Real-time RT-PCR Assay for Rapid, Highly Sensitive and Specific Detection of Human Enterovirus D68 (EV-D68

This technology includes a real-time RT-PCR (reverse transcriptase – polymerase chain reaction) Taqman assay using primers and probes specific for EV-D68 viral protein 1 nucleic acid. This assay provides a more specific identification of EV-D68 strains allowing better diagnosis. Human Enterovirus D68 (EV-D68) is a non-polio enterovirus that can cause mild to severe respiratory illness, especially in infants and children with asthma. The assay is simple, validated, and allows rapid testing and detection of EV-D68 in respiratory samples.

HIV-2 Plasmid DNA Library for Diagnostic Assay Development

This technology includes a HIV-2 plasmid library for use in diagnostic assay development. In December of 2012, the Centers for Disease Control and Prevention (CDC) and the Association of Public Health Laboratories (APHL) proposed a new US laboratory testing algorithm for the diagnosis of HIV infections. This new algorithm recommends additional testing for confirmation of HIV infection using a nucleic acid amplification test (NAAT) in the event of discordant serological test results.

Enterobacteriaceae Strains for Accelerate Diagnostics Licensing

This technology includes a repository of unique Enterobacteriaceae isolates for various therapeutic and diagnostic uses:

Enterobacter cloacae (Known Acquired Resistance: NDM-1) – Strain 0038

Klebsiella pneumoniae (Known Acquired Resistance: CTX-M-14) – Strain 0079

Citrobacter freundii (Known Acquired Resistance: KPC-2) – Strain 0116

Escherichia coli (Known Acquired Resistance: NDM-1) – Strain 0118

Klebsiella pneumoniae (Known Acquired Resistance: NDM-1) – Strain 0148

Escherichia coli (Known Acquired Resistance: NDM-5) – Strain 0150

Diagnostic Real-time TaqMan® PCR for Human Adenovirus Type 4

This technology includes a real-time polymerase chain reaction (PCR) assay using hydrolysis probe (TaqMan®) chemistry which was developed for detection and type-specific identification of human adenovirus type 4 (HAd4) genomic DNA in clinical specimens. The assay uses unique oligonucleotide primer and probes designed to conserved regions of the HAd4 hexon protein gene. Assay reagents and amplification conditions were optimized and sensitivity and specificity characteristics determined with DNA extracts from multiple HAd4 laboratory strains and other respiratory viral pathogens.

Mycoplasma-free PV and SAD/ERA Virus Stocks for Rabies Vaccine Manufacturing

This technology includes mycoplasma-free PV (isolated in 1882) and SAD/ERA (isolated in 1935) virus stock for rabies vaccine development. Rabies virus causes a nearly uniformly fatal disease, but can be prevented by timely vaccination. Two of the most common rabies virus vaccine strains are PV and SAD/ERA, both of which have had extensive passaging in both animals and subsequently cultivation in cells. The rabies vaccine virus stocks stored at CDC are heavily contaminated by mycoplasma.

Crimean-Congo Hemorrhagic Fever Virus (Nairovirus) Replicon Particles System-based Vaccine Candidate

This technology includes a new reverse genetics-based approach that generates Crimean-Congo hemorrhagic fever virus (CCHF) viral replicon particles (CCHF VRPs) to be developed into a vaccine for CCHFV. With mortality rates as high as 80% and with no FDA-approved vaccines or therapeutics, CCHFV is considered a dangerous emerging human pathogen. Unlike transcriptionally competent virus like particles (tc-VLPs), that only include CCHFV virus proteins and minigenome RNA, VRPs undergo one full round of replication closely mimicking authentic viral replication.

Escherichia coli Isolate with MCR-1 Gene for Diagnostic Test Development

This technology includes Escherichia coli isolate with MCR-1 gene which can be used in the development of diagnostic tests. The MCR-1 gene makes bacteria resistant to the antibiotic colistin, which is used as a last-resort drug to treat patients with multi-drug-resistant infections, including carbapenem-resistant Enterobacteriaceae (CRE). This gene exists on a plasmid, a small piece of DNA that is capable of moving from one bacterium to another, spreading antibiotic resistance among bacterial species.