Herpes Simplex Virus type 1 (HSV-1) usually causes oral herpes (cold sores or fever blisters) on the face and mouth. Herpes Simplex Virus type 2 (HSV-2) typically causes genital lesions. Genital herpes is one of the most common sexually transmitted diseases in the United States. Newborns of symptomatic mothers can acquire HSV-2 by passage through an infected birth canal, where primary infection can be severe, possibly leading to serious neurological damage, mental retardation or death. HSV assays that depend on viral culture or direct antigen testing may lack the sensitivity to detect low-level viral titers, and serological tests may not differentiate between past or present infection.
Genetics & IVF Institute’s (GIVF) unique ability to develop testing methods utilizing molecular biology led to Fairfax Cryobank testing all of its donors in early 2001 for HSV 1 & 2 with a proven, DNA by PCR, a reliable Nucleic acid Amplification Test. All Fairfax Cryobank donors have undergone testing for HSV 1 & 2 DNA by PCR in our Molecular Infectious Disease Lab (MIDL) at the Genetics & IVF Institute.
The Molecular Infectious Disease Lab (MIDL), is truly a cutting edge facility which is CLIA certified and dedicated to infectious disease diagnostics using exclusively high quality Polymerase Chain Reaction (PCR) DNA amplification technology. Molecular infectious disease testing by PCR directly detects pathogen-specific nucleic acid, rather than relying on cultures, immunoreactivity or serology to identify the organism. In addition to supporting the many GIVF divisions, MIDL is called upon frequently to provide “stat” results for neonatal units in Northern Virginia, Maryland and Washington D.C. hospitals. Molecular infectious disease testing by PCR can more accurately and more rapidly determine the exact organism which is causing infection, thus improving care and treatment and decreasing the length of the hospital stay.
MIDL is directed by Brian D. Mariani, Ph.D. who has 25 years of experience in molecular genetics, microbiology and biotechnology. Trained at Stanford and Harvard Universities, Dr. Mariani has applied his expertise at GIVF to the design of molecular biology-based detection assays for a variety of infectious microorganisms from diverse clinical specimen types.
MIDL has also been instrumental in Fairfax Cryobank’s ability to provide our colleagues in Canada with high quality donor sperm that meets the Health Canada guidelines. MIDL’s DNA by PCR testing protocols and validation have been submitted and accepted by Health Canada (the Canadian equivalent of the FDA) for many different organisms. Health Canada has the most stringent infectious disease testing requirements of any government regulatory agency.