How do the Rapid Diagnostic Test work: According to the scientific brief published by the WHO on April 8th 2020 “One type of rapid diagnostic test (RDT) detects the presence of viral proteins (antigens) expressed by the COVID-19 virus in a sample from the respiratory tract of a person. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies fixed to a paper strip enclosed in a plastic casing and generate a visually detectable signal, typically within 30 minutes. The antigen(s) detected are expressed only when the virus is actively replicating; therefore, such tests are best used to identify acute or early infection.”
Based on this, on 4 April, India Council For Medical Research had approved the use of this test methodology in clusters where there is a high number of Covid-19 cases is high. Accordingly, India placed orders of these test kits from Chinese firms. However, the logistics issues caused a delay in the arrival of the shipments. Hence, the Govt of India has now allowed made-in-India kits. Along with India, South Korea, Germany and France made kits are also approved. The following are the Indian labs who are approved to produce these kits.
- Voxtur Bio – Gujarat
- Vanguard Diagnostics – Delhi.
- HLL Lifecare – Owned by Govt Of India.
In a prior press release WHO thanked the research organizations who played key role in development of these tests by saying, “In response to the growing COVID-19 pandemic and shortages of laboratory-based molecular testing capacity and reagents, multiple diagnostic test manufacturers have developed and begun selling rapid and easy-to-use devices to facilitate testing outside of laboratory settings. These simple test kits are based either on detection of proteins from the COVID-19 virus in respiratory samples (e.g. sputum, throat swab) or detection, in blood or serum, of human antibodies generated in response to infection.”