Download 2003 Winter

Blackhawk BioSystems:
w w w. s o m a g e n . c o m
Infectious Disease
For more than a decade, Blackhawk BioSystems has been
developing and manufacturing in vitro diagnostic quality
control products for infectious disease testing procedures.
The external controls are stable and designed to monitor
test systems and reagent lot performance near the cutoff,
the most critical zone of an assay. Routine use provides
laboratories with a means of monitoring reproducibility of
results and assuring quality on an on-going basis.
Blackhawk has put additional emphasis on expanding its
Sexually Transmitted Disease (STD) control line, which
includes controls to detect Chlamydia trachomatis,
Gonococcus and Syphilis. The control formats have been
developed in order to accommodate various testing system
technologies, including nucleic acid amplification, DNA
probe and ELISA. Syphilis controls are compatible with
RPR card test, MHATP and ELISA test systems to detect
antibodies to Treponema pallidum and/or reagin.
The well-established products, used by many laboratories
today, include the Virotrol control line for hepatitis marker
and retrovirus test systems and the congenital control line
for ToRCH, Mumps, Measles and Varicella zoster test
systems. In addition, controls exist for assays detecting
antibodies to Epstein Barr Virus (EBV) markers, H. pylori,
Mycoplasma pneumoniae and B. burgdorferi (Lyme
disease).
Blackhawk has also developed a complete line of single
and multi-analyte quality assurance panels. Each panel
consists of 5 members representing a range of reactivity
from non-reactive to strongly reactive. These panels are
suitable for:
• Training and proficiency testing of laboratory personnel
• Validation, test kit comparison and implementation studies
What you should know…
“Point of Care BNP measurement” has been given a “Grade
A, Level 1 Evidence” recommendation – the highest
recommendation for diagnostic test value in the newly
released Canadian Cardiovascular Society 2002/2003
Consensus Guideline Update for the Diagnosis and
Management of Heart Failure.
• Test kit lot to lot comparison and intra/interlaboratory
assessments
Panels exist for Anti-HIV-1/2, HIV-1 Ag, Anti-HCV, AntiHTLV-I/II, HBsAg, Anti-HBc, Anti-HBs, Anti-HSV-1/2 and
Syphilis (3 member panel only).
For additional information on any of these products, contact Somagen
Diagnostics or your Somagen Territory Manager. When you do, don’t
hesitate to request to receive the new, detailed Blackhawk BioSystems
product catalogue.
What this means for the laboratory is that Cardiologists and
Emergency Department physicians will be looking to access
this new Point of Care BNP test as an important aid in the
diagnosis and management of their heart failure patients.
Available under the trade name Triage® BNP, this testing
platform is exclusively distributed in Canada by Somagen™
Diagnostics Inc.
According to the CCS panelists, “BNP has clear cut, proven
benefits in the diagnosis and management of Heart Failure”.
It further states “Patients who present with unclear but
suspected cardiac etiologies may be considered to have
venous blood taken for the measurement of BNP level to
assist with the diagnostic decision and therefore appropriate
management of the dyspnea”
In This Issue
What you should know…
Analysis of Sedimentation
Rates – Providing A
Safer Alternative
“Grave” Review of Ecstacy
Blackhawk BioSystems:
Infectious Disease
Quality Control
Past issues of the Somagen Laboratory Quarterly are available on our website.
Visit our website at www.somagen.com
DIAGNOSIS
BIOSYSTEMS
Quality Control
In addition to the recent profile of Triage® BNP on CBC
television’s National NewsWorld Health Watch as the newest
test to impact heart failure diagnosis, there are numerous
resources available on the benefits of BNP testing for both
those suspected of heart failure and those in ongoing
treatment to control the disease.
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L A B O R A T O R Y Q U A R T E R LY
What you should know… cont’d
Somagen™ Diagnostics Inc. has a
comprehensive library of CD and
print media as well as a team of
Critical Care Nurse Educators and
Specialists that are available to
provide educational seminars and
further information on the use of
this new technology. You can also
access these new CCS guidelines
on the Canadian Cardiovascular
Society website at www.ccs.ca.
To be prepared when your medical
professionals ask for your input on
Point of Care BNP testing, call
Somagen Diagnostics Inc. at 1-800661-9993 and request any number of
our educational resources. Point of
Care BNP...it's in your future.
– Providing A Safer Alternative
Analysis of sedimentation rate
remains one of the most widely used
tests in clinical laboratory medicine.
Its relative simplicity and cost
effectiveness maintains its popularity as a
screening test to detect inflammation,
infection, or possible tissue damage. More
importantly, it’s ability to monitor known disease
progression and the efficacy of treatment has maintained
healthy volumes of testing within the laboratory. The most
popular methodology for the measurement of
sedimentation rate is the classic, manually performed,
Westergren method.
The procedure requires the
technologist or technician to open the collection tube to
pour off the required volume for the test and then aspirate
into the Westergren tube, thereby potentially exposing the
health care worker to blood borne pathogens.
Quiet overnight shift in ER… Six young adults brought by
ambulance from a warehouse “rave”… Drugs reported are
“E”, “G”, “K”, “roofies”, “H”.
Dr. Jeffrey Tyberg, Medical Director, Emergency Services
Toronto East General Hospital notes, “Someone may have
gotten into some “death””
In addition, poly intoxication may result in symptoms of
one drug masking another, “Cocaine taken in combination
with opiates may temporarily mask the opiate-induced
symptoms, leaving the ER unprepared for the lapse of a
patient into a coma after the effects of cocaine wear off”.
Globally we are in an era of synthetic drug use with
frighteningly easy access to backyard chemistry and
nothing to regulate its manufacture or design.
Analysis of Sedimentation Rates
With the emergence of the 21st century, a renowned
appreciation for the safety and well being of health care
professionals is once again on the rise. Outbreaks of the
West Nile Virus, Norwalk and CJD have if anything, caught
societies attention. These outbreaks have raised some
familiar questions. How virulent are these viruses? Are
they transmissible through blood supplies? How are they
transmitted? Once again, this reminds us that it is what we
don’t know is present in samples, that creates the
greatest risk for laboratorians. Personnel
involved with implementing new tests and
instrumentation
are
becoming
increasingly aware that safety is an
important and primary concern, but
what about some of the more
historical tests? The ESR test is one
that immediately comes to mind.
“Grave” Review of Ecstacy
Diesse Diagnostic Systems has developed a safer approach
to the analysis of sedimentation rates using the Ves-Matic
system. The compact, bench top Ves-Matic system employs
a specially designed evacuated tube, containing an
appropriate amount of anticoagulant for the collection of
blood. This collection tube is then transferred directly into
the instrument for mixing and analysis, eliminating the
transfer of blood. The sample is mixed in a standardized
and homogeneous fashion within the instrument and
results are read automatically. The risk of
accidental contamination is reduced by the use
of plastic tubes. The patented design
maintains blood samples in a totally
“closed”
system
during
drawing,
handling, and analyzing procedures,
minimizing technologist exposure.
Not only is the instrument a much safer
alternative,
but
it
also
offers
standardization, a shorter analysis time of
20 minutes, as well as walk away
convenience. Results remain accurate and
reliable, as they are comparable to the
Westergren method. The Ves-Matic instrument
is a step in the right direction towards a safer work
environment for health care professionals.
A candid interview with Corporal Scott Rintoul of the
RCMP Drug Awareness Services in Vancouver revealed
disturbing trends in both the manufacture and calculated
use of multiple drug combinations that are impacting
Canada’s hospital emergency rooms.
Poly-intoxication is on the rise – and people are mixing
their drugs purposely. Deadly by itself, Ecstacy has also
been used in combination with other rave drugs, especially
Alcohol, Cocaine, other Amphetamines or Opiates where
the effects are either enhanced or masked.
Further challenging the mix, Cpl. Rintoul reports “a recent
examination
of
265
supposed
Ecstacy
(3,4methylene/dioxymethamphetamine- MDMA ) samples
taken from the street, raves and nightclubs, showed only
18% of those analyzed were actual MDMA.” Says the
RCMP Second Edition report on Drugs and Raves, “Drug
dealers are not concerned with the safety of the users, only
with making money and gaining customers. They will mix
or sell any substance that is profitable.”
Fast forward to our challenging case in the emergency
department. A physician may be able to determine drugs
of abuse are implicated but complicating the diagnosis and
treatment is the tremendous likelihood of any number of
chemicals.
Treating for one overdosed drug may cause further
damage if other unsuspected drugs are present,
“Flumazenil administration with TCA or BZO ingestion
may cause seizure and/or death” .
There are a variety of drug testing screens available to the
ER to help aid in the rapid diagnosis of a patient with drug
abuse complications however given the precarious
potential for multiple drug combinations, only the most
comprehensive screen can be considered. Biosite
Diagnostics Triage® Drugs of Abuse Panel has an extensive
panel of analytes positioned to identify chemicals most
common to this multi-drug scenerio – including Ecstacy,
Alcohol, Cocaine, Amphetamines, Opiates. Biosite’s broad
cross-referencing tables further add to the assurance that
no metabolite will be over-looked.
In Canada, Ecstasy has been linked to fourteen deaths in a
two-year period. Law enforcement agencies continue to
pursue the underground of clandestine labs and the
capture of their “chemists” but as long as there is a market,
drugs will be made, overdoses will occur and likely more
deaths. The use of a highly accurate, well controlled drugs
of abuse screen will be important to assist ER physicians in
saving lives.
For details on the extensive coverage provided by the
Triage® Drugs of Abuse Screen or further information on
drug awareness, please contact Brian Roskewich, Point of
Care Specialist at 1-800-661-9993 ext. 9532.
1
Boccuzzi-Chmura et al. “Drug Update: Flumazenil (Romazicon) and the Patient with Benzodiazepine Overdose: Rosks versus Benefits”
Journal of Emergency Nursing, Volume 22, Number 4, Aug 1996; 330-333.
2
Resource Consequences of Using a Rapid Drug Panel Urine Screen, Triage, In Suspected Drug Intoxications in ER Patients.
1999 CSCC Poster Presentation. Dr. Kallai-Sanfacon.