March 11, 2014
GPHL Updates:
 Completed Validation for Rubella and Rubeola IgM
 Cepheid GeneXpert PCR – set up, training and validation
testing
 Cepheid GeneXpert Clinical Trials for Chlamydia and GC
PCR – 1st quarter of 2012
 Acquisition of New Applied Biosystems 7500 Real
Time PCR System
 Set-up/install and train staff on new Applied Biosystems
(AB) rt-PCR instrument
 BT Suite Renovation Completed
Update cont’d.
 Acquired and started use of Artel PCS pipette calibration
instrument (2012)
 New tests on the Cepheid GeneXpert: Influenza PCR
(A/B, 2009 H1N1) – Sept 2012, Chlamydia/GC PCR
(urine, genital specimens) – Sept. 2013
 Adopted the new CDC-recommended HIV testing
algorithm (Biorad HIV Ag/Ab Combo, Biorad Multispot)
– Nov. 2013 – capable of confirming HIV
Challenges:
 Funding to procure supplies, reagents and equipment to
sustain current test menu
 Funding to procure supplies, reagents and equipment for
future tests (e.g. water analysis, food testing)
 Training of staff in different updated processes in
bacteriology
 Training of staff in influenza testing to improve and
maintain competency
Plans for Building Capacity
 Level 2 Capacity building at GPHL 2014 – 2015: An SPC-PIHOA
Collaboration Initiative:
o Provide training to skill-up microbiology lab diagnostic capacity
o Provide preparatory training for the enhancement of public health food
and water microbiology lab capacity
o Provide technical assistance to strengthen lab-based surveillance of
PPHSN outbreak-prone diseases
 Start validation of the following tests on the Cepheid GeneXpert:
MTB/RIF, C. difficile PCR
 Awaiting CDC approval to acquire influenza and dengue RT-PCR
reagent kits for AB 7500 PCR instrument for validation studies
 Start Validation for Water Analysis
 If AB 7500 RT-PCR instrument is capable of testing for bacterial
agents in food-borne illnesses, start validation process
Plans for Building Capacity Cont’d.
 Renovate GPHL TB suite to conform with updated safety practices,
to be followed by acquisition of instrument for MTB culture and
sensitivity
o Department of Interior Funding approved for the renovation and
purchase of a BACTEC MGIT 960 system
 Expand influenza panel testing to detect other subtypes
 Installation and training for the NEDSS (National Electronic Disease
Surveillance System (NBS) for surveillance.
 Installation, set up, training for the Indian Health Services’ Resource
patient Management System (RPMS) – laboratory information
system with instrument interface and automated reporting.
Future Plans
January 2014 – Governor of Guam informed that 13million
dollars was approved for a new GPHL under the Department
of Defense (OMNIBUS Appropriations Act of 2014) as part
of the military buildup.
 Proposed Mission Statement: To provide diagnostic
services to regionally important diseases and conditions
that may impact the health of the community and region,
and serve as a regional center of excellence for reference
testing including evaluations of new diagnostic tools and
training.
Projected Capabilities of New GPHL
 Upgraded from Biosafety (BSL) 1/2 to BSL 2/3 equipped
to test clinical, environmental and radiological specimens
o Bacteriology and Virology Department:
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Basic bacterial cultures
Confirmatory testing (i.e. salmonella, shigella, cholera)
Susceptibility testing for different bacterial pathogens such as
gonorrhea
Testing for bacterial toxins from clinical and environmental
samples and viral cultures
Cont’d.
o Serology/Immunology Department
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Dengue, leptospirosis, pertussis, measles, rubella and other
infectious diseases.
Screening for radioactive substances will be added to the test
menu if instrumentation and training is provided.
o Molecular Diagnostic Department
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Expanded nucleic acid amplification test capabilities that will
allow for influenza and dengue subtyping, and other pathogens in
which non-culture tests are helpful in outbreak mitigation.
o Mycobacteriology Department
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Upgraded to perform not just acid-fact bacilli (AFB) smear
microscopy but AFB culture, identification and drug susceptibility
testing.
Sustainability
Funding for staffing and laboratory operations is
projected to be maintained through Government of
Guam sources, HHS/CDC cooperative agreements, and
current plans to develop a revolving fund through
legislation to established a fee schedule for services.
Partnerships with Department of Defense centers,
including the Naval Health Research Center may be
considered to provide additional support for
sustainment.
Regional Plan
The new GPHL will serve the DPHSS and also have the
potential to provide confirmatory testing for numerous
stakeholders and partners including other US Affiliated
Pacific Island laboratories.
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Vision of GPHL is to serve as the regional hub for
laboratory testing and training in Micronesia