Other Infectious Disease Test Kit ImmunoDOT™ Mono-M Epstein-Barr Virus / Cytomegalovirus / Toxoplasma 25 Tests CLIA Non-Waived

Features

• ImmunoDOT is an easy-to-use, visually interpreted, rapid-test format, dipstick ELISA that allows individual patients to be tested for multiple parameters simultaneously
• ImmunoDOT is a sophisticated test format which is a multiparameter, nitrocellulose ELISA with sensitivities and specificities similar to reference method western blots
• The Mono-M Test is a qualitative enzyme immunoassay (EIA) that detects IgM antibodies to Paul-Bunnell heterophil, Epstein-Barr virus capsid antigen (EBV-VCA), and cytomegalovirus (CMV)
• When used in conjunction with Mono-G Test, it is an aid in the serodiagnosis of infectious (EBV) mononucleosis and presumptive serodiagnosis of CMV mononucleosis-like syndrome
• This assay has not been FDA cleared or approved for the screening of blood or plasma donors
• Performance with this device has not been established for either prenatal screening or newborn testing
• Performance of this assay has not been established in a non-clinical laboratory environment (e.g., point of care testing)
• The assay uses an enzyme-linked immunoassay (EIA) dot technique for the detection of antibodies