Challenge

Develop noninvasive or minimally-invasive (e.g., finger stick) devices to conduct standard medical assessments of multiple blood components (e.g. basic metabolic panel and liver function tests) for onboard clinical diagnosis in long-duration space flights, with all aspects of the device’s form factor and operation appropriate for use in outer space given the constraints shown in the above table as well as others that may apply. Preference may be given to multi-function or flexible/modular systems that enable examination of additional analytes.

Analytes of Interest

High Importance	Desirable
Sodium	Blood urea nitrogen (BUN)
Potassium	Aspartate aminotransferase (AST)
Creatinine	Troponin
Glucose	Lactate
Hg and/or Hct	Total (T.) bilirubin
Platelets	Direct/conjugated (D.) bilirubin
Absolute neutrophil	Lipase
Absolute lymphocyte	Blood gasses
Urinalysis	Creatine kinase (CK)
Aldolase/Alkaline phosphate (ALD/ALP)	Partial thromblastin (time) (PT/PTT)

TRISH is soliciting proposals for the rapid transformation of emerging point-of-care (POC) technologies into viable, clinically-focused solutions that facilitate diagnosis of conditions on NASA’s Medical Conditions List during long-duration space flights as well as in terrestrial clinical settings. The solicitation seeks technologies that have a commercial potential that would benefit from investments that make them suitable for long-duration spaceflights. For example, miniaturizing a table-top device into a hand-held device, reducing, or eliminating the need for and extending the shelf-life of consumables, and improving ease-of-use, are all important developments.

Background

While astronauts are generally healthy, medical issues can occur during long-duration space flights as on Earth, and space flight increases the risks for certain medical complications, including muscle atrophy, bone demineralization, cardiovascular deconditioning, motion sickness, visual problems (perhaps related to elevated intracranial pressure), kidney stones (resulting in part from bone demineralization), back pain, urinary retention, toxic exposure, decompression, ear infection, and corneal abrasions (due to an excess of floating objects in-flight) (Strangman, 2017).

The key variables for medical technologies developed for use in deep space are related to performance/accuracy, mass, volume, power, speed, ease of use, reliability/durability, shelf life, and mass/volume of consumables; each of these should be optimized when designing devices for clinical monitoring. Additionally, fluids behave very non-intuitively in microgravity and hence considerable caution and pre-flight testing is required approaches involving fluids. Microfluidics, which depend on capillary action rather than bulk fluid flow, are highly preferred as they significantly reduce these concerns. Other examples of limitations imposed by long-duration space flight and related desirable attributes/specifications for use during long-duration space flights are shown in the following table (adapted from Strangman, 2017):

Spaceflight Limitation	Device Design Attributes/Specifications
Low-resource environment	Multiuse devices Reusable device components Low maintenance components, minimize moving parts Components robust to failure in space environment
Long distances and high cost to orbit	Minimize mass Minimize volume Minimize consumables
Communication delays	Easy-to-use devices Built-in self-guidance or just-in-time training systems Automated data management
Fluids in microgravity	Noninvasive devices Minimize fluid samples Reduce or eliminate fluids required Analog testing (e.g., parabolic flight)
Sealed environment	Use nontoxic materials and fluids Off-gas testing
Limited power generation capabilities	Minimize power demands
Busy astronaut schedules	Minimize time required for training, setup, use, breakdown, and data management

Ideally, solutions would cover all of the desired blood components with a single platform, but a platform that can be demonstrated for a subset of these components and that has the potential to expand to other components is allowable.

To accelerate clinical adoption of these technologies for use in space as well as terrestrial clinical settings, the following performance criteria apply for this solicitation:

Result Availability: Results must be available within 10 to 20 minutes or sooner so that decisions can be made in a timely fashion based on the test results.
Ease of Use: The user interface with the device should be designed to ensure regulatory compliance under the clinical laboratory improvement amendment (CLIA-88) with minimal requirements for intervention by the operator. Results readout must not be subjective but easy to read using color change readout, digital or graphic formats.
Reducing Operator Errors: The device should have built in software safeguards to ensure proper operation and reduce common errors such as lock-out for failed quality control (or failure to perform quality control), lock-out of expired consumables, etc.
Sample Types: Samples that do not require a trained phlebotomist such as capillary finger-stick whole blood or saliva is significantly preferred to venous blood samples.
Storage of Consumables: All consumables including reagents, calibrators and quality control materials should be able to be stored at room temperature. The minimum shelf life is 2 years, although 5 years is preferred.
Device Footprint: Devices should be designed to have as small a footprint as possible. Small handheld devices, or devices that are easily integrated into a spaceflight vehicle, are optimal.
Information Connectivity: All devices should be capable of being interfaced to an electronic medical record system.
Analytic Performance: As a general rule, the device should be equivalent to central laboratory instruments with regard to analytical accuracy, reportable range, and precision.

Strangman G. Space biomedical instrumentation. In: Young LR, Young JP, eds. Encyclopedia of bioastronautics. Springer 2017.

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