Page 41 - COVID_19_June_4_2020
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    ICMR validates completely indigenous diagnostic platform for
COVID-19 diagnosis
As the COVID-19 pandemic is expanding, there is a global shortfall of diagnostic supplies. It is critical for countries to strengthen indigenous production of diagnostic material to ensure uninterrupted availability.
A total of 11 RT-PCR-based indigenous assays were validated and recommended for COVID-19 testing.
In April 2020, the indigenous manufacturer developed TrueNat assay for screening of SARS- CoV-2, causing COVID-19. ICMR undertook successful validation of the E gene screening assay, following which TrueNat-based testing has been initiated by the states for SARS-CoV-2 detection. From April 2020 till date, more than 1.3 lakh screening tests have been conducted by states. However, the rate-limiting step has been the lack of TrueNat confirmatory assay. All the TrueNat positive samples had to be confirmed by RT-PCR-based tests either located in the same or different laboratory.
Recently, the indigenous manufacturer has also developed an RdRp gene-based confirmatory assay of TrueNat which has been successfully validated again by ICMR and has been found to have high sensitivity and specificity. Both the validations have been stringently conducted by DHR/ICMR Virus Research & Diagnostic Laboratory (VRDL) at Bangalore Medical College & Research Institute, Bengaluru.
ICMR has now recommended the TrueNat COVID-19 test as a two-step test: step one, i.e., E gene screening assay for all COVID-19 suspect samples to be followed by step two for the RdRp-based confirmatory test in all E gene positives.
Contact info: Dr Rajni Kant;
Website link:
ICMR advises States to conduct sero-survey to measure
coronavirus exposure in the population using IgG ELISA Test
ICMR has advised the States to conduct sero-survey to measure coronavirus exposure in the population using IgG ELISA test. In an attempt to decide the future course of action against the pandemic, ICMR has communicated a detailed plan to all the states to measure coronavirus exposure in general population as well as in high risk populations.The numbers and frequency in different groups to be tested has been entrusted with states depending upon the requirement and situation in that particular area.
There is continuous demand for various types of diagnostic tests by countries all across the globe.Real-time,i.e.,RT-PCR test is considered gold standard frontline test for clinical diagnosis of SARS-CoV-2, causing COVID-19.The test is useful only when performed in the acute stage of infection (less than 7 days). For several viral infections, antibody tests are useful for disease detection after 5–7 days of illness. Understanding related to antibody tests for COVID-19 is evolving and several tests are being developed globally.
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 detecting acute infection but for indicating episode of SARS-CoV-2 infection in the past. However, detection of IgG antibodies is useful in the following situations:

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