Author: Kaul, Karen L.; Sabatini, Linda M.; Tsongalis, Gregory J.; Caliendo, Angela M.; Olsen, Randall J.; Ashwood, Edward R.; Bale, Sherri; Benirschke, Robert; Carlow, Dean; Funke, Birgit H.; Grody, Wayne W.; Hayden, Randall T.; Hegde, Madhuri; Lyon, Elaine; Murata, Kazunori; Pessin, Melissa; Press, Richard D.; Thomson, Richard B.
Title: The Case for Laboratory Developed Procedures: Quality and Positive Impact on Patient Care Document date: 2017_7_16
ID: jzwwses4_9
Snippet: Herpes simplex virus can also cause infections in neonates, with a frequency of 1:3500 to 1:5000 deliveries in the United States. The infection is acquired by exposure to maternal genital secretions. The presentation of neonatal HSV varies and includes skin, eye, and mouth infection, with encephalitis and disseminated disease in over 50% of cases. Again, rapid diagnosis is needed to prevent morbidity and sequelae from encephalitis. The diagnosis .....
Document: Herpes simplex virus can also cause infections in neonates, with a frequency of 1:3500 to 1:5000 deliveries in the United States. The infection is acquired by exposure to maternal genital secretions. The presentation of neonatal HSV varies and includes skin, eye, and mouth infection, with encephalitis and disseminated disease in over 50% of cases. Again, rapid diagnosis is needed to prevent morbidity and sequelae from encephalitis. The diagnosis of encephalitis is made via PCR of CSF samples, while testing of plasma or serum is critical to diagnose disseminated disease. The ability to use plasma or serum is very important as it may be difficult to obtain enough CSF from a newborn to assess all diagnoses in the differential. Although there are 2 FDAcleared assays to test CSF for HSV, there are no assays cleared for testing serum and plasma. Laboratory-developed testing procedures continue to play a critical role in the diagnosis and management of disseminated HSV infection in newborns.
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