Co-Dx™ Logix Smart® Zika Virus (ZIKV) test kit
Boost speed and accuracy with real-time PCR testing
The Co-Dx Logix Smart Zika test kit uses our patented Co-Primers™ technology to detect the presence or absence of RNA of Zika virus in a reverse transcriptase PCR (RT-PCR) kit that targets conserved regions in the Zika virus genome.
How it works
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).
Test kit components
The Co-Dx Logix Smart Zika test kit includes the following components.
Ready-to-use Master Mix
Includes the complete mix for convenience and an Internal Positive Control (IPC) - Human RNaseP gene marker
Positive Control
Synthetic control intended to amplify all targets included in the kit to ensure integrity of the entire run
Negative Control
Acts as a negative control to verify Master Mix is free from contamination
Additional information
Zika virus testing is essential to aid the control and spread of the virus prior to pregnancy, transfusion or transplantation, or sexual relations. The Co-Dx Logix Smart Zika test kit is intended to aid in the diagnosis of Zika virus in human specimens such as serum, plasma, or urine. It is recommended for serum or plasma to be collected alongside a urine sample.
The Co-Dx Logix Smart Zika test kit was designed and validated as a real-time RT-PCR kit that targets conserved regions in the Asian lineage of the Zika virus genome (PRVABC59), which seems to be the strain that has been most prevalent in the Americas.
This assay is a single step reverse transcription real-time reaction that can be broken down into 3 stages: sample preparation, reverse transcription, and the polymerase chain reaction with real-time monitoring. The assay has an Internal Positive Control (IPC) that also acts as an extraction control to monitor the extraction, amplification, and detection steps.
Test kit performance & specifications
Application
Qualitative RT-PCR, screening
Sensitivity
Specificity
Sample type
Genotype detection
Multi-drug resistance
Type of detection
Time to detection
Thermal cycler compatibility
MIC Co-Dx Box, Eco 48
Limit of detection data
Serum
Urine
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Every test from Co-Dx is designed to be easy to use.
About Zika virus
Zika virus (ZIKV) is a Flaviviridae family virus. It is spread by daytime-active Aedes mosquitoes, such as A. aegypti and 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.
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.
Regulatory clearance
In October 2018, the Co-Dx Logix Smart Zika 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.
Is this test FDA-approved or cleared?
No. This test is not approved or cleared by the U.S. Food and Drug Administration (FDA) and is not available for sale in the United States.
