1 29 March, 2020 | © 2020 Roche

LightMix Modular Wuhan CoV & SARS-CoV-2 Assays

Covid-19 Detection by Real-Time PCR Testing

Ratna Taufani

2 29 March, 2020 | © 2020 Roche

Introduction of SARS-CoV-2: A novel coronavirus

1.World Health Organization (WHO). Coronavirus. Geneva: WHO; 2020 Available from: https://www.who.int/health-topics/coronavirus [Accessed 26 Jan 2020].2.World Health Organization (WHO). Coronavirus Disease Outbreak https://www.who.int/emergencies/diseases/novel-coronavirus-2019 [Accessed 26 Jan 2020].3.Novel Coronavirus(2019-nCoV) Situation Report – 7. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports/ [Accessed 26 Jan 2020].4.Lu R, Zhao X, Li J, et al. Genomic characterization and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding ]The Lancet. Published online January 29

History

According to the World Health

Organization (WHO), the WHO

China Country Office was

informed of cases of

pneumonia of unknown origin

in Wuhan City, Hubei Province,

on 31-Dec-2019. WHO declares

coronavirus a global emergency

on 31-Jan-2020

The Virus

Coronaviruses (CoV) are a large

family of viruses that cause

illness ranging from mild

respiratory infection to more

severe diseases such as Middle

East Respiratory Syndrome

(MERS-CoV) and Severe Acute

Respiratory Syndrome (SARS-

CoV). A novel coronavirus

(SARS-CoV-2) is a new strain

that has not been previously

identified in humans.

Epidemiology

A novel coronavirus (SARS-

CoV-2) was officially

announced as the causative

agent by Chinese authorities on

7-Jan-2020, followed by the

first viral genome sequence

released 10-Jan-2020. The

resulting disease has been

named COVID-19.

Transmission

Coronaviruses are zoonotic,

meaning they are transmitted

between animals and people.

At this time, the exact source is

unknown, although the Huanan

Market in Wuhan is thought to

be the starting point for the

virus outbreak. Human-to-

human transmission has been

confirmed by Chinese and US

government.

3 29 March, 2020 | © 2020 Roche

What is COVID-19?

1 Chen N, Zhou M, Dong X, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020;395:507-13. PMID: 32007143.2. Holshue ML, DeBolt C, Lindquist S, et al. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020. PMID: 32004427.3. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395:497-506. PMID: 31986264.4. Wang D, Hu B, Hu C, et al. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020. PMID: 32031570.5. Centers for Disease Control and Prevention. Coronavirus Disease 2019 (COVID-19)–Evaluating and Reporting Persons Under Investigation (PUI). https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html. Accessed March 4, 2020.

* International Areas with Sustained (Ongoing) Transmission as defined by CDC

SymptomsFever, respiratory symptoms, abdominal pain, diarrhea, vomiting, headache, myalgia

Clinical presentationAsymptomatic infection, mild illness, or fatal disease

TransmissionPerson-to-person via respiratory secretions

IncubationApproximately 5 days

Clinical progressionLimited info available, can become severe

SARS-CoV-2

5 29 March, 2020 | © 2020 Roche

Laboratory-confirmed COVID-19 by positive

NAAT result for at least two different targets

Rapid sample collection

Global Guidelines Detection COVID-19WHO

“Rapid collection and testing of appropriate specimens

from patients meeting the suspect case definition for

COVID-19 is a priority for clinical management and

outbreak control and should be guided by a laboratory

expert. Suspect cases should be screened for the virus with

nucleic acid amplification tests (NAAT), such as RT-PCR”

“A positive NAAT result for at least two different targets

on the COVID-19 virus genome, of which at least one

target is preferably specific for COVID-19 virus using a

validated assay…*”

Testing recommendations for suspected COVID-19 patients

Laboratory testing for coronavirus disease 2019 (COVID-19) in suspected human cases. Interim guidance 2 March 2020 WHO/COVID-19/laboratory/2020.4

Patient with suspect case definition

for COVID-19

6 29 March, 2020 | © 2020 Roche

A positive NAAT result is indicative of active

infection with SARS-CoV-2

Rapid sample collection

Global Guidelines Detection COVID-19CDC

“Clinicians who have identified a potential PUI should

immediately notify their state or local health department. Local

and state public health staff will determine if the person is a

PUI and whether testing for COVID-19 is indicated.”

“For initial diagnostic testing for COVID-19, CDC recommends

collecting and testing upper respiratory (nasopharyngeal AND

oropharyngeal swabs), and lower respiratory (sputum, if

possible) for those patients with productive coughs. Induction

of sputum is not recommended. Specimens should be

collected as soon as possible once a PUI is identified,

regardless of the time of symptom onset.”

Testing recommendations for suspected COVID-19 patients

Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19). Available at: https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html (Accessed 10-Mar-2020)

Patient with suspect case definition

for COVID-19

7 29 March, 2020 | © 2020 Roche

COVID-19 Testing Algorithms

WHO Protocol

Sampling1:

Respiratory material* - nasopharyngeal and oropharyngeal swab in ambulatory patients and sputum (if produced) and/or

endotracheal aspirate or bronchoalveolar lavage (BAL) in patients with more severe respiratory disease*Lower respiratory specimens likely have a higher diagnostic value than upper respiratory tract specimens.

1. Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases Interim guidance 17 January 2020 WHO/2019-nCoV/laboratory/2020.3

2. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020;25(3)

3. Diagnostic detection of 2019-nCoV by real-time RT-PCR. Protocol and preliminary evaluation as of Jan 17, 2020. [Accessed 27 Jan 2020] Available from: https://www.who.int/health-topics/coronavirus/laboratory-

diagnostics-for-novel-coronavirus

Diagnostic Pathway (Polymerase Chain Reaction)2, 3:

1. First line screening assay: E gene assay

2. Confirmatory assay: RdRp gene assay (pan-CoV or specific for 2019-nCoV

8 29 March, 2020 | © 2020 Roche

Indonesia Testing Guidelines

Dirjen Pencegahan dan Pengendalian Penyakit

9 29 March, 2020 | © 2020 Roche

Testing Algorithm

Flow Testing COVID-19 Specimen

Referensi:

Pedoman Kesiapsiagaan Menghadapi Infeksi

Novel Coronavirus (2019-nCoV), Direktorat

Jendral Pencegahan dan Pengendalian

Penyakit, Maret 2020

Referensi:

Pedoman Kesiapsiagaan Menghadapi Infeksi

Novel Coronavirus (2019-nCoV), Direktorat

Jendral Pencegahan dan Pengendalian

Penyakit, Januari 2020

10 29 March, 2020 | © 2020 Roche

Sample Types

Specimen Sample COVID-19’s Patient

Referensi:

Pedoman Kesiapsiagaan Menghadapi Infeksi Novel

Coronavirus (2019-nCoV), Direktorat Jendral

Pencegahan dan Pengendalian Penyakit, Maret 2020

11 29 March, 2020 | © 2020 Roche

Sample Preparation

Specimen Handling

Real-Time RT-PCR Panel for Detection 2019-Novel Coronavirus, Centers for Disease Control and Prevention, Respiratory Viruses Branch, Division of Viral Diseases

Specimen Handling and Storage

• Specimens can be stored at 4 C for up to 72 hours after collection

• If a delay in extraction is expected, store specimens at – 70 C or lower

• Extracted nucleic acids should be stored at – 70 C or lower

• Temperature shipment at 4 C

Specimen Rejection Criteria

• Specimens not kept at 2 – 4 C (≤ 4 days) or frozen at – 70 C or below

• Incomplete specimen labeling or documentation

• Inappropriate specimen type

• Insufficient specimen volume

12 29 March, 2020 | © 2020 Roche

World Health Organization Testing Protocol

Molecular assays to diagnose 2019-nCoV

Reference: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/laboratory-guidance

13 29 March, 2020 | © 2020 Roche

Algorithm Implementation

Countries Experience

Country/

OrganizationWHO US CDC Hong Kong Japan Taiwan Singapore Korea

Screening E-gene N-gene

3 target sites

Human Rnase P

gene (RP)

1 target site

E-geneE-gene

N-gene

E-gene

RdRP-gene

E-gene

N-gene

E-gene

RdRP-gene

Confirmatory RdRP-gene

E-gene

N-gene

RdRP-gene

N-gene RdRP-gene

Comments

Both tests positive

for the patient to

be considered as

COVID19 positive

All tests have to

show positive for

the patient to be

considered as

COVID19 positive

As long as one test

is positive, the

patient is

considered to be

COVID-19 positive

Any E-gene or

RdRP-gene

positive + N-gene

positive, patient is

considered COVID-

19 positive

14 29 March, 2020 | © 2020 Roche

Detection Kit for Covid-19LightMix Modular Wuhan CoV & cobas SARS-CoV-2

Source: cobas® SARS-CoV-2 Test IFU

Intended Use: CE-IVD

cobas® SARS-CoV-2 for use on the cobas® 6800/8800 Systems is a

real-time RT-PCR test intended for the qualitative detection of nucleic

acids from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab

samples from patients with signs and symptoms suggestive of COVID-19

(e.g., fever and/or symptoms of acute respiratory illness).

Results are for the specific detection of SARS-CoV-2 RNA that are

detectable in nasopharyngeal and oropharyngeal swab samples during

infection. Positive results are indicative of SARS-CoV-2 RNA detection,

but may not represent the presence of transmissible virus.

Negative results do not preclude SARS-CoV-2 infection and should not

be used as the sole basis for patient management decisions. Negative

results must be combined with clinical observations, patient history, and

epidemiological information.

Instruction for RUO

LightMix Modular SARS & Wuhan CoV is a real-time PCR

test intended use for qualitative detection of of nucleic acids

from SARS-CoV-2 in nasopharyngeal and oropharyngeal

swab samples from patients with signs and symptoms

suggestive of COVID-19 (e.g., fever and/or symptoms of acute

respiratory illness)

The TIB MOLBIOL design contains 3 single-well assays

targeting the E-gene for broad detection of SARS-CoV-2 and

other Sarbecoviruses (note, different location than Roche

assay), the N-gene as a secondary broad detection assay and

the RdRP-gene for specific detection of SARS-CoV-2

Results are for the specific detection of SARS-CoV-2 RNA

that are detectable in nasopharyngeal and oropharyngeal

swab samples during infection. Positive results are indicative

of SARS-CoV-2 RNA detection,

1. TIB MOLBIOL LightMix® Modular SARS and Wuhan CoV IFUs

15 29 March, 2020 | © 2020 Roche

Detection Kit for Covid-19LightMix Modular Wuhan CoV

Source: cobas® SARS-CoV-2 Test IFU

Instruction: RUO

LightMix Modular SARS & Wuhan CoV is a real-time PCR test intended use for

qualitative detection of of nucleic acids from SARS-CoV-2 in nasopharyngeal and

oropharyngeal swab samples from patients with signs and symptoms suggestive of

COVID-19 (e.g., fever and/or symptoms of acute respiratory illness)

The TIB MOLBIOL design contains 3 single-well assays targeting the E-gene for broad

detection of SARS-CoV-2 and

other Sarbecoviruses (note, different location than Roche assay), the N-gene as a

secondary broad detection assay and

the RdRP-gene for specific detection of SARS-CoV-2

Results are for the specific detection of SARS-CoV-2 RNA that are detectable in

nasopharyngeal and oropharyngeal swab samples during infection. Positive results are

indicative of SARS-CoV-2 RNA detection,

1. TIB MOLBIOL LightMix® Modular SARS and Wuhan CoV IFUs

16 29 March, 2020 | © 2020 Roche Corman Victor M et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020;25(3):pii=2000045. https://doi.org/10.2807/1560-7917.ES.2020.25.3.2000045

1st Publication and Protocol – Corman et al.

17 29 March, 2020 | © 2020 Roche

Corman Victor M et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020;25(3):pii=2000045. https://doi.org/10.2807/1560-7917.ES.2020.25.3.2000045

Gene Intended Use

E-gene Is used as a test to detect Wuhan

and all other bat-associated

SARS-related viruses

(Sarbecovirus)

RdRP-

gene

Specific detection: RdRp detects

the Wuhan CoV (2019-nCoV)

specifically

N-gene Detects Wuhan and all other

SARS-related viruses

(Sarbecovirus)

18 29 March, 2020 | © 2020 Roche

LightMix® Modular Wuhan AssaysSpecifications and Assay Specific

SPECIFICATION

Technology Real-time PCR

Kit Content 1 Vial yellow cap 96 reactions CoV & 1 Vial black cap RN Positive Control Cp 30

Coverage detection E gene, RdRp gene and N gene (depend on needs)

Reagent Lyophilized

Kit size 96 T

Storage Storage at Arrival

Store cooled and at ambient temperature. Do not freeze the lyophilized reagents

Sample Material Tracheal aspirates OR broncho alveolar lavage

Note: coronavirus affects the respiratory system, nasopharyngeal swabs/aspirate are not optimal

Volume PCR reactions 20 µl (total PCR reactions)

Volume sample input 5 µl (for fecal sample extracts) or 10 µl

Test Duration 90 minutes (amplification), extraction sample 1.30 hours (exclude pre-treatment if needed)

PCR Cycling 45 cycles

Specification This assay detect 10 genome equivalent copies or less per reaction

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Workflow

Extraction* (select either manual or automated) qPCR Detection* (select one of the below instruments)

Manual Automated LightCycler 480 Instruments Cobas z480

Manual Extraction

or

Instruments

N/A

Plastic Ware N/A

MagNA Pure 96

- Processing Cartridge

- System Fluid

- Plastic ware

MagNA Pure 24

- Processing Cartridge

- Plastic ware

N/ALC 480 Block Kit

(96)N/A

Multiwell plates + Sealing foil

OR

8-Tube Strips and Adapter plate

AD Plate

Reagents or Kits

- MagNA Pure Lysis

Buffers

- MagNA Pure DNA and

Viral RNA kits

- MagNA Pure Lysis

Buffers

- MagNA Pure 24

Total NA Isolation

Kit

LightCycler Mutliplex RNA Virus Master

OR

RNA Process Control Kits

LightMix Modular Wuhan CoV Assays*

- E-gene

- RdRP-gene

- N-gene

- LightMix Modular EAV Control*

- LightMix Universal Colour Compensation Kit*

Workflow OverviewWhat do customers need to set up the assay?

MagNA Pure 96 MagNA Pure 24LC96 Instrument

(96 well)

LC480 Instrument

(96/384 well)

OR

* Customers can use: (1) Extraction only, (2) qPCR only, (3) Both extraction and qPCR

* Customers that use the MagNA Pure systems need to use the corresponding plasticware and kits (closed platform)

* Customers that use the LightCycler instrument need to use the corresponding plasticware, but can use any mastermix (open platform) and the TIB assays can run on any qPCR platform

OR

High Pure Viral Kits

Z480 Analyzer

21 29 March, 2020 | © 2020 Roche

LightMix® Modular Wuhan CoV Assays

Reaction Mix & Result Interpretation

22 29 March, 2020 | © 2020 Roche

LightMix® Modular Wuhan AssaysResult Interpretation – E Gene

Interpretation

Sample1 Presumptive positive covid -19

Sample 2 Presumptive positive covid -19

Sample 3 Presumptive positive covid -19

23 29 March, 2020 | © 2020 Roche

LightMix® Modular Wuhan AssaysResult Interpretation – RdRp Gene

Interpretation

Sample10 Positive covid -19

Sample 2 Positive covid -19

Sample 3 Positive covid -19

24 29 March, 2020 | © 2020 Roche

Detection Kit for Covid-19cobas SARS-CoV-2

Source: cobas® SARS-CoV-2 Test IFU

Intended Use: CE-IVD

cobas® SARS-CoV-2 for use on the cobas® 6800/8800 Systems is a

real-time RT-PCR test intended for the qualitative detection of nucleic

acids from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab

samples from patients with signs and symptoms suggestive of COVID-19

(e.g., fever and/or symptoms of acute respiratory illness).

Results are for the specific detection of SARS-CoV-2 RNA that are

detectable in nasopharyngeal and oropharyngeal swab samples during

infection. Positive results are indicative of SARS-CoV-2 RNA detection,

but may not represent the presence of transmissible virus.

Negative results do not preclude SARS-CoV-2 infection and should not

be used as the sole basis for patient management decisions. Negative

results must be combined with clinical observations, patient history, and

epidemiological information.

1. TIB MOLBIOL LightMix® Modular SARS and Wuhan CoV IFUs

25 29 March, 2020 | © 2020 Roche

Why did we choose these target regions?

E: envelope protein gene

M: membrane protein gene

N: nucleocapsid protein gene

ORF: open reading frame

S: spike protein gene

Specific nucleic acid sequences from the non-structural

Open Reading Frame (ORF 1a/b) in the genome of the

SARS-CoV-2 virus in the FAM channel

The conserved sequences in the structural envelope (E)

gene common to all Sarbecoviruses including SARS-CoV-2

with a pan-Sarbecovirus assay in the HEX channel to provide

a high degree of robustness.

MN908947 Wuhan-Hu-1

NC_004718.3 SARS-CoV

Orf1a Orf1ab S E M N

Dual-Target AssaySingle AnalyteSingle Well

26 29 March, 2020 | © 2020 Roche

Sample types and assay specifics

*Dead volume of 200μL is identified for the cobas omni Secondary tubes. Other tubes compatible with cobas® 6800/8800 Systems (consult User Assistance Guide) may have different dead volume and require more or less minimum volume.

Sample Nasopharyngeal and oropharyngeal swab samples collected in Copan UTM-RT System

Minimum amount of

sample required600 µL

Sample

processing volume400 µL (dead volume 200 µL)

Test duration Results are available within less than 3.5 hours after loading the sample on the system.

Kit size 192 tests

Shelf life 12 months

Specimen stability See Copan UTM IFU for specimen stability

Kit stability 90 days with 40 re-uses

28 29 March, 2020 | © 2020 Roche

cobas® 6800 System workflow

Improved workflow efficiency

*Example workflow configuration cobas p 480 Instrument with cobas® 6800 System

cobas® 6800 SystemPipette primary tubes Load secondary

tubes

(Pipette swab/media tube)

Universal transfer media

with a flocked swab

Transfer 0.6mL to

secondary tube

Secondary tube specification:

13x75mm; Roche OR any tube

that fits the rack:

30 29 March, 2020 | © 2020 Roche

Results interpretation

Target 1 Target 2 Interpretation

Positive Positive All Target Results were valid. Result for SARS-CoV-2 RNA is Detected.

Positive Negative

All Target Results were valid.

Result for SARS-CoV-2 RNA is Detected. A positive Target 1 result and a negative Target 2 result is suggestive of 1) a sample at concentrations near or

below the limit of detection of the test, 2) a mutation in the Target 2, target region, or 3) other factors.

Negative Positive

All Target Results were valid.

Result for SARS-CoV-2 RNA is Presumptive Positive.

For samples with a repeated Presumptive Positive result, additional confirmatory testing may be conducted, if it is necessary to differentiate between

SARS-CoV-2 and SARS-CoV-1 or other Sarbecovirus currently unknown to infect humans, for epidemiological purposes or clinical management.

Negative NegativeAll Target Results were valid.

Result for SARS-CoV-2 RNA is Not Detected.

Positive InvalidNot all Target Results were valid.

Result for SARS-CoV-2 RNA is Detected.

Invalid PositiveNot all Target Results were valid.

Result for SARS-CoV-2 RNA is Presumptive Positive.

Negative InvalidNot all Target Results were valid.

Sample should be retested. If the result is still invalid, a new specimen should be obtained.

Invalid NegativeNot all Target Results were valid.

Sample should be retested. If the result is still invalid, a new specimen should be obtained.

Invalid InvalidAll Target Results were invalid.

Sample should be retested. If the result is still invalid, a new specimen should be obtained.

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Value proposition of cobas® SARS-CoV-2 Test

Robust, conserved

target region for ORF-

1a/b and E-gene region

Full-process controls

with negative, positive

and internal controls

Common profile

improves throughput

384 results – cobas®

6800 System and 1,056

results – cobas® 8800

System in 8-hours

A fully enclosed system

Ready to use reagents

and controls for mixed

testing up to 3 targets

helps minimize

variability

29 March, 2020 | © 2020 Roche

with only 3 manual

interactions, up to 8

hours of walk away time

Throughput

Accuracy Specificity Contamination

control

Simplicity Hands-on

Time

32 29 March, 2020 | © 2020 Roche

0

9

8

7

6

9

8

7

6

5

4

3

2

1

01

7

6

5

4

3

2

1

0

9

84

Rapid time to results: cobas® 6800/8800 Systems

Delivering more results, faster

| The cobas® 6800/8800 Systems are not available in all markets. | *May vary based on workflow demands

Overnight prepLoading/unloading

results results

1,824 results from

an 8 hour shift*

96 more results

every 90 minutes

First 96 results

in ~3 hours

864 results from

an 8 hour shift*

96 more results

every 90 minutes

First 96 results

in ~3 hours

32 29 March 2020 | © 2019 Roche

cobas® 6800 System cobas® 8800 System

864 4281

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D E G R E E O F C O M P L E X I T Y A N D V A L I D A T I O N R E Q U I R E D 1 - 3

LDT vs. Regulated assay

Burd, E.M., (2010) Validation of Laboratory-Developed Molecular Assays for Infectious Diseases. Clin Micro. Reviews. 23: 550-576. doi:10.1128/CMR.00074-09Roberts, J.P. (2014) Laboratory Developed Tests: The Cutting Edge of Molecular Diagnostics. Accessed March 2017 http://www.biocompare.com/Editorial-Articles/165864-Laboratory-Developed-Tests-The-Cutting-Edge-of-Molecular-Diagnostics/Laboratory Developed Tests: Accessed March 2017 https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/LaboratoryDevelopedTests/default.htm

High Low

US & CE-IVD Tests

Advantages

• More data on performance provided

• Clinical validation, peer reviewed publications

• Operational efficiency; less time for lab; fully

automated

• Less risk; low maintenance for lab

• Instruments and SW - CE-IVD marked to perform

test.

• Automated result calling – CE-IVD marked SW

• Full automated (CE-IVD algo) result calling

Regulatory Status

Has oversight

Detection “Kits”

(CE-IVD reagents and/or protocols)

Advantages

• Lower cost for reagents

• Flexibility of sample type

• Controls/calibrators may be provided

• Some analytical validation provided

but limited to instruments and reagents

tested

• Product insert to provide some guidance on reagents/instruments

• Maybe some publications

Regulatory Status

Has oversight

LDT (homebrew)

Advantages

• Low cost for reagents

• Flexibility of sample

type, controls used

and assay design

• Can be designed

around laboratory

existing system profile

• Open system for

troubleshooting

Regulatory Status

None

34 29 March, 2020 | © 2020 Roche

Fully automatedSemi-automated

Three different assays requiring three different wells

3 single-well assays targeting, the E-gene for

broad detection of SARS-CoV-2 and other

Sarbecoviruses, the N-gene as a secondary broad

detection assay and the RdRP-gene for specific

detection of SARS-CoV-2.

TIB MOLBIOL cobas® SARS-CoV-2 Test

Comparison TIB to cobas® SARS-CoV-2 Test

Dual Target – Two assays in one well

The conserved sequences in the structural

envelope (E) gene common to all Sarbecoviruses

including SARS-CoV-2 with a pan-Sarbecovirus

assay

AUTOMATION

DESIGN

TARGET

TEST

35 29 March, 2020 | © 2020 Roche

Workflow Comparison TIB MOLBIOL vs cobas® SARS-CoV-2 Test

MagNA Pure

96 SystemLightCycler

96

LightCycler

480

Patient Tube with

FLOQ Swab PCR Reaction

Primary Sample

Nucleic Acid Extraction

PCR SetupAmplification

Detection

Authorization Result

positive

negative

Result

Patient Tube with

FLOQ Swab

positive

negative

Result

OR

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LightMix® Modular Wuhan CoV Assays

Countries – Help people to detect Covid-19

Australia Japan Hongkong Singapore

Malaysia Taiwan Korea New Zealand

Philippines Vietnam INDONESIA

38 29 March, 2020 | © 2020 Roche

cobas SARS-CoV-2 Assays

Countries – Help people to detect Covid-19

Australia Thailand

Chulalangkorn Med-U Hosp

India

USA

INDONESIA

52 29 March, 2020 | © 2020 Roche

Doing now what patients need next