A Device for Simultaneous and Rapid Diagnosis and Detection of Recent and Long Term HIV-1 Infection

CDC scientists have developed a device for simultaneous rapid diagnosis of HIV infection and for identification of recent HIV-1 infection. The device utilizes immunochromatographic or flow-through principles to detect HIV antibodies within clinical samples. This device may be used for diagnosis of HIV infection, as well as to distinguish between recent infection (6 months) and long-term infection (>1 year).

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.

Monoclonal Antibodies to the HIV-1 Core Protein p24

The core proteins of HIV-1 are secreted into the environment during replication in the human body. The detection of the core protein p24 (molecular mass of 24 kilodaltons) serves as an indicator of early HIV-1 infection, and assays detecting it have been available since the late 1980s. However, the development of a rapid assay for the detection of HIV-1 p24 has only recently become available.

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.