Procleix Babesia Assay (FDA Approved and CE Marked)
Ref. GRF-PROCLEIX-BABESIA-ASSAYSingle-tube, highly sensitive detection of the ribosomal RNA of the Babesia parasite in whole blood specimens.
About the Product
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.
*includes 6 true positive donations identified in individual donation testing: 1 individual doantion with an initial reactive Procleix Babesia assay result confirmed by IFA was not detected in a 16-sample pool.
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
Technical Characteristics
| Regulatory status | FDA Approved and CE Marked |
|---|---|
| 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 |
| Detected pathogen | Babesia parasite (species B. microti, B. divergens, B. duncani, and B. venatorum) |
| Specificity in whole blood specimens - Individual donations | # of samples: 11,067; True negative: 11,060; True positive: 100; False positive: 7; Specificity %: 0; 95% SCORE confidence interval: 99.97-100 |
| Specificity in whole blood specimens - 16-sample-pools | # of samples: 11,038; True negative: 10,977; True positive: 100; False positive: 60*; Specificity %: 0; 95% SCORE confidence interval: 99.97-100 |
| Analytical sensitivity, in vitro transcripts (copies/mL) - B. microti | 50% Detection Probability (95% Fiducial Limits): 2.06 (1.55–2.56); 95% Detection Probability (95% Fiducial Limits): 8.91 (6.88–12.88) |
| Analytical sensitivity, in vitro transcripts (copies/mL) - B. divergens | 50% Detection Probability (95% Fiducial Limits): 3.90 (3.21–4.62); 95% Detection Probability (95% Fiducial Limits): 11.58 (9.38–15.44) |
| Analytical sensitivity, in vitro transcripts (copies/mL) - B. duncani | 50% Detection Probability (95% Fiducial Limits): 2.54 (2.11–3.01); 95% Detection Probability (95% Fiducial Limits): 6.73 (5.32–9.69) |
| Analytical sensitivity, in vitro transcripts (copies/mL) - B. venatorum | 50% Detection Probability (95% Fiducial Limits): 2.99 (2.33–3.67); 95% Detection Probability (95% Fiducial Limits): 12.44 (9.62–17.87) |
| Analytical sensitivity, Babesia parasites (parasites/mL**) - B. microti | 50% Detection Probability (95% Fiducial Limits): 0.61 (0.43–0.76); 95% Detection Probability (95% Fiducial Limits): 2.98 (2.40–4.09) |
| Analytical sensitivity, Babesia parasites (parasites/mL**) - B. divergens | 50% Detection Probability (95% Fiducial Limits): 0.48 (0.34–0.60); 95% Detection Probability (95% Fiducial Limits): 1.77 (1.45–2.41) |
| Analytical sensitivity, Babesia parasites (parasites/mL**) - B. duncani | 50% Detection Probability (95% Fiducial Limits): 0.72 (0.54–0.88); 95% Detection Probability (95% Fiducial Limits): 3.10 (2.53–4.11) |
| Analytical sensitivity, Babesia parasites (parasites/mL**) - B. venatorum | 50% Detection Probability (95% Fiducial Limits): n/a***; 95% Detection Probability (95% Fiducial Limits): n/a*** |
Technical Information
No technical information available for this product.
Compatibility
Platform: Procleix Panther system
Packaging
No packaging information available for this product.