The Logix Smart™ Zika Virus (ZIKV) test uses our patented CoPrimer™technology to detect the presence or absence of ribonucleic acid (RNA) of Zika virus in a real-time RT-PCR kit that targets conserved regions in the Zika virus genome.

The test operates using a single step reverse transcription real-time PCR reaction in serum or plasma samples, collected alongside with urine, from patients suspected of Zika fever or Zika disease during acute stages of the disease that happen between 2 to 20 days after the onset of the symptomatic or non-symptomatic infection.  The amplified product is then detected within 40 cycles by fluorescent dyes FAM (green) or Cal Fluor 610 (orange).

• Each Logix Smart Zika Virus Test kit contains a complete, ready-to-use master mix.
• A human RNaseP gene marker serves as an Internal Positive Control (IPC) to monitor the quality of each reaction and is designed to also detect inadequate samples.
• Nuclease Free Water is also provided for a negative control.

Kit Specifications

Limit of Detection Data:

*All data is obtained from 341 analytical contrived samples. All tests were performed with QI Amp RNA extraction kits and run on CoDx Box.

Instructions for Use can be found under the Resources tab.

Regulatory Clearance

In October 2018, the Logix Smart ZIKV Test kit received CE mark approval, the principle regulatory clearance allowing the test to be sold as an in vitro diagnostic (“IVD”) for the diagnosis of Zika virus in European Union states and other markets that accept a CE-IVD mark as valid regulatory approval.

Zika virus (ZIKV) is a Flaviviridae family virus. It is spread by daytime-active Aedes mosquitoes, such as A. aegyptiand A. albopictus. The virus was first isolated in 1947 in monkeys and is named after the Zika Forest in Uganda. In 1952, the first human cases of Zika were detected and since then, outbreaks of Zika have been reported in Africa, the Americas, Asia, and the Pacific. Zika outbreaks have probably occurred in many other locations. Because the symptoms of Zika are similar to those of many other diseases, many cases may not have been recognized or properly reported.

In 2015, following increased reports of suspected Zika infections in Brazil, doctors also reported a striking increase in congenital microcephaly cases. Before its emergence into the public consciousness in 2015, Zika virus was not thought to be endemically transmitted in the Americas. Since that time, the World Health Organization (WHO) declared Zika to be an international public health emergency, and it has spread across South and into North America, including the Caribbean.

Studies conducted in Brazil following the initial outbreak found direct correlation between microcephaly cases and Zika occurrences, and helped solidify the link between fetal ZIKV infection and the development of microcephaly (Relich & Loeffelholz, 2017), as well as the link between ZIKV infection and the neurological disorder Guillain-Barré syndrome in adults. Due to the Zika disease’s serious neurological sequelae, in 2018 the WHO issued the Annual review of diseases where the priority for R&D investments for Zika has been raised. While public awareness may have lessened since 2015, the WHO also confirms that need to identify and protect against Zika transmission and potential future should still be addressed in a sustained, persistent manner among communities experiencing the virus.

Given Zika’s ability to be passed along via sexual transmission in addition to mosquito vectors, the key component to preventing the spread of the disease is an early, accurate, and affordable diagnosis for both men and women.