Dow Biomedica, a domestic medical equipment importer, said Monday that it has launched Quidel’s Sofia S. pneumoniae FIA, a pneumonia diagnostic kit.
Compared to the average 22 serotypes of Streptococcus pneumoniae detected by conventional diagnostic kits, Quidel’s device can detect up to 99 serotypes. It can also identify influenza, group A streptococci, respiratory syncytial virus (RSV) and urinary pregnancy response (hCG).
The medical equipment uses a fluorescence immunoassay method, which detects fewer bacteria more sensitively than the immunochromatographic tests done with the naked eye, to derive the test results. The technique has already proved its effectiveness with the company’s previous Influenza A+B kit.
As a result, five clinical trials showed that the company’s kit is 22 percent more sensitive than the conventional pneumonia tests.
The kit has also increased reliability by incorporating a quality control function while allowing general hospitals to use the test equipment in conjunction with its Laboratory Information System (LIS). The results of the tests are also automatically stored and easy to manage.
“The use of a diagnostic kit that detects a wide range of pneumococcal serotypes is vital as pneumococcal streptococci are the primary cause of bacterial pneumonia in pneumonia infections,” the company said in a statement. “It is also crucial as infection by new pneumococcal streptococcal serotypes that are different from existing infection sera are increasing.”
The Sofia S. pneumoniae FIA kit will start sales in Korea after the company obtains import license for the device from the Ministry of Food and Drug Safety, the company added.