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 | 98.6 | -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 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 | |||
| Assay chemistry | Qualitative, transcription-mediated amplification (TMA) | |||
| Indication | Blood screening, source and convalescent plasma, organ and tissue donor screening | |||
| Collection tube | Serum or plasma from EDTA, ACD, or sodium citrate anti-coagulated samples. Oro- and nasopharyngeal samples in Viral Transport Media | |||
| Pool sizes | ID-NAT | |||
| Assay kit size | 1000 or 5000 tests | |||
| Detected virus | SARS-CoV-2 | |||
| Analytical sensitivity in normal blood donor plasma specimens | ||||
| Detection Probability (copies/mL) | ||||
| Panel Tested | 50% (95% fiducial limits) | 95% (95% fiducial limits) | ||
| IVT in Buffer3 | 3.92 (3.09 – 4.79) | 16.50 (12.75 – 23.58) | ||
| AccuPlex in K2EDTA Plasma4 | 4.61 (3.65 – 5.63) | 19.59 (15.09 – 28.04) | ||
| AccuPlex in Serum | 9.41 (7.49 -11.52) | 44.45 (34.10 – 63.13) | ||
| Heat Inactivated Virus in K2EDTA Plasma5 | 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 | ||
| 2332 (1844 plasma and 488 serum samples) | 99.96 | 99.76 – 99.99 | ||
| Analytical sensitivity in swab specimens | ||||
| Detection Probability (copies/mL) | ||||
| Panel Tested | 50% (95% fiducial limits) | 95% (95% fiducial limits) | ||
| AccuPlex in VTM (Viral Transport Medium) | 8.13 (6.68 - 9.64) | 40.96 (33.21 - 53.19) | ||
| Clinical evaluation of swab specimens | ||||
| SARS-CoV-2 concentration | Number of replicates tested | Number of reactive | Percent reactive (95% Cl) | Percent agreement |
| Negative | 456 | 0 | 0 (0 - 6) | 100 |
| 90 copies/mL | 20 | 20 | 100 (88.1 - 100) | 100 |
| 240 copies/mL | 196 | 19 | 100 (87.5 - 100) | 100 |
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 | |||
| 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 simples | |||
| Pool sizes | ID-NAT, 4, 8, 16, 96 | |||
| Assay kit size | 1000 or 5000 tests | |||
| Detected virus | 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 | ||
| 7,948 | 100 | 99.95-100 | ||
| Clinical Sensitivity | ||||
| NEAT Samples | # of samples | % Sensitivity | 95% confidence interval | |
| HIV-1** | 125 | 100 | 97.1-100 | |
| HIV-2** (≥ 100 copies/mL) | 25 | 100 | 86.3-100 | |
| HIV-2** (BLQ or ≥ 10 copies/mL) | 62 | 85.5 | 74.2-93.1 | |
| HCV** | 125 | 100 | 97.1-100 | |
| HBV*** | 125 | 100 | 97.1-100 | |
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 | ||
| 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) | 99.4-100.0 |
| Individual from Whole Blood Donations | 948 | 99.8 | 99.2-100.0 |
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 | |
| 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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