Image: The beginning of HC-FIA (Photo courtesy of SIBET)
Scientists have developed a new platform for rapid detection of SARS-CoV-2 nucleic acids without amplification based on a hybrid capture fluorescence immunoassay (HC-FIA) to meet the need for rapid and accurate detection of nucleic acids at the point of attention.
The use of the S9.6 monoclonal antibody is the hallmark of this process developed by scientists at the Suzhou Institute of Biomedical Engineering and Technology (Suzhou, China). The process recognizes DNA-RNA double-stranded hybrids and enables conversion of nucleic acid tests to immunofluorescence on a single side-flow test strip. The entire test procedure consists of two steps, namely hybridization and immunofluorescence analysis, and can be completed in less than an hour.
The process uses optimized DNA probes to target the 1ab conserved open reading frame, envelope protein, and nucleocapsid regions of the SARS-CoV-2 genome derived from clinical pharyngeal swab specimens. It can reach a detection limit of 500 copies / mL, comparable to commercial kits based on quantitative real-time polymerase chain reaction (qPCR). Furthermore, no significant cross-reaction has been found between the SARS-CoV-2 probes and 55 common pathogens. The performance of the HC-FIA Detection Reagent is free from interferences from hemoglobin, mucin, and various possible drugs that may exist in clinical specimens. The assay and test kit can also be adapted for the detection of other viral RNA.
The HC-FIA process was supported by a randomized, double-blind trial in several hospitals that included 734 samples. The current research not only represents a proof of concept, but has also resulted in the development of a commercial test kit for the diagnosis of SARS-CoV-2. The test kit was recently approved by the National Administration of Medical Products and received the European certification of conformity. The test kit requires little equipment and professional personnel to confirm infection. It can function as a “bag laboratory” and therefore be used as an on-site detection method for outpatient departments, emergency departments, customs and grassroots disease control.
“We are confident that the HC-FIA test is capable of serving as a safe safeguard to contain the epidemic by reducing community spread and imported cases, especially in developing countries,” said WANG Daming, principal investigator of the study. .
Suzhou Institute of Biomedical Engineering and Technology