Introduction

The Savvygen™ Zika Virus test allows the qualitative detection of Zika virus by Real-Time PCR in clinical samples. The product is intended for use in the diagnosis of Zika virus infections alongside clinical data of the patient and other laboratory test outcomes.

Zika virus (ZIKV) is an emerging mosquito-borne pathogen (family Flaviviridae, genus Flavivirus) that was isolated in 1947 from a rhesus monkey in the Zika forest in Uganda. ZIKV is believed to be transmitted to humans by infected Aedes spp. mosquitoes. Several studies have demonstrated that ZIKV is endemic to Africa and Southeast Asia. In fact, in other regions, Zika virus infections have been reported in few cases until 2007 when an epidemic of ZIKV infection in humans occurred in Yap Island and Federated States of Micronesia, in the Pacific region. In humans, ZIKV infection is characterized by mild fever (37.8°C–38.5°C); arthralgia (notably of small joints of hands and feet); myalgia, headache; retroorbital pain; conjunctivitis; and cutaneous maculopapular rash. Many cases of ZIKV infection are asymptomatic or have a mild medical history, no specific symptoms, and/or similar to that caused by the influenza virus. This is the reason the ZIKV infection can be misdiagnosed during the acute (viremic) phase.

Confirmation of ZIKV infections, despite its low viremia, is based mostly on detection of virus RNA in serum by using reverse transcription PCR (RT-PCR.)  The serological detection of IgM antibodies against ZIKV that can be detected by ELISA, however few laboratories have this ability and Zika antibodies can present cross reactivity against other flavivirus (including Dengue). This can make difficult the serologic diagnosis, since a confirmation by neutralization assays is necessary. Consequently, the laboratory diagnosis is a challenge to be faced with the best possible approximation.

The SavvygenTM Zika Virus test is a ready to use test, which contains in each well all the necessary reagents for Real-Time PCR assay in a stabilized format. In addition, an internal control allows the detection of a possible reaction inhibition.

Catalog No Product name Tests/kit Approvals
614-01 Savvygen Zika virus 48 CE