Friday, March 28, 2008

SAMHSA TO APPROVE ORAL FLUID / SALIVA DRUG TESTING

(source: Forensic Sci Int. 2007 Apr 12)

Despite the lack of speed, likely due program mismangement and lobbying on the part of urine labs and large TPAs that have a vested interest in urine testing, SAMHSA will (per the below) have to approve alternative forms of drug testing in order to manage workplace drug abuse.


The U.S. Mandatory Guidelines for Federal Workplace Drug Testing Programs: Current status and future considerations.
Donna M Bush - Division of Workplace Programs, Substance Abuse and Mental Health Services Administration, U.S. Department of Health and Human Services, One Choke Cherry Road, Room 2-1033, Rockville, MD 20857, USA.

The U.S. Department of Health and Human Services (HHS) drug testing standards were published in 1988 and revised in 1994, 1998, and 2004.

In a separate notice, HHS proposed to establish scientific and technical guidelines for the Federal Workplace Drug Testing Program to:

(1) permit laboratory testing of hair, oral fluid, and sweat patch specimens in addition to urine specimens for marijuana, cocaine, phencyclidine, opiates (with focus on heroin), and amphetamines [including methylenedioxymethamphetamine (MDMA), methylenedioxyethamphetamine (MDEA), methylenedioxyamphetamine (MDA)];

(2) permit use of on-site point of collection test (POCT) devices to test urine and oral fluid at collection sites;

(3) permit use of instrumented initial test (screening only) facilities [IITF] to quickly identify negative specimens; and (

4) add training requirement for collectors, on-site testers, and MROs.

This proposal was published in the Federal Register on 13 April 2004, with a 90-day public comment period.

The Substance Abuse and Mental Health Services Administration, HHS, reviewed those comments and is preparing the Final Notice that will define the requirements for such testing, including: specimen collection procedures, custody and control procedures that ensure donor specimen identity and integrity, testing facility, initial and confirmatory test cutoff concentrations, analytical testing methods, result review and reporting, evaluation of alternative medical explanations for presence of drug or metabolite in the donor's specimen, and laboratory certification issues.

Voluntary pilot performance testing (PT) programs for each specimen type are on-going since April 2000 to determine how to prepare PT materials for specimens other than urine to evaluate laboratories' ability to routinely achieve accuracy and precision required.


Certification programs will be developed using the current urine drug testing National Laboratory Certification Program model.

The addition of accurate and reliable workplace drug testing using hair, oral fluid, and sweat patch specimens will complement urine drug testing, and aid in combating industries devoted to suborning drug testing through adulteration, substitution, and dilution.

Tuesday, March 25, 2008

Saliva / Oral Fluid Proteins Mapped

Protein map of human spit created
By Julie Steenhuysen 27 minutes ago

CHICAGO (Reuters) - U.S. researchers have identified all 1,116 unique proteins found in human saliva glands, a discovery they said on Tuesday could usher in a wave of convenient, spit-based diagnostic tests that could be done without the need for a single drop of blood.

As many as 20 percent of the proteins that are found in saliva are also found in blood, said Fred Hagan, a researcher at the University of Rochester Medical Center in New York who worked on the study.

"This is potentially a large field that has many clinical implications in the area of disease diagnostics," said Hagan, whose work was published in the Journal of Proteome Research.

The researchers hope saliva-based tests could be used to diagnose cancer, heart disease, diabetes and a number of other conditions.

"To be able to diagnose disease using saliva, you really have to have a comprehensive understanding of the saliva proteome," Hagan said in a telephone interview.

Like a genome, which lists all of the genes in an organism, a proteome is a complete map of proteins. While genes provide the instruction manual, proteins carry out the instructions by regulating cellular processes.

Researchers from five universities -- the University of Rochester, The Scripps Research Institute, the University of Southern California, The University of California San Francisco and the University of California Los Angeles -- sought to determine the complete set of proteins secreted by the major salivary glands.

BLOOD, SPIT AND TEARS

They collected saliva from 23 healthy men and women of several races. They tested saliva samples using some form of mass spectrometry, which determines the identity of proteins based on measurements of their mass and charge.

They compared their findings with recent protein maps of human blood and tears.

Early analysis has already turned up a number of proteins with known roles in Alzheimer's, Huntington's and Parkinson's diseases; breast, colorectal and pancreatic cancer and diabetes.

Most of the proteins were part of signaling pathways, which are key to the body's response to system wide diseases.

Hagan said the work should accelerate the development of new tools for tracking disease throughout the body.

Already there are saliva-based antibody tests to detect human immunodeficiency virus, or HIV, and hepatitis infections, Hagan said. He said this protein map will provide new targets.

"Monitoring disease as well as drug use could be more easily done with saliva as opposed to blood or urine," he said.

Other groups are working on a saliva-based test for breast cancer that would detect a protein fragment from the HER2 protein. Hagan said such tests could eventually replace uncomfortable and costly mammograms.

"We envision in the future spitting in a tube and looking for a marker like this breast cancer marker. It would be much easier to do, potentially at home," he said.

"Given that we've made this information publicly available, we fully expect a number of research groups will be picking their favorite targets and developing their own tests. That is the intent -- to create a wealth of data to stimulate more research and increase the chances of producing better diagnostic tests," Hagan said.

(Editing by Maggie Fox and Mohammad Zargham)

Tuesday, March 18, 2008

Workplace Drug Abuse Statistics Misleading?

The following statistics are misleading at best.

A review of the data shows that drug abuse rates among workers have been stagnant for past decade.

Any statement that workplace drug abuse is lower, would be unsupportable by the findings.


The data does potentially indicate that that drug abusers have learned to cheat urine-based drug tests. This being supported by research recently concluded by the U.S. Government General Accounting Office (GAO) noting that cheating urine-based testing is easily accomplished and virtually undetectable.


The report also neglects to point out the opiate detection rates continue to climb. .. particularly oxycodones have gone up nearly 40% in one year!

" Use of Methamphetamine Among U.S. Workers and Job Applicants Drops 22 Percent in 2007 and Cocaine Use Slows Dramatically, Reports Quest Diagnostics"

Findings from Quest Diagnostics Drug Testing Index® also show that overall drug positivity remains at record lows

MADISON, NJ, March 12, 2008 — The percentage of positive tests for methamphetamine among U.S. job applicants and workers in the general U.S. workforce dropped more than 22 percent between 2006 and 2007.

These findings, from the Quest Diagnostics Drug Testing Index®, reflect the reversal of an upward trend in use of the drug by more than 73 percent from 2002 to 2004. These data were released today by Quest Diagnostics Incorporated (NYSE: DGX), the nation's leading provider of employment-related drug testing services.


The report also shows that positive tests for cocaine in the general U.S. workforce were down 19 percent between 2006 and 2007 and that overall drug use, among workers subject to drug testing, remains at an all-time low.

Methamphetamine, the most commonly abused type of amphetamine, increased in production and trafficking during the 1990’s to become the most prevalent illegally manufactured synthetic drug in the United States. Analysis of the Quest Diagnostics Drug Testing Index, released semi-annually, suggests that efforts to reduce illicit, clandestine production of methamphetamine may be having an impact on workplace positive tests for the drug.

"The fact that America's workers are using cocaine and methamphetamine at some of the lowest levels in years is further evidence of the tremendous success that law enforcement is having at impacting the nation's illicit drug supply," said DEA Acting Administrator Michele M. Leonhart. "DEA will continue its relentless assault on the drug supply to help keep these dangerous drugs out of our neighborhoods."

While the 2007 Quest Diagnostics Drug Testing Index shows that positive methamphetamine tests have decreased, it also indicates that the use of amphetamine in the general workforce has increased slightly, by about five percent. Testing for methamphetamine and amphetamine was conducted among employees and applicants in the U.S. workforce tested for the class of drugs called amphetamines.

"Although some may conclude that there is a reduced availability for methamphetamine, the fact that our data show an increase in amphetamines suggests that some workers might be replacing one stimulant drug for another in the larger drug class of amphetamines," said Barry Sample, Ph.D., Director of Science and Technology for Quest Diagnostics' Employer Solutions division.

Methamphetamine and amphetamine are both types of stimulants, which typically are used by individuals to increase alertness and relieve fatigue. Stimulants are also used for euphoric effects or to counteract the "down" feeling of tranquilizers or alcohol. Possible side effects of stimulants include increased heart and respiratory rates, elevated blood pressure, dilated pupils and decreased appetite. High doses may cause rapid or irregular heartbeat, loss of coordination or collapse. Indications of possible misuse may include excessive activity, talkativeness, irritability, argumentativeness or nervousness.

Cocaine Use Continues to Decline

The Quest Diagnostics Drug Testing Index shows that the percentage of positive tests for cocaine was down 19 percent among the U.S. general workforce since the first half of 2007 - the largest single-year drop since 1997. Positive tests for cocaine among the general workforce declined to 0.58 percent in 2007 from 0.72 percent in 2006.

Overall Drug Use Remains at All-Time Low

Additionally, drug use by employees remains at its lowest level since Quest Diagnostics began publishing the Drug Testing Index in 1988. Among the combined U.S. workforce, only 3.8 percent of the tests had positive results — the same level reported in 2006 — compared to a high of 13.6 percent in 1988. Further, among safety-sensitive federal workers only, the Drug Testing Index showed that drug use was at an all-time low of 1.8 percent of the tested work force.

The 2007 Drug Testing Index is a summary of results from 8.4 million workplace drug tests performed by Quest Diagnostics between January and December 2007. Results are based on tests that Quest Diagnostics performs for employers that conduct pre-employment, random or for-cause drug testing. For more information, see additional results below.

About the Drug Testing Index

The Drug Testing Index is published as a public service for government, media and industry and has been considered a benchmark for national trends since its inception in 1988. It examines positivity rates — the proportion of positive results for each drug to all such drug tests performed — among three major testing populations: federally mandated, safety-sensitive workers; the general workforce; and the combined U.S. workforce. Federally mandated, safety-sensitive workers include pilots, bus and truck drivers, and workers in nuclear power plants, for whom routine drug testing is mandated by the U.S. Department of Transportation and the Nuclear Regulatory Commission.

About Quest Diagnostics

Quest Diagnostics is the leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its national network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative new diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at: www.questdiagnostics.com.

The statements in this press release which are not historical facts or information may be forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results and outcomes to be materially different. Certain of these risks and uncertainties may include, but are not limited to, competitive environment, changes in government regulations, changing relationships with customers, payers, suppliers and strategic partners and other factors described in the Quest Diagnostics Incorporated 2005 Form 10‑K and subsequent SEC filings.

The Drug Testing Index © 2008 Quest Diagnostics Incorporated. All rights reserved.

Tables Follow
Positive Prevalence Rates for Amphetamine and Methamphetamine —
Percentage of All Tests for “Amphetamines“
2007 2006 2005 2004 2003 Amphetamine 0.40% 0.38% 0.44% 0.45% 0.41% Methamphetamine 0.14% 0.18% 0.28% 0.33% 0.32% Percent Difference - Amphetamine 5.3% -13.6% -2.2% 9.8% Percent Difference - Methamphetamine -22.2% -35.7% -15.2% 3.1%

Positivity Rates for Cocaine
2007 2006 2005 2004 2003 Cocaine 0.58% 0.72% 0.70% 0.72% 0.74% Percent Difference - Cocaine -19.4% 2.9% -2.8% -2.7%

Annual Positivity Rates
For Combined U.S. Workforce
(More than 8.4 million tests from January to December 2007)
Year Drug Positive Rate 1988 13.6% 1989 12.7% 1990 11.0% 1991 8.8% 1992 8.8% 1993 8.4% 1994 7.5% 1995 6.7% 1996 5.8% 1997 5.0% 1998 4.8% 1999 4.6% 2000 4.7% 2001 4.6% 2002 4.4% 2003 4.5% 2004 4.5% 2005 4.1% 2006 3.8% 2007 3.8%

Positivity Rates By Testing Category
Testing Category 2007 2006 2005 2004 2003 Federally Mandated, Safety-Sensitive Workforce 1.8% 2.0% 2.3% 2.3% 2.5% General U.S. Workforce 4.4% 4.4% 4.5% 4.9% 5.0% Combined U.S. Workforce 3.8% 3.8% 4.1% 4.5% 4.5%

Positivity Rates By Testing Reason
For Federally Mandated, Safety-Sensitive Workforce
(More than 1.8 million tests from January to December 2007)
Testing Reason 2007 2006 2005 2004 2003 Follow-Up 2.8% 3.0% 3.1% 3.3% 3.4% For Cause 11.1% 12.5% 13.4% 14.1% 13.8% Periodic 0.75% 0.59% 0.76% 0.51% 0.75% Post-Accident 2.6% 2.7% 3.0% 2.9% 3.1% Pre-Employment 2.0% 2.3% 2.6% 2.7% 2.9% Random 1.5% 1.5% 1.8% 1.8% 1.9% Returned to Duty 3.3% 3.2% 3.0% 2.9% 2.8%

Positivity Rates By Testing Reason
For General U.S. Workforce
(More than 6.6 million tests from January to December 2007)
Testing Reason 2007 2006 2005 2004 2003 Follow-Up 7.7% 7.4% 9.6% 9.9% 9.6% For Cause 19.2% 18.1% 28.3% 27.8% 28.2% Periodic 1.4% 1.9% 2.4% 1.9% 2.2% Post-Accident 5.8% 5.7% 5.8% 5.7% 5.7% Pre-Employment 3.9% 3.9% 3.9% 4.1% 4.1% Random 5.7% 5.5% 6.6% 7.1% 6.6% Returned to Duty 5.6% 5.8% 6.0% 5.5% 5.6%

Positivity Rates By Drug Category
For Federally Mandated, Safety-Sensitive Workforce, as a percentage of all such tests
(More than 1.8 million tests from January to December 2007)
Drug Category 2007 2006 2005 2004 2003 Amphetamines 0.25% 0.28% 0.35% 0.31% 0.29% Cocaine 0.44% 0.58% 0.60% 0.57% 0.59% Marijuana 0.88% 0.94% 1.10% 1.25% 1.34% Opiates 0.18% 0.17% 0.18% 0.17% 0.19% PCP 0.04% 0.03% 0.04% 0.04% 0.04%

Positivity Rates By Drug Category
For General U.S. Workforce, as a percentage of all such tests
(More than 6.6 million tests from January to December 2007)
Drug Category 2007 2006 2005 2004 2003 Amphetamines 0.44% 0.42% 0.48% 0.52% 0.49% Barbiturates 0.24% 0.23% 0.25% 0.27% 0.29% Benzodiazepines 0.67% 0.62% 0.58% 0.58% 0.60% Cocaine 0.58% 0.72% 0.70% 0.72% 0.74% Marijuana 2.34% 2.38% 2.54% 2.88% 2.96% Methadone 0.23% 0.22% 0.23% 0.21% 0.20% Opiates 0.35% 0.32% 0.32% 0.32% 0.34% Oxycodones 0.88%1 0.64%2 0.56%3 -- -- PCP 0.02% 0.01% 0.02% 0.01% 0.03% Propoxyphene 0.58% 0.55% 0.57% 0.63% 0.67%

Positivity Rates By Drug Category
For Combined U.S. Workforce, as a percentage of all such tests
(More than 8.4 million tests from January to December 2007)
Drug Category 2007 2006 2005 2004 2003 Amphetamines 0.40% 0.39% 0.46% 0.49% 0.45% Barbiturates 0.24% 0.23% 0.25% 0.27% 0.29% Benzodiazepines 0.67% 0.62% 0.58% 0.58% 0.60% Cocaine 0.55% 0.69% 0.69% 0.70% 0.71% Marijuana 2.01% 2.04% 2.28% 2.59% 2.67% Methadone 0.23% 0.22% 0.23% 0.21% 0.20% Opiates 0.32% 0.28% 0.29% 0.29% 0.31% Oxycodones 0.88%1 0.64%2 0.56%3 -- -- PCP 0.02% 0.02% 0.02% 0.02% 0.03% Propoxyphene 0.58% 0.55% 0.57% 0.63% 0.67%

Non-Negative Rates By Specimen Validity Test (SVT)4 Category
For Federally Mandated, Safety-Sensitive Workforce, as a percentage of all such tests
(More than 1.8 million tests from January to December 2007)
SVT Category 2007 2006 2005 2004 2003 Acid-Base 0.01% 0.00% 0.01% 0.01% 0.01% Invalid 0.11% 0.12% 0.12% 0.08% 0.08% Oxidizing Adulterants 0.00% 0.00% 0.00% 0.02% 0.03% Substitution 0.05% 0.05% 0.05% 0.06% 0.06%

Non-Negative Rates By Specimen Validity Test (SVT)4 Category
For General U.S. Workforce, as a percentage of all such tests
(More than 6.6 million tests from January to December 2007)
SVT Category 2007 2006 2005 2004 2003 Acid-Base 0.00% 0.00% 0.00% 0.01% 0.01% Invalid 0.13% 0.15% 0.16% 0.10% 0.10% Oxidizing Adulterants 0.00% 0.00% 0.00% 0.01% 0.02% Substitution 0.01% 0.01% 0.01% 0.03% 0.03%

Non-Negative Rates By Drug/SVT Category
For Federally Mandated, Safety-Sensitive Workers, as a Percentage of All Non-Negatives
(More than 35 thousand non-negative test results from January to December 2007)
Drug/SVT Category 2007 2006 2005 2004 2003 Acid/Base 0.47% 0.15% 0.27% 0.32% 0.37% Amphetamines 12.7% 12.6% 14.8% 12.7% 11.4% Cocaine 22.2% 26.3% 25.4% 23.2% 22.7% Invalid 5.5% 5.7% -- -- -- Marijuana 45.2% 43.8% 47.8% 52.4% 53.6% Opiates 9.2% 7.8% 7.7% 7.1% 7.4% Oxidizing Adulterants 0.00% 0.00% 0.06% 0.42% 0.52% PCP 2.1% 1.6% 1.8% 1.4% 1.7% Substituted 2.7% 2.2% 2.3% 2.4% 2.3%

Non-Negative Rates By Drug/SVT Category
For General U.S. Workforce, as a Percentage of All Non-Negatives
(More than 315 thousand non-negative test results from January to December 2007)
Drug/SVT Category 2007 2006 2005 2004 2003 Acid/Base 0.04% 0.04% 0.06% 0.11% 0.16% Amphetamines 9.2% 8.8% 10.1% 10.0% 9.0% Barbiturates 2.8% 2.6% 2.7% 2.7% 2.8% Benzodiazepines 6.9% 6.1% 5.4% 5.0% 5.1% Cocaine 12.2% 15.0% 14.7% 13.8% 13.8% Invalid 2.8% 3.2% -- -- -- Marijuana 48.8% 49.5% 53.0% 55.0% 55.0% Methadone 2.2% 2.0% 2.0% 1.7% 1.6% Methaqualone 0.00% 0.00% 0.00% 0.00% 0.00% Opiates 7.4% 6.6% 6.6% 6.1% 6.3% Oxycodones 1.5% 0.74% -- -- -- Oxidizing Adulterants 0.00% 0.00% 0.05% 0.16% 0.48% PCP 0.35% 0.31% 0.31% 0.28% 0.51% Propoxyphene 5.6% 4.9% 4.9% 4.9% 5.0% Substituted 0.26% 0.27% 0.26% 0.49% 0.58%

Non-Negative Rates By Drug/SVT Category
For Combined U.S. Workforce, as a Percentage of All Non-Negatives
(More than 350 thousand non-negative test results from January to December 2007)
Drug/SVT Category 2007 2006 2005 2004 2003 Acid/Base 0.09% 0.05% 0.08% 0.13% 0.18% Amphetamines 9.6% 9.3% 10.6% 10.2% 9.3% Barbiturates 2.5% 2.3% 2.5% 2.5% 2.5% Benzodiazepines 6.1% 5.4% 4.9% 4.5% 4.7% Cocaine 13.2% 16.4% 15.7% 14.7% 14.6% Invalid 3.0% 3.5% -- -- -- Marijuana 48.4% 48.8% 52.5% 54.8% 54.9% Methadone 2.0% 1.8% 1.8% 1.5% 1.4% Methaqualone 0.00% 0.00% 0.00% 0.00% 0.00% Opiates 7.6% 6.7% 6.7% 6.2% 6.4% Oxidizing Adulterants 0.00% 0.00% 0.09% 0.19% 0.52% Oxycodones 1.4% 0.65% -- -- -- PCP 0.53% 0.46% 0.45% 0.38% 0.61% Propoxyphene 5.0% 4.3% 4.4% 4.4% 4.5% Substituted 0.51% 0.49% 0.45% 0.66% 0.73%

1 More than 500,000 tests

2 Approximately 400,000 tests

3 More than 200,000 tests

4 Specimen validity testing is the evaluation of a specimen to determine if it is consistent with a normal human specimen. Tests for specimen validity include tests to determine whether a specimen is adulterated or substituted.

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