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Literature Sharing: Development and pre-clinical evaluation of a Zika virus diagnostic for low resource settings
Release date:
2025-11-20
According to a report from the Regional Office for the Americas of the World Health Organization, Brazil reported 294 new suspected cases of Zika virus disease between October 19 and November 8, 2025.
Source：Frontiers in Microbiology, 20 November 2023
According to a report from the Regional Office for the Americas of the World Health Organization, Brazil reported 294 new suspected cases of Zika virus disease between October 19 and November 8, 2025. From January 1 to November 8, 2025, the country cumulatively reported 22,831 suspected cases, of which 1,597 were confirmed. Currently, there are no approved vaccines or specific antiviral drugs available globally. Therefore, achieving rapid and accurate detection of the Zika virus is a critical step for predicting and monitoring potential outbreaks.
This article aims to introduce a novel isothermal diagnostic technology—Iso-ZIKV-Dx—which can complete detection within 30 minutes and is suitable for low-resource settings such as field environments.
I. Research Background and Problem
• Threat of Zika Virus (ZIKV): ZIKV is an arbovirus primarily transmitted by mosquitoes (such as Aedes species). Sexual transmission and mother-to-child transmission are also possible. Infection can lead to severe congenital defects such as microcephaly in newborns. Furthermore, a majority of infected individuals are asymptomatic, which poses significant challenges for epidemic monitoring and control.
• Current ZIKV Detection Techniques:
◦ Antibody-based Detection: Due to antigenic cross-reactivity between Zika virus and other flaviviruses (e.g., Dengue virus), serological methods like ELISA are prone to false positives, limiting their application
◦ qRT-PCR: This method requires specialized equipment and trained personnel, restricting its use outside central laboratories.
This study successfully developed a rapid, isothermal diagnostic technology for Zika virus (Iso-ZIKV-Dx), which can detect synthetic ZIKV RNA as low as 500 copies/μL within 30 minutes at a constant temperature of 39°C.
II. Core Technology: Iso-ZIKV-Dx
Primer and Probe Design
The Iso-ZIKV-Dx detection process mainly consists of the following three steps:
1. Rapid Sample Processing: Using TNA-Cifer Reagent E, the clinical sample (e.g., urine) is mixed with the reagent at a 1:1 ratio and incubated at room temperature for 5 minutes. This efficiently inactivates the virus (ensuring operational safety) and releases viral RNA, eliminating the need for complex nucleic acid extraction and purification steps.
2. Isothermal Amplification: Recombinase Aided Amplification (RAA) technology is employed. Unlike PCR, which requires repeated temperature cycles, RAA is performed at a constant 39°C and can amplify target RNA fragments in just 20 minutes, significantly reducing the need for complex equipment.
3. Result Readout: Detection is performed using a Lateral Flow Dipstick (LFD). The amplification product is applied to the dipstick, and results can be visually determined within 5 minutes based on the appearance of the test (T) line and control (C) line.
The entire detection process, from sample processing to obtaining results, can be completed within 30 minutes.
III. Performance Evaluation
1. Sensitivity:
◦ Testing using synthetic ZIKV RNA showed a limit of detection (LOD) of 500 copies/μL.
◦ In simulated infected urine samples, it could detect ZIKV (MR766 strain) as low as 34.28 RNA copies per reaction.
2. Specificity:
◦ The technology specifically identifies ZIKV without cross-reactivity with other commonly co-circulating viruses such as Dengue virus (serotypes 1-4), West Nile virus, Japanese encephalitis virus, Murray Valley encephalitis virus, Yellow fever virus, and Chikungunya virus, effectively avoiding false-positive results.
3. Biosafety:
◦ Experimental verification showed that the sample processing reagent TNA-Cifer Reagent E completely inactivates high concentrations of ZIKV within 5 minutes, ensuring the safety of field operators.
4. Comparison with the Gold Standard:
◦ Compared to the time-consuming (several hours) and equipment-intensive RT-qPCR, Iso-ZIKV-Dx reduces the detection time by approximately fourfold and requires minimal equipment, making it more suitable for rapid field screening.
IV. Significance and Advantages
The Iso-ZIKV-Dx detection technology developed in this study is groundbreaking. It effectively addresses the challenge of performing accurate and rapid detection in resource-limited settings without compromising speed or accuracy.
• Summary of Advantages:
Rapid (<30 minutes), safe (rapid inactivation), simple (no complex equipment needed), accurate (high sensitivity and specificity), low-cost.
• Application Prospects:
◦ Clinical Diagnosis in Resource-Limited Areas: Aids primary healthcare facilities in rapid diagnosis of ZIKV infection, enabling timely public health measures.
◦ Epidemic Surveillance: Can be used for virus monitoring in vectors like mosquitoes, enabling early warning.
◦ Technological Application: The approach combining simple sample processing, isothermal amplification, and test strip detection provides a template for developing rapid tests for other infectious diseases (e.g., Dengue, Malaria).
V. Summary
This study successfully developed and preclinically validated a Zika virus diagnostic technology (Iso-ZIKV-Dx) that integrates rapid sample processing, isothermal amplification, and lateral flow detection. While maintaining high sensitivity and specificity, this technology significantly simplifies the operational workflow and reduces requirements for equipment and specific environments. It provides a powerful tool for rapid diagnosis and epidemic monitoring of ZIKV in low-resource settings, holding significant public health application value.
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