Target product profiles for a micronutrient assessment tool and associated blood collection device for use in population-based surveys: An expert consensus

Authors: SMITH, EMILY - George Washington University; LEE, JOANNE - Camber Collective; Allen, Lindsay - A; BOYLE, DAVID - Path; BRINDLE, ELEANOR - University Of Washington; CRAFT, NEAL - Eurofins Scientific, Inc; DALMIYA, NITA - United Nations Children Fund; ERHARDT, JUERGEN - Eg Consulting (SELF-EMPLOYED); GARRETT, DEAN - Path; JEFFERDS, MARIA ELENA - Centers For Disease Control And Prevention (CDC) - United States; KAVISHE, FESTO - Nelson Mandela African Institute Of Science And Technology; KILLILEA, DAVID - Children'S Hospital Oakland Research Institute; KUNG'U, JAQUELINE - Nutrition International (AFRICAN REGINONAL OFFICE); KURPAD, ANURA - St John'S Research Institute: Sjri; LOECHL, CORNELIA - International Atomic Energy Agency (IAEA); MOORE, SOPHIE - King'S College; NAMASTE, SORREL - Icf International; PFEIFFER, CHRISTINE - Centers For Disease Control And Prevention (CDC) - United States; ROHNER, FABIAN - Groundwork Llc; SCHULZE, KERRY - Johns Hopkins School Of Public Health; SHAHEEN, NAZMA - University Of Dhaka; SOOFI, SAJID - Aga Khan University; WINICHAGOON, PATTANEE - Mahidol University; THOMAS, BETHANIE - Camber Collective; OSENDARP, SASKIA - Micronutrient Forum; RAWAT, RAHUL - Gates Foundation

Submitted to: MedrXiv
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 5/18/2021
Publication Date: 6/1/2021
Citation: Smith, E.R., Lee, J., Allen, L.H., Boyle, D.S., Brindle, E., Craft, N.E., Dalmiya, N., Erhardt, J., Garrett, D., Jefferds, M., Kavishe, F., Killilea, D.W., Kung'U, J.K., Kurpad, A., Loechl, C.U., Moore, S.E., Namaste, S.M., Pfeiffer, C.M., Rohner, F., Schulze, K., Shaheen, N., Soofi, S., Winichagoon, P., Thomas, B., Osendarp, S., Rawat, R. 2021. Target product profiles for a micronutrient assessment tool and associated blood collection device for use in population-based surveys: An expert consensus. MedrXiv. https://doi.org/10.1101/2021.05.13.21257124.
DOI: https://doi.org/10.1101/2021.05.13.21257124

Interpretive Summary: Micronutrient deficiencies are a significant public health problem affecting a large portion of the world’s population. Disproportionately affected populations—infants, young children, adolescents and women of reproductive age including pregnant women — are especially susceptible to the health consequences of insufficient micronutrient intakes. However, assessment of micronutrient deficiencies is not routinely included in population health surveys. This nutrition data gap hampers policy, program, and promotion efforts to prevent and treat micronutrient deficiencies. To address one of the barriers to micronutrient assessment, an expert group created a consensus of a target product profile (TPP) for a micronutrient assessment tool and associated blood collection device for use in population surveys. Experts in laboratory medicine, micronutrient assessment, population-based surveys, and product development reviewed proposed TPP standards and collaboratively established minimum and optimal characteristics. These experts defined the target population as infants and children from 6-59 months, adolescents and women of reproductive age 12-49 years including pregnant women. At minimum, the assessment tool should be a multiplex ELISA formatted for >1 analyte that uses a serum or plasma sample prepared from venous blood obtained by a phlebotomist with a 2-week training. Given the use case was specific for population surveys, experts agreed the minimum tool could be semi-quantitative, with analytical specificity of 99%. The TPP also considers the variable field environments for testing (e.g. storage conditions and time to results). The consensus TPP developed can be used to guide selection of existing technologies into population-based surveys, as well as future investment in product development. Partnerships focused on research and development—including industry, public sector, nonprofit, and academic institutions—can help advance the field and fill the micronutrient data gap

Technical Abstract: Micronutrient deficiencies are a significant public health problem affecting a large portion of the world’s population. Disproportionately affected populations—infants, young children, adolescents and women of reproductive age including pregnant women — are especially susceptible to the health consequences of insufficient micronutrient intakes. However, assessment of micronutrient deficiencies is not routinely included in population health surveys. This nutrition data gap hampers policy, program, and promotion efforts to prevent and treat micronutrient deficiencies. To address one of the barriers to micronutrient assessment, an expert group created a consensus of a target product profile (TPP) for a micronutrient assessment tool and associated blood collection device for use in population surveys. Experts in laboratory medicine, micronutrient assessment, population-based surveys, and product development reviewed proposed TPP standards and collaboratively established minimum and optimal characteristics. These experts defined the target population as infants and children from 6-59 months, adolescents and women of reproductive age 12-49 years including pregnant women. At minimum, the assessment tool should be a multiplex ELISA formatted for >1 analyte that uses a serum or plasma sample prepared from venous blood obtained by a phlebotomist with a 2-week training. Given the use case was specific for population surveys, experts agreed the minimum tool could be semi-quantitative, with analytical specificity of 99%. The TPP also considers the variable field environments for testing (e.g. storage conditions and time to results). The consensus TPP developed can be used to guide selection of existing technologies into population-based surveys, as well as future investment in product development. Partnerships focused on research and development—including industry, public sector, nonprofit, and academic institutions—can help advance the field and fill the micronutrient data gap