Raising the Bar for Performance Testing

The Aptima HIV-1 Quant Dx assay leads the hunt for HIV-1 diagnosis and viral load monitoring.

Panther has new prey

Freedom to work the way you chooseRun what assays you want, when you need them, and how you want to

*In development.

Reduceturnaround time

Reduce costsIncrease productivity

WHAT

Run as few as 1 or as many as 94 clinical samples, with no additional controls required.

Unload and store reagents as needed to reduce waste.

No sample transfer or pipetting required.

HOW

S

Run the Aptima® HIV-1 Quant Dx assay in parallel with Aptima assays for:

CT/NGHPVTrichomonasvaginalis

HCV*HBV*

True random access.

Don’t wait for a batch.

Access the instrument at any time to load additional samples or reagents.

WHEN

Viral load testing has evolved: The Panther® System Takes Automation to the Next LevelEvery step of nucleic acid testing, from sample to result, can be completed on the Panther system.

A Single, Integrated Instrument

“ With random access, the ability to continuously load samples and time to first result of about 150 minutes, this assay is a major improvement in the viral load monitoring of HIV-1 infection.”

– Martin Obermeier, Medical Center for Infectious Diseases, Berlin

Allows you to directly load centrifuged vacutainers

Performs extraction, amplification and detection with full automation

Does not require manual manipulation, pipetting, or transfer of plates, tubes or carriers before amplification

Aptima® HIV-1 Quant Dx Assay: Performance by Design

tat

env

vif

pol

gag

5’

0 1000 2000 3000 4000 5000 6000 2000 8000 9000 9719

3’

nef

LTR

LTRvpu

rev

vpr

1

2

3

Three levels of protection against mutations for reliable diagnosis and monitoring of HIV-1

Dual Target Assay Two targets, pol and LTR, within highly conserved genomic regions to ensure accurate detection and quantitation.

Sophisticated Primer Design Increased primer length able to withstand multiple mutations.

Redundancy of Oligos Multiple, redundant oligos to provide additional protection.

Raising the Bar for Performance TestingThorough establishment and verification of LLoQ across HIV-1 groups and subtypes with rigorous standards: 3 reagent lots, 30 replicates per lot, 23 runs.

Low variation and high precision even at low viremia:

bThis panel member was diluted 1:3 with specimen diluent and tested to evaluate the precision of the diluted sample.

The total number of replicates tested was 162 for each panel; only replicates with a numerical value were analyzed.aIncludes inter-instrument, inter-operator, inter-lot and inter-run analysis.

*LLoQ - Lower Limit Of Quantitation

9.10

7.34

6.15

5.20

2.53

1.56

1.58

1.13

30

10

30

10

30

15

15

30

10

15

0.16

0.17

0.15

0.15

0.10

0.08

0.09

0.08

Subtype A

Subtype CRF01_AE

Subtype CRF02_AG

Subtype B

Subtype C

Subtype D

Subtype F

Subtype G

Group N

Group O

1.80

2.37

2.47b

2.95

3.80

4.93

5.69

6.71

137

157

160

162

162

159

162

162

MeanConcentration(log copies/mL)

Number ofValid Replicates

Coefficient ofVariation (%)

LLoQ(copies/mL)

SD

Panel

Totala

Verification of LLoQ* by HIV-1 Subtype or Group1

Precision of the Aptima® HIV-1 Quant Dx Assay1

Item Quality

Demand more from your HIV-1 assay

PB-00338-001 Rev. 003 ©2015 Hologic, Inc. All rights reserved. Hologic, Science of Sure, Aptima, Panther and associated logos are trademarks or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. This information is intended for medical professionals and is not intended as a product solicitation or promotion where such activities are prohibited. Because Hologic materials are distributed through websites, eBroadcasts and tradeshows, it is not always possible to control where such materials appear. For information on specific products available for sale in a particular country, please contact your Hologic representative or write to diagnostic.solutions@hologic.com.

Reference

1. Aptima HIV-1 Quant Dx assay [package insert], San Diego, CA; Hologic, Inc., 2015.

Visit AptimaVirology.com

The Aptima HIV-1 Quant Dx assay is currently not for sale in the U.S.

Catalog #

Product Design

Intended Use• Diagnosis of primary HIV-1 infection• Confirmation of HIV-1 infection• HIV-1 viral load monitoring

• Primary tube (PPT, ACD, EDTA, SST, serum): 1.2 mL• Secondary tube: 700 μL• 240 μL with validated dilution protocol

• Real-time transcription-mediated amplification (TMA)

• pol/LTR

• M, N, O

• Qualitative: Serum or Plasma• Quantitative: Plasma

Technology

Target Region

Groups

Sample Types

Sample InputVolume

Performance

LoD* • 12 copies/mL (3rd WHO International Standard)

• 30 copies/mL (Reaction volume: 0.5 mL plasma)

• <10% CV† and <0.2 SD across assay range

• 30 to 10 million copies/mL

• 100% (95% Cl: 99.4%-100%)

LLoQ

Precision

Linear Range

Specificity

Ordering Information

Item Quantity Catalog #

100 tests PRD-03000Aptima® HIV-1 Quant Dx Assay Kit(1 assay box, 1 calibrator kit, 1 control kit)

Aptima HIV-1 Quant Dx Controls Kit 5 of each control(low, negative, high) PRD-03002

Aptima HIV-1 Quant Dx Calibrator Kit 5 calibrators PRD-03001

Product Design

Intended Use• Diagnosis of primary HIV-1 infection• Confirmation of HIV-1 infection• HIV-1 viral load monitoring

• Primary tube (PPT, ACD, EDTA, SST, serum): 1.2 mL• Secondary tube: 700 μL• 240 μL with validated dilution protocol

• Real-time transcription-mediated amplification (TMA)

• pol/LTR

• M, N, O

• Qualitative: Serum or Plasma• Quantitative: Plasma

Technology

Target Region

Groups

Sample Types

Sample InputVolume

Performance

LoD* • 12 copies/mL (3rd WHO International Standard)

• 30 copies/mL (Reaction volume: 0.5 mL plasma)

• <10% CV† and <0.2 SD across assay range

• 30 to 10 million copies/mL

• 100% (95% Cl: 99.4%-100%)

LLoQ

Precision

Linear Range

Specificity

Ordering Information

Item Quantity Catalog #

100 tests PRD-03000Aptima® HIV-1 Quant Dx Assay Kit(1 assay box, 1 calibrator kit, 1 control kit)

Aptima HIV-1 Quant Dx Controls Kit 5 of each control(low, negative, high) PRD-03002

Aptima HIV-1 Quant Dx Calibrator Kit 5 calibrators PRD-03001

*LoD - Limit of Detection

†CV - Coefficient of Variation

Product Design

Intended Use• Diagnosis of primary HIV-1 infection• Confirmation of HIV-1 infection• HIV-1 viral load monitoring

• Primary tube (PPT, ACD, EDTA, SST, serum): 1.2 mL• Secondary tube: 700 μL• 240 μL with validated dilution protocol

• Real-time transcription-mediated amplification (TMA)

• pol/LTR

• M, N, O

• Qualitative: Serum or Plasma• Quantitative: Plasma

Technology

Target Region

Groups

Sample Types

Sample InputVolume

Performance

LoD* • 12 copies/mL (3rd WHO International Standard)

• 30 copies/mL (Reaction volume: 0.5 mL plasma)

• <10% CV† and <0.2 SD across assay range

• 30 to 10 million copies/mL

• 100% (95% Cl: 99.4%-100%)

LLoQ

Precision

Linear Range

Specificity

Ordering Information

Item Quantity Catalog #

100 tests PRD-03000Aptima® HIV-1 Quant Dx Assay Kit(1 assay box, 1 calibrator kit, 1 control kit)

Aptima HIV-1 Quant Dx Controls Kit 5 of each control(low, negative, high) PRD-03002

Aptima HIV-1 Quant Dx Calibrator Kit 5 calibrators PRD-03001

PerformanceProduct Design

Ordering Information