By Apollo 24/7- 21 September 2020
The SARS-CoV-2, the virus responsible for causing COVID-19, has so far affected 213 countries and territories around the world. To battle the pandemic, medical researchers around the globe have been working tirelessly developing vaccines, researching treatment options, and ramping up the availability of relevant medical products. One of the critical medical products that is of interest to many health regulatory bodies and the general population is the Coronavirus testing kits.
In this article, we will talk about the various kinds of tests available, the test kits approved for use in India, and how these test kits work.
There are two main reasons why testing for the Coronavirus infection is crucial:
The other reason why testing for COVID-19 is important is to identify people who have been exposed to the virus (contact tracing) and offer them quick treatment.
In the broader public health picture, testing for antibodies (serology test) produced against the Coronavirus is done to understand the level of immunity in a community. Doctors are also exploring the use of these antibodies to treat severely ill COVID-19 infected people as a part of the treatment plan better known as convalescent plasma therapy.
Broadly, there are two types of tests available for COVID-19:
In India, the real-time Reverse Transcription Polymerase Chain Reaction or RT-PCR test is the standard test for detecting cases of COVID-19 due to its accuracy of detection as well as its ability to test 90 samples at a time. The RT-PCR test requires a specialized laboratory set up and takes 4 to 5 hours from sample receipt to obtaining the results.
Due to the specialized laboratory requirements, this test can be performed only at places with molecular virology facilities. Hence, for places where the RT-PCR test cannot be performed, testing is done through CBNAAT and TrueNat systems. Though these systems have a quick turnaround time of 30 to 60 minutes, they come with a limitation – they can test only 3 to 4 samples at a time.
As of now, there are 1,000 COVID-19 testing labs (RT-PCR – 557, CBNAAT – 80, and TrueNat – 363) that have been approved by the ICMR. Despite this, access to testing in India is still a challenge due to its large population. Hence, the ICMR has approved the use of rapid antigen detection tests for COVID-19. These tests can help in the early detection and quick containment of COVID-19.
Due to its moderate sensitivity, antigen detection tests should be followed by an RT-PCR test when the results of the former tests negative for the virus but the individual shows COVID-19 symptoms. Antigen-based COVID-19 testing is recommended in the following settings:
So far, 24 antigen test kits have been evaluated by the ICMR out of which 3 antigen test kits have been approved for use. They have been listed below:
While COVID-19 Antigen Lateral Test Device and STANDARD Q COVID-19 Ag can be performed bedside, the COVID-19 Ag Respi-Strip requires a specialized setup.
The COVID-19 Antigen Lateral Test Device and STANDARD Q COVID-19 Ag tests follow the same working methodology which is as follows:
The COVID-19 Ag Respi-Strip of CorisBioConcept has a different methodology of use:
As mentioned earlier, the antibody test is carried out only for surveillance (serosurveys) and under the following situations:
Only two antibody tests have been approved by the ICMR for conducting serosurveys:
As of now, there are 19 IgG ELISA/CLIA COVID-19 kits (out of 142 kits) that have been validated as satisfactory by the ICMR.
Many Coronavirus testing kits are being developed in India and globally to combat the growing number of COVID-19 cases. These tests can detect active as well as past infections and are being relied on by health officials to understand the behaviour and the prevalence of the Coronavirus. The data from these tests can offer significant insights needed to stop or slow the progression of the disease.
For any questions relating to Coronavirus, do an online doctor consultation with our team of experts.
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