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)
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