow migration of oral fluids and
the high hydrophobicity of the parent marijuana chemical --
9
-tetrahydrocannabinol
(THC). In the urine screening of marijuana users, the main detectable molecule is the
metabolite 11-nor-
9
-tetrahydrocannabinol-9-carboxylic acid or THCCOOH.
However, in several studies, such metabolite cannot be found in oral fluids. Instead
THC from marijuana smoke residue appears to be the only detectable molecule.
Since this is a residual molecule and not a secretion product from the oral cavity, its
presence is rapidly depleted over a short time period after smoking. Furthermore,
THC is very sticky and adheres to most materials. Hence, to detect marijuana in
oral fluids, this factor has to be taken into consideration.
f. Since it is a regulatory requirement that presumptive positive results indicated by a
drug screen need to be confirmed in the laboratory by a more definitive procedure
such as a gas chromatography/mass spectrometry (GC/MS) or liquid
chromatography/mass spectrometry (LC/MS), considerations must be made to
provide a sample for such purposes if the drug screen is positive.

This paper will examine how the design of the Oratect II device addresses these issues, followed
by a general description of its performance.

2
3. Design of the Oratect Device
The Oratect device (see Oratect product insert enclosed with test kits) is designed to be an on-
site, simple and easy-to-use drug screen. To address the issues raised in Section 2 above, the
following characteristics have been incorporated into the design:
a. The collection device is directly linked to the lateral flow immunoassay test strips. This
patented incorporation of two functional aspects of an on-site drug screen allows a
simplified procedure and decreases the time requirement for obtaining a test result. With
a collection time of usually 3 minutes and the test times of 5 minutes, a test result can be
routinely obtainable in about 8 minute from start to finish. By using lateral flow
immunoassay, test results can be obtained on-site without the use of any instrumentation.
b. To overcome the issue of dry mouth, an early version of Oratect used citric acid to
stimulate saliva flow and required 1.1 ml of oral fluid to complete the testing and
confirmation processes. However, the use of citric acid has been shown to be
problematic due to the high viscosity and pH variability of the oral fluids, causing
difficulties in the migration of colloidal gold in the lateral flow immunoassay system
despite the use of strong buffers. This results in incidences of no-flow. The Oratect II
utilizes the rubbing of the collection pad against the mouth cavity to stimulate saliva
production and reduces the amount of oral fluids needed for the whole procedure down to
0.55 ml.
c. Special proprietary chemistry is incorporated into the collection pad and the
immunoassay strips to overcome the variability encountered in oral fluids.
d. Since the cut-off concentrations proposed by SAMHSA are much lower for the
commonly monitored drugs, the immunoassay tests for the Oratect II have been fine
tuned so that the lower detection cut-offs can be achieved.
e. Overcoming the stickiness of THC and developing a sensitive enough test for its
detection has been the greatest challenge of on-site drug test manufacturers. Oratect II
employs a special food grade chemistry to help the mobility of THC on the col