The GB SARS-CoV-2 Real-Time RT-PCR kit will help in the qualitative detection of novel coronavirus in the respiratory tract specimens such as sputum, as well as serum or plasma
Taiwanese medical device company General Biologicals (GBC) has developed a new molecular testing kit for the identification of novel coronavirus (SARS-CoV-2) in human beings with suspected Covid-19 disease.
The GB SARS-CoV-2 Real-Time RT-PCR kit is an in-vitro nucleic acid amplification test (NAT) designed to qualitatively identify SARS-CoV-2 in the respiratory tract specimens such as sputum, as well as serum or plasma.
GBC’s test kit facilitates delivers results within two hours
By using reverse transcriptase-polymerase chain reaction (RT-PCR) and TaqMan probe technology, the firm’s PCR kit enables one-step real-time testing and delivers results between 1.5 hours and two hours.
The test kit allows to detect all serial dilutions of in-vitro transcription RNA of the target gene, as well as uses internal control (IC) as an indicator of the RT-PCR performance to minimise the false results. Each kit is provided sufficient reagents to conduct 100 tests.
GBC’s PCR kit, which already secured CE mark approval, has been approved by government health organisations such as the Central Drugs Standard Control Organisation (CDSCO) in India, the Taiwan Food and Drug Administration (TFDA) and the Australia registration.
The test is also under evaluation by the US Food and Drug Administration (FDA) to grant the emergency use authorisation (EUA) status.
GBC is currently exporting the PCR kit to severe corona-affected countries such as India, Mexico and Indonesia.
The company is also engaged in the development of other Covid-19 testing solutions, including SARS-CoV-2 antigen test and antibody test.
The antigen test is a rapid diagnostic test that will help identify specific proteins on the surface of the virus through nasal or throat swab. Results will be provided between 10 minutes and 15 minutes.
In addition, the firm is developing serological test called total antibody ELISA test that will help identify Immunoglobulin M (IgM) and Immunoglobulin G (IgG) to determine the presence of SARS-CoV-2 in patients.
GBC president Frank said: “With an increased need for reliable Covid-19 testing solutions worldwide, we are hoping our new kits will play a vital role in containing the global spread of the virus.
“Our PCR testing kit will produce results in as fast as 90 minutes with over 95 percent accuracy, which allows countries to rapidly detect and contain the virus.”