Trends in rapid testing

April 1, 2009

“There is an ongoing trend to make rapid diagnostic
testing faster, easier, and more accurate. Additionally, laboratories
are seeking ways to incorporate automation and advanced data-management
capabilities to increase efficiency and improve workflow. 3M Health Care
is proud to offer the laboratory a rapid, reliable diagnostic tool.
Utilizing innovative RAMP lateral flow immunoassay technology, our
automated Rapid Detection Reader provides objective, qualitative results
by removing the subjective nature of visually reading and interpreting
test strips or cassettes. It is equipped with data-management and
LIS-connectivity capabilities, which help to reduce reporting errors.
The product can record, store, and print (with the purchase of a
printer) test data — all enabling the laboratory flexibility in time and
test management. Expandable to run new tests as they become available,
the Reader currently runs the 3M Rapid Detection Flu A+B Test.”

Brian Anderson


Global Marketing

3M Health Care

Maker of 3M Rapid Detection Reader

Demand grow while resources are limited

“The newest trend in rapid tests, specifically in the
area of fecal occult blood testing (FOBT), is driven, in large part, by
a graying population and shifting reimbursement policies. The
high-sensitivity performance of fecal immunochemical tests (FIT) has
served the current testing environment well. But as demand grows,
hospitals will necessarily require testing solutions that allow for more
precise management of limited diagnostic resources, like colonoscopy. To
serve this evolving market, we can anticipate automated FOBTs designed
to run on random-access chemistry analyzers as well as physician-office
labs' stand-alone instruments. Automating FOBTs will make it possible
for hospitals to adjust cutoffs in accordance with their diagnostic and
disease-management resources, helping to reduce the cost of care.”

Randy Pawlovich

Group Manager

Primary Care Diagnostics

Beckman Coulter

Maker of Hemoccult SENSA and Hemoccult

Highly accurate biomarker provides fast turnaround

“Maturation of biomarker science has been one of the
most promising innovations within the healthcare industry over the last
several years — a development that holds true potential to improve
patient outcomes. Biomarkers can play a large role in diagnostics and
patient care, as they improve decision making, accelerate drug
development, and reduce development costs. In the same way that the
heart releases telltale biomarkers (i.e., BNP and troponin) when under
great stress, the body releases biomarkers when it is battling a serious
infection. Procalcitonin (PCT), a prohormone of calcitonin, is produced
by numerous cell types and organs after pro-inflammatory stimulation,
especially when caused by bacterial challenge. In healthy people, plasma
PCT concentrations are found to be below 0.05 ng/mL but can increase up
to 1000 ng/mL in patients with severe sepsis or septic shock. Very high
levels of PCT have been observed during acute-disease conditions with
severe systemic reactions to infection and also in cases of severe
sepsis or septic shock. Elevated PCT levels indicate bacterial infection
accompanied by a systemic inflammatory reaction. Localized infections do
not generally cause circulating PCT increases. Slightly elevated PCT
concentrations are observed in bacterial infections with minor systemic
inflammatory response. Not only is this biomarker highly sensitive and
specific, but it can also be measured in the clinical lab in about 20
minutes, delivering lifesaving information to doctors for a condition
that can rapidly turn fatal.”

Vincent Tumminello

Senior Marketing Manager


NAMaker of VIDAS B•R•A•H•M•S PCT Assay A

Ongoing simplification of methods

“The industry has seen the tremendous growth in 'near
patient' rapid testing, particularly in diabetes, cardiac, and a few
infectious diseases. The demand for more rapid testing has put pressure
on the laboratory and diagnostic manufacturers to provide more rapid
testing for sophisticated methods that are performed in the laboratory,
such as PCR testing for infectious diseases. We expect to see a
continuing simplification of laboratory methods through instrument
design/automation that allow sophisticated testing to be performed in
less complex settings. After all, laboratories, physicians, and
diagnostic developers have a common goal in principle: accurate,
reliable results that lead to correct therapy or patient management.”

Kyle Armantrout

Director of Marketing

Diagnostic Products

Focus Diagnostics

Maker of MRSA Real-Time PCR

Latest methods for trichomoniasis detection

“We know that trichomoniasis is associated with
ascending infection (i.e., pelvic inflammatory disease, endometritis,
and post-operative infections). Other preventable health consequences
can include increased risk of HIV infection, tubal damage, ectopic
pregnancy, infertility, and cervical cancer. During pregnancy,
cervicitis/vaginitis microorganisms can increase risks of pre-term
delivery, biologic immaturity at birth, and
infection-/inflammation-caused perinatal organ injury. Estimates of the
number needed to treat to prevent one case of pre-term birth are as low
as one in six. Studies show it is imperative that trichomoniasis
be diagnosed and treated early. Although wet mount is the most commonly
used method to diagnose trichomoniasis, its sensitivity is dependent
upon the motility of the organism. Most trichomonas organisms are no
longer motile by the time the sample reaches the lab. Current rapid
tests which detect the antigen are not dependent upon the organism's
motility, thereby improving the chance of detecting this sexually
transmitted infection, and, ultimately, reducing the health consequences
associated with it.”

James McGregor, MD, CM

Division of Maternal Fetal Medicine, Keck School of Medicine

University of Southern California

for Genzyme

Maker of OSOM Trichomonas Rapid Test

Enhance your infection-control program

“Our new selective and differential culture medium
facilitates the isolation and identification of methicillin-resistant
Staphylococcus aureus
(MRSA) from environmental surfaces. This new
contact plate contains a chromogenic medium that aids in the prevention
and control of MRSA infections in healthcare settings. MRSA strains
grown in the presence of chromogenic substrates produce deep pink to
magenta colonies. Simply touch the media to the test surface and
incubate. Cefoxitin is included in the formula to inhibit non-MRSA
strains. Additional selective agents have been added to increase the
sensitivity and specificity to the medium by inhibiting Gram-negative
organisms, yeast, and most other Gram-positive cocci. Results are ready
in 16 to 24 hours via an easy color-change read-out. We can also enhance
infection-control programs with free on-site training.”

Chris Catani


Sales, Marketing, and Customer Service

Hardy Diagnostics

Maker of Product HardyCHROM MRSA Contact Plate

Physicians' choose for patients' convenience

“According to the Centers for Disease Control and
Prevention, colorectal cancer has emerged as the nation's second leading
cause of cancer deaths. Recent screening rates are increasing among U.S.
adults aged 50 years and older (60.8 % in 2006 vs. 53.9% in 2002). As a
result, clinicians have been implementing procedures based on this
research. There continue to be discussions among clinicians on which
method to adopt in their practices [guaiac fecal occult blood test
(FOBT) vs. immunochemical fecal occult blood test (iFOBT)]. Recent data
shows guaiac FOBT has limitations such as low clinical sensitivity, low
specificity, and false positive results, primarily due to dietary
substances (e.g., meat, fruits, drugs, and others), which have adverse
effects on the test, leading to unnecessary invasive procedures. As a
result, many clinicians have strongly supported the use of the iFOBT,
which detects the globin component of human hemoglobin in feces. Various
data supports iFOBT tests using one or two samples of feces have
improved sensitivity (a lower number of false positives) and acceptable
specificity (a higher number of true positives). Additionally, no
dietary restriction is required for iFOBT testing. Modern iFOBT kits are
comprised of a sampling method that utilizes one card, which contains
two iFOBT tabs for the collection of fecal material, one immunochemical
specimen-preparation tube, and a test-cassette system for analysis. This
provides a time efficient and cost-effective screening method. Moreover,
iFOBT has now emerged as the physicians' choice for their patients'

Larry Porter


LifeSign LLC

Maker of Status Colon Assure Guaiac & iFOBT Kit

One test detects 12 viruses — fast

“Molecular testing for respiratory viruses is an
exciting development. Viruses cause the majority of respiratory
infections, yet physicians rarely test for them because it is difficult
to get clinically relevant results with traditional testing methods,
such as cell culture, which can take several days to provide results.
With a molecular test like Luminex' xTAG Respiratory Viral Panel (RVP) —
cleared by the FDA in 2008 — with one patient sample, doctors can detect
12 respiratory viruses from the common cold and influenza, to RSV and
metapneumovirus in a matter of hours. Its accurate results give doctors
a clear view of patients' infections and allows them to prescribe
correct treatments quickly. This improves patient care and can help
reduce the inappropriate use of medications — an important benefit as we
see more pathogens becoming resistant to antibiotics and antivirals.”

Jeremy Bridge-Cook, PhD

VP – Luminex Molecular Diagnostics

Luminex Corp.

Maker of xTAG Respiratory Viral Panel

Important tests for the ED

“There has been an emerging need for rapid diagnostic
tests, especially in the areas of the hospital such as the emergency
department, where a fast result for critical-care tests for situations
such as a heart attack are needed. An example of this is the RAMP
Troponin I test, which, with a test time of fewer than 20 minutes, can
make the difference in how fast a patient is treated, thereby, perhaps
saving a life. The earliest rapid tests were simple; some were visually
read, therefore lacking sensitivity, and subject to interpretation. The
trend, in fact the demand, is that the rapid tests be every bit as
accurate as testing in the main lab. This includes sensitivity,
accuracy, and, more recently, electronic connectivity to the lab and
hospital computer systems so that result reporting and billing are done
automatically. The latest demand also includes the need for quality
control for both the instruments and for the test kits themselves; the
same requirements as the systems in the main lab. Our new RAMP 200 meets
these new requirements with a built-in LAN connection for communication
to lab and hospital computers, and automatic instrument QC and liquid QC
features. In addition, the full-color VGA touch-screen and user prompts
make operation of the system simple and intuitive. Laboratory features
combined with rapid-test results is now the new standard in near-patient
and point-of- care testing.”

S. Wayne Kay, CEO

Response Biomedical

Maker of RAMP 200 Clinical System and RAMP Troponin I Assay

The fight against MRSA

“Hospitals must do more with less, especially in
light of current economic conditions. There is also the consistent
desire for faster results leading to earlier patient diagnosis and
treatment. The challenge is to 'marry' the two without sacrificing
accuracy for economy. Laboratories must seek to balance the speed of the
results received and how quickly they are acted upon versus the impact
of the results on medical care and associated costs. As one example,
MRSA is a major public-health concern with occurrences on the rise and
annual costs ranging from $3.2 to $4.2 billion. Hospitals must look
internally for funding necessary for detection, prevention, and control.
We offer a chromogenic medium, Spectra MRSA that is a ready-to-use
labor-saving test easily adoptable in any healthcare facility to enable
continuous surveillance of all patients for MRSA colonization. With the
highest positive predictive value, 98.1%, for any commercially available
MRSA screening product, our product combines simplicity of traditional
culture methods with accuracy exceeding advanced diagnostic tools to
provide actionable results 24/7.”

Andy Thomson, VP and General Manager

Microbiology NA

Remel, a Thermo Fisher Scientific company

Maker of Spectra MRSA, and the Xpect and ProSpecT families of direct specimen tests