Updated on February 26, 2024

·

Created on September 1, 2021

Zika paper-based rapid diagnostic test

Upcoming Update

A paper-based diagnostic device to detect viral threats

Developed By
  1. Wyss Institute
Tested By
  • Wyss Institute
Content Partners
Unknown

Author

Product Description

A Zika paper-based diagnostic device is a molecular diagnostic tool embedded into paper that uses blood, urine or saliva to provide results in a short time. It is composed of three components: An amplifier for the genetic sequences found in the patient sample; a toehold switch sensor to recognize if the sequences found are from Zika virus, and a third component to determine the strain of the virus. This product is still a proof of concept, and additional testing is needed to ensure safety and efficacy before actual deployment.

 

Target SDGs

SDG 3: Good Health and Well-Being

Market Suggested Retail Price

$1.00

Target Users (Target Impact Group)

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

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

User Provision Model

Product not commercially available yet.

Distributions to Date Status

None

Consumables

Paper tests

Detection sensitivity

98% sensitivity -similar to Zika CDC RT-qPCR-, and 100% accuracy to differentiate Zika from Dengue. 

Indispensable equipment for function (Y/N)

Electronic optical reader

Maintenance or calibration required by user at time of use? (Y/N)

No

Number of Tests Performed

1

Power supply type: Continuous, Recharging only (V, time required, battery life), Other

Not required

Time required for procedure (minutes)

3 hours

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.
  

Product Schematics

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

Pardee K., 2016, “Rapid, Low-Cost Detection of Zika Virus Using Programmable Biomolecular Components,” Cell, 165 (5), pp. 1255-1266

Hall R., Macdonald J., 2016, “Synthetic Biology Provides a Toehold in the Fight against Zika,” Cell Host & Microbe, 19(6), pp. 752-754,

Silva SJRD., Pardee K., Pena L., 2019, “Loop-Mediated Isothermal Amplification (LAMP) for the Diagnosis of Zika Virus: A Review,” Viruses,12(1):19.

da Silva, S.J.R., Pardee, K., Balasuriya, U.B.R. et al., 2021, “Development and validation of a one-step reverse transcription loop-mediated isothermal amplification (RT-LAMP) for rapid detection of ZIKV in patient samples from Brazil,” Sci Rep, 11, pp. 4111 

Karlikow, M., Silva, S. J. R. D., Guo, Y., Pardee, K., 2021, Developing a lab-in-a-box and low-cost paper-based sensors for ZIKV and CHIKV diagnosis in Latin America. V International Symposium of Immunologicals.

Silva, S. J. R. D., Mendes, R. P. G., Pena, L., 2021, Low-cost protocol for rapid detection of ZIKV from patient and mosquito samples using a direct-RT-qPCR assay without RNA extraction step. V International Symposium of Immunologicals.

Karlikow, Margot, “Developing a lab-in-a-box and low-cost paper-based sensors for ZIKV and CHIKV diagnosis in Latin America“, V International Symposium, 2021

Compliance with regulations

Unknown

Evaluation methods

Field trial of the paper-based system for Zika diagnostics in endemic countries. The test matched the Zika CDC RT-qPCR in specificity and sensitivity, with a comparable accuracy of 98%.

Other Information

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

Leave a Reply

Explore similar solutions

Agriculture

February 14, 2024

DFA Paper-based liver function test (AIDS, TB)

Read Solution

Implemented by

Diagnostics for all

Agriculture

March 10, 2024

DDG Rapid Assessment of Infectious Diseases (RAID) Device

Read Solution

Implemented by

Disease Diagnostic Group

Agriculture

February 14, 2024

EasyNat TB-CPA Diagnostic Kit

Read Solution

Implemented by

USTAR Biotechnologies (Hangzhou) LTD

Agriculture

March 11, 2024

SOMATOINFRA Diagnostic System

Read Solution

Implemented by

OrthoTrauma

Agriculture

February 26, 2024

Gazelle Diagnostic Device

Read Solution

Implemented by

Hemex Health

Agriculture

March 8, 2024

Jute Cellulose-based PPE

Read Solution

Agriculture

February 15, 2024

Fyodor Urine Malaria Test (UMT)

Read Solution

Implemented by

Fyodor Biotechnologies

Agriculture

March 8, 2024

LAMP on Disc COVID-19 Test

Read Solution

Implemented by

Karolinska Institutet

Agriculture

January 4, 2024

Promethean Rapid Milk Chiller

Read Solution

Implemented by

Promethean

Agriculture

February 21, 2024

Towards Safer School Construction: A Community-Based Approach

Read Solution

Implemented by

Global Alliance for Disaster Risk Reduction & Resilience in the Education Sector

All Solutions

Contribute to E4C's Library of Breakthrough Sustainable Development Technology Solutions

Suggest A Solution

Get more information about Solutions Library and its features.

Learn More

Have thoughts on how we can improve?

Give Us Feedback

Join a global community of changemakers.

Become A Member