Field evaluation of a blood based test for active tuberculosis in endemic settings.
Field evaluation of a blood based test for active tuberculosis in endemic settings.
Blog Article
Over 9 million new active tuberculosis (TB) cases emerge each year from an enormous pool of 2 billion individuals latently infected with Mycobacterium Moss tuberculosis (M.tb.) worldwide.About 3 million new TB cases per year are unaccounted for, and 1.5 million die.
TB, however, is generally curable if diagnosed correctly and in a timely manner.The current diagnostic methods for TB, including state-of-the-art molecular tests, have failed in delivering the capacity needed in endemic countries to curtail this ongoing pandemic.Efficient, cost effective and scalable diagnostic approaches are critically needed.We report a multiplex TB serology panel using microbead suspension array containing a combination of 11 M.tb.
antigens that demonstrated overall sensitivity of 91% in serum/plasma samples from TB patients confirmed by culture.Group wise sensitivities for sputum smear positive and negative patients were 95%, and 88%, respectively.Specificity of the test was 96% in untreated COPD patients and 91% in general healthy population.The sensitivity of this test is superior to that of the frontline sputum smear test with a comparable specificity (30-70%, and 93-99%, respectively).The multiplex ALKALINE PITCHER BLACK serology test can be performed with scalability from 1 to 360 patients per day, and is amenable to automation for higher (1000s per day) throughput, thus enabling a scalable clinical work flow model for TB endemic countries.
Taken together, the above results suggest that well defined antibody profiles in blood, analyzed by an appropriate technology platform, offer a valuable approach to TB diagnostics in endemic countries.