Procleix Dengue Virus Assay

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

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

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

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

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

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

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

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
  • 250-test bottle
  • 1000 test kit
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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