PROCLEIX® WNV Assay
Performance Characteristics - Cadaveric Donors
Performance of Cadaveric Blood Specimens from the Tissue Donors Reproductibility
The inter-assay reporductibility of the PROCLEIX® WNV Assay with cadaveric blood specimens was assessed by determining the %CVs obtained when each of the 20 cadaveric and 20 control specimens were tested with 2 clinical lots for a total of 120 replicates (see table 1).
Table 1: PROCLEIX® WNV Assay with Cadaveric and Control Specimens Spiked with 150 copies/mL of WNV
| Sample | Sample | Number of donors |
Number of replicates |
% Reactive (95% CI) |
Mean Analyte S/CO |
%CV |
|---|---|---|---|---|---|---|
| PROCLEIX® System | Cadervic | 20 | 120 | 100% (97.5 - 100) |
27.46 | 18 |
| Control | 20 | 120 | 100% (97.5 - 100) |
28.30 | 14 |
CI = Confidence Interval
Specificity
WNV-negative cadaveric serum specimens were tested to determine the specificity of the PROCLEIX WNV Assay. Forty-five cadaveric specimens and 45 normal blood donor specimens were tested in the PROCLEIX® System. The cadaveric and control specimens were tested using three clinical lots (see table 2).
Table 2: Specificity of PROCLEIX® WNV Assay in Cadaveric Blood Specimens
| Control | Cadaveric | |
|---|---|---|
| n | 44* | 45 |
| Mean IC S/CO | 2.13 | 2.07 |
| Analtye S/CO | 0.12 | 0.15 |
| Percent Specificity | 100 | 100 |
| 95% CI | 94-100 | 94-100 |
* 45 samples were tested. ONe sample was invalid and not used in the results analysis.
n = number of samples
CI = Confidence Interval
Sensitivity
WNV-negative cadaveric serum specimens spiked with a low level of WNV (approximately 150 copies/mL) were tested within 6 hours of spiking to determine the sensitivity of the PROCLEIX WNV Assay. Forty-five cadaveric specimens and 45 normal blood donor specimens were tested on the PROCLEIX System. The spiked cadaveric and control samples were tested using three clinical lots (see table 3).
Table 3: Sensitivity of PROCLEIX® WNV Assay in Cadaveric Blood Specimens
| Control | Cadaveric | |
|---|---|---|
| n | 45 | 45 |
| Analtye S/CO | 33.16 | 29.55 |
| Percent Specificity | 100 | 100 |
| 95% CI | 94-100 | 94-100 |
n = number of samples
CI = Confidence Interval
PROCLEIX is a trademark of Novartis Vaccines and Diagnostics, Inc.
Developed by Gen-Probe in collaboration with Chiron. Manufactured by Gen-Probe Incorporated. Distributed by Novartis Vaccines and Diagnostics.