Scientists develop fast lateral stream immunoassay for fluorescence detection of SARS-CoV-2 RNA
The SARS-CoV-2 HC-FIA detection system. Credit: SIBET
The COVID-19 pandemic has highlighted the need for rapid and accurate detection of nucleic acids at the treatment site. To meet this need, scientists at the Suzhou Institute of Biomedical Engineering and Technology have developed a novel, amplification-free, rapid SARS-CoV-2 nucleic acid detection platform based on a hybrid capture fluorescence immunoassay (HC-FIA).
The use of the monoclonal antibody S9.6 is the defining feature of this method, which recognizes double-stranded DNA-RNA hybrids and enables the conversion of nucleic acid tests to immunofluorescence on a simple lateral flow measuring stick.
The entire test procedure involves two steps, hybridization and immunofluorescence analysis, and can be completed in less than an hour.
The method uses optimized DNA probes to target the conserved open reading frame 1ab, envelope protein, and nucleocapsid regions of the SARS-CoV-2 genome obtained from clinical throat swab samples. It can reach a limit of detection of 500 copies / ml, comparable to commercial kits based on quantitative polymerase chain reaction (qPCR) in real time. In addition, no significant cross-reaction was found between the SARS-CoV-2 probes and 55 common pathogens.
The HC-FIA Detection Reagent performance is free from interference from hemoglobin, mucin, and various potential drugs that may be present in clinical specimens. This assay and test kit can also be adapted to detect other viral RNAs.
The HC-FIA process described here was supported by a randomized, double-blind, multi-hospital study with 734 samples. The current research is not only a proof-of-concept, but has also led to the development of a commercial test kit for the diagnosis of SARS-CoV-2. The test kit was recently approved by the National Medical Products Administration and received European conformity certification.
The test kit requires little equipment and professional staff to confirm infection. It can function as a “suitcase laboratory” and thus be used as an on-site detection method for ambulances, emergency rooms, customs and basic diseases.
“We are confident that the HC-FIA test can serve as a safe guard in containing the epidemic by reducing community prevalence and imported cases, particularly in developing countries,” said Wang Daming, lead researcher on the study.
This work with the title “Rapid Lateral Flow Immunoassay for the fluorescence detection of SARS-CoV-2-RNA” was published on December 3, 2020 in Nature Biomedical Engineering.
The new SARS-CoV-2 test is a simple, inexpensive and efficient alternative to SARS-CoV-2 tests
Daming Wang et al. Rapid Lateral Flow Immunoassay for the fluorescence detection of SARS-CoV-2 RNA, Nature Biomedical Engineering (2020). DOI: 10.1038 / s41551-020-00655-z Provided by the Chinese Academy of Sciences
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