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Procleix Babesia Assay

Procleix Babesia Assay

Single-tube, highly sensitive detection of the ribosomal RNA of the Babesia parasite in whole blood specimens.
Assay Performance Characteristics*
Platform Procleix Panther system
Assay chemistry Qualitative, transcription-mediated amplification (TMA)
Indication Whole blood and blood component screening
Collection tube Whole blood from K2EDTA, K3EDTA, Sodium Citrate, and Citrate Phosphate Dextrose Adenine Solution (CPDA) anti-coagulated samples
Pool sizes ID-NAT, 8, 16
Assay kit size 5000 tests
Detected pathogen Babesia parasite (species B. microti, B. divergens, B. duncani, and B. venatorum)
Specificity in Fresh Blood Donor Whole Blood Specimens
Sample type # of samples True Negative Specificity % 95% SCORE confidence interval
Individual donations 11,067 11,060 100 99.97-100
16-sample pools 11,038 10,977 100 99.97-100
Analytical Sensitivity
  In vitro transcripts, copies/mL   Babesia parasites, parasites/mL**  
Babesia species 50% 95% 50% 95%
B. microti 2.06 (1.55–2.56) 8.91 (6.88–12.88) 0.61 (0.43–0.76) 2.98 (2.40–4.09)
B. divergens 3.90 (3.21–4.62) 11.58 (9.38–15.44) 0.48 (0.34–0.60) 1.77 (1.45–2.41)
B. duncani 2.54 (2.11–3.01) 6.73 (5.32–9.69) 0.72 (0.54–0.88) 3.10 (2.53–4.11)
B. venatorum 2.99 (2.33–3.67) 12.44 (9.62–17.87) n/a*** n/a***

Regulations:

The Procleix Babesia assay is CE marked and FDA approved.

References:

* Procleix Babesia assay package insert, GDSS-IFU-000030

** B. divergens and B. duncani were washed in PBS prior to dilution in human whole blood to remove free parasitic ribosomal RNA

*** Not quantifiable due to frozen specimen

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 98.5 -0.06 0.10 (2.5%)
3000 59 3.48 | 3.43 99.9 0.00 0.11 (3.2%)
1000 60 3.00 | 3.00 99.7 -0.01 0.20 (6.6%)
500 189 2.70 | 2.69 99.90% 
(99.64‐99.97%) 		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)
Assay chemistry 100% 
(99.81‐100.00%) 		100% 
(99.81‐100.00%)

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 SARS-CoV-2 Assay1

Procleix SARS-CoV-2 Assay1

CE marked: SARS-CoV-2 RNA in blood or plasma donations, and respiratory specimens
Assay Performance Characteristics2
Platform Procleix Panther system
Indication Qualitative, transcription-mediated amplification (TMA)
Collection tube Blood screening, source and convalescent plasma, organ and tissue donor screening
Pool sizes Serum or plasma from EDTA, ACD, or sodium citrate anti-coagulated samples. Oro- and nasopharyngeal samples in Viral Transport Media
Assay kit size ID-NAT
Detected virus 1000 or 5000 tests
SARS-CoV-2
IVT in Buffer3
Analytical sensitivity in normal blood donor plasma specimens
  Detection Probability (copies/mL)
Panel Tested 50% (95% fiducial limits) 95% (95% fiducial limits)
AccuPlex in K2EDTA Plasma4 3.92 (3.09 – 4.79) 16.50 (12.75 – 23.58)
AccuPlex in Serum 4.61 (3.65 – 5.63) 19.59 (15.09 – 28.04)
Heat Inactivated Virus in K2EDTA Plasma5 9.41 (7.49 -11.52) 44.45 (34.10 – 63.13)
2332
(1844 plasma and 488 serum samples) 		2.46 (1.91 – 3.01) 9.56 (7.45 – 13.59)
Specificity in fresh and frozen plasma samples, and serum
# of samples Specificity % 95% SCORE confidence interval
AccuPlex in VTM (Viral Transport Medium) 99.96 99.76 – 99.99 100
Analytical sensitivity in swab specimens
  Detection Probability (copies/mL)
Panel Tested 50% (95% fiducial limits) 95% (95% fiducial limits)
Negative 8.13 (6.68 - 9.64) 40.96 (33.21 - 53.19) 0 (0 - 6) 100
Clinical evaluation of swab specimens
SARS-CoV-2 concentration Number of replicates tested Number of reactive Percent reactive (95% Cl) Percent agreement
90 copies/mL 456 0 100 (88.1 - 100) 100
240 copies/mL 20 20 100 (87.5 - 100)
Assay chemistry 196 19

Documentation (US only):

Procleix SARS-CoV-2 Assay  Instructions For Use  (For Emergency Use Authorization (EUA) only)
Procleix SARS-CoV-2 Assay EUA Fact Sheet for Healthcare Providers  3-EUA201734  
Procleix SARS-CoV-2 Assay EUA Fact Sheet for Patients  4-EUA201734  

Regulations:

The Procleix SARS-CoV-2 assay is CE marked and EUA in the US.

References:

1. Only available in Spain and Northern Ireland

2. Procleix SARS-CoV-2 assay package insert, GDSS-IFU-000047-EN v. 4.0 (ex US)

3. IVT: In vitro transcript

4. AccuPlex: AccuPlex SARS-CoV-2 Positive Reference Material from SeraCare (Milford, MA)

5. Heat Inactivated Virus: Heat Inactivated SARS-Related Coronavirus 2 (SARS-CoV-2) NR-52286 from BEI Resources (Manassas, VA)

6. One of the specimens included in the unspiked and 240 copies/mL sample sets was SARS-CoV-2 positive and thus eliminated from the study

Procleix UltrioPlex E Assay

Procleix UltrioPlex E Assay

Single-tube, highly sensitive detection of HEV RNA, HIV-1 RNA, HIV-2 RNA, HCV RNA, and HBV DNA in blood and plasma donations.
Assay Performance Characteristics*
Platform Procleix Panther system
Indication Qualitative, transcription-mediated amplification (TMA)
Collection tube Blood screening, source plasma, cadaveric (non-heart-beating donors)
Pool sizes Serum or plasma from EDTA, ACD, heparin or sodium citrate anti-coagulated simples
Assay kit size ID-NAT, 4, 8, 16, 96
Detected virus 1000 or 5000 tests
7,948 HEV (genotypes 1-8)
HIV-1 Group M (subtypes A-H, J, K, L, CRF01_AE, BF, BG, CRF02_AG, and CRF37_cpx), Group N, Group O and Group P
HIV-2 (subtypes A-B)
HCV (genotypes 1-8; subtypes 1a, 1b, 2a/c, 2b, 3a, 3b, 3e, 3, 4a, 4b/c, 4g, 5a, 6a, 6c, 7a, 7b and 8a)
HBV (genotypes A-J) and pre-core mutants
Specificity in Fresh and Frozen Normal Blood Donor Plasma Specimens
# of samples Specificity % 95% SCORE confidence interval
HIV-1** 100 99.95-100 97.1-100
Clinical Sensitivity
NEAT Samples # of samples % Sensitivity 95% confidence interval
HIV-2** (≥ 100 copies/mL) 125 100 86.3-100
HCV** 25 100 74.2-93.1
HBV*** 62 85.5 97.1-100
Assay chemistry 125 100 97.1-100
Indication 125 100

Regulations:

The Procleix UltrioPlex E assay is CE marked.

References:

*Procleix UltrioPlex E assay package insert GDSS-IFU-000053-EN v. 1.0

**RNA

***DNA

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
Collection tube Qualitative, transcription-mediated amplification (TMA)
Pool sizes Blood screening, source plasma, cadaveric (non-heart-beating donors)
Assay kit size Serum or plasma from EDTA, ACD, heparin or sodium citrate anti-coagulated samples
Detected virus ID-NAT, 4, 8, 16
Pools from Whole Blood Donations 1000 or 5000 tests
Individual from Whole Blood Donations HIV-1 Group M (subtypes A-G)
HIV-1 Group N
HIV-1 Group O
HCV (genotypes 1-6)
HBV (genotypes A-G) 		99.4-100.0
Specificity in Fresh and Frozen Normal Blood Donor Plasma Specimens
Sample # of samples Specificity % 95% SCORE confidence interval
HIV-1 B (copies/mL)** 1019 99.9 99.2-100.0
Individual from Whole Blood Donations 948 99.8 99.4-100.0
Analytical Sensitivity
  Detection probabilities (IU/mL)
Panel tested 50% (95% fiducial limits) 95% (95% fiducial limits)
Assay chemistry 12.4 (11.0-14.0) 28.8 (25.8-32.7) 99.2-100.0
Indication 948 99.8

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
Collection tube Qualitative, transcription-mediated amplification (TMA)
Pool sizes Blood screening, source plasma, cadaveric (non-heart-beating donors)
Assay kit size Serum or plasma from EDTA, ACD, heparin or sodium citrate anti-coagulated samples
Detected virus ID-NAT, 4, 8, 16
8011 1000 or 5000 tests
HIV-1 WHO 97/650 (IU/mL) 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
HIV-2 WHO 08/150 (IU/mL) 99.9 99.80-99.95
Analytical Sensitivity
  Detection probabilities (IU/mL)
Panel Tested 50% (95% fiducial limits) 95% (95% fiducial limits)
HCV WHO 06/100 (IU/mL) 5.4 (4.5-6.1) 18.0 (15.0-23.5)
HBV WHO 97/750 (IU/mL) 2.6 (2.3-3.0) 10.4 (8.9-12.6)
Assay chemistry 0.9 (0.8-1.0) 3.0 (2.5-3.9)
Indication 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
Collection tube Qualitative, transcription-mediated amplification (TMA)
Pool sizes Blood screening, source plasma, cadaveric (non-heart-beating donors)
Assay kit size Serum or plasma from EDTA, ACD, heparin or sodium citrate anti-coagulated samples
Detected virus ID-NAT, 4, 8, 16
3043 1000 or 5000 tests
HIV-1 WHO 97/650 (IU/mL) 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 %
HCV WHO 06/100 (IU/mL) 99.97
Analytical Sensitivity
  Detection probabilities (IU/mL)
Panel tested 50% (95% fiducial limits) 95% (95% fiducial limits)
HBV WHO 97/750 (IU/mL) 4.7 (4.0 – 5.3) 21.2 (18.2 – 25.7)
Assay chemistry 1.2 (1.1 – 1.4) 5.4 (4.5 – 6.7)
Indication 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
Collection tube Qualitative, transcription-mediated amplification (TMA)
Pool sizes Blood screening, source plasma, cadaveric (non-heart-beating donors)
Assay kit size Serum or plasma from EDTA, ACD, heparin or sodium citrate anti-coagulated samples
Detected virus ID-NAT, 4, 8, 16
Procleix Panther system* 5000 tests
Procleix Tigris system** WNV (lineages I-II) 99.90-100
Specificity in Fresh and Frozen Normal Blood Donor Plasma Specimens
System # of samples Specificity % 95% SCORE confidence interval
Procleix Panther System 3933 100 99.86–99.96
Procleix Tigris System 60388*** 99.91
11.9 (9.6–15.9)
12.9 (10.6–16.7)
12.0 (10.0–15.2)
Analytical Sensitivity
  Detection probabilities (copies/mL)
System Panel tested                                     50% (95% fiducial limits) 95% (95% fiducial limits)
Assay chemistry 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)
8.9 (7.3–11.5)
9.1 (7.6–11.2)
16.7 (13.9–21.0)
Indication 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)

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
Collection tube Qualitative, dual-region detection, transcription-mediated amplification (TMA)
Pool sizes Blood screening, source plasma, cadaveric (non-heart-beating donors)
Assay kit size Serum or plasma from EDTA, ACD, heparin or sodium citrate anti-coagulated samples
Detected virus ID-NAT, 4, 8, 16
1000 or 5000 tests
Zika (strains Asian and African)
Specificity in Normal Blood Donor Plasma & Serum Specimens
# of samples Specificity % 95% SCORE confidence interval
Asian Strain**
African Strain***
Analytical Sensitivity
  Detection probabilities (IU/mL)
Panel tested 50% (95% fiducial limits) 95% (95% fiducial limits)
1.06 (0.92–1.20) 3.87 (3.25–4.78)
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)

Diagnostics Disclaimer

This information is intended for physicians and healthcare professionals only.

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