Zika paper-based rapid diagnostic test

Market Suggested Retail Price

$1.00

Target Users (Target Impact Group)

Distributors / Implementing Organizations

Unknown

Manufacturing/Building Method

This device takes approximately 5 days to be manufactured at the synthetic biology laboratories from the Wyss Institute for Biologically Inspired Engineering.

Intellectural Property Type

Patent Protected

User Provision Model

Product not commercially available yet.

Distributions to Date Status

None

Design Specifications

Following the World Health Organization (WHO) criteria for rapid diagnostic tests, researchers aimed to create a sterile and abiotic platform that can be utilized outside of laboratory conditions without concern over biosafety. Requirements:

• High-quality, easy-to-use tests for use in a resource-poor setting
• Quick and easy to perform and requiring little or no additional equipment
• Designed for use with a single or limited number of samples, making them more economical than, e.g., ELISA in low-throughput laboratories
• Possible to store at room temperature for an extended period
• Able to give same-day results, thus providing timely treatment interventions.

Technical Support

Provided by manufacturer.

Replacement Components

N/A

Lifecycle

Single use, disposable test. 1 year in storage.

Manufacturer Specified Performance Parameters

Testing time is less than 3 hours. The amplification and DNA detection process uses a NASBA (nucleic acid sequence based amplification) due to its high sensitivity. The chance for false-positive results due to contamination are minimized by the use of sequence-specific toehold switch sensors and CRISPR/ Cas9-mediated selection downstream of the amplification. This paper-based test is able to detect 2.8 fM Zika concentrations in plasma samples, which make it clinically relevant. It is fast, easy-to-use, and requires no costly qPCR machine and PCR infrastructure, no cold-chain required. Only needs an electronic optical reader, which was also designed for low resource settings.

Vetted Performance Status

Tests were performed by the manufacturer, collecting samples from three Latin American countries: Ecuador, Brazil and Colombia.The device showed high specificity against similar regional viruses (Dengue and Chikungunya), similar sensitivity when compared to RT-qPCR for the Zika detection, and a diagnostic accuracy of 98.5% with 268 patient samples. 

Safety

Additional testing would be needed to ensure safety and efficacity before actual deployment of this device.

Complementary Technical Systems

Electronic optical reader

Academic Research and References

Compliance with regulations

Unknown

Other Information

Similar applications of this diagnostic platform have been made for Chikungunya and COVID-19 by the same researcher.