Why in news
NIV has been using the CDC Trioplex RT-PCR test kit, developed by the Centers for Disease Control and Prevention (CDC), Atlanta, for Zika virus testing since the first case in India was detected in November 2016.
The CDC Trioplex RT-PCR kit can detect Zika, dengue, and chikungunya viruses and was granted emergency use authorization by the U.S. FDA.
Challenges in Diagnostic Testing in India:
Unlike the U.S. FDA, which approves diagnostic tests based on synthetic genomic fragments, the Indian drug regulator requires validation using clinical samples.
This requirement has hampered the development of diagnostic tests in India, as novel or dangerous virus samples must be sent to NIV (National Institute of Virology) , limiting other labs' access to clinical samples.
Efforts by the Institute of Advanced Virology (IAV), Thiruvananthapuram:
IAV developed an in-house assay for Zika virus testing and validated it using multiple methods.
The institute received 18 Zika samples during a smaller outbreak in January 2022 and detected PCR-positive and IgM-positive cases while investigating a dengue outbreak in Kollam district.
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