General Biologicals Corporation (GBC) has developed the GB SARS-CoV-2 Real-Time RT-PCR ("PCR Kit"): a reliable molecular testing kit for the detection of the novel coronavirus in humans.

The PCR Kit is an in-vitro nucleic acid amplification test (NAT) for the qualitative detection of novel coronavirus (SARS-CoV-2) in the respiratory tract specimens such as sputum, as well as serum or plasma. Utilizing Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and TaqMan probe technology.

GB SARS-CoV-2 Real-Time RT-PCR

GBC's PCR Kit allows one-step real-time testing with results available within 1.5-2 hours. All serial dilutions of in-vitro transcription RNA of the target gene can be detected (102, 104, 106, 108 copies/ml < 37 Ct). The testing kit also features internal control (I.C.) as an indicator of the RT-PCR performance, which can reduce the results of false-negatives. Each kit contains sufficient reagents to perform 100 tests.

"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," said Frank, President at GBC.

GBC's PCR kit is C.E. marked and has been approved by government health organizations worldwide, including the Central Drugs Standard Control Organization (CDSCO) in India, the Taiwan Food and Drug Administration (TFDA), and Australia registration.

A review is also underway for Emergency Use Authorization (EUA), and Food and Drug Administration (FDA) approval in the U.S. The kit is currently being exported to hard-hit countries such as India, Mexico and Indonesia.

GBC's Antigen Rapid and Elisa Total Ab Test

In addition to its PCR Kit, GBC is currently developing other COVID-19 testing solutions, including a SARS-CoV-2 antigen test and antibody test. Molecular tests, such as the PCR Kit, are considered the industry standard for the detection of an active COVID-19 infection in patients but, depending on the test, it can take anywhere from one day to one week to receive the results.

The antigen test is a rapid diagnostic test that detects specific proteins on the surface of the virus via a nasal or throat swab. Results are available in 10 to 15 minutes.

GBC is also developing a total antibody ELISA test, a serological test that detects Immunoglobulin M (IgM) and Immunoglobulin G (IgG) to determine the presence of SARS-CoV-2 in patients. Antibody tests can reveal if a patient has had COVID-19 and has built up an immune response but cannot be used to diagnose an active infection.

The development of both testing solutions will be completed by July. The tests will then be exported to Europe, South Asia and South Africa before GBC applies for FDA and EUA approval for distribution in the U.S.