08 May 2020 | News
Import License issued by CDSCO in public interest due to emergency health situation
Image credit- shutterstock.com
Roche Diagnostics India has announced that it is readying to bring their serology-based SARS-CoV-2 test - Elecsys Anti-SARS-CoV-2 – having received the Import License issued by the Central Drug Standard Control Organization (CDSCO), due to the emergency health situation in public interest. It is significant to note that the test received CE IVD certification iiiand USFDA emergency use authorization (EUA) iva few days ago.
Elecsys Anti‑SARS‑CoV‑2 is an immunoassay for the in vitro qualitative detection of antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS‑CoV‑2) in human serum and plasma.
The test is intended as an aid in the determination of the immune reaction to SARS‑CoV‑2. The test runs on all cobas e analysers, and these fully automated systems can provide SARS-CoV-2 test results in approximately 18 minutes for a single test, with a test throughput of up to 300 tests/hour, depending on the analyzer.
Elecsys Anti‑SARS‑CoV‑2 test may also be used together with molecular tests, like Roche’s cobas SARSCoV-2 PCR test, to aid in the diagnosis of suspected COVID-19 patients.