Since the beginning of April, Abbot have been producing the portable tests for SARS-CoV-2 at a rate of 50,000 tests a day. The test is a molecular based assay, which examines a patient sample for RNA fragments of the coronavirus genome. When present in high-levels, these pieces of genetic information can be rapidly detected.
Although a positive result can be revealed in under five minutes, to obtain a definitive negative result, the test needs to run for around 13 minutes, as Bloomberg has reported. The assay is called the RealTime SARS-CoV-2 EUA test.
The test is designed to detect the immunoglobulin (IgG), which is the antibody to SARS-CoV-2. This is a protein that the body produces during the later stages of infection, remaining for several months after a person has recovered for the infection. The test uses chemicals to shatter the virus’ outer shell so it spills out its genetic material. By detecting the antibodies the test helps to determine if an individual was previously infected with the virus.
The test is available for the U.S. market, with Abbott having been granted emergency use authorization from the U.S. Food and Drug Administration (FDA). The permission relates to “for use by authorized laboratories and patient care settings.”
Commenting on the test for Digital Journal, Lux Research Analyst Nardev Ramanathan tells us that “the test has received Emergency Use Authorization from the U.S. FDA and is extremely useful to expedite the testing process. The test, however, relies on large amounts of genomic material to be present, which doesn’t happen in the early stages of the infection.”
Ramanathan adds that: “Interested parties should also monitor for tech that can detect smaller amounts of genomic material (with a high degree of sensitivity and specificity), which is a biomarker for the earliest stages of infection. People are asymptomatic but still infectious then and need to be identified and isolated to better flatten the curve. Tests like the one developed in Singapore promise to do this, and in under five minutes as well, but none is commercially available at the time of writing.”
