POINT OF CARE TECHNOLOGY

WA ODE MIFTAH HUDAYAH

P1505212401

miftah.ode@gmail.com
• The design of IVD devices, especially those intended for
use at the point of care or at home, is getting sleeker,
more compact, and more intuitive

• The IVD devices of today and tomorrow will cause you

to draw unavoidable comparisons between them and your
personal, handheld electronic devices.

PREFACE
www.ivdtechnology.com
 HISTORICAL VIEW OF
POCT

• The first diagnostic test is thought to have been urine

testing for diabetes.
• Healers in 1500 BC ants mysterious emaciating
disease
• In 1600s, testing the urine was the method to diagnose
diabetes

Point of care testing, Price and Hicks, 1999

Clinics in Laboratory Testing : POCT Lewandrowski, 2009
The earliest and most
basic POC test was
dipstick urinalysis.

Urine dipstick in 1957

was the first true POC
device
• Next technological breakthrough
• Development of the handheld glucose meter
• First blood glucose meter was the Ames Reflectance Meter (A.R.M)
in 1969
• Only available to physicians
• Components were Dextrostix, a reflectance meter and a photoelectric cell
• First meters developed for home use came on the market in the
early 1980s
• Ames Glucometer
• Accu-check meter by Boehringer Mannheim (now Roche)
• GlucoScan by LifeScan (now Johnson and Johnson)

HISTORICAL VIEW OF POCT

www.cap.org
http://www.mendosa.com/memories.htm
• Growth has been stimulated by:
• Technological advancement
• Demands for faster turnaround times
• Waived testing designation under CLIA88
• Creation of specialty clinics
• Demand for self-testing and patient control

• Evolution is continuing…

EVOLUTION OF POCT
www.cap.org
• Much of the research and development is looking toward
bringing testing to underserved populations and developing
nations

• Even in patients who are high risk, testing is limited by several

factors
• Expense
• Location
Most testing takes place in
centralized or regional laboratories

WHERE IS POCT
GOING?
 • WHO has developed guidelines for development of
diagnostics for low-resource settings

• ASSURED
• Affordable
• Sensitive
• Specific
• User-friendly
• Rapid and Robust
• Equipment-free
• Deliverable to end-users

Peeling et al 2006 Sex Transm Infect 82: v1-v6

• “It can be near the bedside, but it’s not always happening
where you can run a wire….now, wireless has fueled this idea
that clinicians truly are nomadic. Doctors now have tools
available 24/7 and the ‘anytime, anywhere’ network has
become a reality.”

• Care at the bedside and anywhere else the patient might be; or
where decisions are made by a caregiver, wherever they may be.

Today’s POCT Definition

Health Data Management, December 2003
• Faster Therapeutic Turnaround Time
• Rapid Medical Decision
• Elimination of Identification and Transport Issues
• Decrease in Pre-analytical Problems
• Smaller Specimen Volume
• Probably Less Expensive (alternate care centers)

*Clinical Reasons for POCT in the

21 Century
st
www.cap.org
www.medicalautomation.com
 MINIATURIZED TECHNOLOGY
• Taking current technology and shrinking it down allows more tests
to be placed on a single device and allows more testing with a
smaller sample volume
• Microarrays (multiple microscopic detection spots placed on a chip)
• Determination of inflammatory and sepsis markers CRP, IL-6 and PCT in
plasma
• Simultaneous analysis of 12 plasma proteins (PSA and 11 cytokines) in 10
minutes from a single drop of blood
• Electrochemical immunosensor to simultaneously detect tumor markers
(CA 153, Ca 125, Ca 199 and CEA) with immobilized gold nanoparticles
with peroxidase-tagged antibodies

Olasagasti and Ruiz de Gordoa, Translational Research 2012;160:332-345

MINIATURIZED TECHNOLOGY
• Aptamers
• In vitro created nucleic acid molecules that are capable of binding
specific target molecules or cells
• Can be used for analysis of protein samples
• Used in a dry-reagent strip application for the detection of thrombin
• Detection of Ramos cancer cells (Burkitt’s lymphoma cell line)
• Can be used even when certain structural knowledge of the target is unknown
• Magnetic particles
• Convenient way of separating target proteins
• Detect proteins based on their magnetic properties
• Analysis of CRP could be done with 4 μl of whole blood within 5 minutes
and had good correlation with reference method

Olasagasti and Ruiz de Gordoa, Translational Research 2012;160:332-345

 • Four such products—three already on the market here in
the United States and one recently developed by a
venture-capital-backed start-up company—are the
iBGStar blood glucose monitoring system by Sanofi, the
OraQuick In-Home HIV Test by OraSure Technologies,
the Alere INRatio2, and Bio-Meme’s smartphone-based
PCR device, respectively.

Four IVD Devices Influenced by

Consumerization
www.ivdtechnology.com
 • iBG Star
• iPhone and iPad compatible glucometer
• Can sync dara with a diabetes manager
application
• Data can ne emailed or shown to the patient’s
healthcare provider

• Glokoo
• Created a Lognook app for iPhone
• Cable connect iPhone to glucose meter
(supports 17 different meters) and allows
download of meter data
• Can email or fax dara to healthcare provider

SMART PHONES AND

DIABETES
OraQuick In Home Test
For HIV
• Approved by the FDA
for home use in July
2012

• Same test as the

OraQuick Advance that
has been in use by health
professionals since 2004
• Use in 2009
• Designed to transmit data wirelessly
to computers and, ultimately,
physicians
• For anticoagulation management is
small, unintimidating
• Results are provided in about one
minute.

• Received FDA approval to market its

Determine HIV 1/2 Ag/Ab Combo for
the detection of HIV-1 p24 antigen
and antibodies to HIV-1/HIV-2

Alere INRatio2
• Smartphone-based PCR machine for point-of-care
diagnostics.
• Start-up Biomeme and brought
• Convenient, low-cost lab for quick DNA diagnostics and
on-site disease tracking
• mobility, professional-caliber DNA lab diagnostics at low
cost, connectivity, accuracy via qPCR, and ease of use.

• Connected your smartphone over Bluetooth, you slot it into

the mobile PCR machine. Then you crack open a test kit
that’s designed to detect different diseases (sold separately,
think of it as health-conscious twist on the old razor-and-
blade model) and do a bit of pipetting. After a bit of sample
test prep — co-founder and bizdev lead Max Perelman says
‘even VCs’ have been unable to screw up the process—you
load the sample into the top of the machine and wait for
your results.”

Bio-Meme’s smartphone-
based PCR device
 • One of the fastest growing aspects of clinical laboratory testing
Estimated to be increasing at least 10-12% per year, with some areas increasing 30% per year
• In contrast, central laboratory testing has grown 6-7% per year
• What is driving this increase?
• Technical advances making POC testing more accurate, more robust, cheaper and easier
• Changes in the clinical environment that makes it necessary for shorter hospital stays and
quicker patient turnaround
• New therapies that require rapid laboratory results in hospitals but also in outpatient clinics
• Heavy promotion by industry due to favorable profit margins
• Increasing shift of care to the home setting
• Not just blood glucose testing, but self-monitoring of anticoagulation
• Can be used in conjunction with telemedicine to care for patients with chronic conditions

GROWTH OF POINT-OF-CARE TESTING

www.cap.org
Clinics in Laboratory Testing: Point-of-Care Testing, Lewandrowski, 2009
• Not likely
• While more tests currently in the laboratory will move to the POC,
new highly complex and esoteric tests will replace them
• However, the movement to increase POCT could help ameliorate the
shortage of qualified medical technologists
• Factors that might decrease POCT
• Increased regulation
• Cost considerations and reimbursement issues

WILL POCT REPLACE THE CLINICAL

LABORATORY?
THANK YOU