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

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

Dec 01, 2023 98 likes •251 views

PANTHER: WASTE AND CONTAMINATION MANAGEMENT Mr. T odd Richmond Hologic Marketing HOLOGIC Womens Health Company Diagnostics Cervical Health Breast / Skeletal health Global Access Initiative PANTHER SYSTEM AND HIV-1 ASSAY PANTHER

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SLIDE 1

PANTHER: WASTE AND CONTAMINATION MANAGEMENT

  • Mr. T
  • dd Richmond – Hologic Marketing
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SLIDE 2

HOLOGIC

Women’s Health Company Diagnostics Cervical Health Breast / Skeletal health

Global Access Initiative

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SLIDE 3

PANTHER SYSTEM AND HIV-1 ASSAY

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SLIDE 4

The Panther system provides the following advantages:

PANTHER SYSTEM

  • 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

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SLIDE 5

FULL AUTOMATION FROM SAMPLE-TO-RESULT

Maximize Productivity

Sample Preparation Extraction Amplification & Detection Results Analysis

Total Automation on a Single Instrument

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SLIDE 6

REAL-TIME TMA THROUGHPUT AND CAPACITY

20 80 140 200 260 320 380 440 500 560 620 680 740

100 200 300 400 500 600 700 800 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

NUMBER OF RESULTS NUMBER OF RESULTS NUMBER OF RESULTS NUMBER OF RESULTS TIME (HOURS) TIME (HOURS) TIME (HOURS) TIME (HOURS)

Up to 320 results in 8 Up to 320 results in 8 Up to 320 results in 8 Up to 320 results in 8 hr hr hr hr shift 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 2nd

nd nd nd shift

shift shift shift First 5 results First 5 results First 5 results First 5 results released released released released 2 2 2 2 hr hr hr hr and 41 min and 41 min and 41 min and 41 min

Up to 750 tests Up to 750 tests Up to 750 tests Up to 750 tests in approx.15 in approx.15 in approx.15 in approx.15 hr hr hr hr

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SLIDE 7

Limit of Detection Limit of Detection Limit of Detection Limit of Detection (LoD) (LoD) (LoD) (LoD) Limit of Detection Limit of Detection Limit of Detection Limit of Detection (LoD) (LoD) (LoD) (LoD) 12 copies/mL Dynamic Range Dynamic Range Dynamic Range Dynamic Range Dynamic Range Dynamic Range Dynamic Range Dynamic Range 30 – 10 million copies/mL Intended Use Intended Use Intended Use Intended Use Intended Use Intended Use Intended Use Intended Use Monitoring / Diagnosis ‘21 Diagnosis and monitoring Sample Requirement Sample Requirement Sample Requirement Sample Requirement Sample Requirement Sample Requirement Sample Requirement Sample Requirement Reaction volume 0.5 mL

Primary Tube Sampling

  • Minimum of 1200 μL plasma / serum
  • Plasma: EDTA, ACD, PPT
  • Serum: SST, serum tubes

Secondary Tube Sampling

  • Minimum of 700 μL plasma / serum required with

Hologic Specimen Aliquot Tube (SAT)

  • Dilution for low volume samples with

automated software calculation to neat concentration

APTIMA HIV-1 QUANT DX ASSAY

7

Monitoring 4.8 IU/mL (Plasma) 5.9 IU/mL (Serum) 10 – 9 log10 IU/mL Reaction volume 0.5 mL

Dual target, multiple probes: pol & LTR

Aptima HIV Aptima HIV Aptima HIV Aptima HIV-

  • 1 Quant

1 Quant 1 Quant 1 Quant

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SLIDE 8

CLINICAL PERFORMACE FROM 3RD PARTY INVESTIGATORS

Weismann et al., Journal of Clinical Microbiology (2018) Oct;56(10)

The Aptima HIV-1 assay provides consistent, trusted results for viral load monitoring with full subtype coverage

50 copies / mL 200 copies / mL

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SLIDE 9

CLINICAL PERFORMACE FROM 3RD PARTY INVESTIGATORS

  • Reproducibility

Clinical Correlation

The Aptima HIV-1 assay provides consistent, trusted results for viral load monitoring with full subtype coverage

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SLIDE 10

WASTE AND CONTAMINATION MANAGEMENT

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SLIDE 11

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

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SLIDE 12

LIQUID WASTE COMPOSITION

Material Material Material Material % by volume % by volume % by volume % by volume TCR TCR TCR TCR 12.20% Sample Sample Sample Sample 9.76% Wash Wash Wash Wash 24.39% Oil Oil Oil Oil 2.44% Amp Amp Amp Amp 1.22% Enzyme Enzyme Enzyme Enzyme 0.61% Promotor Promotor Promotor Promotor 0.61% Deactivation Deactivation Deactivation Deactivation 48.78% pH pH pH pH 9

Reportable Component Reportable Component Reportable Component Reportable Component: : : : MgCl, KCl, Trizma HCl, Trizma Base, Zinc Acetate, Glycerol Reportable Component Reportable Component Reportable Component Reportable Component: : : : Triton X, EDTA, Trelahose, HEPES, N-Acetyl-L-Cysteine, KCl, Glycerol Reportable Component Reportable Component Reportable Component Reportable Component: : : : Lithium Hydroxide, HEPES, Lauryl Sulfate, Succinic Acid Reportable Component Reportable Component Reportable Component Reportable Component: : : : NaOH, Sodium Hypochlorite, Sodium Bicarbonate Reportable Component Reportable Component Reportable Component Reportable Component: : : : NaOH, Lauryl Sulfate Sodium, EDTA Reportable Component Reportable Component Reportable Component Reportable Component: : : : Polydimethylsiloxane

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SLIDE 13

DEACTIVATION OF REACTIONS

  • Bleach

Bleach Bleach Bleach

  • Denatures nucleic acid
  • Effective at low concentrations
  • Universally employed as disinfectant
  • Guanidinium thiocyanate (GTC)

Guanidinium thiocyanate (GTC) Guanidinium thiocyanate (GTC) Guanidinium thiocyanate (GTC)

  • Used as a general protein denaturant
  • T
  • xic reagent; requires Hazardous Waste

Management

  • Traditional method for reaction inactivation
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SLIDE 14

THANK YOU! QUESTIONS?