Zika Virus Serological Reagents

The Zika virus serological reagents are primarily designed to aid in the presumptive clinical diagnosis of Zika virus infection when used alongside other clinical and laboratory findings. Diagnostics typically involve detecting the virus’s RNA or proteins, or measuring the presence of antibodies through serological assays. Current serological tests primarily focus on identifying IgM antibodies reactive with Zika virus antigens, though positive results from these tests are not definitive for Zika infection. In response to the Zika epidemic, various commercial serological assays have been developed for clinical and research applications, ensuring that laboratory testing adheres to established safety and performance benchmarks.

Intended for the presumptive qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Specimens from symptomatic patients or returning travellers from endemic areas must be collected not earlier than day 8 after the onset of symptoms or risk of exposure, respectively.

Intended Use: The system is used for qualitative detection of Zika virus IgM antibodies in human serum, plasma, venous whole blood, or fingerstick samples. It is recommended to collect specimens 8 days after symptom onset or potential exposure, and if negative, testing must be repeated one week later.

Device Description: It is Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The technical method of this device is Immunological methods / ELISA.

The assay consists of two reagent packs (ZIKV-M and ZIKV-C). The first reagent pack is designed for the detection of IgM antibodies against Zika virus. The second reagent pack is designed for the detection of Zika virus reactive IgG antibodies and functions to aid in the interpretation of the Zika IgM result.  Each reagent pack consists of a molded plastic container called the Reagent Integral which contains the PMPs, specimen diluent, and assay buffer reagents each in individual compartments.  The two kit calibrators and conjugates for each reagent pack are provided with the kit, but not on the reagent integral.

• Precision/Reproducibility
• Traceability (controls, calibrators, or method)
• Retrospective Study
• Analytical Sensitivity
• Assay cut-off.
• Analytical Specificity (Cross-Reactivity)
• Interfering Substances
• Precision – Intra and Inter-assay
• Prozone effect study/Hook effect study

The same is applicable for CE Marking under IVDR also.

Clinical Testing is mandatory for 510k submission and IVDR CE Marking