Guardian Technologies International introduces Signature Mapping TBDx™ (SM TBDx), an automated diagnostic solution using sophisticated detection algorithms to identify TB under microscopy in sputum samples, at the laboratory level.
Signature Mapping TBDx successfully concluded the Phase I clinical evaluation at the South African National Health Laboratory Service’s (NHLS) Recheck Program, and has been invited to return for Phase II (Final Phase) clinical trials in early 2010. Sensitivity and specificity results from Phase I are very encouraging, exceeding 92% against present microscopy methods, which yield much lower detection rates.
The breakthrough application significantly advances the efficiency, accuracy, consistency and speed of TB diagnosis by microscopy. Signature Mapping TBDx further eliminates the majority of human factor limitations that currently hamper the accurate diagnosis of this disease, a disease that globally infects 9 million people, with a mortality of almost 2 million per annum.
Today’s most commonly used TB diagnostic test, sputum microscopy, is more than 100 years old and detects only half of the world’s new TB cases. While new and more sophisticated genetic TB diagnostics are available, their cost and sophistication restricts their usage to mainly developed countries and complex individual cases. Developing nations continue to rely on sputum microscopy and subsequent culturing as the cornerstone diagnostic methods.
These developing nations, that bear more than 80% of total global TB burden, lack the equipment, trained personnel, and monetary resources to support the mass TB screening and diagnosis using the newer tests now available. Current sputum analysis methods have historically demonstrated low sensitivity and specificity, lengthy delays between sample collection and diagnosis, and inconsistent quality due to human limitations. The high throughput, huge volume of samples, and significant variations in sputum staining quality further challenge the already overburdened lab technicians and health care systems.
Since TB is the world’s second leading cause of death, with persons with active TB infecting on average an additional 10 to 12 people before manifesting their illness, improving diagnostic methods is a critical factor in reducing the spread of this infectious, but generally treatable disease.
SM TBDx’s greatest advantage for TB diagnosis is its ability to quickly screen patient samples more consistently and efficiently than humans, to deliver an accurate diagnosis, particularly on a negative sample or when there are very few TB bacilli present. In these cases, technologists spend hours viewing hundreds of fields of view (FOV) looking for the ‘needle in a haystack’ on a negative sample. Worse, they may miss the one or two bacilli in a sample and misdiagnose the patient as negative, only to have them return months later with a more advanced stage of TB and having infected others in the interim.
Signature Mapping TBDx can also be deployed as an effective decision support tool to quickly review all FOVs and identify which FOVs to review to confirm a diagnosis. By eliminating the need to review hundreds of FOVs per patient, and millions per year, SM TBDx enables skilled technologists to shift their efforts to more productive, higher value laboratory work.
Guardian Technologies, a provider of high-performance security and health care solutions based on Intelligent Imaging Informatics (3i™), has been working in a very close collaborative relationship with NHLS and The Aurum Institute for Health Research, Guardian’s clinical partner in South Africa, to develop Signature Mapping TBDx to meet the NHLS’s diagnostic and quality management requirements. SM TBDx automates the diagnostic process, neutralizing the human limitations associated with routine sputum microscopy and overcoming extremes in slide quality and consistency. The Signature Mapping laboratory/pathology platform, the core engine for TBDx, can be developed and applied to many laboratory-diagnosed diseases such as malaria, leprosy and cancer.
Dr. Gerrit Coetzee, Head of the South African National TB Reference Laboratory, said, "The NHLS has welcomed this collaboration to develop an advanced TB detection and diagnostic technology to automate the detection process, with the promise of increased productivity and economic gains through the more rational deployment of scarce technologist staff.
"With TB patient volumes growing annually, automation will enable us to produce results more efficiently while providing diagnoses that are more accurate and consistent to stem the spread of TB. We have been impressed with the strides Guardian Technologies has made in developing the Signature Mapping detection system. We are looking forward to having them return for Phase II testing of throughput and clinical performance after integrating their detection technology with a fully integrated automated microscope and slide processing and management system, which NHLS would be keen to deploy. A successful integration of an automated technology could translate to saving thousands of lives and improving quality of life for South Africans."
Bill Donovan, Guardian Technologies’ President, stated, "Signature Mapping TBDx delivered the superior results that we anticipated, and we are very pleased that the NHLS has requested that we integrate it with a customized high-throughput automated slide handling system. We believe that the SM TBDx-integrated system will be unrivaled in its ability to accurately diagnose TB at an affordable cost to the developing world."
Dr. David Clark, The Aurum Institute’s Deputy CEO, said, "Much exciting progress has been made in taking this technology from concept to reality. We are looking forward to completing the project, rolling the technology out in high burden TB countries, and then developing new solutions for other diseases that plague the globe."