01/2025 – To the start of the new year ADT Biotech’s LyteStar™ Enterovirus HFMD Typing Kit has achieved regulatory approval by the Malaysian Medical Device Authority (MDA).
The LyteStar™ Enterovirus HFMD Typing Kit is intended for the specific detection and subtyping of Enterovirus RNA in human throat, vesicles, lesions or rectal swabs in VTM, and blood and cerebrospinal fluid (CSF) specimens. The LyteStar™ Enterovirus HFMD Typing RT-PCR Kit 1.0 is a four-target assay comprising a screening assay targeting pan-Enterovirus 5’ UTR region, and a typing assay that further differentiates Enterovirus serotypes A71 (EV71), via targeting of the VP3-VP1 genes, and Coxsackievirus A16 (CVA16) and Coxsackievirus A6 (CVA6), via targeting the VP1 gene. The kit includes an Internal Control detected in the 5th fluorescent channel.