Products & Services
Point of Care – Rapid Antigen Test
Due to the highly contagious nature and global health crises, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO) and continues to have devastating impacts on healthcare systems and the world economy including the U.S.To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of clinical COVID-19 cases is critical. An effective screening regimen in a workplace, campus or other community setting can be established using the quick results provided by antigen tests.As an intended point-of-care (POC) designated test with a 10 min processing time, CareStart™ COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.
FDA EUA Authorized
2019-nCoV Real-Time PCR Kit (Swab)
This “Gold Standard” RT-qPCR test demonstrated 100.0% accuracy in clinical trials and was used to help Korea contain its COVID-19 outbreak before receiving FDA EUA authorization on May 21, 2020.
FDA EUA Authorized
COVID-19 IgG/IgM Rapid Test
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirusi in human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings.
FDA EUA Authorized
PCR/Saliva Testing Services from High Complexity Laboratory
PCR detects the genetic information of the virus, the RNA. That’s only possible if the virus is there and someone is actively infected. PCR tests are used to directly detect the presence of an antigen, rather than the presence of the body’s immune response, or antibodies. By detecting viral RNA, which will be present in the body before antibodies form or symptoms of the disease are present, the tests can tell whether or not someone has the virus very early on.
FDA EUA Authorized