infection to active disease. For this, the WHO conducted two surveys, first in May
2016 and second in January 2017. The latter had more specific participation,
engaging all stakeholders including academia, multilateral and international agencies, NGOs, civil society and community representatives, endemic countries, test
developers, and members of the New Diagnostics Working Group (NDWG) to
arrive at a consensus TPP. The consensus meeting report outlines TPPs for optimal
features of the test and can be summarized as follows [12]:
Intended Use
• Goal of test – To predict and quantitatively correlate the progression of infection
to active disease within the next 2 years, to reflect the effect of treatment
• Type of specimen – Invasive specimen like capillary whole blood (finger-prick
sample) or noninvasive specimens like saliva, urine, stool, or breath
• Target population – Persons who highly likely came in contact with affected
persons, individuals showing early symptoms marking the progression of the
disease
• Target user – Health workers with minimal lab training
• Setting (lowest level of implementation in healthcare system) – Health post or
tertiary level
Performance Characteristics
• Sensitivity – !90% sensitivity
• Specificity – !90% specificity
• Reproducibility – Inter-assay CV 10.0% at high and low extremes of the assay
Operational Characteristics
• No. of steps – <2
• Sample preparation – None or fully integrated
• Volume measurement – None
• Data analysis – Integrated
• Time to results – <24 h
• Biosafety – Universal precautions
• Operating temperature – 5
–50
C, 90% humidity
• Controls – Internal positive only and positive and negative both for external
controls
• Maintenance/calibration – None
• Power requirements – Should not require any instrument for charging and should
be equipped with rechargeable batteries with life up to 8 h
• Result capturing, documentation, data display – Reader should be able to save or
print results without any special instrumentation
• Data export (connectivity and interoperability) – The user should be able to
export the data in the format compatible with his/her computer
• Electronics and software – None
• Training – <1-day long training for health workers with minimal lab training
Defining Target Product Profiles (TPPs) for Aptamer-Based Diagnostics
201
2016 and second in January 2017. The latter had more specific participation,
engaging all stakeholders including academia, multilateral and international agencies, NGOs, civil society and community representatives, endemic countries, test
developers, and members of the New Diagnostics Working Group (NDWG) to
arrive at a consensus TPP. The consensus meeting report outlines TPPs for optimal
features of the test and can be summarized as follows [12]:
Intended Use
• Goal of test – To predict and quantitatively correlate the progression of infection
to active disease within the next 2 years, to reflect the effect of treatment
• Type of specimen – Invasive specimen like capillary whole blood (finger-prick
sample) or noninvasive specimens like saliva, urine, stool, or breath
• Target population – Persons who highly likely came in contact with affected
persons, individuals showing early symptoms marking the progression of the
disease
• Target user – Health workers with minimal lab training
• Setting (lowest level of implementation in healthcare system) – Health post or
tertiary level
Performance Characteristics
• Sensitivity – !90% sensitivity
• Specificity – !90% specificity
• Reproducibility – Inter-assay CV 10.0% at high and low extremes of the assay
Operational Characteristics
• No. of steps – <2
• Sample preparation – None or fully integrated
• Volume measurement – None
• Data analysis – Integrated
• Time to results – <24 h
• Biosafety – Universal precautions
• Operating temperature – 5
–50
C, 90% humidity
• Controls – Internal positive only and positive and negative both for external
controls
• Maintenance/calibration – None
• Power requirements – Should not require any instrument for charging and should
be equipped with rechargeable batteries with life up to 8 h
• Result capturing, documentation, data display – Reader should be able to save or
print results without any special instrumentation
• Data export (connectivity and interoperability) – The user should be able to
export the data in the format compatible with his/her computer
• Electronics and software – None
• Training – <1-day long training for health workers with minimal lab training
Defining Target Product Profiles (TPPs) for Aptamer-Based Diagnostics
201