Zika paper-based rapid diagnostic test
Dr. Keith Pardee
A paper-based diagnostic device to detect viral threats
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.
Regions vulnerable to this pandemic threat (South America, Central America and the Caribbean – Countries: Brazil, Colombia, Puerto Rico)
ZIKV Detect™ 2.0 IgM Capture ELISA is the only product validated by the FDA for Zika diagnosis.
Goal 3: Good health and well-being
Trained healthcare professionals in need of rapid diagnostic tools
This device takes approximately 5 days to be manufactured at the synthetic biology laboratories from the Wyss Institute for Biologically Inspired Engineering.
Product not commercially available yet.
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.
- 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.
Source: Research article about the product.
Provided by manufacturer.
Single use, disposable test. 1 year in storage.
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.
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.
With the lead of Dr. Keith Pardee, the University of Toronto and PardeeLab provided support to validate this technology. First laboratory tests were performed at Wyss Institute for Biologically Inspired Engineering, in association with Massachusetts Institute of Technology, Boston University, Arizona State University, Cornell University, University of Wisconsin-Madison,and the Broad Institute.
Additional testing would be needed to ensure safety and efficacity before actual deployment of this device.
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.
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%.
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