Procleix Babesia Assay

Procleix Babesia Assay

Single-tube detection of the ribosomal RNA of the Babesia parasite in blood and plasma donations.
Designed IUO Assay Performance Characteristics* (US IND, performance characteristics are not established, not available for sale)
Platform Procleix Panther system
Assay chemistry Qualitative, transcription-mediated amplification (TMA)
Indication Blood screening, source plasma, cadaveric (non-heart-beating donors)
Collection tube Serum or plasma from EDTA, ACD, heparin or sodium citrate anti-coagulated samples
Pool sizes ID-NAT, 4, 8, 16
Assay kit size 5000 tests
Detected pathogen Babesia parasite (species B. microti, B. divergens, B. duncani, and B. venatorum)

Regulations:

The Procleix Babesia assay is for investigational use only, under US IND.

References:

* Procleix Babesia assay package insert, AW-15655 Rev. 001 (IUO), performance characteristics have not been established

Procleix Dengue Virus Assay

Procleix Dengue Virus Assay

Single-tube, highly sensitive detection of the Dengue virus RNA in blood and plasma donations.
Assay Performance Characteristics*
Platform Procleix Panther system
Assay chemistry Qualitative, transcription-mediated amplification (TMA)
Indication Blood screening, source plasma, cadaveric (non-heart-beating donors)
Collection tube Serum or plasma from EDTA, ACD, heparin or sodium citrate anti-coagulated samples
Pool sizes ID-NAT, 4, 8, 16
Assay kit size 5000 tests
Detected virus Dengue virus (serotypes 1-4)
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 (copies/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 3.90 (3.07-4.76) 18.81 (14.49-26.80)
DENV-4** 5.96 (5.00-7.07) 28.95 (22.14-41.14)

Regulations:

The Procleix Dengue virus assay is CE marked.

References:

* Procleix Dengue virus assay package insert, AW-13713-001 Rev. 002 (exUS)

**Normal model was used. For the other serotypes, the Gompertz model was used

Procleix HEV Assay

Procleix HEV Assay

Single-tube, highly sensitive detection of the hepatitis E virus RNA in blood and plasma donations.
Assay Performance Characteristics*
Platform Procleix Panther system
Assay chemistry Qualitative, transcription-mediated amplification (TMA)
Indication Blood screening, source plasma, cadaveric (non-heart-beating donors)
Collection tube Serum or plasma from EDTA, ACD, heparin or sodium citrate anti-coagulated samples
Pool sizes ID-NAT, 4, 8, 16
Assay kit size 1000 or 5000 tests
Detected virus HEV (genotypes 1-4)***
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** 2.02 (1.71-2.32) 7.89 (6.63-9.83)

Regulations:

The Procleix HEV assay is CE marked.

References:

* Procleix HEV assay package insert, 504513EN Rev. 001 (exUS)

** PEI code: 6329/10

*** HEV genotype 3 has only been validated for 3a, 3b and 3f; genotype 4 has only been validated for 4c

Procleix Parvo/HAV Assay

Procleix Parvo/HAV Assay

Single-tube, highly sensitive detection of the Parvovirus B19 DNA and hepatitis A virus RNA in blood and plasma donations.
Assay Performance Characteristics*
Platform Procleix Tigris system or Procleix Panther system
Assay chemistry Quantitative Parvo B19, qualitative HAV, transcription-mediated amplification (TMA)
Indication Blood screening, source plasma, cadaveric (non-heart-beating donors)
Collection tube Serum or plasma from EDTA, ACD, heparin or sodium citrate
anti-coagulated samples
Pool sizes ID-NAT, 4, 8, 16, 48, 96, 256, 512
Assay kit size 1000 tests
Detected virus Parvovirus B19 (genotypes 1, 2, and 3a)
HAV (genotypes I, II, and III)
Accuracy & Precision Parvovirus B19 Quantitation on Procleix Panther System*
B19 (IU/mL) N (number of replicates tested) Input and Observed log (IU/mL) % Accuracy Mean log difference (IU/mL) Standard deviation (%CV)
100,000 54 5.00 | 5.12 102.5 0.12 0.13 (2.6%)
30,000 54 4.48 | 4.55 101.5 0.07 0.15 (3.3%)
10,000 54 4.00 | 3.94 98.6 -0.06 0.10 (2.5%)
3000 59 3.48 | 3.43 98.5 -0.05 0.11 (3.2%)
1000 60 3.00 | 3.00 99.9 0.00 0.20 (6.6%)
500 189 2.70 | 2.69 99.7 -0.01 0.20 (7.3%)
Specificity of the Procleix Parvo/HAV Assay*
Number of
specimens tested
HAV 95% ( 95% CI) B19 1000 IU/mL  cutoff (95% CI) B19 500 IU/mL 
cutoff (95% CI)
2010                                     100% 
(99.81‐100.00%)
100% 
(99.81‐100.00%)
99.90% 
(99.64‐99.97%)

Regulations:

The Procleix Parvo/HAV assay is CE marked, and is available as an in-process test in the US and the EU.

References:

*Procleix Parvo/HAV assay on the Procleix Panther system CE marked package insert, AW-12749-001 Rev. 003

Procleix Ultrio Assay

Procleix Ultrio Assay

Single-tube, highly sensitive detection of HIV-1 RNA, HCV RNA, and HBV DNA in blood and plasma donations.
Assay Performance Characteristics*
Platform Procleix Tigris system
Assay chemistry Qualitative, transcription-mediated amplification (TMA)
Indication Blood screening, source plasma, cadaveric (non-heart-beating donors)
Collection tube Serum or plasma from EDTA, ACD, heparin or sodium citrate anti-coagulated samples
Pool sizes ID-NAT, 4, 8, 16
Assay kit size 1000 or 5000 tests
Detected virus HIV-1 Group M (subtypes A-G)
HIV-1 Group N
HIV-1 Group O
HCV (genotypes 1-6)
HBV (genotypes A-G)
Specificity in Fresh and Frozen Normal Blood Donor Plasma Specimens
Sample # of samples Specificity % 95% SCORE confidence interval
Pools from Whole Blood Donations 1019 99.9 99.4-100.0
Individual from Whole Blood Donations 948 99.8 99.2-100.0
Analytical Sensitivity
  Detection probabilities (IU/mL)
Panel tested 50% (95% fiducial limits) 95% (95% fiducial limits)
HIV-1 B (copies/mL)** 12.4 (11.0-14.0) 28.8 (25.8-32.7)
HCV WHO 96/790 (IU/mL) 1.3 (1.1-1.5) 3.0 (2.7-3.4)
HBV WHO 97/746 (IU/mL) 4.3 (3.7-4.9) 10.4 (9.2-12.2)

Regulations:

The Procleix Ultrio assay is CE marked and FDA approved.

References:

* Procleix Ultrio assay package insert, 502623 Rev. 005

** Conversion factor for HIV-1 = 0.6 copies/IU (Palla et al. Vox Sang. 2006; 90:59-62)

Procleix Ultrio Elite Assay

Procleix Ultrio Elite Assay

Single-tube, highly sensitive detection of HIV-1 RNA, HIV-2 RNA, HCV RNA, and HBV DNA in blood and plasma donations.
Assay Performance Characteristics*
Platform Procleix Panther system
Assay chemistry Qualitative, transcription-mediated amplification (TMA)
Indication Blood screening, source plasma, cadaveric (non-heart-beating donors)
Collection tube Serum or plasma from EDTA, ACD, heparin or sodium citrate anti-coagulated samples
Pool sizes ID-NAT, 4, 8, 16
Assay kit size 1000 or 5000 tests
Detected virus HIV-1 Group M (subtypes A-H, CRF01_AE, CRF01_AG, CRF01_AB, K)
HIV-1 Group N
HIV-1 Group O
HIV-2 (subtypes A-B)
HCV (genotypes 1-6)
HBV (genotypes A-H)
Specificity in Fresh and Frozen Normal Blood Donor Plasma Specimens
# of samples Specificity % 95% SCORE confidence interval
8011 99.9 99.80-99.95
Analytical Sensitivity
  Detection probabilities (IU/mL)
Panel Tested 50% (95% fiducial limits) 95% (95% fiducial limits)
HIV-1 WHO 97/650 (IU/mL) 5.4 (4.5-6.1) 18.0 (15.0-23.5)
HIV-2 WHO 08/150 (IU/mL) 2.6 (2.3-3.0) 10.4 (8.9-12.6)
HCV WHO 06/100 (IU/mL) 0.9 (0.8-1.0) 3.0 (2.5-3.9)
HBV WHO 97/750 (IU/mL) 0.9 (0.8-1.1) 4.3 (3.8-5.0)

Regulations:

The Procleix Ultrio Elite assay is CE marked and FDA approved.

References:

* Procleix Ultrio Elite assay package insert, 503049 Rev. 002

Procleix Ultrio Plus Assay

Procleix Ultrio Plus Assay

Single-tube, highly sensitive detection of HIV-1 RNA, HCV RNA, and HBV DNA in blood and plasma donations.
Assay Performance Characteristics*
Platform Procleix Tigris system
Assay chemistry Qualitative, transcription-mediated amplification (TMA)
Indication Blood screening, source plasma, cadaveric (non-heart-beating donors)
Collection tube Serum or plasma from EDTA, ACD, heparin or sodium citrate anti-coagulated samples
Pool sizes ID-NAT, 4, 8, 16
Assay kit size 1000 or 5000 tests
Detected virus HIV-1 Group M (subtypes A-H)
HIV-1 Group N
HIV-1 Group O
HCV (genotypes 1-6)
HBV (genotypes A-G)
Specificity in Fresh and Frozen Normal Blood Donor Plasma Specimens
# of samples Specificity %
3043 99.97
Analytical Sensitivity
  Detection probabilities (IU/mL)
Panel tested 50% (95% fiducial limits) 95% (95% fiducial limits)
HIV-1 WHO 97/650 (IU/mL) 4.7 (4.0 – 5.3) 21.2 (18.2 – 25.7)
HCV WHO 06/100 (IU/mL) 1.2 (1.1 – 1.4) 5.4 (4.5 – 6.7)
HBV WHO 97/750 (IU/mL) 0.7 (0.6 – 0.8) 3.4 (3.0 – 4.1)

Regulations:

The Procleix Ultrio Plus assay is CE marked and FDA approved.

References:

* Procleix Ultrio Plus assay package insert, AW-13598-001 Rev. 003

Procleix WNV Assay

Procleix WNV Assay

Single-tube, highly sensitive detection of the West Nile virus RNA in blood and plasma donations.
Assay Performance Characteristics*
Platform Procleix Tigris system or Procleix Panther system
Assay chemistry Qualitative, transcription-mediated amplification (TMA)
Indication Blood screening, source plasma, cadaveric (non-heart-beating donors)
Collection tube Serum or plasma from EDTA, ACD, heparin or sodium citrate anti-coagulated samples
Pool sizes ID-NAT, 4, 8, 16
Assay kit size 5000 tests
Detected virus WNV (lineages I-II)
Specificity in Fresh and Frozen Normal Blood Donor Plasma Specimens
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
Analytical Sensitivity
  Detection probabilities (copies/mL)
System Panel tested                                     50% (95% fiducial limits) 95% (95% fiducial limits)
Procleix Panther System Health Canada
reference standard
WNV Lineage I IVT
WNV Lineage II IVT

2.0 (1.6–2.4)
2.8 (2.3–3.2)
3.1 (2.7–3.6)

11.9 (9.6–15.9)
12.9 (10.6–16.7)
12.0 (10.0–15.2)
Procleix Tigris System Health Canada
reference standard
WNV Lineage I IVT
WNV Lineage II IVT

2.0 (1.6–2.3)
2.4 (2.1–2.8)
4.4 (3.8–5.1)

8.9 (7.3–11.5)
9.1 (7.6–11.2)
16.7 (13.9–21.0)

Regulations:

The Procleix WNV assay is CE marked and FDA approved.

References:

* Procleix WNV assay on Procleix Panther system package insert, 503746 Rev. 002

** Procleix WNV assay on Procleix Tigris system package insert, 502164 Rev. 004

*** Pools of 16 and individual samples

Procleix Zika Virus Assay

Procleix Zika Virus Assay

Single-tube, highly sensitive detection of two highly conserved regions of the Zika virus RNA in blood and plasma donations.
Assay Performance Characteristics*
Platform Procleix Panther system
Assay chemistry Qualitative, dual-region detection, transcription-mediated amplification (TMA)
Indication Blood screening, source plasma, cadaveric (non-heart-beating donors)
Collection tube Serum or plasma from EDTA, ACD, heparin or sodium citrate anti-coagulated samples
Pool sizes ID-NAT, 4, 8, 16
Assay kit size 1000 or 5000 tests
Detected virus Zika (strains Asian and African)
Specificity in Normal Blood Donor Plasma & Serum Specimens
# of samples Specificity % 95% SCORE confidence interval
1015 100 99.6-100
Analytical Sensitivity
  Detection probabilities (IU/mL)
Panel tested 50% (95% fiducial limits) 95% (95% fiducial limits)
Asian Strain** 1.06 (0.92–1.20) 3.87 (3.25–4.78)
African Strain*** 2.94 (2.54–3.37) 11.71 (9.78–14.57)

Regulations:

The Procleix Zika virus assay is CE marked.

References:

* Procleix Zika virus assay package insert, AW-15886-001 Rev. 004

** Specimen from 2015 Zika outbreak in Brazil

*** Synthetic transcript based on Zika isolate MR766 (GenBank – AAY632535)

This information is intended for physicians and healthcare professionals only.

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