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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
19 29 March, 2020 | © 2020 Roche
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.
31 29 March, 2020 | © 2020 Roche
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
33 29 March, 2020 | © 2020 Roche
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
37 29 March, 2020 | © 2020 Roche
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
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