On-site in vitro Diagnostic: Real-time Loop-Mediated Isothermal Amplification Detection of HIV-2 Groups A and B

This CDC-developed technology entails a nucleic acid-based HIV-2 in vitro diagnostic assay that is well-suited for use in mobile testing units/vehicles or resource-limited settings, for example, many areas of West Africa. Because HIV-2 requires unique treatment regimens, accurate, early diagnosis is crucial for effective care and directing treatment. Recently, new HIV testing recommendations have been proposed for laboratory settings, which include the use of a HIV-1/HIV-2 discriminatory assay.

Novel Enzyme-Based Immunoassay for Simultaneous Detection of Hepatitis C Virus Antigen and Antibody in Human Serum or Plasma

CDC scientists have developed a novel enzyme immunoassay for the simultaneous detection of hepatitis C virus (HCV) core antigen and circulating HCV antibodies. Serological testing procedures for HCV circulating antibodies are well established. There is, however, a window of time between HCV infection and seroconversion that generates an opportunity for false negative results. This period varies from two months in immunocompetent subjects to six to twelve months in immunodeficient patients.

Cardiolipin Modification for Immunoassay Detection of Syphilis

Syphilis is a sexually transmitted disease (STD) that remains a global health threat. Syphilis rates in the United States have also been increasing. Left untreated, syphilis infection can span decades and have serious complications including blindness, dementia and paralysis. Syphilis in pregnancy causes prematurity, low birthweight, neonatal death, and infections in newborns. Improvements in syphilis detection are needed to facilitate early diagnosis of active infections and monitor treatment with antibiotics.

Diagnostic Assay with Modified Cardiolipin for Detecting Active Syphilis Infections

Syphilis is a sexually transmitted infection that remains a global health threat. The World Health Organization estimates that more than 12 million new cases are reported in adults annually worldwide. Syphilis rates are rising domestically as well. The rapid plasma reagin (RPR) test (including automated version) and the Venereal Disease Research Laboratory (VDRL) test are commercially available and used to detect/screen active infection.

Monoclonal Antibody to Detect the Antiretroviral Drug Emtricitabine – for HIV Drug Adherence Monitoring

The U.S. Food and Drug Administration and World Health Organization (WHO) approved the antiretroviral drug emtricitabine (FTC)/ tenofovir disoproxil fumurate (TDF) combination for HIV pre-exposure prophylaxis (PrEP) in high risk populations. Efficacy of PrEP depends strongly on adherence to taking the FTC/TDF pill daily. In the US, the Centers for Disease Control and Prevention (CDC) estimates that 1.2 million Americans will benefit from PrEP. FTC is also a key component of antiretroviral therapy (ART) regimens of HIV-infected persons and significantly associated with adherence.

Simian T-Cell Lymphotropic Virus Strain Type 3 (STLV-3) Subtype D Variant, a Highly Divergent STLV-3, for Development of Diagnostics, Therapeutics, Vaccines and Research Tools

Simian T-cell lymphotropic viruses (STLV) are nonhuman primate retroviruses closely related to the human T-lymphotropic virus (HTLV). Types I, II, and III of HTLV have been found in humans and are believed to have originated from cross-species transmission of STLV from infected nonhuman primates. The HTLV viruses are known to cause leukemia, lymphoma, and neurological disorders.

Improved Protein Quantification Process and Vaccine Quality Control Production

This CDC invention is a method for identifying and quantifying a group of proteins in a complex mixture by a liquid chromatography-tandem mass spectrometry assay. The technology was developed for influenza although it can be used for a wide variety of protein quantification applications. As specifically developed, conserved peptides from the proteins of influenza (hemagglutinin, neuramidase, matrix 1 and 2, and nucleoprotein) have been synthesized and labeled to be used as internal standards for the quantification of those proteins in a complex (biological or manufactured) matrix.