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Sensitivity of NAT blood screening assays in performance evaluation and proficiency programs Harry van Drimmelen, Nico Lelie, (VQC-Sanquin) and the principal.

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Presentation on theme: "Sensitivity of NAT blood screening assays in performance evaluation and proficiency programs Harry van Drimmelen, Nico Lelie, (VQC-Sanquin) and the principal."— Presentation transcript:

1 Sensitivity of NAT blood screening assays in performance evaluation and proficiency programs Harry van Drimmelen, Nico Lelie, (VQC-Sanquin) and the principal investigators participating in the multi-center studies and EQAS program

2 viral standards proficiency panelsreference panels run controls inter-laboratory comparison validation of assays VQC Concept external quality control program

3 Data sets included in probit analysis VQC proficiency program for NAT blood screening assays (n=2512) Validation studies for implementation of NAT assays in blood screening laboratories (n=11563)

4 Evaluation panels PeliCheck HIV-RNA genotype B* PeliCheck HCV-RNA genotype 1** VQC HCV-RNA proficiency panel * VQC HIV-RNA proficiency panel ** ** Dilutions of the VQC HIV-RNA genotype B standard * Dilutions of the VQC HCV-RNA genotype 1 standard

5 Performance of Procleix TMA laboratories on HCV-RNA panels (probit analysis) Proficiency panels PeliCheck panels Potency 0.97 (0.48-2.07) n prof = 382, n validation = 719

6 Performance Nuclisens-Ampliscreen assay on HCV-RNA panels (probit analysis) Proficiency panels PeliCheck panels Potency 1.11 (0.65-1.95) n prof = 107, n validation = 381

7 Detection limits on PeliCheck and proficiency panels in geq/ml (as calculated by probit analysis; parallel lines) Assay Marker Proficiency PeliCheck 50 % 95 % 50 % 95 % Nucl.-Ampl. HIV 5.9 (4-9) 32 (20-62) 4.6 (3-6) 25 (16-47) Nucl.-Ampl. HCV 7.7 (5-12) 51 (32-90) 6.9 (5-9) 46 (32-75) TMA duplex HIV 5.6 (2-12) 46 (21-128) 4.0 (2-7) 33 (17-91) TMA duplex HCV 10 (6-18) 94 (51-209) 11 (7-16) 96 (56-205) Ampliscreen HIV 11 (8-15)113 (77-184) 7 (4-10) 68 (42-127) Ampliscreen HCV 11 (8-14) 96 (68-152) 10 (6-15) 89 (53-169)

8 Roche Multiprep-Ampliscreen detection limits in geq/ml Marker 50 % 95 % n* HCV-RNA 10 (8-13) 95 (68-148) 471 HBV-DNA 8 (6-13) 100 (55-291) 158 HIV-RNA 9 (7-11) 102 (70-166) 480 * Number VQC standard dilutions tested in performance evaluation studies and proficiency program

9 Conclusion and discussion The limiting dilution results on PeliCheck validation panels and proficiency panels are comparable

10 Performance Procleix TMA laboratories on HIV-RNA panels (probit analysis) Proficiency panels PeliCheck panels Potency 1.41 (0.58-4.36) n prof = 366, n validation = 897

11 Performance Nuclisens-Ampliscreen assay on HIV-RNA panels (probit analysis) Proficiency panels PeliCheck panels Potency 1.28 (0.76-2.29) n prof = 107, n validation = 168

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