Measles Virus IgM ELISA Test Kit 96T Early Acute Infection Detection

Specifications

• Sample Type: Human serum or plasma (EDTA, heparin)
• Sample Volume: 100 μL per well (1:100 dilution)
• Incubation Temperature: 37°C
• Incubation Time: 60 min (Sample) + 30 min (Conjugate) + 15 min (Substrate)
• Detection Wavelength: 450 nm (reference: 620-630 nm)
• Storage Condition: 2-8°C, protect from light
• Shelf Life: 12 months from date of manufacture
• Format: 96-well break-apart strip microplate

Performance Characteristics

• Clinical Sensitivity: 98.5% (in acute-phase samples collected 3-14 days post-onset)
• Clinical Specificity: 99.2%
• Overall Agreement: 98.9% compared to reference method
• Intra-assay CV: ≤ 8.0%
• Inter-assay CV: ≤ 10.0%
• Cross-reactivity: No significant cross-reactivity with Rubella, Mumps, VZV, HSV, CMV, EBV, Parvovirus B19, or Enterovirus
• Rheumatoid Factor Interference: Built-in RF adsorbent minimizes false positives from rheumatoid factor

Clinical Significance

• Primary acute measles infection (in non-vaccinated individuals)
• Recent vaccine-induced seroconversion (in recently vaccinated individuals)
• Reinfection or booster response (in previously immune individuals, typically with lower IgM titers)

Intended Use

• Early diagnosis of acute measles virus infection in symptomatic patients
• Outbreak investigation and public health surveillance
• Confirmatory testing for suspected measles cases
• Differentiation between acute infection (IgM positive) and past immunity (IgG positive only)
• Serological monitoring in vaccination programs

Sample Collection and Storage

• Collect blood samples by standard venipuncture
• Serum samples should be separated from clotted blood within 2 hours of collection
• Plasma samples should be separated promptly and stored appropriately
• Samples may be stored at 2-8°C for up to 7 days
• For long-term storage, aliquot and freeze at -20°C or below
• Avoid repeated freeze-thaw cycles (maximum 3 cycles)
• Do not use hemolyzed, lipemic, or icteric samples

Storage and Handling

• Store all kit components at 2-8°C upon receipt
• Do not use reagents beyond the expiration date printed on the label
• Allow all reagents to reach room temperature (18-25°C) before use
• Mix reagents gently by swirling; avoid foaming
• Return unused reagents to 2-8°C immediately after use
• Protect TMB substrate from direct sunlight and metal contamination
• Wash buffer concentrate may form crystals at low temperature; warm to room temperature and mix thoroughly before dilution

Quality Control

• Negative control OD value < 0.100
• Positive control OD value ≥ 0.800
• Cut-off calibrator OD value falls within the specified range