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Quality with a Purpose

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  All ISO standards are reviewed and revised regularly to make sure they remain relevant to the marketplace. ISO 13485:2016 responds to the latest QMS practices, reflecting the evolution in medical device technology and changes in regulatory requirements and expectations. Transasia is the first Indian IVD Company to receive the ICMED 13485 quality certificate in 2018 for indigenously manufactured medical devices.   ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. Designed to be used by organizations throughout the lifecycle of a medical device, from initial conception to production and post-production, it includes final decommission and disposal. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services. En

Lab medicine in the post COVID era: Technology to drive better accessibility and testing capabilities

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  The pandemic has led to a paradigm shift in the diagnostic industry. Direct-to-home testing and focus on preventive healthcare are disrupting the industry to become more patient-centric in the future.      Until a few years back, the role of clinical laboratory was to provide vital information on disease diagnosis aiding medical professionals in management through appropriate interventions. However, advancements in IT enabled diagnostics techniques, for both equipment and testing, have led to greater efficiencies.  Building better testing capabilities- Advancements in product technology and the need for convenient sampling is leading to a paradigm shift for less invasive tests that rely on saliva and dried blood spots. Sampling of saliva is beneficial for the healthcare professionals too, as it spares them the risk of being exposed to the infected sample during collection. Similarly, dried blood spots technique is gaining preference for neonatal tests.    As technology continues to

Viral hepatitis - A cause for major healthcare burden in India

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  Viral hepatitis is a growing concern in India and is recently equated as a threat comparable to the “big three” communicable diseases – HIV/AIDS, Malaria, and Tuberculosis. While we continue our fight against COVID-19, let’s not forget that, hepatitis too can’t wait!   Hepatitis, referred to as inflammation of the liver, can be caused due to alcohol abuse, medications, and certain medical conditions. However, hepatitis is often caused by a virus; and the most common types viral hepatitis are hepatitis A, hepatitis B and hepatitis C. Viral hepatitis can lead to severe liver disease including hepatocellular cancer. A global health concern, hepatitis-related illness, claims one life, every 30 seconds!   Viral hepatitis is a cause for major healthcare burden in India and is recently equated as a threat comparable to the “big three” communicable diseases – HIV/AIDS, Malaria, and Tuberculosis. The Government of India launched a new National Viral Hepatitis Control Program (NVHCP) on World

The growing preference for automated urine analyzers

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  Urinalysis is one of the most frequently performed clinical investigations carried out in both inpatient and outpatient settings, due to its high information content and accessibility. Over the past two decades, technological advancement has led to the development of modern fully automated urine sediment analyzers, that make it possible to standardize results and increase laboratory productivity. Time and again, routine urinalysis has proved its clinical utility for screening, diagnosing and monitoring of renal, urological and metabolic conditions. It also plays an important role in the evaluation of liver function and several urological malignancies. Urinary tract infections (UTIs) are extremely common worldwide. In addition to detecting leukocytes and nitrites, urine microscopy identifies bacteria. These findings are crucial to the treatment process. In the current pandemic, urinalysis is useful in unveiling potential renal impairment due to COVID-19. Technological advancements A

COVID RELIEF EFFORTS: Transasia donates critical equipment worth more than Rs. 2.25 crores to several state governments- 200 BiPAP machines, 40 cell counters and 30 coagulation analyzers for D Dimer testing

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  Transasia Bio-Medicals Ltd., India’s Leading IVD Company has stepped up its efforts to augment the capacity of various state governments to provide timely medical support to COVID-19 patients.  As India fights the second wave of the pandemic, Transasia has swiftly arranged to provide 200 BiPAP machines along with 40 cell counters and 30 coagulation analyzers, worth more than Rs. 2.25 crores which have been distributed to various COVID-dedicated hospitals across India. On receiving a request from the Tamil Nadu government, apart from 25 BiPAP machines that provide oxygen support, Transasia also donated 32 units of H 360, three-part differential hematology analyzer, and 5 and 3 units of H 560 and Elite 580 respectively, five-part differential hematology analyzer s. These equipments aid  in monitoring disease severity in COVID patients. Similarly, in Delhi, Transasia has provided 30 BiPAP machines along with 30 units of ECL 105, coagulation analyzers. ECL 105 will help Doctors in

New trends in diagnostics - Shaping the post COVID era

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  While the second wave of COVID-19 continues to challenge us, it has also led to a series of seismic shifts that will have positive implications in the near future. India has made significant advancements in the field of disease detection and healthcare delivery, over the last few years. In fact, in India, healthcare has been one of the largest sectors in terms of employment and revenue generation and continues to grow at a brisk pace. However, the pandemic has put to test even the most developed global healthcare systems, and India is no exception.  As is rightly said, crisis changes customer requirements or forces them to adopt new ones. Likewise, in healthcare too, many new market forces are already at play: Shift from reactive to proactive diagnostics: There was a time when a patient underwent a diagnostic test only when prescribed by Doctors. However, in the recent past, diagnostics has been adopted as a proactive tool even by healthy individuals for early wellness testing, bette

Molecular Diagnostics picks up pace

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Molecular diagnostics (MDx) is witnessing a fast-paced growth for detection of infectious micro-organisms as well as ailments like oncology. Laboratories are relying on MDx as a powerful tool for improving efficiency, with early diagnosis and accurate detection.   Molecular tests help in identifying infections or ailments at early stages; enabling clinicians with information for personalized and precise treatments. Accurate and early diagnosis prevents further transmission, and rationalizes antibiotic use, thereby minimizes chances for antibiotic resistance.   Polymerase Chain Reaction (PCR) PCR applies primer mediated enzymatic amplification of DNA to synthesize new strand of DNA complementary to the targeted template strand. Of late, quantitative real-time PCR (qPCR) is gaining popularity for detection of pathogens. This technology requires less than 5 hours, is simple, reproducible, and offers a quantitative output.   Isothermal Amplification Methods Current advancem