Evaluation of Blood Screening Nucleic Acid Tests (NAT) for Detection of Various HCV and HIV Genotypes

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Dinah Ray
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1 Evaluation of Blood Screening Nucleic Acid Tests (NAT) for Detection of Various HCV and HIV Genotypes

2 Authors Boston Biomedica, Inc. Barbara J. Weiblen Alan Doty Sylvia Crush-Stanton Mark Manak Roche Yanfeng Yang Misty Hope-Wisbeski Elizabeth Dragon James Gallarda Rita Sun Chiron Stella Quan Peter Yan Bruce Herring Bruce Phelps Chyang Fang

3 Methods NAT Screening Methods: Chiron Procleix TMA HIV-1/HCV Assay Roche Molecular Systems COBAS AmpliScreen HCV Test, v.2.0 Diagnostic NAT Methods: Bayer Quantiplex HIV RNA 3.0 Assay (bdna) Organon Teknika NucliSens HIV-1 QT Assay Roche AMPLICOR HCV MONITOR Test, v1.0 Roche AMPLICOR HCV MONITOR Test, v2.0 Roche AMPLICOR HIV-1 MONITOR Test, v1.0 Roche AMPLICOR HCV Test, v2.0

4 Study Design Characterized specimens representing various HCV genotypes and HIV clades were coded and sent to Roche and Chiron for blind testing by the NAT screening methods currently in use for Blood Bank pool testing. Specimens were not pooled with other negative specimens, but were tested neat. Results were compared with existing BBI data from methods available in diagnostic laboratories.

5 31 HCV Specimens PHV901 HIV Seroconversion Panel genotype 1a, 11 members PHV917 HCV Seroconversion Panel genotype 2, 10 members PHV909 HCV Seroconversion Panel genotype 3, 3 members A405 HCV RNA Reference Control, 100 IU/ml PHW802 HCV RNA Sensitivity Panel 16 members, genotypes 1, 2, and 3 half log dilutions from 10,000 to 100 IU/ml

6 36 HIV Specimens WWRB302 Worldwide HIV Panel clades A, B, C, D, E, F, G group O and HIV-2 30 members PRB954 HIV Seroconversion Panel clade B 6 members

7 PHV901 HCV Seroconversion Panel genotype 1a COBAS bleed day AMPLICOR, v2.0 TMA AmpliScreen 01 0 Negative Negative Negative Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Negative Negative Negative Negative Negative Negative Negative Negative Negative Positive Positive Positive Negative Positive Positive

8 PHV909 HCV Seroconversion Panel genotype 3 AMPLICOR COBAS bleed day MONITOR, v2.0 TMA AmpliScreen ,000 Positive Positive ,000 Positive Positive ,000 Positive Positive

9 PHV917 HCV Seroconversion Panel genotype 2b AMPLICOR COBAS bleed day MONITOR, v1.0 AMPLICOR, v2.0 TMA AmpliScreen copies/ml 01 0 BLD Positive Positive Positive >500,000 Positive Positive Positive >500,000 Positive Positive Positive >500,000 Positive Positive Positive BQR Positive Positive Positive BQR Positive Positive Positive Positive Positive Positive BLD Positive Positive Positive BLD Negative Positive 2/3 Positive BQR Positive Positive Positive

10 COBAS Genotype IU/ml AMPLICOR, v2.0 TMA AmpliScreen A405 HCV RNA 1b 100 Positive Positive Positive Reference Control

11 PHW802 HCV RNA Sensitivity Panel Genotype IU/ml TMA Ampliscreen 01 1a 6000 Reactive Reactive 02 1a 2000 Reactive Reactive 03 1a 600 Reactive Reactive 04 1a 200 Reactive Reactive 05 1a 60 Reactive Reactive 06 2b 8000 Reactive Reactive 07 2b 3000 Reactive Reactive 08 2b 800 Reactive Reactive 09 2b 300 Reactive Reactive 10 2b 80 Reactive Reactive 11 2b Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive Reactive 16 neg 0 Nonreactive Nonreactive

12 PRB954 HIV-1 Seroconversion Panel BD bdna AMPLICOR Bleed Day Quantiplex 3.0 NucliSens MONITOR v1.0 TMA copies/ml copies/ml copies/ml 01 0 BLD BLD BLD Negative 02 2 BLD BLD BLD Negative 03 7 BLD BLD BLD Positive BLD 1000 Positive ,000 Positive , , ,000 Positive >500,000 >1,000,000 >800,000 Positive

13 WWRB302 Worldwide HIV Performance Panel bdna AMPLICOR Origin Clade Quantiplex NucliSens MONITOR TMA copies/ml copies/ml copies/ml 02 Ghana A 60,000 20, Reactive 05 Ghana A 20,000 20, Reactive 09 Ivory Coast A 20, Reactive 13 Uganda A 20,000 40, Reactive 21 China B' Reactive 26 USA B 20, ,000 20,000 Reactive 27 USA B/D ,000 5,000 Reactive 29 Argentina B 300 BLD 900 Reactive 12 Mozambique C 50,000 20,000 70,000 Reactive 18 Uganda C 10,000 30,000 20,000 Reactive 19 Zimbabwe C Reactive 20 Zimbabwe C Reactive

14 bdna AMPLICOR Origin Clade Quantiplex 3.0 NucliSens MONITOR, v1.0 TMA copies/ml copies/ml copies/ml Uganda D 20,000 90,000 50,000 Positive Uganda D Positive Uganda D ,000 10,000 Positive Uganda D Positive Thailand E BLD Positive Thailand E Positive Thailand E Positive Argentina F Positive Ghana G 700 BLD 2000 Positive Ghana G Positive Ivory Coast G 10,000 BLD 1000 Positive

15 bdna AMPLICOR Origin Clade Quantiplex NucliSens MONITOR TMA 01 Spain Group O 100 BLD BLD Reactive 07 Ivory Coast HIV-2 BLD BLD BLD Nonreactive 11 Mozambique HIV-2 BLD BLD BLD Nonreactive 25 India HIV-2 BLD BLD BLD Nonreactive 10 Ivory Coast Neg BLD BLD BLD Nonreactive 30 Argentina Neg BLD BLD BLD Nonreactive

16 Conclusion Both NAT methods used for blood screening are able to detect less common genotypes of HCV with sensitivity similar to currently available commercial diagnostic test methods. TMA is able to detect less common subtypes of HIV with sensitivity similar to currently available commercial diagnostic test methods.

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