NAT / BLOOD SCREENING - PRODUCT RANGE

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1 NAT / BLOOD SCREENING - PRODUCT RANGE QC Sample Name Analytes Assay / Instrument Page QConnect TriScreen Roche cobas TaqScreen MPX Test, v 2.0 (s201) Roche cobas MPX Test (6800/8800) QConnect Grifols Ultrio Plus (Tigris) 20 QConnect Grifols Ultrio Elite (Panther) QConnect Roche TaqScreen MPX Test, v 1.0 (s201) 21 QConnect HIV NAT Low All quantitative (viral load) assays including: Abbott M2000sp/rt, Roche COBAS AmpliPrep/TaqMan, Roche cobas 6800/8800 QConnect HBV NAT Low All quantitative (viral load) assays including: Abbott M2000sp/rt, Roche COBAS AmpliPrep/TaqMan, Roche cobas 6800/8800 QConnect HCV NAT Low All quantitative (viral load) assays including: Abbott M2000sp/rt, Roche COBAS AmpliPrep/TaqMan, Roche cobas 6800/8800 QConnect CMV NAT Low CMV DNA All qualitative and viral load CMV DNA assays 23 QConnect NATNEG Negative All blood screening and clinical NAT BLOOD SCREENING MULTIMARKER RANGE TriScreen QConnect TriScreen Sealed: 18 months at NT10101 Positive control 10 x 1.4 ml E-label product key: 19

2 BLOOD SCREENING SINGLE ANALYTE RANGE QConnect Sealed: 18 months at NT11001 Positive control 10 x 1.4 ml E-label product key: QConnect Sealed: 18 months at NT10801 Positive control 10 x 1.4 ml E-label product key: 20

3 BLOOD SCREENING SINGLE ANALYTE RANGE QConnect Sealed: 18 months at NT10701 Positive control 10 x 1.4 ml E-label product key: NAT SINGLE ANALYTE RANGE HIV NAT low QConnect HIV NAT low Sealed: 18 months at NT21001 Positive control 10 x 1.4 ml E-label product key: 21

4 NAT SINGLE ANALYTE RANGE HBV NAT low QConnect HBV NAT low Sealed: 18 months at NT20701 Positive control 10 x 1.4 ml E-label product key: HCV NAT low QConnect HCV NAT low Sealed: 18 months at NT20801 Positive control 10 x 1.4 ml E-label product key: 22

5 NAT SINGLE ANALYTE RANGE CMV NAT low QConnect CMV NAT low Sealed: 18 months at CMV DNA NT20401 Positive control 10 x 1.4 ml E-label product key: NATNEG QConnect NATNEG Sealed: 18 months at Negative for,, and CMV DNA NT10102 Negative control 10 x 1.4 ml E-label product key: 23

6 EXACT DIAGNOSTIC PANELS Adenovirus Verification Panel Dynamic Range 200 cp/ml - 2,000,000 cp/ml ADVP100 5 Panel Members 5 x 1.0 ml BKV Verification Panel Dynamic Range 200 IU/mL - 20,000,000 IU/mL BKVP100 6 Panel Members 6 x 1.0 ml CMV Verification Panel Dynamic Range 400 IU/mL - 4,000,000 IU/mL CMVP100 5 Panel Members 5 x 1.0 ml 24

7 EXACT DIAGNOSTIC PANELS EBV Verification Panel Dynamic Range 500 IU/mL - 5,000,000 IU/mL EBVP100 5 Panel Members 5 x 1.0 ml HBV Verification Panel Dynamic Range 100 IU/mL - 100,000,000 IU/mL HBVP100 7 Panel Members 7 x 1.0 ml HCV Verification Panel Dynamic Range 100 IU/mL - 30,000,000 IU/mL HCVP100 7 Panel Members 7 x 1.0 ml 25

8 EXACT DIAGNOSTIC PANELS HCV Genotype Panel Content: HCV Genotypes 1a, 1b, 2, 3, 4, 5 HCVGTP 6 Panel Members 6 x 1.0 ml HIV Verification Panel Dynamic Range 100 cp/ml - 6,000,000 cp/ml HIVP100 7 Panel Members 7 x 1.0 ml HBV Analytical Measurement Range Panel 100 IU/mL, 100,000 IU/mL, 10,000,000 IU/mL HBVAMR 3 Panel Members 3 x 1.0 ml 26

9 EXACT DIAGNOSTIC PANELS HCV Analytical Measurement Range Panel 500 IU/mL, 50,000 IU/mL, 5,000,000 IU/mL HCVAMR 3 Panel Members 3 x 1.0 ml HIV Analytical Measurement Range Panel 600 cp/ml, 60,000 cp/ml, 6,000,000 cp/ml HIVAMR 3 Panel Members 3 x 1.0 ml Zika Verification Panel Dynamic Range 200 cp/ml - 2,000,000 cp/ml ZKVP100 5 Panel Members 5 x 1.0 ml 27

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