Procleix Dengue Virus Assay
Assay Performance Characteristics¹| Specificity in Fresh and Frozen Normal Blood Donor Plasma Specimens | ||
|---|---|---|
| # of Samples | Specificity % | 95% SCORE confidence interval |
| 2000 | 100 | 99.8-100 |
| Analytical Sensitivity | ||
| Detection probabilities (c/mL) for combined lots with in vitro synthesized transcripts | ||
| Serotype | 50% (95% fiducial limits) | 95% (95% fiducial limits) |
| DENV-1 | 5.44 (4.43-6.51) | 21.04 (16.75-28.35) |
| DENV-2 | 5.56 (4.45-6.75) | 25.95 (20.19-36.16) |
| DENV-3 | 18.81 (14.49-26.80) 28.95 (22.14-41.14) |
|
Note:
*Normal model was used. For the other serotypes, the Gompertz model was used.
References:
¹Procleix Dengue Virus Assay Package Insert, AW-13713-001 Rev. 002 (exUS).
Procleix HEV Assay
Assay Performance Characteristics¹| Specificity in Fresh and Frozen Normal Blood Donor Plasma Specimens | ||
|---|---|---|
| # of Samples | Specificity % | 95% SCORE Confidence Interval |
| 4494 | 99.98 | 99.87-100 |
| Analytical Sensitivity | ||
| Detection Probability (IU/mL) | ||
| Panel Tested | 50% (95% fiducial limits) | 95% (95% fiducial limits) |
| HEV WHO International standard (PEI code 6329/10) |
2.02 (1.71-2.32) | 7.89 (6.63-9.83) |
References:
¹Procleix HEV Assay Package Insert, 504513EN Rev. 001 (exUS)
Procleix Parvo/HAV Assay
| Accuracy & Precision Parvovirus B19 Quantitation* | |||||
|---|---|---|---|---|---|
| B19 (IU/mL) | Input Log (IU/mL) | Observed Log (IU/mL) | % Accuracy | Mean Log Difference | Standard Deviation |
| 100,000 | 5 | 5.12 | 102.5 | 0.12 | 0.09 |
| 30,000 | 4.48 | 4.49 | 100.3 | 0.01 | 0.14 |
| 10,000 | 4 | 3.95 | 98.8 | -0.05 | 0.13 |
| 3000 | 3.48 | 3.45 | 92.2 | -0.03 | 0.1 |
| 1000 | 3 | 2.89 | 96.5 | -0.11 | 0.16 |
| 500 | 2.7 | 2.58 | 95.8 | -0.11 | 0.18 |
| Specificity of the Procleix Parvo/HAV Assay¹ (95% Cl) | |||||
| Number of Specimens Tested | HAV Specificity | B19 Specificity 1000 IU/mL cutoff | B19 Specificity 500 IU/mL cutoff |
||
| 2,210 | 100% (99.83-100.00%) | 100% (99.83-100.00%) | 99.91% (99.67-99.98%) | ||
*These data were generated on the Tigris system.
References:
¹Procleix Parvo/HAV Assay Package Insert, AW-13280-001 Rev. 001 (ExUS).
Procleix Ultrio Assay
| Analytical Sensitivity of the Procleix Ultrio Assay and Discriminatory Assays on the Procleix Tigris System for the Detection of HIV-1, HCV and HBV¹ | |||||
|---|---|---|---|---|---|
| Analytical Sensitivity | |||||
| Panel Tested | Assay | Detection Probabilities 95% (95% fiducial limits) | |||
| HIV-1 B | Ultrio | 28.8 (25.9-32.7) copies/mL,* 47.9 (43.1-54.5) IU/mL² | |||
| HIV-1 B | dHIV-1 | 32.2 (28.7-36.7) copies/mL,* 53.6 (47.9-61.2) IU/mL² | |||
| HIV WHO (97/656) | dHIV-1 | 20.3 (18.1-3.1) IU/mL | |||
| HCV WHO (96/790) | Ultrio | 3.0 (2.7-3.4) IU/mL | |||
| HCV WHO (96/790) | dHCV | 3.2 (2.8-3.6) IU/mL | |||
| HBV WHO (97/746) | Ultrio | 10.4 (9.2-12.2) IU/mL | |||
| HBV WHO (97/746) | dHBV | 8.5 (7.6-9.8) IU/mL | |||
| Specificity of the Procleix Ultrio Assay and Discriminatory Assays in Normal Blood Donors¹ | |||||
| Specificity | |||||
| Ultrio Assay | dHIV-1 Assay | dHCV Assay | dHBV Assay | ||
| Procleix Tigris System | 99.60% | 100% | 99.73% | 100% | |
Note:
*Conversion factor for HIV-1 = 0.6 copies/IU.
References:
¹Procleix Ultrio Assay Package Insert, 502187EN Rev. 002.
²Palla et al. Vox Sang. 2006; 90:59-62.
Procleix Ultrio Elite Assay
| 100% clinical sensitivity for HIV-1, HCV, and HBV | ||||
|---|---|---|---|---|
| Clinical Sensitivity of the Procleix Ultrio Elite Assay in Known Positive Samples¹ | ||||
| All (N = 620) | HIV-1 (N = 214) | HCV (N = 203) | HBV (N = 203) | |
| Diluted (1:16) samples (95% CI)* | 100 (99.4-100) |
100 (98.3-100) |
100 (98.2-100) |
100 (98.2-100) |
| Increased Blood Safety Through High Assay Performance | ||||
| Detection Probabilities (IU/mL)¹ | ||||
| Panel Tested | 50% (95% fiducial limits) | 95% (95% fiducial limits) | ||
| HIV-1 WHO (97/650) | 5.4 (4.5-6.1) | 18.0 (15.0-23.5) | ||
| HIV-2 WHO (08/150) | 2.6 (2.3-3.0) | 10.4 (8.9-12.6) | ||
| HCV WHO (06/100) | 0.9 (0.8-1.0) | 3.0 (2.5-3.9) | ||
| HBV WHO (97/750) | 0.9 (0.8-1.1) | 4.3 (3.8-5.0) | ||
Note:
*HIV-2 samples were not tested in a 1:16 dilution.
References:
¹Procleix Ultrio Elite Assay Package Insert, 503049EN Rev. 002 (exUS).
Procleix Ultrio Plus Assay
| Analytical Sensitivity of the Procleix Ultrio Plus Assay and Discriminatory Assays on the Procleix Tigris System¹ | ||||
|---|---|---|---|---|
| Analytical Sensitivity | ||||
| Panel Tested | Assay | Detection Probabilities 95% LOD (95% fiducial limits) | ||
| HIV-1 WHO (97/650) | Ultrio Plus | 21.2 (18.2-25.7) IU/mL | ||
| HIV-1 WHO (97/650) | dHIV-1 | 18.9 (16.3-22.9) IU/mL | ||
| HCV WHO (06/100) | Ultrio Plus | 5.4 (4.5-6.7) IU/mL | ||
| HCV WHO (06/100) | dHCV | 4.4 (3.7-5.6) IU/mL | ||
| HBV WHO (97/750) | Ultrio Plus | 3.4 (3.0-4.1) IU/mL | ||
| HBV WHO (97/750) | dHBV | 4.1 (3.5-4.9) IU/mL | ||
| Specificity of the Procleix Ultrio Plus Assay and Discriminatory Assays in Normal Blood Donors¹ | ||||
| Specificity | ||||
| Ultrio Plus Assay | dHIV-1 Assay | dHCV Assay | dHBV Assay | |
| Procleix Tigris System | 99.97% | 100% | 100% | 99.72% |
References:
¹Procleix Ultrio Plus Assay Package Insert, 503644EN Rev.002 (exUS).
Procleix WNV Assay
Assay Performance Characteristics¹˒²| Analytical Sensitivity | |||
|---|---|---|---|
| Analyte | Assay System | Detection Probabilities in IDT (copies/mL) 95% (95% fiducial limit) | |
| WNV RNA from the Health Canada Reference Standard | Procleix Panther System | 11.9 (9.6-15.9) | |
| Procleix Tigris System | 8.9 (7.3-11.5) | ||
| Detection Probabilities (copies/mL) of WNV Lineages 1 & 2 IVT RNA | |||
| System | Lineage 1 95% (95% fiducial limits) |
Lineage 2 95% (95% fiducial limits) |
|
| Procleix Panther System | 12.9 (10.6-16.7) | 12.0 (10.0-15.2) | |
| Procleix Tigris System | 9.1 (7.6-11.2) | 16.7 (13.9-21.0) | |
| Specificity of the Procleix WNV Assay in Normal Negative Donations¹˒³ | |||
| System | # of Samples | Specificity % | 95% SCORE Confidence Interval |
| Procleix Panther System | 3933* | 100 | 99.90-100 |
| Procleix Tigris System | 60388** | 99.91 | 99.86-99.96 |
Notes:
*Fresh and frozen.
**Pools of 16 and individual samples.
References:
¹Procleix WNV Assay on the Procleix Panther System Package Insert, 503746EN Rev. A (exUS).
²Linnen, JM et al. J Med Virol 2007; 79:1422-30.
³Procleix WNV Assay on the Procleix Tigris System Package Insert, 502164 Rev. 001 and 502439EN Rev. 002.
Procleix Zika Virus Assay
| Design Detail | Specification* |
|---|---|
| Assay | Qualitative, dual-region detection, in vitro nucleic acid amplification test (TMA) designed for detection of Zika virus (ZIKV) RNA in human plasma |
| Analytical sensitivity | 95% LOD around 10-20 copies/mL |
| Analytical specificity | >99.5% |
| Platform | Procleix Panther system |
| Testing format | IDT and pooled testing |
| Collection tubes | K2-EDTA, K3-EDTA, Sodium Citrate 4% and ACD-A |
| Assay kit size |
|
| Time to first result | 3.5 hours from loading, and then 5 results every 5 minutes |
| Normal Individual Plasma Donor*** | |
| N | R |
| 200 | 0 |
Notes:
*Subject to completion of validation studies
**In vitro transcript spiked into buffer solution
***Source: Hologic. Data on File
This information is intended for physicians and healthcare professionals only.
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