Foldscope

Target SDGs

Market Suggested Retail Price

$1.00

Market Suggested Retail Price (Secondary Currency)

1.75

Target Users (Target Impact Group)

Small and Medium-sized Enterprises, Public Sector Agencies, NGOs

Distributors / Implementing Organizations

Foldscope was implemented by Foldscope instruments Inc, Centers for Global Health and the Gates Foundation and the following partners; Moore Foundation, India's Dept of Biotechnology, Simons Foundation and MilliporeSigma . The company has a wide range of distributors in many parts of the world. The company also has a pool of donors as well.

Competitive Landscape

Direct competitors include CellScope Oto and UC Berkeley CellScope.

Manufacturing/Building Method

Materials include folded paper, bead of glass, watch battery, light-emitting diode, and on/off switch. One of the unique design features of the microscope is the use of inexpensive micro lenses instead of the precision-ground, curved, glass lenses used in traditional microscopes. These poppy-seed-sized lenses were originally mass-produced in various sizes as an abrasive grit that was thrown into industrial tumblers to knock the rough edges off metal parts. In the simplest configuration of the Foldscope, one 17-cent lens is press-fit into a small hole, call an aperture, in the center of the slide-mounting platform. Some of the more sophisticated versions have multiple lenses, including condenser lenses, doublet lenses and light filters.

Intellectural Property Type

Patent

User Provision Model

The user can purchase or order the foldscope directly from foldscope instruments or other distributors across the world.

Distributions to Date Status

According to the designers Over one million Foldscope units have been distributed to 135+ countries

Design Specifications

The product has a magnification up to 2,000x and a resolution of 800nm. It has a Battery Source: 3V button battery required to power the electrical slider switch. Illumination sources include white LED for bright-field foldscopes and blue LED for fluorescence foldscopes. It weighs only 8 grams with dimensions of (70 x 20 x 2 mm³). Foldscope can survive being dropped from a 3-story building. The Foldscope may be printed out on standard paper and constructed by hand within several minutes.

Product Schematics

Technical Support

The Manufacturer has provided a user guide and other resources for users on their website The goal is to make it easy to assemble and use the microscope, with users able to fold and construct the Foldscope in about 20 minutes. Currently, the device's assembly is so simple that majority of the device may be printed and assembled at home . However, if Foldscope is released for disease diagnostics, this will likely require more manufacturer oversight.

Replacement Components

The user can purchase additional components like the Foldscope Paper Slides and the Foldscope Cover Slips. The components for the original Foldscope are listed in its original publication, but replacement components for use and placement in the specific product may not be available based upon what changes will be necessary to apply the concept to disease diagnostics. One challenge cited is that the original paper construction may not stand the test of time in rural communities where dust and liquids may easily contaminate the device; thus, the design may need to be redeveloped for a device with a much longer life span.

Lifecycle

Unknown   In the event that Foldscope is used to examine hazardous samples, it would need to be disposed of after a single use.

Manufacturer Specified Performance Parameters

Constraints set out by the Prakash Lab: durable, functional, inexpensive, lightweight, small, easy to use and replace, requires no external power, and examine specimens on a glass slide similar to traditional microscopes

Vetted Performance Status

A research study demonstrated that the Foldscope lens has substantial agreement with conventional microscope camera with an accuracy of 80%, a sensitivity and specificity of 85 and 90% in cervical cytology microscopy research. It has also been used and tested by a lot of people. Users have shared their testimonies on the manufacturer's website Has already gone through years of research in the field, continuing to undergo clinical testing and international fieldwork in both diagnostics and education. Disease-specific Foldscope designs have gone through early bench-testing and yielded data, including high-magnification bright-field images of Giardia lamblia, Leishmania donovani, Trypanosoma cruzi (Chagas parasite), Escherichia coli, and Bacillus cereus, and low-magnification brightfield images of Schistosoma haematobium and Dirofilaria immitis. In the future, dark-field and fluorescence Foldscopes will also be adapted for diagnostics, and sensitivity and specificity will be measured for various disease-specific Foldscopes in the field as clinical validations against existing diagnostic standards.

Safety

Safety is unknown, however, foldscope is easy-to-use and replace. Please follow instructions and cautions as given.

Complementary Technical Systems

Foldscope is designed as a "stand alone" instrument for educational applications. For clinical applications it can be coupled with a camera phone to record images and movies.. Embedding flat rare-earth magnets in paper provides means for magnetic self-alignment, allowing the Foldscope to be reversibly coupled to a conventional smartphone for image capture, for smartphone-based diagnostics, or for telemedicine.

Academic Research and References

Compliance with regulations

None, though clinical research and testing is underway. Foldscope is not currently approved for diagnostics applications in human health

Evaluation methods

Bench testing materials and methods are described in their published papers. Additional clinical/field testing was funded by the Bill and Melinda Gates Foundation with a $100,000 grant to test Foldscope in Thailand, India, and Uganda.

Other Information

None.