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Sensitivity of NAT Blood Screening Assays: Performance Evaluation & Proficiency Programs

Explore the sensitivity of NAT blood screening assays in performance evaluation and proficiency programs. This study by Harry van Drimmelen, Nico Lelie, and the principal investigators involved in multi-center studies and EQAS program discusses VQC proficiency program, viral standards, proficiency panels, reference panels, and more.

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Sensitivity of NAT Blood Screening Assays: Performance Evaluation & 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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