PANTHER: WASTE AND CONTAMINATION MANAGEMENT Mr. T odd Richmond - PowerPoint PPT Presentation

PANTHER: WASTE AND CONTAMINATION MANAGEMENT Mr. T odd Richmond – Hologic Marketing

HOLOGIC Women’s Health Company Diagnostics Cervical Health Breast / Skeletal health Global Access Initiative

PANTHER SYSTEM AND HIV-1 ASSAY

PANTHER SYSTEM The Panther system provides the following advantages: • Random and Continuous Access • Consolidated menu that combines Viral load, Women’s Health and STI testing • Ability to run assays simultaneously • Proven Flexibility, Reliability and Performance • Small footprint saves space and costs; suited for scalability and redundancy • Panther serves as a foundation for future capabilities and content

FULL AUTOMATION FROM SAMPLE-TO-RESULT Results Analysis Amplification & Detection Extraction Maximize Productivity Sample Preparation Total Automation on a Single Instrument

REAL-TIME TMA THROUGHPUT AND CAPACITY nd shift Up to 320 results in 8 hr Up to 320 results in 8 Up to 320 results in 8 Up to 320 results in 8 hr shift hr hr shift shift shift Additional 420 run unassisted into 2 Additional 420 run unassisted into 2 Additional 420 run unassisted into 2 Additional 420 run unassisted into 2 nd nd nd shift shift shift 800 740 680 700 620 600 560 NUMBER OF RESULTS NUMBER OF RESULTS NUMBER OF RESULTS NUMBER OF RESULTS 500 500 Up to 750 tests Up to 750 tests Up to 750 tests Up to 750 tests 440 in approx.15 hr in approx.15 in approx.15 in approx.15 hr hr hr 380 400 320 300 260 First 5 results First 5 results First 5 results First 5 results 200 released released released released 200 2 2 2 hr 2 hr and 41 min hr hr and 41 min and 41 min and 41 min 140 80 100 20 0 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 TIME (HOURS) TIME (HOURS) TIME (HOURS) TIME (HOURS)

APTIMA HIV-1 QUANT DX ASSAY Aptima HIV Aptima HIV Aptima HIV- Aptima HIV -1 Quant - - 1 Quant 1 Quant 1 Quant Monitoring / Diagnosis ‘21 Intended Use Intended Use Intended Use Intended Use Intended Use Intended Use Intended Use Intended Use Dual target, multiple probes: pol & LTR Monitoring Diagnosis and monitoring Limit of Detection Limit of Detection Limit of Detection Limit of Detection Limit of Detection Limit of Detection Limit of Detection Limit of Detection 4.8 IU/mL (Plasma) 12 copies/mL (LoD) (LoD) (LoD) (LoD) (LoD) (LoD) (LoD) (LoD) 5.9 IU/mL (Serum) 30 – 10 million Dynamic Range Dynamic Range Dynamic Range Dynamic Range Dynamic Range Dynamic Range Dynamic Range Dynamic Range 10 – 9 log 10 IU/mL copies/mL Reaction volume 0.5 mL Reaction volume 0.5 mL Sample Requirement Sample Requirement Sample Requirement Sample Requirement Sample Requirement Sample Requirement Sample Requirement Sample Requirement Secondary Tube Sampling Primary Tube Sampling • Minimum of 1200 μ L plasma / serum • Minimum of 700 μ L plasma / serum required with Hologic Specimen Aliquot Tube (SAT) • Plasma: EDTA, ACD, PPT • Dilution for low volume samples with • Serum: SST, serum tubes automated software calculation to neat concentration 7

CLINICAL PERFORMACE FROM 3RD PARTY The Aptima HIV-1 assay provides INVESTIGATORS consistent, trusted results for viral load monitoring with full subtype coverage 200 copies / mL 50 copies / mL Weismann et al., Journal of Clinical Microbiology (2018) Oct;56(10)

CLINICAL PERFORMACE FROM 3RD PARTY The Aptima HIV-1 assay provides INVESTIGATORS consistent, trusted results for viral load monitoring with full subtype coverage Reproducibility Clinical Correlation � ����� ������������������������ ������ ��������������������� � � � � � � � � � ������ � �������������������

WASTE AND CONTAMINATION MANAGEMENT

WASTE MANAGEMENT AND CONTAMINATION CONTROL Deactivation Queue Waste Deflector Solid Waste Container Liquid Waste Bottle

LIQUID WASTE COMPOSITION Material Material Material Material % by volume % by volume % by volume % by volume Reportable Component Reportable Component Reportable Component: Reportable Component : : : Reportable Component: Reportable Component Reportable Component Reportable Component : : : Lithium Hydroxide, HEPES, TCR TCR TCR TCR 12.20% NaOH, Lauryl Sulfate Lauryl Sulfate, Succinic Acid Sodium, EDTA Sample Sample Sample Sample 9.76% Wash Wash Wash Wash 24.39% Reportable Component Reportable Component Reportable Component Reportable Component: : : : Oil Oil Oil Oil 2.44% Polydimethylsiloxane Amp Amp 1.22% Amp Amp Reportable Component Reportable Component Reportable Component Reportable Component: : : : Enzyme Enzyme 0.61% Enzyme Enzyme Triton X, EDTA, Trelahose, Reportable Component Reportable Component Reportable Component Reportable Component: : : : HEPES, N-Acetyl-L-Cysteine, Promotor Promotor Promotor Promotor 0.61% MgCl, KCl, Trizma HCl, KCl, Glycerol Deactivation Deactivation Deactivation Deactivation 48.78% Trizma Base, Zinc Acetate, Glycerol Reportable Component Reportable Component: Reportable Component Reportable Component : : : pH pH 9 pH pH NaOH, Sodium Hypochlorite, Sodium Bicarbonate

DEACTIVATION OF REACTIONS • Guanidinium thiocyanate (GTC) Guanidinium thiocyanate (GTC) Guanidinium thiocyanate (GTC) Guanidinium thiocyanate (GTC) • Bleach Bleach Bleach Bleach • Used as a general protein denaturant • Denatures nucleic acid • T oxic reagent; requires Hazardous Waste • Effective at low concentrations Management • Universally employed as disinfectant • Traditional method for reaction inactivation

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