Table 1.
Kit feature |
|||
---|---|---|---|
Version | Result outcomes | Threshold value for positivity | Detection system |
ZIKV Detect™ IgM Capture ELISA | Presumptive Zika Positive | N/A | Mab SLE 6B6C-1 HRP |
Possible Zika Positive | |||
Presumptive Other Flavivirus Positive | |||
Negative | |||
ZIKV Detect™ 2.0 IgM Capture ELISA | Presumptive Zika Positive | 0.130 + Average OD450 on ZIKV antigen | MAB SLE 6B6C-1 followed by anti-mouse IgG HRP |
Presumptive Other Flavivirus Positivea | |||
Negative |
Specimens formerly in the Possible Zika Positive category are classified as “Presumptive Other Flavivirus Positive” in ZIKV Detect™ 2.0 IgM Capture ELISA if the CCA/NCA ratio is ≥5.0, and “Negative” if the CCA/NCA ratio is < 5.0.