Procleix Babesia Assay (FDA Approved and CE Marked)
Single-tube, highly sensitive detection of the ribosomal RNA of the Babesia parasite in whole blood specimens.
The Procleix Babesia assay is CE marked and FDA approved.
Assay Performance Characteristics*
- Procleix Panther system
-
Qualitative, transcription-mediated amplification (TMA)
- Procleix Panther system
-
Whole blood and blood component screening
- Procleix Panther system
-
Whole blood from K2EDTA, K3EDTA, Sodium Citrate, and Citrate Phosphate Dextrose Adenine Solution
(CPDA) anti-coagulated samples
- Procleix Panther system
-
ID-NAT, 8, 16
- Procleix Panther system
-
ID-NAT, 8, 16
- Procleix Panther system
-
Babesia parasite (species B. microti, B. divergens, B. duncani, and B. venatorum)
| 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 |
|
Pool sizes |
ID-NAT, 8, 16 |
|
ID-NAT, 8, 16 |
ID-NAT, 8, 16 |
|
Detected pathogen |
Babesia parasite (species B. microti, B. divergens, B. duncani, and B. venatorum) |
Specificity in Whole Blood Specimens from Whole Blood Donors
- # of samples
-
11,067
- True negative
-
11,060
- True positive
-
100
- False positive
-
7
- Specificity %
-
0
- 95% SCORE confidence interval
-
99.97-100
- # of samples
-
11,038
- True negative
-
10,977
- True positive
-
100
- False positive
-
60*
- Specificity %
-
0
- 95% SCORE confidence interval
-
99.97-100
| Sample type | # of samples | True negative | True positive | False positive | Specificity % | 95% SCORE confidence interval |
|---|---|---|---|---|---|---|
|
Individual donations |
11,067 |
11,060 |
100 |
7 |
0 |
99.97-100 |
|
16-sample-pools |
11,038 |
10,977 |
100 |
60* |
0 |
99.97-100 |
Analytical Sensitivity
In vitro transcripts, copies/mL
- 50% Detection Probability (95% Fiducial Limits)
-
2.06 (1.55–2.56)
- 95% Detection Probability (95% Fiducial Limits)
-
8.91 (6.88–12.88)
- 50% Detection Probability (95% Fiducial Limits)
-
3.90 (3.21–4.62)
- 95% Detection Probability (95% Fiducial Limits)
-
11.58 (9.38–15.44)
- 50% Detection Probability (95% Fiducial Limits)
-
2.54 (2.11–3.01)
- 95% Detection Probability (95% Fiducial Limits)
-
6.73 (5.32–9.69)
- 50% Detection Probability (95% Fiducial Limits)
-
2.99 (2.33–3.67)
- 95% Detection Probability (95% Fiducial Limits)
-
12.44 (9.62–17.87)
| Babesia species | 50% Detection Probability (95% Fiducial Limits) | 95% Detection Probability (95% Fiducial Limits) |
|---|---|---|
|
B. microti |
2.06 (1.55–2.56) |
8.91 (6.88–12.88) |
|
B. divergens |
3.90 (3.21–4.62) |
11.58 (9.38–15.44) |
|
B. duncani |
2.54 (2.11–3.01) |
6.73 (5.32–9.69) |
|
B. venatorum |
2.99 (2.33–3.67) |
12.44 (9.62–17.87) |
Babesia parasites, parasites/mL**
- 50% Detection Probability (95% Fiducial Limits)
-
0.61 (0.43–0.76)
- 95% Detection Probability (95% Fiducial Limits)
-
2.98 (2.40–4.09)
- 50% Detection Probability (95% Fiducial Limits)
-
0.48 (0.34–0.60)
- 95% Detection Probability (95% Fiducial Limits)
-
1.77 (1.45–2.41)
- 50% Detection Probability (95% Fiducial Limits)
-
0.72 (0.54–0.88)
- 95% Detection Probability (95% Fiducial Limits)
-
3.10 (2.53–4.11)
- 50% Detection Probability (95% Fiducial Limits)
-
n/a***
- 95% Detection Probability (95% Fiducial Limits)
-
n/a***
| Babesia species | 50% Detection Probability (95% Fiducial Limits) | 95% Detection Probability (95% Fiducial Limits) |
|---|---|---|
|
B. microti |
0.61 (0.43–0.76) |
2.98 (2.40–4.09) |
|
B. divergens |
0.48 (0.34–0.60) |
1.77 (1.45–2.41) |
|
B. duncani |
0.72 (0.54–0.88) |
3.10 (2.53–4.11) |
|
B. venatorum |
n/a*** |
n/a*** |
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