Table 3.
Clinical Performance of CII-ArboViroPlex rRT-PCR assay for ZIKV, DENV, CHIKV and WNV in Serum and for ZIKV in urine
| Category | ZIKV Positive | DENV Positive | CHIKV Positive | WNV Positive |
|---|---|---|---|---|
| Positive Controls | ||||
| ZIKV Positive (Serum) n=41 | ||||
| CII ArboViroPlex | 39/41* | 0/41 | 0/41 | 0/41 |
| Comparator assays# | 41/41 | 0/41 | 0/41 | 0/41 |
| ZIKV Positive (Urine) n=26 | ||||
| CII ArboViroPlex | 25/26* | 0/26 | 0/26 | 0/26 |
| Comparator assays# | 26/26 | 0/26 | 0/26 | 0/26 |
| DENV Positive (n=24 serum) | ||||
| CII ArboViroPlex | 0/24 | 24/24 | 0/24 | 0/24 |
| Comparator assays# | 0/24 | 24/24 | 0/24 | 0/24 |
| CHIKV Positive (n=20 serum) | ||||
| CII ArboViroPlex | 0/20 | 0/20 | 20/20 | 0/20 |
| Comparator assays# | 0/20 | 0/20 | 20/20 | 0/20 |
| WNV Positive (n=19 serum) | ||||
| CII ArboViroPlex | 0/19 | 0/19 | 0/19 | 19/19 |
| Comparator assays# | 0/19 | 0/19 | 0/19 | 19/19 |
| Negative Controls | ||||
| Negative Controls(n=61 serum) | ||||
| CII ArboViroPlex | 0/61 | 0/61 | 0/61 | 0/61 |
| Comparator assays# | 0/61 | 0/61 | 0/61 | 0/61 |
| Negative (n=50 urine) | ||||
| CII ArboViroPlex | 0/50 | 0/50 | 0/50 | 0/50 |
| Comparator assays# | 0/50 | 0/50 | 0/50 | 0/50 |
| Positive agreement (Serum) | (39/41) | (24/24) | (20/20) | (19/19) |
| Positive % agreement | 95.10% | 100.00% | 100.00% | 100.00% |
| 95% CI | 89.8–99.2% | 93.5–100.0% | 92.3–100.0% | 92.1–100.0% |
| Negative agreement (Serum) | (124/124)❖ | (141/141)❖ | (145/145)❖ | (146/146)❖ |
| Negative % agreement | 100.00% | 100.00% | 100.00% | 100.00% |
| 95% CI | 97.1–100.0% | 96.1–99.9% | 97.5–100.0% | 97.5–100.0% |
| Positive agreement (Urine) | (25/26) | NA | NA | NA |
| Positive percent agreement | 96.20% | |||
| 95% CI | 89.9–99.7% | |||
| Neative agreement (Urine) | 100% | NA | NA | NA |
| Negative % agreement | (50/50) | |||
| 95% CI | 92.9–100.0% | |||
❖
Includes clinical positive specimens for other viral targets as additional negatives, e.g. for Zika virus the CHIKV, DENV and WNV positive specimens were included as negatives in the Zika virus performance.