Zika Virus IgM Micro-Capture ELISA Kit

Full Name: Zika Virus IgM µ-Capture ELISA Kit
Reactivity: Human
Sample Type: Serum, Plasma
Sensitivity: diagn. 100.0%

BACKGROUND

Zika virus disease can cause mild infections which are usually not harmful and it is mostly spread through mosquitoes, some cases of sexual transmission have also been reported. Infected people display the virus within their blood, saliva, urine, semen and fluid in the eye. It is able to cause birth defect which include underdeveloped heads or even brain damage (known as microcephaly).

Zika virus is closely related to other arboviruses displaying symptoms such as; red eyes, fever, headache, skin irritation, muscle/joint pain and general discomfort. Generally speaking, these signs can persist for up to seven days.

INTENDED USE

Human Zika virus IgM ELISA kit is designed for in-vitro detection of human IgM micro (µ) capture antibodies against Zika virus (Zika-IgM) using human serum or plasma samples. This assay has a minimum analytical sensitivity limit of diagn. 100.0%.

CONTENT

All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

Zika Virus Coated Microplate (IgM).
Sample Diluent.
Stop Solution.
Washing Buffer (20x Conc.).
Zika Virus Conjugate.
TMB Substrate Solution.
Positive Control.
Cut-Off Control.
Negative Control

SENSITIVITY

The minimum detection sensitivity level of human IgM micro (µ) capture antibodies to Zika virus (Zika-IgM) using current Zika virus IgM ELISA kit was diagn. 100.0%. The dynamic range for this assay was to a specific cut-off point.

ASSAY CHARACTERISTICS

– Cut-Off: 10 U
– Positive: > 11 U
– Equivocal: 9 – 11 U
– Negative: < 9 U
– Diagnostic Specificity: 98.62 %
– Diagnostic Sensitivity: 100 %
– Interferences: Interferences with hemolytic, lipemic or icteric samples are not observed.
– Cross Reactivity: No significant evidence of false-positive results due to cross-reactions.

REFERENCES

Positive IgM for Zika virus in the cerebrospinal fluid of 30 neonates with microcephaly in Brazil. Lancet. (2016) 387 (10030): 1811-2. Cordeiro M.T., et al.
Evaluation of a commercially available Zika virus-IgM ELISA: specificity in focus. Diagn Microbiol Infect Dis. (2017) 88 (3): 233-235. Kadkhoda K., et al.
Zika- another threat on the epidemiological map of the world. Int Marit Health. (2016) 67 (1): 31-7. Review. Korzeniewski K., et al.
Evaluation of Euroimmun Anti-Zika Virus IgM and IgG Enzyme-Linked Immunosorbent Assays for Zika Virus Serologic Testing. J Clin Microbiol. (2017) 55 (8): 2462-2471. L’Huillier A.G., et al.
Ascertaining fetal Zika virus infection based on IgM antibody test in endemic settings. Ultrasound Obstet Gynecol. (2017) 49 (6): 809. Herrera T.T., et al.
Zika virus: Global health challenge, threat and current situation. J Med Virol. (2017) 89 (6): 943-951. Review. Aziz H, Zia A., et al.

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