One Step Immunochromatographic Kits
Immunochromatographic Lateral Flow Assays
Immunochromatographic assays were first described in the late 1960s and were originally developed to assess the presence of serum proteins. Other early assays that used an immunochromatographic technique include those for the quantification of drugs in biological fluids, theophylline in whole blood, and mouse immunoglobulin. Over the past decade many immunochromatographic assays have been reported for the detection of infectious diseases, cancer, cardiovascular problems, pancreatitis, and illicit drugs.
Typical handheld assay strip/device contains a colloidal gold-labeled detector antibody dried onto a filter pad affixed to a nitrocellulose strip. A capture antibody is applied in a line on the strip and dried. To perform the test, a specimen is suspended in buffer and added to the pad containing the colloidal gold labeled detector antibody. The antibody specifically binds to antigen presented in the specimen, and the resulting complex wicks down the membrane where it binds to the capture antibody. A positive reaction is visualized as a pink/purple line created by the bound colloidal gold.
Similar assays using different detection systems have been described in the literature, including those based on latex particles and upconverting phosphatases.
Novamed's lead products are RotaStick, AdenoStick and Combi (Rota/Adeno) Stick kits, the latest third generation direct antigen detection immunochromatographic kits, which are used to detect, either separately or in combination, the presence of intestinal viruses in human fecal specimens.
Novamed's RSV Stick is a rapid immunochromatographic test for use in the qualitative screening of human nasopharyngeal samples for detection of respiratory syncytial virus (RSV) antigen. Our StrepAStick is a true one-step antigen test, which allows for the rapid detection of group A Streptococcal antigen, directly from patient throat swab specimens. Novamed's StrepBStick test is a rapid qualitative one step assay for the detection of Streptococcus Group B antigen from recto-vaginal swab specimens. GonorrheaStick is a rapid one step immunochromatographic test for the visual detection of gonorrhea antigen in secretory specimens and urine, as an aid in the diagnosis of gonococcus infection. Novamed's H. pylori Fecal Ag Assay is a rapid, visual immunochromatographic assay for the qualitative detection of Helicobacter pylori antigen in fecal samples. Novamed's hCG Pregnancy Testing Kit is a rapid one step hCG visual test for the qualitative detection of human chorionic gonadotropin (hCG) at 10 mIU/mL or 25mIU/mL in urine or serum.
These tests are easy-to-use, one-step, and highly sensitive, with results in five minutes or less. Each test has built-in controls, is conveniently packed, with room temperature storage. Testing requires minimum specimen manipulation, and no instrumentation is needed. Most patients can be tested and treated in the same office visit.