ICMR had earlier claimed that the test kit has an impressive 100 percent specificity and 98 percent sensitivity.
The Indian Council of Medical Research (ICMR), country's apex health research body has advised states to conduct sero-survey to measure COVID-19 exposure in the population using IgG ELISA test.
The test kit that will be used in the survey was developed and validated indigenously by scientists at ICMR-National Institute of Virology (NIV) for antibody detection for SARS-CoV-2.
What is the purpose of sero-survey?
Seroprevalance, or sero-surveys, would help understand the proportion of population exposed to SAR-CoV-2 infection including asymptomatic or individuals who do not show any signs of COVID-19.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
Depending on the level of sero-prevalence of the infection, appropriate public health interventions can be planned and implemented for prevention and control of the disease.
Periodic sero-surveys are useful to guide the policy makers. For instance, a survey in high risk or vulnerable populations such as healthcare worker, frontline workers, immune-compromised individuals, individuals in containment zones, etc. would show who has been infected in the past and if they have now recovered.
Once bitten, twice shy
The government had earlier attempted to do a nationwide sero-survey. But the plan was shelved after it found that the imported Chinese rapid antibody test kits had accuracy issues.
This time, ICMR seems to have ironed out the issues. The agency has said that test has undergone intense validation in three stages and has been found to have high sensitivity and specificity. To fast track production and increase availability of the IgG ELISA test, ICMR has transferred this technology to many pharmaceutical companies such as Zydus Cadila, J Mitra & Company, Meril Diagnostics, Voxture Bio, Trivitron Healthcare, Karwah Enterprises, Avecon Healthcare, etc. The technology has been transferred to various entities without an exclusivity clause.
How accurate are these tests?
ICMR had earlier claimed that these test kit has an impressive 100 percent specificity and 98 percent sensitivity.
Sensitivity is the percentage of persons with the disease, who are correctly identified by the test, and specificity refers to the percentage of people without the disease who are correctly tested negative or excluded by the test.
High accuracy is extremely crucial if we have to correctly estimate the prevalence of COVID-19 infection in the population. Also, care has to taken while conducting the survey to avoid sampling bias.
How is IgG antibody test useful in sero-survey?
Currently, real-time RT-PCR test is considered gold standard frontline test for diagnosing of SARS-COV-2, which causes COVID-19. The test is useful only when performed in the acute stage of infection that is less than seven days.
For several viral infections, antibody tests are useful for disease detection after five-seven days of illness. IgG antibodies generally start appearing after two weeks of onset of infection once the individual has recovered after infection and last for several months. Therefore, the IgG test is not useful for testing acute infection but indicates episode of SARS-CoV-2 infection in the past.Click here for Moneycontrol’s full coverage of the novel coronavirus pandemic