Description:
Background: During the past decade, several companies have developed lateral flow immunochromatographic devices to detect antibodies to individual communicable diseases. More recently, these platforms have also been adapted to detect specific antigens associated with these infections. These inexpensive point-of-care (POC) tests offer considerable advantages over conventional laboratory tests, since they can be performed in remote, peripheral settings with little or no instrumentation by primary health care workers. This also allow for counseling (and treatment if appropriate) at the initial consultation. Point-of-care (POC) tests have been used successfully to screen pregnant women for HIV and syphilis to prevent vertical transmission of these infections and therefore prevent congenital disease. In addition, in areas remote from formal, organized blood banks, these and other POC tests have been used to screen potential blood donors to prevent transfusion related infections. Unfortunately, these tests are usually performed as individual tests for antibodies or antigens for single infections. This results in a series of test strips being run in parallel, which may have different flow characteristics, buffers and run times that may lead to confusion and potential inaccuracies.
Project Goal: CDC is seeking the development of a highly sensitive, highly specific, rapid and easy to use, disposable multiplex immunochromatographic screening device to detect Hepatitis BsAg and malarial antigen together with antibody to Human Immunodeficiency Virus 1 and 2 (HIV 1/2) and syphilis in a single finger-stick sample of whole blood. The purpose is for screening pregnant women with the intent to prevent vertical transmission of infection. CDC is also interested in a single device to detect Hepatitis BsAg and malarial antigen together with antibody to Hepatitis C Virus (HCV), Human Immunodeficiency Virus 1 and 2 (HIV 1/2) and syphilis in a single finger-stick sample to screen blood donors for transfusion-related infections in settings where conventional laboratory facilities are not available. Optimization of assays to detect both antibodies and specific antigens in the same cassette device on a single specimen is strongly encouraged.
Impact: It is anticipated that the development of these two multiplex immunochromatographic test cassettes could result in a significant reduction in rates of congenital HIV and syphilis, together with other infections that can be transmitted from mother to child. In addition, these tests would help make blood transfusions safer in areas where laboratory testing is either not available, or of poor quality.
