Rapid Test Continuous Quality Improvement

Dr. Parekh obtained his B.S. and M.S. from University of Bombay, India before moving to the United States where he earned his doctorate in Biochemistry/Virology from Louisiana State University working on lentiviruses. He did his post-doctoral research at Scripps Research Institute in La Jolla, California working on hemorrhagic fever viruses. He worked as a Senior Scientist/Project Leader at Bio-Rad Laboratories in California where he was engaged in research and development of HIV and HTLV diagnostic assays, including Western blot assays.

Since 1990, his work focused on improving accuracy of HIV diagnosis, understanding HIV-1 and HIV-2 cross-reactivity and type-specific diagnosis, SIV surveillance in humans, early infant diagnosis, factors affecting perinatal transmission, evaluation/improvement of viral load assays, and development of HIV-1 incidence assays. As a Section Chief of HIV Serology, he ran HIV reference laboratory for several years helping to resolve difficult diagnosis. As a Team Lead of HIV Serology/Incidence Team in ILB and now as Associate Chief for Research and Innovation, Dr. Parekh provides critical laboratory support to global HIV work for PEPFAR in more than 40+ countries, assuring high quality of HIV testing in our programs and in surveys, including in PHIA surveys. Innovative quality assurance tools and HIV-1 incidence assays he developed in his laboratory have become the standards in many countries to ensure accuracy of HIV testing, estimate HIV-1 incidence, measure the impact of HIV programs, and identify hot-spots of new infections in near real-time. He has earned several awards including DHHS Secretary’s Award (twice), several nominations for Shepard Award for best publications (winning it twice) and Federal Laboratory Consortium’s Award for Excellence in Technology Transfer, among others. He has authored/co-authored more than 160 papers, review articles, or book chapters.

Mireille B. Kalou is a medical doctor with a master’s degree in public health – Infectious Disease. Mireille has over 20 years of experience in laboratory science, capacity building, program design and management. Mireille had spearheaded and laid cornerstones to the PEPFAR centrally funded HIV Rapid Test Quality Improvement Initiative while supporting its adoption by ministries of health in multiple countries in African, Asia and the Caribbean Region. Since 2018 she has been serving as senior Laboratory Advisor to oversee the PEPFAR lab portfolio of Haiti (2018-2021) and Eswatini (2022 to present). In that capacity, she has collaborated with laboratory stakeholders in countries to strengthen laboratory services and systems, develop national strategic plans, provide technical guidance for the establishment of the national public health laboratory. In addition, she is supporting the MoH Port Health team in their efforts to strengthen border health capacity for screening travelers in and out of Eswatini. As the new activity manager for the Ministry of Health Cooperative Agreement, she chaired an PEPFAR interagency task team to align two government-to-government funding mechanisms. She has been recognized several times for her outstanding contributions. She has received the American Embassy Mission Honor Award in Cameroon, the Mission National Meritorious Honor Award in Haiti and in Eswatini, and the Center for Global Health Excellence in Laboratory Quality Award. She has authored and co-authored more than 20 articles in peer-reviewed journals and book chapter. In her free time, Mireille spends quality time with her daughter, enjoys baking, walking, relaxing with a nice book and whenever possible, discovering new places.

Trudy Dobbs is currently a Biologist at the CDC’s Division of Global HIV and TB (DGHT).

Trudy has over 35 years of experience in strengthening HIV diagnostic quality, from her early career in the Newborn Screening Quality Assurance (QA) Program supporting QA measures for HIV surveillance in childbearing women, to her work in both domestic and global HIV laboratory programs within DGHT.

In addition to specializing in research for HIV diagnostics and surveillance and co-leading Quality Management System (QMS) activities for her lab’s International Organization for Standardization (ISO) accreditations, Trudy has been a member of DGHT’s HIV Rapid Test Continuous Quality Improvement (RTCQI) core team which seeks to strengthen RTCQI practices in PEPFAR countries to enhance HIV rapid testing accuracy and reliability. She has specific responsibility as international subject matter expert (ISME) working with laboratorians and Ministries of Health supporting RTCQI training and program implementation in many countries of Africa and Asia. RTCQI programs she supports include tester and site certifications, integrated proficiency testing systems, and two- to three-test algorithm transitions.

Trudy looks forward to continuing to support quality management systems and innovative strategies for global HIV diagnostics and surveillance.

Kelsie Decker-Pulice is currently a microbiologist on the HIV Serology and Incidence Team. She focuses on international HIV serology testing, quality assurance, and various program optimization activities. She has supported several PEPFAR Population-based HIV Impact Assessments (PHIAs) in: Eswatini, Lesotho, Uganda, Malawi, Zambia, Botswana, and Tanzania by conducting lab trainings in country which focused on quality assurance in HIV rapid testing, waste management, blood collection, and sustaining the in- country laboratories well after the PHIA. Kelsie also has six years of experience in A2LA accreditation audits.

She is currently the RTCQI and serology ISME for Brazil, Ukraine, Uganda, Tanzania, Cote D’Ivoire and Lesotho and works with these countries to ensure quality testing and data usage.

Kelsie looks forward to providing technical assistance and guidance to strengthen quality management systems at the national, regional, and district levels.

Kemba is a Public Health Scientist with background in pharmacology and molecular genetics, more than 20 years of research experience and several years (since 2016) experience in Laboratory Quality Management Systems (QMS). She is a Subject Matter Expert (SME) for HIV Recency and HIV Rapid Test Continuous Quality Improvement (RTCQI) program development and implementation. Her service as an RTCQI SME has assisted several countries build laboratory capacity and strengthen programs, particularly Proficiency testing and National (Site and Tester) Certification programs. She has helped to establish RTCQI programs in Malawi, Botswana, and South Africa, develop the RTCQI website, e-Tools, other program tools and training materials during the early days of RTCQI and continues to provide consultation and technical assistance to maintain and promote sustainability of quality programs in multiple countries.

She possesses extensive experience in laboratory quality assurance and improvement in context of public health, through her over 15-year service in CAP, ISO accredited HIV serology laboratory for applied research as well as WHO-accredited regional reference laboratory of the WHO’s Western Pacific Region for polio virologic surveillance. She provided technical supports under PEPFAR program to ensure the testing quality of HIV rapid diagnostic assay and HIV recent infection surveillance using a rapid test e.g., in Zimbabwe, Namibia, South Africa, DRC, Caribbean region, and Ghana. She also supported the continuous quality improvement of laboratory network for virologic surveillance in China, as part of WHO’s global laboratory network for polio eradication.

Floris is a laboratory quality management expert and certified assessor for ISO 15189, and ISO/IEC 17025 standards; Certified Strengthening of Laboratory Management Towards Accreditation (SLMTA) trainer; and Quality Management System (QMS) trainer for (ISO/IEC 17025, ISO 15189, ISO 15190 and CAP) laboratory standards. She is a Subject Matter Expert (SME) for Population Based HIV Impact Assessment (PHIA) Surveys, HIV Recency, and HIV Rapid Test Continuous Quality Improvement (RTCQI) program development and implementation.

Among her accomplishments are a successful track record of assisting laboratories in multiple countries acquire international accreditation; Proficiency testing program development and implementation in compliance with ISO/IEC 17043 standard; Design, development and validation of laboratory testing algorithms (HIV, Syphilis, Hepatitis, COVID-19); and Program management.

Amitabh Adhikari is a distinguished computer scientist currently supporting the International Laboratory Branch at the Centers for Disease Control and Prevention (CDC) in Atlanta. With a robust background in information technology, medical informatics, and public health informatics, he holds a Healthcare Information and Management Systems certification (CPHIMS) and boasts over 24 years of experience in the field. His expertise encompasses mathematical modeling and the development of information systems tailored for public and clinical laboratories.

For the past 12 years, Amitabh has played a pivotal role in providing consulting services to the Laboratory Branch and Health Informatics Team, focusing on the design, development, implementation, and support of informatics projects in PEPFAR-supported countries. His proficiency in creating IT architecture and strategic technology roadmaps has been instrumental in the effective deployment of public health solutions globally.

Amitabh's leadership experience is highlighted by his significant contributions to public health technology solutions, particularly in the context of The President's Emergency Plan for AIDS Relief (PEPFAR). He has actively engaged in health informatics initiatives, enhancing the capacity of countries to manage and respond to public health challenges.

Academically, Amitabh holds a Master's degree in Physics from the University of Delhi and a Master of Technology degree from the Indian Institute of Technology (IIT), Kanpur, India. His qualifications are further bolstered by several certifications, including:

• PMI Certified Project Management Professional (PMP)
• CompTIA Security+
• Certified Professional in Healthcare Information and Management Systems (CPHIMS)
• TOGAF 9 Certified Enterprise Architect
• Foundation Certification in Information Technology Infrastructure Library (ITIL)
• SAS Certified Advanced Programmer for SAS 9
• Certified in HL7 2.4 Controls Specialist

As he continues to advance in his career, Amitabh remains dedicated to leveraging his extensive knowledge and experience to improve public health outcomes through innovative informatics solutions.

Keisha received a Bachelor of Science degree in Microbiology and Cell Science at the University of Florida, Gainesville. Her early career as a microbiologist involved collaborating with Saint Louis University on studies involving the cellular and humoral immune responses of HIV infected patients in HIV-1 vaccine and treatment clinical trials. Keisha continued her work in HIV in 2009 where she managed a global portfolio of capacity building efforts in PEPFAR-supported countries to strengthen quality assurance measures for HIV diagnostics and surveillance programs at national and sub-national levels. She has fostered collaborations with different organizations and partners including, the World Health Organization (WHO), U.S. Agency for International Development (USAID), Institut de Recherche en Santé de Surveillance Epidémiologique et de Formation (IRESSEF), the African Field Epidemiology Network (AFENET), the African Society for Laboratory Medicine (ASLM) and the Foundation for Innovative New Diagnostics (FNID) in order to implement robust quality management systems in PEPFAR-support countries.

From 2018 to 2022, Keisha served as the program coordinator for the HIV Rapid Test Continuous Quality Improvement Initiative (RTCQI) where she provided technical assistance and training to laboratorians and Ministries of Health, in PEPFAR-supported countries to help implement innovative and comprehensive approaches to ensure the accuracy and reliability of HIV diagnostic testing. She has provided technical assistance with protocol development, laboratory and field training and survey implementation for the Population-based HIV Impact Assessment (PHIA) and HIV-1 Recent Infection Surveillance in PEPFAR countries.

Keisha has over 20 years’ experience working in College of American Pathology (CAP), International Organization for Standardization (ISO) and Clinical Laboratory Improvement Amendment (CLIA) certified laboratories for public health and clinical research. As she forges ahead in a new career path, Keisha continues to support quality management systems and innovative strategies for diagnostics and surveillance both domestically and internationally.

Madelyn Baez-Santiago, PhD, is a microbiologist and the project lead for the Rapid Test Continuous Quality Improvement (RTCQI) initiative at the International Laboratory Branch (ILB) within CDC HQ.

She holds a doctorate in neurobiology and brings a multidisciplinary background that bridges basic science and applied public health. Her work focuses on strengthening HIV diagnostic quality through the implementation of sustainable quality assurance systems in resource-limited settings.

With extensive experience in laboratory systems, infectious disease diagnostics, and global health programs, Dr. Baez-Santiago plays a key role in advancing the accuracy and reliability of rapid testing services worldwide, contributing to critical public health research and quality improvement efforts in HIV diagnostics and testing.

Jeni Vuong is a committed public health microbiologist with over a decade of experience in infectious disease diagnostics.

Based at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA, she has provided essential expertise in bacterial meningitis and HIV. Jeni has contributed significantly to both domestic and global health efforts, including laboratory capacity strengthening, surveillance, and outbreak response for meningitis pathogens, as well as advancing innovative approaches to improve HIV diagnostic quality.

Her work has supported major global initiatives such as the Global Health Security Agenda and the President's Emergency Plan for AIDS Relief (PEPFAR).

Mervi Detorio is currently a Microbiologist on the Serology/Incidence Team within the International Laboratory Branch (ILB) at the Division of Global HIVand TB, Center for Global Health, US Centers for Disease Control and Prevention (CDC).

Mr. Detorio earned a Bachelor of Science in Medical Technology from Manila Central University in the Philippines. He began his career in 1988 as a Research Assistant at the Research Institute for Tropical Medicine in the Philippines, where he contributed to HIV/AIDS research studies. In 1994, he joined Japan Chemical Research Pharmaceuticals, a drug discovery firm in Kobe, Japan. In 1999, he relocated to Canada and became part of Dr. Mark Wainberg’s team at the McGill University AIDS Center in Montreal, Quebec, where he conducted extensive research on HIV drug resistance. In 2003, he joined Dr. Raymond Schinazi’s group at Emory University in Atlanta, Georgia, where he continued his research on the development of HIV drug resistance before joining the International Laboratory Branch (ILB)at the CDC in 2015.

In his current role, Mr. Detorio provides technical assistance in protocol development, laboratory training, and survey implementation for HIV incidence surveillance, Population-based HIV Impact Assessment (PHIA) surveys, and HIV Rapid Recency initiatives in PEPFAR countries. He is a member of the HIV Rapid Test Continuous Quality Improvement (RTCQI) core team which seeks to enhance RTCQI practices in PEPFAR countries

Mr. Detorio has co-authored over 50 peer-reviewed publications in scientific journals, showcasing his research findings.

Robert Domaoal is a microbiologist at the CDC’s Division of Global HIV & TB (DGHT), where he plays a key role in strengthening HIV diagnostic quality through Rapid Test Continuous Quality Improvement (RT-CQI) initiatives. As the International Subject Matter Expert (ISME) for countries including the Philippines, South Sudan, Mozambique, and Namibia, Rob provides technical leadership to enhance HIV rapid testing accuracy and reliability.

He collaborates with ministries of health, national laboratories, and implementing partners to review HIV testing algorithms, evaluate rapid test kits, and support the transition to three-test strategies. Rob has contributed to the development and review of RT-CQI training modules, external quality assessments for lay testers, and the implementation of electronic proficiency testing systems.

His work includes advising on national HIV testing policies, coordinating logistics for test kit procurement, and supporting laboratory capacity building. Rob’s efforts have directly improved testing quality and access in multiple countries, ensuring alignment with global standards and CDC guidance.

Through his RT-CQI leadership, Rob exemplifies a commitment to public health impact by advancing laboratory quality systems and supporting sustainable improvements in HIV diagnostic services worldwide.