The UK-based Covid-19 Volunteer Testing Network launched April 9 to provide essential additional testing capacity to front-line workers. The project, started by Mike Fischer CBE, helps small laboratories convert to run critical antigen testing and identify Covid-19 cases among local healthcare workers – at no cost to Government.
The UK has thousands of small laboratories with the right equipment, personnel and processes to run Covid-19 testing. Although some of the critical RT-PCR machines in university and healthcare settings have already been requisitioned by central Government, thousands of others are currently sitting idle in small, ‘long-tail’ facilities up and down the United Kingdom.
Fischer set up SBL, a non-profit medical research laboratory in Oxfordshire, which is already running 250-500 tests a week for 10 GP surgeries in the local area.
“Although our facility is small – with just three full-time staff, two containment hoods and two real-time machines – we were quickly able to convert to Covid-19 testing using the Centre for Disease Control protocols and are now running up to 500 tests a week for the staff at 10 local GP surgeries on a same-day basis,” said Fischer.
“If other labs could join the effort we could quickly scale to providing tens of thousands of tests a day in complement to the central program.”
“If we are going to beat this pandemic, we need to employ every resource we can to make sure that our essential health care workers can go to work safely. Even at our small facility, we have been able to run up to 500 tests a week for NHS staff on a same-day basis. By creating an emergency network of volunteer laboratories like ours across the UK, we can quickly and efficiently create the capacity we need to deliver tens of thousands of additional tests every day.”
The Covid-19 Volunteer Testing Network is being coordinated on an entirely voluntary basis and is looking for further labs to join the effort. “We hope existing equipment can be used in situ with qualified staff volunteering to conduct the tests. We are able to provide guidance, protocols, documentation and reporting,” Fischer added.
The Fischer Family Trust has also made £1 million in funding available to support the purchase of consumables for the tests if labs are unable to cover these.
For more information about the Covid-19 Volunteer Testing Network, visit: www.covid19-testing.org

The advent of molecular biology techniques has revolutionized disease diagnosis. CLI discussed with Dr Chandrasekhar Nair from Molbio Diagnostics the benefit that these techniques have brought and how these technologies are being adapted for point-of-care use for rapid diagnosis and the benefit of rural populations.

What has the impact of molecular biology been on disease diagnosis and treatment?

Accurate and timely diagnosis of infectious diseases is essential for proper medical management of patients. Early detection of the causative agent also enables care providers to intervene in a precise rather than presumptive manner and institute adequate measures to interrupt transmission to the susceptible population in the hospital or community.
The conventional diagnostic model for clinical microbiology has been labour and infrastructure intensive and frequently requires days to weeks before test results are available. Moreover, due to the complexity and length of such testing, this service was usually directed at the hospitalized patient population. Bacterial/viral culture has been – and continues to be – the gold standard for detection. However, time taken for some pathogens to grow, coupled with the difficulty in culturing some pathogens has resulted in a demand for alterna tive techniques that would allow direct pathogen detection in clinical samples rapidly.
The application of engineering techniques to the technological revolution in molecular biology has greatly improved the diagnostic capabilities of modern clinical microbiology laboratories. In particular, rapid techniques for nucleic acid amplification and characterization combined with automation and user-friendly software have significantly broadened the diagnostic arsenal. Among the molecular techniques, applicability of PCR-based methods has gained popularity as it allows for rapid detection of unculturable or fastidious microorganisms directly from clinical samples.
Clinical laboratories are increasingly finding utility of molecular techniques in diagnosis and monitoring of disease conditions. Nucleic acid amplification tests are becoming very popular in the diagnosis and management of viral infections [hepatitis B and V viruses (HBV, HCV), human immunodeficiency virus (HIV), influenza virus, etc] because they allow determination of the viral load. In most cases, they are now considered a reference, or gold standard method for diagnostic practices such as screening donated blood for transfusion-transmitted viruses [cytomegalovirus (CMV), HIV, HCV, etc]. Another important case is the use of molecular tests for the detection of the tuberculosis (TB)-causing bacterium Mycobacterium tuberculosis (MTB). Considering the limited sensitivity of smear microscopy, coupled with the steady rise in drug-resistant MTB, rapid molecular tests appear promising.

What are the challenges of implementing molecular diagnostic techniques in developing countries?

For a long time the field of molecular diagnostics has been limited to the domain of large centralized laboratories because of its dependency on complex and expensive infrastructure, highly skilled manpower and special storage conditions. This investment has also resulted in the need for batch testing to make such facilities affordable. As a result, patients and samples need to travel long distances for a test to be conducted and results are delayed, resulting in a loss of follow-up. These factors have led to a concentration of such facilities in urban centres, and poor reach of molecular diagnostics techniques, particularly in low and middle income countries (LMICs). The poor testing rates in the current COVID-19 pandemic are evidence of such dependence on centralized facilities, limiting the ability to test on demand and take appropriate action.
The lack of timely access to good diagnostics resulting in either delayed or inaccurate diagnosis by other methods has been increasingly resulting in spread of disease and poor treatment outcomes.

How can these challenges be overcome?

We need to increase the reach of molecular diagnostics techniques. Given the economic constraints in LMICs, point-of-care technology (POCT) hold a lot of promise and several major global initiatives are devoted to providing such devices. Facilities for testing that can be deployed, set up and run quickly, at affordable costs, with minimal infrastructure requirements and training are critical to the success of the efforts to increase reach. Mobile data coverage, that exists with reasonable density in LMICs, could also be leveraged for better programme management and hotspot detection.
The success of these technologies also depend on uncompromised performance and adherence to quality standards.
Furthermore, designers of POCT devices need to focus on key user requirements which include: (1) simplicity of use; (2) robustness of reagents and consumables; (3) operator safety; and (4) easy maintainability.

What is Molbio Diagnostics doing to meet these demands?

The Truelab® Real Time Quantitative micro PCR System from Molbio Diagnostics brings PCR technology right to the point of care, at all laboratory and non-laboratory settings, primary centres, in the field, near patient – essentially at all levels of healthcare, thereby decentralizing and democratizing access to molecular diagnostics. With a large and growing menu of assays for infectious diseases, this rapid, portable technology enables early and accurate diagnosis and initiation of correct treatment right at the first point of contact. The platform is infrastructure independent and provides complete end-to-end solution for disease diagnosis. With proven ability to work even at primary health centres and with wireless data transfer capability, this game changing technology brings in a paradigm shift to the global fight in control and management of devastating infectious diseases.
Under the aegis of the Council of Scientific and Industrial Research and New Millennium Indian Technology Leadership Initiative partnership, Bigtec Labs (research and development wing of Molbio Diagnostics Pvt. Ltd.) has developed a portable and battery-operated micro PCR system that has since been extensively validated [under the Department of Biotechnology and Indian Council of Medical Research (DBT & ICMR)]. Bigtec has also developed various tests and nucleic acid preparation devices to facilitate ‘sample to result’ molecular diagnostics in resource limited settings. The micro PCR system has since been launched in India through the parent company, Molbio Diagnostics, which has its manufacturing and marketing base in Goa, India.
The system works on disease specific Truenat™ microchips for conducting a real-time PCR. The sample preparation (extraction and purification) is done on a fully automated, cartridge-based Trueprep® AUTO sample prep device. The purified nucleic acids are further amplified on the Truelab® Real Time Quantitative micro PCR System which enables molecular diagnostics for infectious diseases at the point of care.
This compact battery-operated system has single testing capability and provides sample to result within 1 hour. Hence, it enables same-day reporting and initiation of evidence-based treatment for the patient.It also has real-time data transfer capability (through SMS/email) for immediate reporting of results in emergency cases. Physicians benefit from this technology by having a definitive diagnosis, early in the infection cycle, without patients/samples having to travel extensively to centralized facilities.
The Truelab® Real Time Quantitative micro PCR System from Molbio Diagnostics is a cost-effective and sensitive device that can detect diseases accurately with high specificity. The device is battery-operated and portable. This offers the additional advantage of placing the device in almost any kind of laboratory setting, unlike other devices that require uninterrupted power supply, elaborate infrastructure and air-conditioning.
Considering our platform’s potential to perform molecular diagnostics for infectious diseases at the point of care, India has initiated screening for COVID-19 using the Truenat™ Beta CoV test available on the Truelab® Real Time Quantitative micro PCR System. This will allow same-day testing, reporting, and initiation of patient isolation, if required – thereby reducing the risk of infection spreading while waiting for results.
The successful translation of our innovative concept into a product was made possible by Molbio’s multi-disciplinary workforce – with a constant mission to enable better medicine through precise, faster, cost-effective diagnosis at the point of care; to provide every patient access to the best healthcare through cutting edge technologies. Molbio aims to be a leading global player in the point-of-care diagnostics arena by continuing to innovate and bring new technologies for social betterment.

The company is based in India – how does this affect what you do, how is the clinical lab diagnostics industry developing in India and does it create more chances for you?

In India, we have over between 45¦000–50¦000 in vitro diagnostic laboratories – every one of which uses routine conventional diagnostic methods. Only a handful of them have adopted molecular diagnostic testing for reasons mentioned above. But this is changing with the advent of Molbio’s Truelab® platform, with regular standalone laboratories that were, up to now, outsourcing molecular testing, starting to perform the tests themselves. In the short span of a few years, Molbio has established itself as a company focused on making a significant impact in aiding infectious disease diagnostics worldwide with our extensive testing menu.
Our test range covers infectious diseases such as TB, the entire hepatitis range, High risk HPV, H1N1, along with the recent addition of tests for COVID-19, catering to a large population base and addressing diseases with a very significant global mortality percentages. Our rapid test development for Nipah virus and the leptospirosis-causing Leptospira bacteria show our commitment to neglected tropical diseases. Going forward, Molbio will continue to increase the assay range looking at the needs of the global LMIC geography.
The Truenat™ MTB and MTB-RIF tests have started playing a significant role in India’s mission to becoming TB-free by 2025. We would be happy to partner with other National TB Programmes in achieving sustainable development goals well before 2030.
Our vision has always been ‘innovate to have a real impact’ and hence Molbio will continue to bring in newer POCT platforms so that the benefits of science and technology reach the masses.
The interviewee
Dr Chandrasekhar Nair, BE, PhD, chief technical officer, Molbio Diagnostics

For further information visit Molbio Diagnostics (http://www.molbiodiagnostics.com)

As the COVID-19 pandemic progresses in countries around the globe, there is an urgent need for rapid and reliable point-of-need detection testing. Dolomite Microfluidics and Mologic are working together to accelerate the development and launch of these tests.
UK-based Mologic is a leading developer of rapid response diagnostic tests for diseases such as malaria and Ebola virus disease. Clients include the Bill & Melinda Gates Foundation, where Mologic is leveraging its core technology through its Centre for Advanced Rapid Diagnostics (CARD) to develop the next generation of ultra-sensitive point-of-care diagnostics which are easy to use andinexpensive to manufacture – critical to the success of many global health programmes. Most recently, Mologic has received UK Government funding to develop and manufacture a high sensitivity test for COVID-19 that generates results within minutes – rather than hours or days – without the need for a laboratory or specialist equipment.
The technology behind these tests involves the use of precisely manufactured nanoparticles. Dolomite specialises in equipment that allows the development and scale-up of precision nanoparticles. This is achieved by using microfluidic technology to retain advanced control of production conditions. Dolomite is working with Mologic to combine ground-breaking diagnostic technology with continuous flow microfluidic manufacturing processes to accelerate the validation and release of Mologic’s COVID-19 diagnostic test.

Cambridge, UK-based Horizon Discovery Group, specializing in the application of gene editing and gene modulation for cell line engineering, has released an arrayed CRISPR knockout screening service for primary human B cells to its cell-based screening services.
The new B cell screening service, the first of its kind in the market, will enable researchers to identify genes that affect the function of B cells and examine how this impacts other immune cell types, particularly in infectious diseases, cancer, and auto-immune disorders, such as COVID-19, Burkitt’s lymphoma and multiple sclerosis respectively.
Primary human cells – cells that are freshly isolated from donors – are known to be difficult to study in the lab. However, working with these cells brings scientists one step closer to healthy or diseased micro-environments, enabling them to better understand disease etiology and therapeutic mechanisms, and thereby advance drug discovery and development programs.
“The interest in harnessing the immune system for effective therapies continues to grow, with the global cell therapy market predicted to reach $8.21bn by 2025. Expanding our services to encompass screening of both primary T and B cells is another example of our commitment to apply decades of gene editing experience in support of drug discovery and development for the treatment of human disease,” said Terry Pizzie, CEO, Horizon Discovery.