Molecular Diagnostics

PRODUCT CATALOG

INTERNATIONAL

®

Molecular Diagnostics

Quidel is a leading manufacturer of diagnostic healthcare solutions serving to

enhance the health and well-being of people around the globe through the

development of diagnostic solutions that can lead to improved patient out-

comes and provide economic benefits to the healthcare system.

Our product base and technology platforms have continued to expand

through internal development and acquisitions of other products and tech-

nologies allowing for a core competency that includes:

Immuno and molecular assay development

Automated manufacturing lateral flow (LF) technologies

Direct fluorescent antibodies (DFA) production

Monoclonal antibody characterization

Current molecular solutions for infectious disease testing often require

tradeoffs between throughput, lengthy turnaround times, highly complex

workflows, and unsustainable costs. With Solana, you can stop compromising,

and start treating.

Solana is a small, easy to use bench top instrument offering scalable and

flexible solutions for molecular testing that delivers highly accurate results in

an actionable timeframe. Combined with a growing menu of molecular assays,

Solana is providing results you

can trust when accuracy is

critical, on a platform built for

your lab.

Making highly accurate, molecular results faster and more accessible than ever before.

The Accurate. Sustainable. Molecular Solution. Solana, a small bench top instrument, is a simplified molecular testing platform that’s making molecular diagnostics faster

and easier than ever before, without sacrificing performance. Solana combines Quidel’s proprietary helicase-dependent

amplification (HDA) with fluorescence detection to deliver results you can trust in an actionable timeframe.

High volume throughput capabilities, batch up to 12 tests per run

Gold standard sensitivity

LIS connectivity

Barcode technology

External and internal memory storage

Catalog # Qty Description

20278 1 Solana Instrument

Includes:

N/A 1 95°C Lysis Heat Block

N/A 1 Printer

N/A 1 Labels

N/A 1 Workflow Tray

N/A 3 Transfer Rack

N/A 1 Stylus

Solana bench top instrument a mere 9.4” x 9.4” x 5.9”

Solana Influenza A+B Assay

For the qualitative detection and differentiation of influenza

A and influenza B viral RNA Accurate detection with nasopharyngeal or nasal swab specimens

Results in 45 minutes

Batch up to 12 tests per run

Use as a confirmation method for negative

rapid results

Wide range of transport media capability

Simple procedure

Sustainable reagent pricing

Flexible instrument placement options


M300 48 tests Solana Influenza A+B Assay

Virena Solana is compatible with Virena, Quidel’s

proprietary, global wireless data management

system that provides near real-time de-identified

patient results to assist in disease mapping and

surveillance. With Virena, clinicians can trend

and report on positivity rates and other metrics

in patient populations. For more information

visit quidel.com.

® Solana RSV + hMPV Assay

For the qualitative detection and differentiation of

respiratory syncytial virus and human metapneumovirus Accurate detection with nasopharyngeal or nasal swab specimens


Batch up to 12 tests per run

Use as a confirmation method for negative

rapid results

Wide range of transport media capability

Simple procedure


Flexible instrument placement options


M306 48 tests Solana RSV + hMPV Assay

Solana SARS-CoV-2 Assay

For the qualitative detection of SARS-CoV-2 viral RNA

Accurate detection with nasopharyngeal or nasal swab specimens


Batch up to 11 tests per run with positive control

Gold standard sensitivity

Confidence in pandemic response

management

Orderable with swabs and media


Simple procedure

Flexible instrument placing options


M313 96 tests Solana SARS-CoV-2 Assay

Solana GAS Assay

For the qualitative detection of Group A Streptococcus

nucleic acids Accurate detection with throat swab speciemns Results in 30 minutes Batch up to 12 tests per run No culture back up Reduced hands-on time vs. culture Simple procedure Competitive reagent pricing Flexible instrument placement options

Catalog # Qty Description M301 48 tests Solana GAS Assay

Solana Strep Complete Assay For the qualitative detection of Group A Streptococcus and

pyogenic Group C/G nucleic acids Accurate detection with throat swab specimens Results in 30 minutes Batch up to 6 tests per run No culture back up Reduced hands-on time vs. culture Simple procedure Competitive reagent pricing Flexible instrument placement options

Catalog # Qty Description M305 48 tests Solana Strep Complete Assay

Solana Bordetella Complete Assay

For the qualitative detection and differentiation of

Bordetella pertussis and Bordetella parapertussis

nucleic acids Accurate detection with nasopharyngeal swab specimens Results in 50 minutes Batch up to 12 tests per run Use as a confirmation method for negative

rapid results Simple procedure Competitive reagent pricing Flexible instrument placement options


M308 48 tests Solana Bordetella Complete Assay

Solana C. difficile Assay For the qualitative detection of the Clostridium difficile

Toxin A gene (tcdA) Accurate detection with unformed stool specimens Results in 30 minutes Batch up to 12 tests per run Simple procedure Competitive reagent pricing Flexible instrument placement

options Catalog # Qty Description M307 48 tests Solana C. difficile Assay

Solana Trichomonas Assay For the qualitative detection of Trichomonas nucleic acids Accurate detection with clinically collected vaginal swab swab or urine specimens

Results in 30 minutes Batch up to 12 tests per run More sensitive than wet mount, rapids

and culture Objective results Simple procedure Competitive reagent pricing Flexible instrument placement options

Catalog # Qty Description M304.S 48 tests Solana Trichomonas Assay – Swab M304.U 48 tests Solana Trichomonas Assay – Urine Solana GBS Assay For the qualitative detection of Group B Streptococcus

nucleic acids Accurate detection with vaginal or rectal swab specimens following 18 to 24 hours of incubation in an enrichment broth culture

Results in 30 minutes Batch up to 12 tests per run Reduced hands-on time vs. traditionalculture methods

Simple procedure Competitive reagent pricing Flexible instrument placement options

Catalog # Qty Description M311 48 tests Solana GBS Assay Solana HSV 1+2/VZV Assay For the qualitative detection and differentiation of Herpes

simplex virus type 1 and 2, and Varicella-zoster virus DNA or

nucleic acids Accurate detection with cutaneous or

mucocutaneous swab specimens Results in 50 minutes Batch up to 12 tests per run Simple procedure Competitive reagent pricing Flexible instrument placement options

Catalog # Qty Description M302 48 tests Solana HSV 1+2/ VZV Assay

The Accurate. Sustainable. Molecular Solution.

All Solana assays are CLIA Moderately Complex

Workflow Benefits of Solana Assays Feature Benefit Isothermal amplification Ensures molecular sensitivity with multiple analytes.

Eliminates thermal cycling to aid in faster time to result (as little as 30 minutes). Allows for different samples (up to 12) to be processed concurrently in a single

run. Simplified molecular workflow Avoids the need for specialized molecular operator training.

Enables molecular testing on 3rd shift and in near-patient settings. 12-tube chamber Decreases turn around times as different patient samples are run at one time.

Supports flexible panel testing on one or multiple samples. Small foot-print Facilitates placements in near-patient locations (e.g. emergency rooms, STAT

labs, doctors’ offices). QC patient and data management Captures and stores QC data automatically to reduce time spent on manual

record keeping. USB data export Assists in the transfer of information without the need to direct connection to

LAN. LIS connectivity Avoids transcriptional errors.

Streamlines reporting. Decreases time wasted on manual documentation.

Solana12-tube chamber

Minutes0 60 120 180 240

CompetitiveIsothermal System

single-tube chamber

Sample/Cartridge Prep System Programming Lysis/Extraction Step Assay Run Time

Assay run time for 12 samples

Other single-tube chamber test systems take up to 5 times longer to process the same

12 samples than Solana in a single run.

Example procedure Fast and flexible protocols allow for up to 144 samples run daily in an 8 hour shift.

LysisTube

50 μL 50 μL

DilutionTube

ReactionTube

Close lid tightly and proceedto next step.

Mix bypipetting

up and down.

Insert into Solana,input sample ID and

initiate program

Review results.Optional print

or export

95˚C5 Min.

Quidel | Molecular Diagnostics | quidel.com | 800.874.1517 | 858.552.1100

BR1003005EN00 (01/21)

EMERGENCY USE AUTHORIZATION

Lyra SARS-CoV-2 Assay

Lyra Direct SARS-CoV-2 Assay

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Feature Benefit

Multiple sample types

Actionable timeframe

Flexible workflows

Open platform solution

Flexible 96-test format

Nasopharyngeal, oropharyngeal, or nasal swab specimens for ease of collection.

Results in less than 75 minutes once placed in thermocycler.

The Lyra Direct Assay allows for workflow flexibility to support low to high testing volumes.

Allows for easy implementation to existing extraction processes or thermocycler.

Kit contains all reagents to run 96 tests – with the external controls included

Workflow Benefits

Lyra Direct SARS-CoV-2

Currently EUA on the following systems:

Applied Biosystems®7500 Fast Dx

Applied Biosystems 7500 Standard

Roche LightCycler® 480 Instrument II

Roche cobas® z 480

Qiagen Rotor-Gene® Q

Bio-Rad CFX96 Touch™

Thermo Fisher QuantStudio™ 7 Pro

Lyra SARS-CoV-2

Currently EUA on the following systems:

Applied BioSystems® 7500 Fast Dx

Applied Biosystems 7500 Standard

QuantStudio Real-Time PCR Instrument

Roche LightCycler® 480,

BiRad CFX96 Touch

Qiagen Rotor-Gene-Q.

Qualitative real-time PCR tests providing accurate detection and identification SARS-CoV-2

Lyra SARS CoV-2 and Lyra Direct SARS CoV-2 assays utilize Real Time PCR that targets the conserved non-struc-

tural polyprotein (pp1ab) of the SARS CoV-2 virus for the accurate detection of the 2019 novel coronavirus that

causes COVID-19.

The Lyra Direct SARS-CoV-2 Assay eliminates the need for RNA purification, allowing for simple manual sample

processing before the sample is added to the Master Mix.

The Lyra SARS-CoV-2 assays are focused on optimizing a lab’s workflow to make these tests simple and easy to

implement.


*Refer to the Package Insert for more information.

Lyra SARS-CoV-2 Clinical Performance*

A study using ninety-two positive contrived samples created by spiking ninety-two individual clinical samples deter-

mined to be negative for SARS-CoV-2 by the Lyra SARS-CoV-2 Assay prior to spiking with one of three concentrations

of genomic SARS-CoV-2 RNA. All ninety-two contrived samples were positive in the Lyra SARS-CoV-2 Assay.

Sample RNA Concentration # Positives/# Tested Mean SARS-CoV-2 Ct %CV

unspiked 0/92 NA NA

1x LoD (8.00E-01 cp/μL) 44/44 26.9 5.7

3x LoD (2.40E00 397 cp/μL) 24/24 22.8 3.4

5x LoD (4.00E00 cp/μL) 24/24 22.4 3.0

Performance against the expected results are:

PPA – 92/92 = 100% (95% CI: 95.99%-100%) NPA – 92/92 = 100% (95% CI: 95.99%-100%)

Lyra Direct SARS-CoV-2 Clinical Performance*

A study using thirty positive nasopharyngeal contrived samples were created by spiking thirty individual clinical

samples determined to be negative for SARS-CoV-2 by the Lyra Direct SARS-CoV-2 Assay prior to spiking with one

of two concentrations of gamma-irradiated SARS-CoV-2. Twenty-nine of thirty contrived samples were positive in

the Lyra Direct SARS-CoV-2 Assay.

Clinical evaluation in spiked nasopharyngeal swab specimens


unspiked 0/30 NA NA

1x LoD (3.40e+4 cp/mL ) 19/20 27.06 6.6

5x LoD (1.7E+5 cp/mL ) 10/10 23.51 4.7

Performance against the expected results are:

PPA – 29/30 = 97% (95% CI: 83.3%-99.4%) NPA – 30/30 = 100% (95% CI: 88.6%-100%)

A study using fifteen positive oropharyngeal contrived samples were created by spiking fifteen individual clinical

samples determined to be negative for SARS-CoV-2 by the Lyra SARS-CoV-2 Assay prior to spiking samples with

one of three concentrations of gamma-irradiated SARS-CoV-2. Fifteen of fifteen contrived samples were positive

in the Lyra Direct SARS-CoV-2 Assay.

Clinical evaluation in spiked oropharyngeal swab specimens


unspiked 0/8 NA NA

1x LoD (3.40e+4 cp/mL) 7/7 23.2 5.1

10x LoD (3.4e+5cp/mL) 4/4 20.1 0.6

100x LoD (3.4e+6cp/mL) 4/4 17.1 0.5

Performance against the expected results are: PPA – 15/15 = 100% (95% CI: 79.6%-100%) NPA – 8/8 = 100% (95% CI: 67.6%-100%)


Lyra Cat. # Description Kit Size

M120 Lyra SARS-CoV-2 Assay (includes controls) 96-Reaction Kit

M939 Lyra SARS-CoV-2 Assay and Transport Media with Flocked Swab Set 96-Reaction Kit 100 swabs l 100 transport media

M938 Lyra SARS-CoV-2 Assay and Transport Media with Mini-tip Flocked Swab Set 96-Reaction Kit 100 swabs l 100 transport media

M100 Lyra Influenza A+B Assay 96 Reaction Kit

M106 Quidel Molecular Influenza A+B Control Set

M103 Lyra RSV + hMPV Assay 96-Reaction Kit

M107 Quidel Molecular RSV + hMPV Control Set

M113 Lyra Adenovirus Assay 96-Reaction Kit

M110 Quidel Molecular Adenovirus Control Set

M114 Lyra Parainfluenza Virus Assay 96-Reaction Kit

M115 Quidel Molecular Parainfluenza Virus Control Set

Lyra Direct Cat. # Description Kit Size

M124 Lyra Direct SARS CoV-2 Assay (includes controls) 96 Reaction Kit

M942 Lyra Direct SARS CoV-2 Assay (includes controls) Microfuge Tube 96 Reaction Kit Nasal/Oropharyngeal Swabs and Transport Tubes

M943 Lyra Direct SARS CoV-2 Assay (includes controls) Microfuge Tube 96 Reaction Kit Nasopharyngeal Swabs and Transport Tubes

M944 Lyra Direct SARS CoV-2 Assay (includes controls) Microwell 96 Reaction Kit Nasal/Oropharyngeal Swabs and Transport Tubes

M105 Lyra Direct C. difficile Assay 96-ReactionKit

M207 Quidel Molecular Direct Rapid DNA Stool Sample Prep Kit (required for M105)

M108 Quidel Molecular C. difficile External Controls 40-Reaction Kit

M102 Lyra Direct HSV 1+2/VZV Assay 96-Reaction Kit

M121 Quidel Molecular HSV 1+2/VZV External Controls 10-Reaction Kit

M112 Lyra Direct Strep Assay 96-Reaction Kit

M111 Quidel Molecular Strep A+G Control Set 10-Reaction Kit

Lyra Assays


Lyra Direct Microfuge Tube Format – Patient Sample

Sample Preparation

Amplification and Detection

Add Process Buffer Swirl Swab in Process Buffer

Rehydrate Master Mix

Mix Mix and cool

Place on ThermocyclerPlace on ThermocyclerAdd to PCR Plate Vortex sample and add to PCR Plate

Heat for 10 minutes at 95˚C

Lyra Direct Microwell Workflow – Patient Sample

Sample Preparation

Amplification and Detection

Thermomix @ 95°C — 10 minutes

HG

FE

DC

BA

Add Process Buffer

Allow to cool5

10

15

20

25

30

35

40

45mL

HG

FE

DC

BA

Swirl Swab in Process Buffer

HG

FE

DC

BA

Add to PCR Plate Mix Sample then add to PCR plate

HG

FE

DC

BA

Place on Thermocycler Place on Thermocycler Rehydrate Master Mix


Quidel | Molecular Diagnostics | quidel.com | 800.874.1517 | 858.552.1100

BR

M120002EN

00 (06/20)


Molecular Diagnostics

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