Enterovirus 71 and Coxsackievirus A16 RNA Diagnostic Kit(Fluorescence PCR)

【Principle】

This test kit applies magnetic bead method to extract viral nucleic acid from oropharyngeal swab or fecal specimens. It uses specific primers and fluorescent probes designed for the relatively conserved regions of Enterovirus 71 (EV71) and Coxsackievirus A16 (CA16) genomes, matched with RT-PCR reaction solution, using Real-time PCR detection and high efficiency internal standard technologies to realize the rapid detection of human enterovirus RNA.

【Intended use】

Hand, foot and mouth disease (HFMD) is an infectious disease caused by enterovirus. There are more than 20 types of enteroviruses that may cause HFMD, among them EV71 and CA16 are the most common ones. This test kit is used for the qualitative detection of nucleic acid of EV71 and CA16 in clinical swab or fecal specimens as an aid for the clinical diagnosis and differential diagnosis of the etiology of HFMD.

【Characteristics】

【Advantages】

● The technology of extracting nucleic acid by magnetic bead method and RT-PCR amplification reaction system are used to separate specimens from background and interfering substances, which has strong anti-interference ability;

● No need for heating, boiling and centrifugation in the operation, which simplifies the operation and reduces the chance of contamination;

● High analytical sensitivity and good repeatability, both inter-assay and intra-assay coefficient of variation (CV)  ≤ 5%;

● High efficiency internal standard technology to avoid false negative test results;

● EV71/CA16 mixed system is adopted to reduce the number of extraction and realize accurate qualitative analysis.