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 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 Assay
Procleix SARS-CoV-2 Assay
SARS-CoV-2 RNA in blood or plasma donations, and respiratory specimens.Procleix SARS-CoV-2 Assay Instructions For Use (US only)
Fact sheets will be uploaded once the assay has received Emergency Use Authorization from FDA. The test has been validated but FDA's independent review of this validation is pending.
| Assay Performance Characteristics* | ||||
|---|---|---|---|---|
| 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 | |||
| 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 Buffer** | 3.92 (3.09 – 4.79) | 16.50 (12.75 – 23.58) | ||
| AccuPlex in K2EDTA Plasma*** | 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 Plasma**** | 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 | 45***** | 0 | 0 (0 - 6) | 100 |
| 90 copies/mL | 20 | 20 | 100 (88.1 - 100) | 100 |
| 240 copies/mL | 19***** | 19 | 100 (87.5 - 100) | 100 |
Regulations:
The Procleix SARS-CoV-2 assay is CE marked.
References:
*Procleix SARS-CoV-2 assay package insert, GDSS-IFU-000047-EN v. 2.0 (ex US).
**IVT: In vitro transcript
***AccuPlex: AccuPlex SARS-CoV-2 Positive Reference Material from SeraCare (Milford, MA)
****Heat Inactivated Virus: Heat Inactivated SARS-Related Coronavirus 2 (SARS-CoV-2) NR-52286 from BEI Resources (Manassas, VA)
*****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 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)
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