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Genetic Signatures Automated EasyScreen Assays

D1: Path Lab Bulletin
D3: Catalogue of Resources

Genetic Signatures has recently entered the UK and European market after 5 years of success in Australia building up 30-40% market share in the syndromic testing space with our innovative 3baseTM technology.

All Genetic Signatures panels run on automated platforms that automate both sample extraction and PCR set-up. The GS1-HT allows processing of up to 96 samples per run in around 2 hours, whereas the GS1000 allows processing of up to 192 samples in around 2 hours (including positive and negative controls, excluding PCR cycling time.

This automation is compatible with both 96 and 384 well PCR set-up on one platform using a universal extraction kit for all sample types.

Our current CE-IVD marked SARS-CoV-2 (Cat# RP011) can be run independently or in combination with any other multiplex panels from Genetic Signatures (e.g. respiratory, enterics and others).

All our kits have been designed to provide rapid and accurate detection of the respective targets with high sensitivity and specificity.

The EasyScreen™ Respiratory Kits are qualitative in vitro diagnostic tests for the detection of selected targets in respiratory specimens treated using an EasyScreen™ Sample Processing Kit. The device specifically detects nucleic acid sequences from viral and bacterial pathogens of the respiratory system. Compatible specimens include swabs (dry, or in UTM), sputum, bronchial washings, and Nasopharyngeal Aspirates.

The EasyScreen™ Enteric Kits are qualitative qualitative real time PCR tests for the detection of selected targets from stool (or rectal swabs) of patients with diarrhoea or as a confirmatory test from cultured bacteria. The kits are divided into common detection panels, with specific bacterial, viral and protozoan [classes] and reflex kits to allow speciation where clinically important.

Samples can be run with individual panels or in combination panels across disease areas, with the same cycling profile for each testing area

Our assays are optimised for use with the Biorad CFX and the ThermoFisher QuantStudio, which can be provided as part of the solution if required

Is the method already deployed in a UK hospital or clinical setting?

Our products are used in UK hospital labs.

Where is the kit manufactured?

Kits are manufactured in Australia.

What is the turn around time (sample-to-result) for this method?

This is dependent on the mix of panels chosen. For a Respiratory 5-tube master mix configuration (RP007+RP011), the turnaround time on the GS1-HT sample to result is 4.5 hours for 94 samples

How will your solution communicate directly with the Laboratory Information Management System (LIMS)?

Results can be transferred unidirectionally from the PCR platform into LIMS system.

How quickly could this be deployed and what are the dependencies?

Lead time is around 2-3 weeks. Assay is currently available and supply chain of extraction, detection and plastics is guaranteed.

What is the likely production volume?

SARS-CoV-2 production capacity is currently at around 100,000 tests per week globally. We are working with sites processing up to 800 samples per day

What are the risks and barriers to using this at scale?

None. Instrumentation is benchtop and installed to fit scale of testing and kits shipped as planned to ensure capacity is met.

Who are you already partnering with on this?

Direct supply to NHS, private and university laboratories as well as other sites globally. Further details and references available upon request.

Have you validated this method, if so, how and what were the results of the validation?

Main panels are fully validated for clinical use and are CE-IVD marked. Some extended panels are available for research use only.

Full analytical and clinical performance criteria are available on request.  

See below for detailed respiratory and enterics panels.

 

Regulatory

Respiratory Panels

 

Regulatory

Enterics Panels

CE

EasyScreen™ Respiratory Pathogen Detection Kit (RP007/RP007-HT)

 

CE

EasyScreen™ Enteric Bacterial targets (EB001/EB001-HT)

 

 

 

 

 

 

Influenza A

 

 

Campylobacter spp.

 

Influenza B

 

 

Toxigenic Clostridioides difficile

 

Human Metapneumovirus

 

 

Salmonella spp.

 

Bordetella pertussis/ Bordetella parapertussis

 

 

Yersinia enterocolitica

 

Rhinovirus

 

 

Shigella spp./Enteroinvasive E.coli (EIEC)

 

Parainfluenza 1/3

 

 

Listeria monocytogenes

 

Mycoplasma pneumoniae

 

 

 

 

Enterovirus

 

CE

EasyScreen™ C.difficile targets (CDD001)

 

Adenovirus

 

 

 

 

Respiratory syncytial virus- A/B

 

 

tcdA/tcdB toxin genes

 

Parainfluenza 2

 

 

 

 

 

 

CE

EasyScreen™ C.difficile Reflex targets (CDD002)

CE

EasyScreen™ Coronavirus Detection Kit (RP003/RP003-HT)

 

 

 

 

 

 

 

Hypervirulent Clostridioides difficile incl. ribotype 027 & 078 targeting:

 

Coronavirus HKU-1

 

 

tcdC gene deletion at position 117

 

Coronavirus OC43

 

 

binary toxin gene (cdtA)

 

Coronavirus NL63/229E

 

 

gyrA gene mutation (fluoroquinolone resistance)

 

 

 

 

 

CE

EasyScreen™ SARS-CoV-2 Detection Kit (RP011/RP011-HT)

 

CE

EasyScreen™ Enteric Protozoan targets (EP001/EP001-HT)

 

 

 

 

 

 

SARS-CoV-2

 

 

Dientamoeba fragilis

 

 

 

 

Entamoeba histolytica

RUO

EasyScreenTM Atypical Respiratory Pathogen Detection Kit (RP009/RP009-HT)

 

 

Cryptosporidium spp.

 

 

 

 

Giardia lamblia/intestinalis

 

Bordetella pertussis

 

 

Blastocystis spp.

 

Bordetella holmesii

 

 

 

 

Bordetella parapertussis

 

CE

EasyScreen™ Enteric Viral Targets (EV002/EV002-HT)

 

Legionella longbeachae

 

 

 

 

Mycoplasma pneumonia

 

 

Norovirus GI

 

Legionella pneumophila

 

 

Norovirus GII

 

Chlamydophila pneumoniae

 

 

Rotavirus A

 

Pneumocystis jirovecii

 

 

Astrovirus

 

Chlamydophila psittaci

 

 

Adenovirus Universal

 

 

 

 

Sapovirus

 

 

 

 

Bocavirus

 

 

 

 

Enterovirus

 

 

 

 

Adenovirus 40/41

 

 

 

 

 

 

 

 

RUO

EasyScreen™ Enteric E.coli targets (EB004)

 

 

 

 

 

 

 

 

 

Escherichia coli O157 (Z3276)

 

 

 

 

ETEC (LT)

 

 

 

 

ETEC (ST)

 

 

 

 

EPEC (eae)

 

 

 

 

Stx-1

 

 

 

 

Stx-2

 

 

 

 

 

 

 

 

RUO

EasyScreen™ Enteric Pathogenic Bacteria targets (EB005)

 

 

 

 

 

 

 

 

 

Aeromonas

 

 

 

 

Vibrio cholera

 

 

 

 

Vibrio spp.

 

 

 

 

 

 

 

 

RUO

EasyScreen™ Enteric Protozoan Core targets (EP002)

 

 

 

 

 

 

 

 

 

Giardia lamblia/intestinalis

 

 

 

 

Entamoeba histolytica

 

 

 

 

Cryptosporidium spp.

 

 

 

 

 

 

 

 

RUO

EasyScreen™ Enteric Protozoan Extended targets (EP005)

 

 

 

 

 

 

 

 

 

Dientamoeba fragilis

 

 

 

 

Blastocystis hominis

 

 

 

 

Enterocytozoon bieneusi

 

 

 

 

Cyclospora cayetanensis

 

 

 

 

Entamoeba histolytica

 

 

 

 

Encephalitozoon intestinalis

 

 

 

 

Cryptosporidium spp.

 

 

 

 

Giardia lamblia/intestinalis

Commenting is closed

Bev Matthews 6 months ago

Status labels added: D: Ready to share, D1: Path Lab Bulletin, D3: Catalogue of Resources

Bev Matthews 6 months ago

Hello John, your submission has been assessed and we will share in the Pathology Lab Bulletin as well as add to the Catalogue of Resources. Thank you Bev

Users tagged:

Tom Jordan 6 months ago

Hi John, we have now published this on our bulletin which will be available on the RCPath website and on the bulletins page on this platform. Tom

Users tagged:

Tom Jordan 6 months ago

Status label removed: D: Ready to share

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