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Award-Winning Device Completes First Semi-Automated

System for HPV Screening of Women in Low-Resource Settings


Cervical cancer is the most common cancer among the length of the interval between screens and reducing
women in developing countries. A detectable and often pre- the total number of lifetime screens required.” (p. xi-xii)
ventable disease, cervical cytology (Pap smears) is currently However, according to the WHO report, there are a num-
the most common and effective form of cervical cancer ber of challenges in HPV testing, including: cost, depen-
detection. However, in developing countries - which com- dence on reagents, requirement for a molecular diagnostic
prise 80% of cervical cancer deaths - they lack the medical laboratory, and its low specificity in younger women and
supplies and manpower needed to test and treat cervical populations with significant rates of HIV. Furthermore,
cancer. The main cause of cervical cancer is since HPV DNA testing, like cytology, is tra-
the human papillomavirus (HPV), which ditionally not a test that provides results at the
is transmitted through sexual intercourse time of the visit or soon afterwards, many of
and activity. There are many strains of the the traditional barriers to cytological screen-
virus, but a number of them are potentially ing remain.
deadly, as they cause cervical cancer. Men Tackling these challenges, QIAGEN, a
can be HPV carriers without knowing and provider of sample and assay technologies,
pass it on to multiple partners. In underde- created a test system designed to screen
veloped countries, where contraception is for HPV. The system, which is made up of
limited and health resources are inadequate, three major components: The controller,
the problem is growing. the thermoshaker and the luminometer, can test 96 samples
Studies conducted in conjunction with the World Health at a time. Additionally, the system decreases test time of
Organization (WHO) conclude “the vast majority of cervi- the typical cervical exam from days to hours – eliminating
cal cancer cases worldwide are caused by persistent infec- the barrier of delayed results. QIAGEN also required that a
tions with some high-risk types of the human papillomavi- person with limited training/experience in medical testing
rus family. From the perspective of defining preventative and who was unable to read or understand the English lan-
strategies, the HPV-attributable fraction should be consid- guage, be able to use the system. This required an easy-to-
ered 100%”. Additionally, the report suggests that, in most use interface with simple icons to provide instructions, test
cases, the sensitivity of testing for HPV over the traditional status and results. In order to reduce user error(s), system
cytology is approximately 10% higher in determining the set-up was designed to be straight-forward and automati-
presence cervical cancer. The WHO’s (2002) report found cally detect the three component cables’ correct connection.
additional advantages of HPV testing versus traditional By doing so, minimally trained persons could run the test,
cytology, which include: thereby eliminating the need for additional manpower and
• The objectivity of the test resulting in very low inter- formal labs and healthcare facilities.
and intra-observer variability. To initiate this design, QIAGEN developed a new as-
• The possibility of almost complete automation of the
process. This should ensure high throughput at a stan
dard level of quality.
• Built-in quality control procedures.
• Opportunities for self-sampling for HPV DNA in some
populations with limitations in health care facilities
and manpower, albeit with some loss of sensitivity.
• The high sensitivity of the HPV DNA test to identify
HSIL [high grade dysplasia] in women aged 30 and
above.
• Gains in effectiveness could be achieved by increasing Left to right: QIAGEN thermoshaker, controller & luminometer

InHand Electronics, Inc. • 30 West Gude Drive • Suite 550 • Rockville, MD 20850 • v: 800.983.8441 • f: 240.558.2019 • www.inhand.com
say procedure for rapid detection of HPV in women in low application that met all of QIAGEN’s requirements and
resource settings, followed by a series of clinical trials. completed the detailed instruction process.
Making the system available for field use required a team The software began with a mock-up of user interface
of engineers to create a control mechanism. The mechanism screen shots, which where then shown to QIAGEN; cus-
would act as a virtual chemist and make the test easy-to-use tomer feedback was incorporated to improve the design and
for the technicians in developing countries. To implement overall application logic. The original program required the
the solution required a small, low-power and lightweight chemists to turn on and manually manipulate the ther-
user interface control unit to present the test instructions. moshaker in set-up, temperature change, etc. InHand’s final
The unit had to walk the technicians through tasks to com- software solution streamlined the effort, creating minimal
plete the test. The unit’s step-by-step directions - which in- steps for technicians, as to reduce error and increase ease-
cluded auto-detection of RS-232 and USB ports - controlled of-use. Utilizing the hardware, the new software program
a shaker table and a luminometer, and would alert users of can save all the information and requires almost no manual
any errors during the procedure. The device was required to: manipulation; the device and software were required to take
Run WindowsCE, boot directly to the application, be basic care of the system test complexities, including all condi-
and not flashy to deter theft, and tional test sequence items, such as
be rugged and able to survive temperature control, with the use
spills, including chemicals. of ambient temperature sensing
Additionally, the device ne- within the hardware design.
cessitated control of the shaker Lastly, QIAGEN needed the
table(s) and luminometer(s); device to permit the ability to up-
this included sending com- date the process flow and timing in
mands and receiving responses the field without recompiling the
from the device and providing application. InHand created a con-
specific step-by-step directions figurable solution that allows QIA-
as a linear process to the user GEN scientists to use a simple text
including error conditions, alert editor to modify critical aspects of
messages and other information. the process control. The simplic-
QIAGEN’s specifications also ity of the software was achieved
required that the device be able through a linear design which
to store test results and make them available for review on, bridged the gap between QIAGEN’s and InHand’s areas
and downloadable from, the device. Lastly, the device was of expertise. The result: A software program that provides
required to pass tests for compliance with CE safety and technicians with step-by-step instructions, while hiding the
EMC standards. technical aspects of the test instruments, then reading the
Requiring a four month turn-around, QIAGEN sought results, utilizing software written with specific calculations
the engineering expertise of InHand Electronics, a leading of positive or negative and saving results to an SD Card.
provider of embedded solutions of wireless and handheld With this information, the presence of HPV in women
devices. After understanding QIAGEN’s complete require- with limited medical care can be detected within hours - not
ments and collaborating on best solutions, InHand created days. The women who test positive for HPV can then be
a custom device and application software which met all treated for cervical cancer before it becomes life threaten-
requirements with quick turn-around. The solution utilized ing. With InHand’s single board computer and custom en-
InHand’s standard COTS Fingertip4 single board computer, closure and application and Microsoft Windows Embedded
which includes: 128MB of SDRAM, 64MB of on-board Compact expertise, QIAGEN was able to deploy their assay
Flash, LCD controller, touch screen controller, USB Host test quicker and, in turn, help thousands of women. Thanks
and Client, 3 Serial Ports, and SD and CF slots, with the de- to this collaboration, the new, language independent system
vices utilizing 2 serial ports and USB 1.1 Host and InHand’s assay test and subsequent treatment can save thousands of
COTS daughter card, Fingerboard, which includes: LCD lives in developing countries, while drastically reducing the
connector, touch screen connector, Serial port headers, and number of women who lose their lives to such a preventable
USB Host and Client connectors. Additionally, InHand de- disease.
signed in a NEC 4.1” WVGA display with integrated 4-wire
resistive touch screen and created a custom enclosure, by
using injection molded ABS plastics via a rapid, low-cost World Health Organization. (2002). Cervical Cancer Screenings in
process. Utilizing Microsoft’s .NET compact framework Developing Countries: Report of WHO Consultation. Retrieved
enabled InHand to quickly create an easy-to-use GUI-driven from http://whqlibdoc.who.int/publications/2002/9241545720.pdf.

InHand Electronics, Inc. • 30 West Gude Drive • Suite 550 • Rockville, MD 20850 • v: 800.983.8441 • f: 240.558.2019 • www.inhand.com