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A dried blood spot or a swab of saliva, urine, or a lesion is mixed for 15 seconds into a tube containing Pathogen Transport Media. Two drops of the inoculated media are then added to reaction tubes. These reaction tubes are placed in the instrument or a heat source, such as a dry block. After approximately 30 minutes, results are reported by the instrument or can be observed by the naked eye using a fluorescent lamp or lateral flow.
Cytomegalovirus (CMV)
Point-of-Care
Why CMV POC is important
Affecting nearly 1 in 200 of all live births in the US, congenital CMV (cCMV) is a prevalent cause of sensorineural hearing loss (SNHL) in children and a significant cause of visual impairment. If a woman contracts the virus for the first-time during pregnancy, the baby has at least a 40% chance of being infected. Furthermore, a pregnant person can pass CMV to their unborn baby due to either a reinfection during pregnancy or reactivation of an earlier infection. cCMV infections are preventable if treated early, emphasizing the need for a rapid test reporting infection in a matter of minutes that can be used on all newborns.
Populations who could benefit
Pregnant women, newborns
Herpes Simplex Virus (HSV) Point-of-Care
Why HSV POC test is important
There is an urgent need for a POC to detect HSV, in particular in neonates suspected of having congenital HSV. Untreated neonatal HSV has only a 40 percent survival rate and even the early initiation of high-dose intravenous acyclovir therapy may result in significant disability among survivors. Antiviral therapy for HSV infection has reduced the mortality of neonatal HSV infection from 60% to about 10%, but rapid detection is needed to identify babies in need of treatment. Infectious disease specialists agree that there is a need for accurate and rapid diagnosis of neonatal HSV infection, which is crucial for making earlier informed therapeutic decisions. Faster and accurate diagnosis is also needed for genital herpes, as this can reduce infection morbidity and possible further HSV transmission.
Populations who could benefit
Pregnant women, neonatal patients, people who do not have immediate access to hospitals/primary-care clinics
Syphilis Point-of-Care
Why Syphilis POC is important
HSV and T. pallidum (the causative agent of syphilis) infections can cause clinically indistinguishable genital and anogenital ulcers and are sexually transmitted. Untreated syphilis or HSV infections in pregnant women can also be transmitted to the fetus at any time during pregnancy or at birth. Congenital syphilis is associated with significant morbidity (bone deformities, neurologic impairment) and mortality in infants. Cases of congenital syphilis markedly increased from 2012 to 2019, from 8.4 to 48.5 cases per 100,000 live births (an increase of 477%) as per the CDC (link below).
Epstein-Barr Virus
Point-of-Care
Why EBV POC test is important
EBV infects greater than 95% of the population, usually without symptoms. However, EBV can cause infectious mononucleosis, or “Mono”, which is most common among teens and adults (CDC link below). In immunosuppressed individuals, EBV can cause many diseases such as nasopharyngeal carcinoma, Burkitt’s lymphoma, and other B-cell lymphomas. EBV is spread from person to person by saliva.
