Immunoassay for Detecting Zika Virus Infection
AssigneeDiaSorin S.p.A.
InventorsFabrizio Bonelli, Tina Bunnell, James Wassenberg
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Abstract
The present invention relates to a method for detecting Zika virus (ZIKV) infection in a biological sample from a subject. The method comprises testing the sample for IgM- and IgG-ZIKV NS1 antibodies and determining the ZIKV IgM and ZIKV IgG signal intensities; and scoring the sample as positive or negative for ZIKV infection based on the combined results of such determinations. The biological sample is preferably blood, serum, plasma, cerebrospinal fluid, saliva or urine.
Claims22
An in vitro method for the detection of Zika virus (ZIKV) infection in a biological sample from a subject, comprising the steps of:
- a) testing the sample for IgM antibodies specific to ZIKV NS1 protein or an epitope or immunogenic fragment thereof and determining the ZIKV IgM signal intensity;
- b) testing the sample for IgG antibodies to ZIKV NS1 protein or an epitope or immunogenic fragment thereof and determining the ZIKV IgG signal intensity;
- c) establishing a first ZIKV IgM signal intensity threshold and a second ZIKV IgM signal intensity threshold, wherein the second ZIKV IgM signal intensity threshold is higher than the first ZIKV IgM signal intensity threshold;
- d) establishing at least a third ZIKV IgG signal intensity threshold;
- e) detecting the presence or absence of ZIKV infection in the sample according to the following criteria:
- i) a ZIKV IgM signal intensity lower than the first ZIKV IgM signal intensity threshold is indicative of the absence of ZIKA infection;
- ii) a ZIKV IgM signal intensity higher than the second ZIKV IgM signal intensity threshold is indicative of the presence of ZIKA infection;
- iii) when the ZIKV IgM signal intensity is higher than the first ZIKV IgM signal intensity threshold and lower than or equal to the second ZIKV IgM signal intensity threshold:
- iiia) a ZIKV IgG signal intensity lower than the at least third ZIKV IgG signal intensity threshold is indicative of the absence of a ZIKV infection;
- and
- iiib) a ZIKV IgG signal intensity higher than the at least third ZIKV IgG signal intensity threshold is indicative of the presence of a ZIKV infection.
Dependencies are inferred from the claim text.