The current SARS-COV-2 tests by private labs adhering to Government guidelines are conducted on a molecular biology platform, which has been the standard procedure for more than 25 years.
By Ameera Shah
A primary conversation in the public domain today is around rethinking our testing strategy for COVID19. Many experts have opined whether India is doing enough testing and where we are falling short in monitoring and reporting the number of cases. There are also varied views on the current testing methodology of RT-PCR – that it is not scalable due to need for improved equipment, skilled manpower, and an inadequate number of kits within the public healthcare system in India.
A Unified Testing Goal, Strategy and Guidelines
According to available ICMR data, India has conducted around 8,30,201 tests as of 30 April 2020.
With positive cases rising in India each day, the need of the hour is to significantly scale-up testing
across locations. The central government in collaboration with ICMR has now laid a very strong base to prepare for large-scale testing by enlisting public and private NABL-accredited labs across the country. Also, with respect to the testing strategy, there is still a disconnect and a lack of alignment on goals between the center and the states. Revisiting this and working towards a unified and structured testing goal will help private labs scale up its capacity and offer up to ten times more tests in a day. The only goal to scale up testing at this point is to help flatten the curve at the earliest time- frame possible.
Quality Assurance: Private Labs come with strong credentials
The Third National Family Health Survey asserts that the private medical sector remains the primary source of healthcare, catering to 70% of households in urban areas and 63% of households in rural areas. The top private diagnostic laboratories in India have taken care of the testing needs of more than 60 million patients cumulatively every year. All the authorized diagnostic services enlisted by ICMR as per the recent notification of 28 April 2020, has undergone a rigorous process of NABL accreditation and follows the best available protocols and quality control. Most of them use instruments that are USFDA and CE-marked from reputed and trusted medical brands. Moreover, the workforce is trained and endorsed by the accreditation agencies. A few large private lab chains are also CAP approved, which is an American gold standard accreditation, equivalent in quality to American and Singapore laboratories.
The current SARS-COV-2 tests by private labs adhering to Government guidelines are conducted on a molecular biology platform, which has been the standard procedure for more than 25 years. These have the quality validation with ICMR. Laboratories are making efforts to use the best available sample collection kits which can ensure sample integrity, protocols to transport samples in special viral transport medium, and testing on quality equipment. Labs also are taking additional care to ensure adherence to bio-safety guidelines as well as reporting protocols to ICMR, state, and city authorities.
Positive reports are credible
There are a lot of questions being raised over the credibility of reports. Various media reports have emerged on how testing reports are different from lab to lab. However, there are very few reports that explain to people why there may be changes in reports.
1. A patient tested positive can turn negative as early as within five days. Scientific Studies show that virus can get cleared as early as 4.3 days of infection.
2. There are different kits that have been approved by ICMR and each of these kits have different sensitivity levels and this may lead to variation in results.
3. A nasopharyngeal swab is collected from deep inside the nose and an oropharyngeal swab is collected from deep inside the throat. Improper collection leads to not having enough virus in the sample for it to be detected during testing.
4. Another reason for a false-negative result is when the sample is not stored or transported properly. The RT PCR test involves detection of the Viral RNA and the RNA in the virus tends to get inactivated or damaged and is non detectable, if not transported correctly. The samples need to be transported in a special viral transport medium following proper protocols to ensure sample integrity.
Private labs not at the side-lines but equal partner in the fight
An analysis of data submitted by Maharashtra Government’s Public Health Department reveals that private labs have contributed equally to the testing of over 100912 samples in the state. Private labs also have dedicated collection centers and have also ramped up isolated COVID labs to speed up diagnostics despite the initial shortage of kits and multiple logistical issues. We have also established drive-through testing centers and installed walk-in mobile kiosks to minimize to optimize the use of PPEs, masks and gloves, minimize inconvenience caused to patients and reduce stigma for technicians working in hazmat suits.
In addition, challenges faced by the lab workforce to test and collect samples has been immense. Currently many private labs are reeling under the mounting pressure of high operating costs. With advances being a norm for many manufacturers and suppliers and deferred/delayed payments from hospitals (both private and Government), the cost pressure is rising. Smaller labs are finding it difficult to scale up. The non-availability of public transport has limited the access to enough supplies and manpower. Staff members are also facing public ire while on duty, but the teams have still managed to hold the fort in times of necessity to serve the nation. With the pressure to report tests in a good turnaround time, lab staffs are foregoing rest and sleeping on the floors of labs, doing 16-hour shifts each day, not meeting their families for weeks and putting their own lives at risk.
Innovations that can scale up testing
With over 130 zones designated as RED ZONES, it is important to scale up testing to flatten the curve in these cities and districts. Identifying and isolating positive patients through testing is the only way forward. Large private laboratories have the capacity to conduct between 800-1500 tests a day and this can be scaled up 10x with a few innovative measures.
One such example is pooling of samples in areas where there is low prevalence and for community surveillance amongst asymptomatic individuals. This will help assess the status of a larger number of population and will also come in great use as and when the lockdown will have to be eased. Setting up more mobile booths across hospitals will reduce dependency on PPEs thereby improving costs. We also need to explore the possibility of adopting self-collection kits where patients can safely collect their own sample and post it to a lab along with the test requisition form. This can not only reduce the cost but also greatly improve the speed of testing. There is also a lot of studies that support that Saliva could be a better sample than a nasopharyngeal swab and we also need to consider this possibility. A study by Yale School of Public Health also concluded that there was less variability in results with the self-sample collection of saliva. For accurate large-scale SARS CoV 2 testing, moving to self-collection and saliva sample may be the best option for India.
Vaccine trials offer some hope
There is still a lot that we do not know about the virus and how it affects humans. Reports of young people dying from strokes and thrombosis have come up in the last few days. While in a few, COVID toes have been reported, autoimmune diseases are seen in some others. There is a race to produce a vaccine and some trials look promising. However, we need to remember that there are over 11 (18!) different strains of the virus that are being studied currently and we still do not know if vaccine trials focus on the strain types that are seen in India. Moreover, a vaccine usually addresses only 2-3 types of strains and this could pose a challenge to its efficacy. A vaccine is still a long way to go and there is no known cure or treatment. The only thing that we are sure of today is the testing protocol and that is why we cannot afford to let our guard down with respect to testing our
Catering to India’s 1.3 billion population is a huge task and calls for a smoother operational mechanism for the success of this collaborative approach. State governments need to step up measures and ensure a hurdle-free procedure and a safe environment for the medical and testing workforce. There is a need to simplify processes and prerequisites for labs, improve access to make it more convenient for patients to get motivated and go for testing. The need of the hour is trust and cooperation for the government and private labs to come together and meet the enormous testing needs. Metropolis stands together with the government in this fight and we will do everything that we can to support the people of this country in this hour of need.
(The author is Managing Director and Promoter, Metropolis Healthcare as part of NATHEALTH Thought leadership series. Views expressed are personal.)