Co-Dx™ Logix Smart® ZDC (ZIKV-DENV-CHIKV) test kit
Boost speed and accuracy with real-time PCR testing
The Co-Dx Logix Smart ZDC test kit uses our patented Co-Primers™ technology to differentiate between the RNA of Zika, dengue (all 4 serotypes), and chikungunya viruses and to detect and amplify regions of the viruses’ genomes.
How it works
The test operates using a single step real-time reverse transcriptase polymerase chain reaction (RT-PCR) process in serum samples, collected alongside with urine, from patients suspected of being infected with Zika, dengue, or chikungunya.
The Co-Dx Logix Smart ZDC test kit is designed and validated to identify Zika, dengue, or chikungunya viruses even when more than one target is present, such as in co-infections. The presence of one target does not interfere with detection of any other targets. If a patient specimen is positive for Zika, a CSF specimen can also be collected to search for neurological infection.
Test kit components
The Co-Dx Logix Smart ZDC 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
The Co-Dx Logix Smart ZDC test kit is intended for molecular biology applications to aid in the differentiation and diagnosis of Zika, dengue, and chikungunya in human serum and urine specimens. It is recommended for serum to be collected alongside a urine sample.
The Co-Dx Logix Smart ZDC test kit was designed and validated as a real-time RT-PCR kit that targets and differentiates between conserved regions in the genomes of the three pathogens.
This assay can be broken down into 3 stages: sample preparation, reverse transcription, and the polymerase chain reaction with real-time monitoring. The assay has an IPC that also acts as an extraction control to monitor the extraction, amplification, and detection steps.
Test kit performance & specifications
Application
Qualitative PCR screening
Sample type
Type of detection
Thermocycler Run Time
50 cycles (60-90 minutes, depending on PCR equipment)
Thermocycler
Sensitivity
(77-98%)
(80-100%)
(89-100%)
(94-100%)
Specificity
(90-100%)
(81-100%)
Limit of detection data
Zika Virus
Chikungunya Virus
Dengue Virus Types 1-4
* Results obtained from observational study of 2364 datapoints obtained from the contrived samples
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About the diseases
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.
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.
Dengue Virus
Like Zika, dengue (DENV) is a mosquito borne-viral infection spread by the daytime-active Aedes mosquito species A. aegypti and A. albopictus. Dengue fever is a flu-like illness. There are 4 genotypes/serotypes of dengue virus (DENV1, DENV2, DENV3, and DENV4). Immunity is acquired for long periods for each type, although the immunity to one type does not prevent the infection from the other types. In hyperendemic areas, infection of dengue virus is as frequent as up to four times per individual. The illness spectrum varies from asymptomatic, classic dengue fever, and severe or hemorrhagic dengue fever, which can be fatal (Wilder-Smith & Gubler, 2008). Halstead & O’Rourke (1977) proposed that the severe dengue condition could be caused by an antibody dependent enhancement (ADE) response where the antibodies acquired in a previous infection enhances the immune response to following infectious causing dengue shock syndrome, which can be fatal.
Chikungunya Virus
Like Zika and dengue, chikungunya (CHIKV) is a mosquito borne-viral infection transmitted by the bite of the daytime-active Aedes mosquito species A. aegypti and A. albopictus. The symptoms of chikungunya include fever and joint pain very similar to Zika and dengue. The disease can be severe, especially for young children and the elderly. Patients can develop a post-acute or chronic arthropathy lasting 21 to 90 days in acute cases, and three months to more than two years in chronic cases (PAHO/WHO, 2017).
Regulatory clearance
In March 2019, the Co-Dx Logix Smart ZDC 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, dengue, and/or chikungunya in European Union states and other markets that accept a CE-IVD marking as valid regulatory approval.
This product is for export only and is not for sale in the United States.
