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A Focussed Target

Thyrocare's Focus TB arm is an initiative to provide a high-end TB testing menu at affordable prices to the Indian market

By: Jayata Sharma

Thyrocare is known to have brought in the concept of affordable diagnostics in the Indian healthcare industry. In fact, many laboratories and hospital brands in India, Middle East and South East Asian countries, use Thyrocare to complete their menu and deliver quality at an affordable cost.
Taking their vision ahead, a recent addition in their kitty is the Focus TB brand.
Focus TB is focused on affordable and quality TB diagnostics powered by Thyrocare Technologies Limited, which is India's first and most advanced totally automated laboratory having its strong presence in more than 2000 cities/towns in India and internationally.
Meticulously created and monitored systems, well-chosen and trained manpower, wise selection of the best global technologies for specialised testing and an uncompromised approach to instrumentation has ensured that Thyrocare is looked upon as a yardstick for quality by stakeholders in the diagnostic industry.
The uniqueness of Thyrocare is its effort to innovate and remain at par of the global standards for best of quality service delivery, at the most cost-effective prices. The same principal also runs its latest baby – Focus TB.
Today, half of the new cases of TB worldwide arise only from six countries, and India is one of them. According to WHO, in 2015, India has the highest TB burden, with an estimated incidence of 2.2 million as compared to the global incidence of 9.6 million. It is predicted that 40% of the Indian population has TB infection and the majority of them have Latent TB rather than the active form of the disease. Stalling the spread of this disease and preventing its progression necessitates early detection and identification of TB. However, access to sophisticated diagnostics and high-quality treatment comes as a costly affair for most TB patients. This leads to inconsistencies in proper follow-up of this disease, in turn leading to uneven patient care and under-diagnosis.
Hence, Thyrocare has joined the Initiative for Promoting Affordable and Quality TB Tests (IPAQT) as a partner laboratory. This initiative has made all WHO-endorsed Tuberculosis (TB) tests available at affordable prices in the private sector.
The WHO endorsed TB tests, phenotypic tests that consist of Microscopy (ZN and Fluorescence), Liquid Culture (MGIT 960, BD), and genotypic testing consist of CBNAAT (GeneXpert MTB/RIF) and Line Probe Assay (LPA), are made available at affordable prices to patients by the Focus TB brand.
In this interview, Dr. Chaitali Nikam, Manager, Focus TB, Thyrocare Technologies Limited, dwells a bit deeper into the initiative and how they are strategically planning to curb the disease in our country.

Industry Trends

Thyrocare has joined the Initiative for Promoting Affordable and Quality TB Tests (IPAQT) as a partner laboratory. This initiative has made all WHO-endorsed Tuberculosis (TB) tests available at affordable prices in the private sector

Why was Focus TB launched?

India continues to have the highest number of TB cases in the world, as per the Global TB Report 2017 revealed by World Health Organization (WHO). Our country has a very high burden of TB, including Multi Drug Resistant (MDR)-TB cases and accounts for 24% of the world's incident TB cases. Quality laboratory testing is essential in order to reach the goal of TB elimination in India. Improvements in laboratory testing must be maintained and translated into expedited and enhanced treatment and control. All of this formed the basis for the launch of Focus TB.

It is unique to be launching a specialised TB lab.

It is imperative that the laboratory community should provide healthcare providers and TB controllers with accurate results within acceptable turn-around times while providing a safe work environment for laboratory personnel. Accessible laboratories with quality assured tests for TB are one of the essential elements in the control of the TB epidemic. Thyrocare is one of the leading laboratories operating throughout India, and we recognise our important role and responsibility in providing services and infrastructure to support the fight against a TB-free India. We strive to provide results of the highest accuracy and precision and deliver efficient turn-around times along with seeking new ways to improve the efficiency of our service delivery. That is why we planned a targeted approach towards TB testing.

What makes the quality of testing at Focus TB one of the best in the business?

State-of-the-art facility, sophisticated equipment required to process the samples with maintaining quality standards along with dedicated staff and an ample budget with which to change for betterment, develop and implement processes, create metrics, and monitor performance so that TB testing can continually improve. And we communicate this intensively with the service providers as well.

Tell us in detail which tests are available under this umbrella.

Smear Microscopy: Direct ZN microscopy of sputum smears are done to quickly detect the TB infection. Mycobacterium has a distinguished thick lipid cell wall that remains stained even after washing with acid-fast reagents. This is a simple and an inexpensive method for quick detection of acid-fast bacilli. Fluorescent microscopy is more sensitive than ZN microscopy for the detection of TB bacterium.

TB culture (MGIT) and drug susceptibility testing: Liquid and solid cultures are used as definitive diagnosis of M.Tuberculosis complex (MTBC) and to distinguish it from other mycobacterial species. DST technique is used to test for resistance of TB bacteria to certain drugs. At Thyrocare, we are performing liquid culture by MGIT 960 and drug susceptibility testing for 13 drugs with critical concentrations recommended by WHO.

TB PCR: This is a rapid molecular diagnostic technique with high sensitivity for TB diagnosis in sputum and other body fluids. This test uses DNA amplification for detection of M.Tuberculosis.

CBNAAT or GeneXpert: This is one of the latest techniques in the field of TB diagnostics. The need for fast and accurate results is ever increasing and it is also important to determine drug resistance. GeneXpert MTB/RIF comes as an ideal solution for high sensitivity and specificity. This technology helps in detecting simultaneously MTBC and rifampicin resistance. The GeneXpert MTB/RIF test is a cartridge-based nucleic acid amplification assay (CB-NAAT), which uses real time-PCR for detection of an MTB-specific region of rpoB gene. It detects mutations associated with rifampicin resistance.

MDR/XDR LPA: Multi-drug resistance TB poses a potential threat to TB control due to its treatment challenges. Line probe assay is a novel technology for rapid detection of anti-TB drug resistance, in first line and second line drugs. This assay involves extraction of M.Tuberculosis DNA from clinical specimens and subjecting it to PCR for the amplification of the resistance determining regions of the gene using biotinylated primers. After amplification, the labelled PCR products are hybridised to specialised probes that are immobilised on a strip. The hybrids fixed on the strips are detected by colorimetric development, detecting the presence of MTBC and mutant genes for resistance.

Industry Trends

Focus TB has joined the Initiative for Promoting Affordable and Quality Tests (IPAQT) as a partner laboratory to make quality and affordable diagnostic tests more accessible for TB; and we are providing them at about half the current market price




How was the lab planned & how much load can it take at a go?

Designing of this state-of-the-art TB diagnostics facility by ensuring all the critical aspects of the process, requirements and safety have been considered with proper documentation. As aerosol generates highly infectious bacterium, all mandate precautions have been considered. Major concern in safety precaution are negative pressure rooms. They were designed in accordance with class 10 K as per schedule M class B bio safety.
The laboratory is divided into two major segments of Phenotypic and Genotypic by maintaining unidirectional workflow in both the areas. Negative pressure rooms are assembled with static pass boxes, which open into discard autoclaving room that prevent back flow of hazardous cultures and samples.
Phenotypic section is divided into: Sample receiving area, Sample Processing area, Microscopy, Media preparation Room, Sterile autoclave Room, Culture reading Room, Instrumentation Room, Negative Pressure Room (two), and Waste disposal autoclave Room.
Safety shower and eye washes have been installed as and where required by considering the highest safety measures for the laboratory personnel. All lab executives are trained to use N95 mask with rubber head and dedicated gowns, lab coats in required premises with implementation of good laboratory practises.
While the Genotypic section is divided into: Pre-amplification area, DNA Extraction Room, Amplification Room, and the Post PCR Room.
This section handles work related to molecular diagnostics. Primary lysis takes place in Negative Pressure rooms and lysed cells/killed cells or lysates are further processed in this area. Four segregated areas and unidirectional work flow resist the cross contamination and carry over contamination of amplicons in molecular section.
Dedicated lab coats, instruments and pipettes are located in each section and rooms. It is a mandate to use these in the same location without transferring it into different locations, even room shifting is banned. This ensures the smooth flow of working in unidirectional workflow by managing good laboratory practises in accordance with infection control policies.
We also have the latest technologies required for accurate testing, like the MGIT, GeneXpert, GT BLOT, and Rotor GeneQ.

Focus TB is being branded as a more affordable option for testing. Can you give us a comparison of the prices in the market and Focus TB's costs?

Focus TB is an initiative for Promoting Affordable and Quality Tests (IPAQT) partner laboratory to make quality and affordable diagnostic tests more accessible for TB. And we are providing them at about half the current market price.

How are you able to maintain high quality at such affordable costs?

We have always believed in economies of scale. We primarily work with the small and medium sized laboratories and work as a reference laboratory for them. This helps us generate volume, which in turn helps us negotiate well with the suppliers and vendors. Without the volume, this cost is not possible, and without this cost, this volume is not possible and we have been known in the industry for being a disruptive cost player.

How many tests were done since the launch? What is your target for this year?

The total number of sample processed till date is above 2000 and we are aiming at 200 samples a day as the immediate next target.

How are you spreading awareness regarding your new testing menu?

By distributing handbills and brochures to PHCs, clinicians, pulmonologists, at government facilities, hospitals, and nursing homes. Also, by advertisement in newspapers and magazines. Plus, by educating all Thyrocare service providers.

How can various industry stakeholders become partners with Focus TB (individual labs, hospitals, doctors, etc.)?

They can get in touch with us directly. We have made TB testing affordable and reachable for all stake holders. Hence, it is expected that all quality and cost-conscious stakeholders would consider us first before thinking of re-inventing the wheel on their own.