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Sensitivity of NAT blood screening assays in performance evaluation and proficiency programs

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. VQC Concept external quality control program.

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Sensitivity of NAT blood screening assays in performance evaluation and proficiency programs

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  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. VQC Conceptexternal quality control program viral standards proficiency panels reference panels run controls inter-laboratory comparison validation of assays

  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 HCV-RNA genotype 1 standard ** Dilutions of the VQC HIV-RNA genotype B standard

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

  6. Performance Nuclisens-Ampliscreen assay on HCV-RNA panels (probit analysis) Proficiency panels PeliCheck panels Potency 1.11 (0.65-1.95) nprof = 107, nvalidation = 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) PeliCheck panels Proficiency panels Potency 1.41 (0.58-4.36) nprof = 366, nvalidation = 897

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

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