West Nile virus (WNV) serological reagents are devices that use antigens and antisera to detect anti-WNV IgM antibodies in human serum. They are used in clinical laboratories to help diagnose viral meningitis or encephalitis caused by WNV. 

West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti-West Nile virus IgM antibodies, in human serum, from individuals who have signs and symptoms consistent with viral meningitis/encephalitis. The detection aids in the clinical laboratory diagnosis of viral meningitis/encephalitis caused by West Nile virus.

Class II (special controls). The special control is FDA’s guidance entitled “Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus.

Intended Use: It is intended for the qualitative detection of IgG antibodies to West Nile virus in human serum and plasma (K + -EDTA, Li+ -heparin). This test is intended as an aid in the presumptive laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with meningitis/encephalitis, in conjunction with other laboratory and clinical findings. Positive results must be confirmed by the plaque reduction neutralization test (PRNT) or by using the current CDC guidelines for diagnosis of this disease. The assay characteristics have not been established for testing cord blood, neonates, prenatal screening, and general population screening of patients without symptoms of meningoencephalitis.

Device Description: West Nile Virus ELISA (IgG) test kit is used to detect IgG antibodies against the West Nile virus. It involves adding patient samples and controls to microtiter wells coated with recombinant West Nile virus antigen (glycoprotein E). After incubation and washing steps, an anti-human IgG HRP enzyme conjugate is added. A chromogen substrate reacts with the enzyme, and the color change is measured at 450 nm using an ELISA reader. The test detects antibodies specific to the West Nile virus, with the antigen sourced from recombinant glycoprotein E.

• Precision/Repeatability
• Reproducibility
• Linearity/assay reportable range
• Analytical Specificity/Cross-Reactivity
• Interference
• Assay cut-off

The same is applicable for CE Marking under IVDR also.

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