Tuberculosis (TB) is caused by a bacteria (Mycobacterium Tuberculosis) that most often affect the lungs. While TB is curable and preventable, it is still one of the top 10 causes of death worldwide. In 2017, 10 million people fell ill with TB; of which 1 million were children. Multidrug-resistant (MDR) TB is reaching crisis levels threating the health security of people. The world-wide effort is on to eradicate TB by the year 2030.
The Risks of Tuberculosis
Tuberculosis mostly affects adults in their most productive years. However, all age groups are at risk. Over 95% of cases and deaths are in developing countries. TB occurs in every part of the world. In 2017, the largest number of new TB cases occurred in the South-East Asia and Western Pacific regions, with 62% of new cases, followed by the African region, with 25% of new cases.
Smear Microscopy Misses Nearly Every Second Positive TB Case
Symptoms & Diagnosis
When a person develops active TB disease, the symptoms (such as cough, fever, night sweats, or weight loss) may be mild for many months. This can lead to delays in seeking care, and results in transmission of the bacteria to others. People with active TB can infect 10 to 15 other people through close contact over the course of a year. Many countries still rely on a long-used method called sputum smear microscopy to diagnose TB. Trained laboratory technicians look at sputum samples under a microscope to see if TB bacteria are present. Microscopy detects only half the number of TB cases and cannot detect drug-resistance.
Case for India
India accounts for a quarter of the TB patients worldwide. India also has the highest number of Multidrug-resistant TB patients in the world. India however is also in the forefront of addressing the TB menace. India has taken concerted steps to eradicate TB by the year 2025.
TB-LAMP is robust and easy to perform
The LoopampTM workflow allows for easy DNA extraction and preparation of reaction mixes in a few steps with only a minimum of equipment and reagents. Reagent storage and shipment at room temperature as well as the excellent test performance make molecular pathogen testing available in rural areas with limited settings.
NGIVD has partnered with Human Diagnostics Worldwide, Germany to exclusively bring this product to India.
- High specificity and sensitivity
- Low turnaround times
- Simple processing
- High degree of robustness
- Easy result interpretation, either visually (HumaLoop) or using a turbidimeter (HumaTurb system)
- Laboratories can increase their efficiency as they can complete 60 to 70 tests in a day compared to only 10 to 20 tests with other instruments
- Diagnosis time with this product reduces from 1 week to just 1.5 hours
- TB Lamp is also cost-effective as it involves just a quarter of the competing instruments
WHO recommends TB-LAMP* as an alternative for smear microscopy
- TB-LAMP detects > 15 % more positive TB cases
- Is also applicable to confirm negative smear results
- Can be used as the first line test for all patient groups when the GeneXpert system is not available
Benefits of TB LAMP
- Fast results (in just one hour) enables patient to be diagnosed accurately in one visit. Clinical investigation is also the fastest among all available techniques
- No need for repeat sputum samples – a small quantity of sample 60uL is sufficient (especially useful in EPTB testing)
- Can be used at peripheral labs, enabling diagnosis to reach patients even in remote corners of the country
- Cost of adoption is a fraction compared to other available molecular diagnostics tests
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Multiplexing to detect all forms of TB
The revolutionary RU-1 uses multiplexing technology to detect all forms of Tuberculosis. With a capacity to test up to 360 samples a day, RU-1 aids in the rapid diagnosis of more patients; allowing them to start their treatments at the earliest. All that the RU-1 needs is a sample of Venous Blood or Dried Blood Spots to conduct its test. This means the large rural population in remote areas can get access to this vital test.
- RU-1 is a novel multiplex assay that detects multiple biomarkers of Mycobacterium Tuberculosis complex, enabling high sensitivity and specificity
- RU-1 meets the stringent specifications of WHO, and is currently undergoing clinical performance validation at AIIMS and NITRD under the guidance of ICMR
- Patent for RU-1 is filed in India
- The sample is used for detection of 11 to 15 Biomarkers simulaneously, with 90 to 95 % sensitivity in 2 hrs of read-time from samples to results
- The daily start-up and shut-down times are only 15 to 30 minutes
- The space occupied is similar to a normal haematology analyser machine
- It can work in temperature range of 20-30 degree
- With the Multiplex technology, 90 samples can be run in a single run of 1.0 to 1.5 hrs
- Typically, one lab or machine can test 200 to 300 patients’ samples with at least 10 to 20 number of analytes
Benefits of RU-1
- Affordability: With an economical Cost per Test (CPT) it makes it affordable to one an all
- Flexibility: Achieve a wider array of goals with the ability to analyse proteins and nucleic acids
- Versatility: Just one sample is enough to test for all forms of TB
- Efficiency: Can test upto 300 samples a day
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