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Seegene Announces The Launch Of Seeplex MTB ACE Detection Test

Seegene announced that it has introduced Seeplex MTB ACE detection test for the earlier laboratory confirmation of the TB pathogen (Mycobacterium tuberculosis). Seeplex MTB ACE provides simple and fast detection in a single multiplex PCR that uses multiple genetic targets like IS6110 and MPB64. Seeplex MTB ACE test is intended as a helpful tool in the eradication efforts by offering a significant improvement over previous testing methods. For example, current methods are hindered by speed (culture typically required 2-8 weeks for results) and low sensitivity (acid-fast bacilli smear microscopy produced results in 24 hours but at the cost of missing a significant portion of TB cases) and low specificity (culture and microscopy methods not being able to differentiate between M. tuberculosis and non-tuberculosis mycobacteria). The company’s TB test uses a single multi-target amplification for specific detection of M. tuberculosis, and is based on the novel proprietary DPO (Dual Priming Oligonucleotides) PCR technology. IS6110 is the most widely used target gene for detecting M. tuberculosis, however several M. tuberculosis strains lack the insertion sequence IS6110. By simultaneously amplifying IS6110 and MPB64, Seeplex MTB ACE is able to identify infections that would otherwise go undiagnosed in a procedure that produces no false positive and false negative results. This TB test detects both extra-pulmonary and pulmonary TB from various specimens, such as sputum, body fluid, bronchial washing, urine, stool, CSF, and bone marrow aspiration. Internal control is co-amplified and co-detected with M. tuberculosis which adds as an important feature for the test. When detecting M. tuberculosis from various specimens PCR inhibition can occur, resulting in false negative results. The internal control minimizes erroneous test results. In a study highlighted at the 49th Annual Meeting of the Korean Society for Laboratory Medicine 2008, a Korea-national university hospital tested 188 respiratory specimens for TB using culture, AFB stain, Roche's Amplicor MTB and the Seeplex MTB ACE test. This study concluded that Seeplex MTB ACE test was more sensitive with higher specificity than the Amplicor PCR test, while having the same reaction time as the Amplicor test.