Elecsys® Zika IgG

Immunoassay for the qualitative determination of IgG-antibodies to Zika virus

The Zika virus is a flavivirus transmitted to humans by Aedes mosquito species. The increasing presence of Aedes species, particularly of Aedes aegypti, and Aedes albopictus, as a vector of disease worldwide may lead to the emergence of Zika epidemics in urban areas.¹

Zika virus may be transmitted from a pregnant woman to her fetus, from a mother to a newborn at birth and through breast feeding.^2,3 Zika virus has also been detected in semen and reported to have been transmitted through sexual intercourse.⁴ In addition, Zika virus may be transmitted via transfusion and through laboratory exposure.⁵

Zika infection is asymptomatic in most (estimated 80 %) cases. When symptomatic, Zika virus infection may be difficult to distinguish clinically from diseases caused by other arboviruses, including Dengue and Chikungunya virus.⁶ Laboratory evidence of Zika infection is obtained by testing samples for viral nucleic acid or virus-specific IgM and IgG antibodies.

The Elecsys^® Zika IgG is a highly specific immunoassay for the qualitative detection of IgG-antibodies in human serum or plasma.

Elecsys^® Zika IgG

Systems

cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
Testing Time

18 minutes
Test principle

One-step double antigen sandwich immunoassay.
Calibration

2-point
Interpretation

COI <1.0 = non-reactive
COI ≥1 = reactive
Sample material

Serum collected using standard sampling tubes or tubes containing separating gel. Li‑heparin and K2‑EDTA as well as K2‑EDTA plasma tubes containing separating gel.
Sample volume

20 μL
Onboard stability

14 days
Intermediate precision in positive samples

cobas e 411 analyzer: CV 2.5 – 3.4 %
cobas e 601 / cobas e 602 modules CV 2.5 – 3.1 %
Relative sensitivity

93.11 % (n = 305) with samples from patients with suspected infection from Zika epidemic region (LATAM) and after resolution
Analytical specificity

100 % (n = 202) in potentially cross-reacting samples, including other flavivirus infections, characterized to be non-reactive for Zika IgG
Relative specificity

Samples from LATAM:
100 % (n = 92) in samples from patients before Zika epidemics and after resolution
100 % (n = 55) in samples from patients with suspected infection from Zika epidemic region and after resolution

Samples from Europe:
99.82 % (n = 1,087) in samples from blood donors and after resolution
100 % (n = 500) in samples from pregnant women and after resolution

References

Pierson, T. C., Diamond, M. S. (2013). In Knipe DM, Howley PM (ed), Fields Virology, 6th ed, vol 2. Wolter Kluwer. Flaviviruses, 747-794.
Rasmussen, S. A., Jamieson, D. J., Honein, M. A. et al. (2016). Zika Virus and Birth Defects – Reviewing the Evidence for Causality. N Engl J Med. 374(20), 1981-1987.
Blohm, G., Lednicky, J., Marquez, M. et al. (2017). Evidence for Mother-to-Child transmission of Zika Virus Through Breast Milk. Clin Infect Dis.
Musso, D., Roche, C., Robin, E., Nhan, T., Teissier, A., Cao-Lormeau, V. M. (2015). Potential sexual transmission of Zika virus. Emer Infect Dis. 21(2), 359-61.
Musso, D., Nhan, T., Robin, E. et al. (2014). Potential for Zika virus transmission through blood transfusion demonstrated during an outbreak in French Polynesia, November 2013 to February 2014. Euro Surveill 19(14).
Marano, G., Pupella, S. P., Vaglio, S. et al. (2015). Zika virus and the never-ending story of emerging pathogens and transfusion medicine. Blood Transfus Nov 5, 1-6.

Elecsys® Zika IgG

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