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Ultraprecise Antigen 10-in-1 Pool Testing by Multiantibodies Transistor Assay
Changhao Dai1,2, Mingquan Guo3, Yanling Wu4
1State Key Laboratory of Molecular Engineering of Polymers, Department of Macromolecular Science, Fudan University, Shanghai 200433, China.
Insights
A new multi-antibody transistor assay offers highly sensitive and precise antigen pool testing for infectious diseases. This rapid, population-scale screening method achieves near-perfect agreement with PCR, improving epidemic control strategies.
Area of Science:
- Biotechnology and Biosensing
- Infectious Disease Diagnostics
- Nanotechnology
Background:
- Effective infectious disease screening demands rapid, affordable, population-scale testing methods.
- Antigen pool testing enhances throughput but often suffers from lower accuracy compared to polymerase chain reaction (PCR).
- Existing transistor sensors for antigen detection lack the required sensitivity and precision for reliable pool testing.
Purpose of the Study:
- To develop a highly sensitive and precise multi-antibody transistor assay for antigen pool testing.
- To improve the overall percent agreement (OPA) of antigen pool testing with the gold-standard PCR.
- To enable rapid, population-scale screening for infectious diseases like COVID-19.
Main Methods:
- Fabrication of a multi-antibodies transistor assay utilizing specific configurations to capture SARS-CoV-2 spike S1 proteins.
- Characterization of antigen-binding affinity and limit of detection (LOD) in artificial saliva.
- Validation of the assay using nasopharyngeal swabs and comparison with PCR results, including development of a portable integrated platform for pooled screening.
Main Results:
- Achieved a high antigen-binding affinity down to 0.34 fM and an exceptionally low LOD of 3.5 × 10-17 g mL-1 for SARS-CoV-2 spike S1 protein.
- Demonstrated approximately 100% OPA with PCR for 60 nasopharyngeal swabs within an average diagnosis time of 38.9 seconds.
- Developed a portable platform enabling 10-in-1 pooled screening, significantly increasing testing throughput.
Conclusions:
- The developed multi-antibodies transistor assay overcomes the limitations of traditional antigen pool testing, offering high precision and sensitivity.
- This technology provides a valuable tool for precise diagnoses and enables efficient, population-wide screening of infectious diseases.
- The assay holds significant potential for future epidemic prevention and control strategies.
Abstract:
Effective screening of infectious diseases requires a fast, cheap, and population-scale testing. Antigen pool testing can increase the test rate and shorten the screening time, thus being a valuable approach for epidemic prevention and control. However, the overall percent agreement (OPA) with polymerase chain reaction (PCR) is one-half to three-quarters, hampering it from being a comprehensive method, especially pool testing, beyond the gold-standard PCR. Here, a multiantibodies transistor assay is developed for sensitive and highly precise antigen pool testing. The multiantibodies capture SARS-CoV-2 spike S1 proteins with different configurations, resulting in an antigen-binding affinity down to 0.34 fM. The limit of detection reaches 3.5 × 10-17 g mL-1SARS-CoV-2 spike S1 protein in artificial saliva, 4-5 orders of magnitude lower than existing transistor sensors. The testing of 60 nasopharyngeal swabs exhibits ∼100% OPA with PCR within an average diagnoses time of 38.9 s. Owing to its highly precise feature, a portable integrated platform is fabricated, which achieves 10-in-1 pooled screening for high testing throughput. This work solves the long-standing problem of antigen pool testing, enabling it to be a valuable tool in precise diagnoses and population-wide screening of COVID-19 or other epidemics in the future.
